Nghị định 98/2021/NĐ-CP quản lý trang thiết bị y tế

DECREE

On the management of medical devices

___________

Pursuant to the Law on Organization of the Government dated June 19, 2015; the Law dated November 22, 2019 amending and supplementing a number of articles of the Law on Organization of the Government and the Law on Organization of Local Administration;

Pursuant to the Law on Investment dated June 17, 2020;

At the proposal of the Minister of Health;

The Government promulgates the Decree on the management of medical devices

 

Chapter I

GENERAL PROVISIONS

 

Article 1. Scope of regulation

1. This Decree provides for the management of medical devices, including the classification of medical devices; the manufacture, clinical research, placement of medical devices on the market, the purchase and sale, export, import of medical devices, and the provision of services related to medical devices; the information and advertisement of medical devices; the management of medical devices prices, and the management and use of medical devices at medical facilities.

2. This Decree does not apply to:

a) Raw materials and semi-finished products used for manufacture of medical devices, except raw materials containing narcotic substances and precursors;

b) Raw materials used for manufacture of medical devices, which are samples of blood, serum, plasma, urine, fecal, body fluids or other human biological specimens that are subject to biosafety requirements upon import/export as prescribed by the law provisions;

c) Medical gases;

d) Fittings for medical devices;

dd) Research Use Only (RUO) and Laboratory Use Only (LUO) products.

Article 2. Interpretation of terms

1. “Medical device” means any instrument, implant, apparatus, material, in-vitro reagent and solution, or software that meets all the following requirements:

a) The device is intended by the product owner to be used, whether separately or in combination with each other, for human beings for one or more of the following purposes:

- To diagnose, prevent, supervise, treat, and alleviate a disease or to compensate for an injury or trauma;

- To examine, replace, modify, or assist surgery activities or physiological processes;

- To support or sustain life;

- To control conception;

- To disinfect medical devices;

- Provide information serving diagnosis, monitoring and treatment through the examination of human biological specimens.

b) The device does not use pharmacological, immunological, or metabolic mechanism of action in or on the human body, or if it is used, it may only assist the device to achieve any of the purposes as prescribed at Point a of this Clause.

2. “In vitro diagnostic medical device” means a reagent, calibration solution, control material, instrument, apparatus, equipment or system or other products intended by the product owner to be used, whether separately or in combination, in vitro for the examination of human biological specimens.

3. “Personalized medical device” means a medical device that is specifically made in accordance with a medical practitioner’s written prescription, with specific designed characteristics intended for the sole use of a particular individual.

4. “Fitting” means a product that is intended specifically by its product owner to be used together with a particular medical device to enable or assist such device to achieve its intended purpose.

5. “Product owner” means any organization or individual that:

a) Supplies the medical device under its/his/her own name, or under any trademark, design, trade name or other name or mark owned or controlled by it/him/her;

b) Is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing, or modifying the medical device, or for assigning a purpose to such device.

Article 3. Principles of management of medical devices

1. The quality, safety and efficacy of the medical device must be verified.

2. Adequate, accurate and timely information about specifications and intended purposes of medical devices and potential risks must be provided to the users.

3. The traceability of medical devices must be ensured.

4. Medical devices shall be managed in accordance with their classified level of risks and relevant national technical regulations and/or national standards issued or recognized by competent State management agencies or announced standards applied by organizations/individuals in accordance with the law provisions.

5. Medical devices which are measuring devices or radiation equipment must be managed in accordance with the law provisions on measurement and the law provisions on atomic energy and this Decree.

6. Chemicals and preparations intended solely for disinfection of medical devices shall be managed in accordance with this Decree. Chemicals and preparations intended for other purposes, in addition to the disinfection of medical devices, shall be managed in accordance with the law provisions on insecticidal and germicidal chemicals and preparations for medical and household use.

7. Medical devices, raw materials or ingredients used for manufacturing of medical devices, and substances for external quality assessment that contain narcotic substances and precursors must be managed in accordance with the law provisions on drug control, if they are imported or exported, and this Decree.

8. The provisions on classification, issuance of registration number, and declaration of eligibility for trading medical devices as prescribed in this Decree shall not apply to:

a) Software used for medical devices;

b) Medical devices traded as normal goods and imported as gifts or presents given to individuals or organizations other than health facilities.

 

Chapter II
CLASSIFICATION OF MEDICAL DEVICES

 

Article 4. Types of medical devices

Medical devices shall be classified into the following 4 types according to their levels of potential risks related to their designs and manufacture:

1. Type-A medical devices are those at low level of risks.

2. Type-B medical devices are those at low-moderate level of risks.

3. Type-C medical devices are those at moderate-high level of risks.

4. Type-D medical devices are those at high level of risks.

Article 5. Principles for classification of medical devices

1. The classification of medical devices must be conducted on the basis of their classified levels of risks.

2. Any medical device which only has one intended purpose but is classified into two or more levels of risks shall be classified into the type representing the highest level of risks.

3. Any medical device which has multiple intended purposes, each of which represents various levels of risks, shall be classified into the type representing the highest level of risks.

4. In cases where the medical device is designed to be used in combination with another medical device, each of such medical devices shall be classified separately.

In vitro diagnostic medical devices which are equipment or systems used in testing process as well as reagents, titrants, calibration solutions or control materials may be classified into separate levels of risks but shall be classified into the type representing the highest level of risks posed by the final purpose of the combination of such medical devices. In vitro diagnostic medical devices which are other products being used in or supporting testing process may be classified into separate levels of risks.

5. The Minister of Health shall detail the classification of medical devices in accordance with the Association of Southeast Asian Nations (ASEAN) treaties on classification of medical devices to which Vietnam is a signatory.

6. The classification of medical devices must be conducted by the classification bodies whose names are specified in the declarations of applicable standards or the certificates of medical device registration.

Article 6. Cancellation of classification results

1. Classification results shall be cancelled in the following cases:

a) The incorrect classification results reduce the level of risks of the medical devices;

b) The records of classification results are found fraudulent.

2. Procedures for cancellation:

a) Within 01 working day from the date on which conclusion of a medical device falling into one of the cases as prescribed in Clause 1 of this Article is given, the Ministry of Health shall issue a written decision on cancellation of classification results, which requests the classification body to take measures to remedy the consequences caused by its violations (if any) and remove the cancelled classification result from the Portal on Management of Medical Devices.

Copies of the written decision on cancellation of classification results shall be sent to the classification body, the provincial-level Departments of Health, General Department of Customs, and border-gate customs offices, and published on the Portal on Management of Medical Devices.

b) After receiving the decisions on cancellation of classification results, the classification bodies shall cancel all classification results specified in the decision and take measures to remedy the consequences caused by its violations.

c) After receiving the decisions on cancellation of classification results, the authority that has received the application dossiers for declaration of applicable standards or the application dossiers for registration (hereinafter referred to as “application dossiers for registration number”) shall review the registration numbers issued by itself. It shall follow procedures for revoking the registration numbers of medical devices that have been issued using classification results specified in the Ministry of Health’s decisions on cancellation of classification results.

Article 7. Handling of medical devices whose classification results are cancelled

1. In cases where a medical device whose classification result is cancelled has not been granted the registration number:

a) The organization or individual submitting an application dossier for registration number shall send a written request to the authority receiving such application dossier for registration number to suspend procedures for issuance of registration number.

b) After receiving the written request from the organization or individual as prescribed at Point a of this Clause, or the decision on cancellation of classification results, the authority receiving the dossier shall refuse to issue the registration number.

2. In cases where a medical device whose classification result is cancelled has been granted the registration number but has not been granted customs clearance:

a) The registration number holder shall stop following procedures for customs clearance, request the checkpoint customs authority to suspend procedures for customs clearance, and request the registration number issuer to revoke the issued registration number.

b) After receiving the written request from the registration number holder or the decision on cancellation of classification results, the customs authority shall suspend procedures for customs clearance, and the registration number issuer shall follow procedures to revoke the issued registration number.

3. In cases where a medical device whose classification result is cancelled has been granted the registration number and customs clearance but has not been purchased:

a) The registration number holder shall:

- Stop placing the medical device on the market and recall the medical device granted the registration number using the classification result that has been cancelled;

- Send a report to the customs authority that granted customs clearance, in which the quantity of the medical device that has been granted customs clearance must be specified, and do not follow procedures for import of the following shipments until the relevant medical device is granted a new registration number using the correct classification result;

- Send a written report to the registration number issuer, in which the quantity of the medical device that has been granted customs clearance must be specified, together with the purchase and sale contracts (if any);

- Reapply for the registration number.

b) After receiving the registration number holder’s written request or the decision on cancellation of classification results:

- The customs authority shall refuse to grant customs clearance;

- The registration number issuer shall revoke the issued registration number.

4. In cases where the medical devices have been sold to health facilities:

a) The registration number holder shall:

- Send a written report to the registration number issuer, in which the quantity of the medical devices that have been sold to health facilities must be specified;

- Send written notices to the health facilities that purchased the medical devices.

b) In cases where the medical devices granted the registration numbers using incorrect classification results do not pose threats to patients’ heath, the health facilities may keep using such medical devices and the registration number holder shall supplement the documents about registration of such medical devices after new registration numbers are granted.

c) In cases where the medical devices granted the registration number using incorrect classification results are found to pose threats to patients’ heath, the health facilities shall stop using such medical devices and the registration number holder shall implement necessary remedial measures for ensuring normal operation of such health facilities.

Chapter III
MANUFACTURE OF MEDICAL DEVICES

 

Article 8. Requirements for quality control by medical device manufacturers

1. Their quality control systems must comply with ISO 13485.

2. A manufacturer of the medical device that contains narcotic substances and precursors shall, in addition to the requirements prescribed in Clause 1 of this Article, also meet the following requirements:

a) Having a system for monitoring the dispatching, warehousing, inventory and use of narcotic substances and precursors as well as the medical devices and raw materials containing narcotic substances and precursors;

b) Medical devices and raw materials containing narcotic substances and precursors must be safely stored in a separate area in the same warehouse or in a separate warehouse.

Article 9. Application dossiers for declaration of eligibility for manufacture of medical devices

An application dossier for declaration of eligibility for manufacture of medical devices includes:

1. A written declaration of eligibility for manufacture of medical devices.

2. A certificate of conformity with ISO 13485 issued by a conformity assessment body as prescribed by the law provisions.

3. Documents proving the satisfaction with eligibility requirements prescribed in Clause 2, Article 8 of this Decree.

Article 10. Requirements for application dossiers for declaration of eligibility for manufacture of medical devices

1. An application dossier for declaration of eligibility for manufacture of medical devices shall be prepared as 01 set, in which:

a) Documents included in the application dossier must be clearly printed and arranged in the order as prescribed in Article 9 of this Decree; each document shall include content sections separated by section breaks, have cover pages, and be listed in a list of documents.

b) Documents in a language other than English and Vietnamese must be translated into Vietnamese. Vietnamese translations must be notarized in accordance with the law provisions.

2. Requirements for several documents in an application dossier for declaration of eligibility for manufacture of medical devices:

a) The original of the certificate of conformity with quality control standards, or its certified true copy, or a copy certificated by the applicant for declaration of eligibility for manufacture of medical devices must be included in the dossier.

b) The originals of documents proving the applicant’s satisfaction with eligibility requirements as prescribed in Clause 2, Article 8 of this Decree, certificated by the applicant for declaration of eligibility for manufacture of medical devices, must be included in the dossier.

Article 11. Procedures for declaration of eligibility for manufacture of medical devices

1. Before initiating manufacture of medical devices, the manufacturer shall submit a dossier for declaration of eligibility for manufacture of medical devices to the Department of Health of the province where its factory is located (the manufacturer’s factory is specified in its certificate of quality control system). In cases where there are multiple factories located in different provinces, the application dossiers shall be submitted to each province.

2. After receiving the application dossier (including the receipt of application fee as prescribed by the Ministry of Finance), the Department of Health of the province where the factory is located shall publish on the Portal on Management of Medical Devices all information about such application dossier for declaration of eligibility for manufacture of medical devices.

3. During its operation, the manufacturer shall prepare a notice of changes enclosed with documents related to such changes and update such documents to its application dossier for declaration of eligibility for manufacture of medical devices published on Portal on Management of Medical Devices within 03 working days from the occurrence of such changes.

 

Chapter IV
CLINICAL RESEARCH ON MEDICAL DEVICES

 

Article 12. Clinical research stages for medical devices

1. Stage 1: The preliminary research to determine the safety of the medical device for patients and its usability for medical practitioners and healthcare workers.

2. Stage 2: The confirmatory research to ascertain and establish evidence for the safety and efficacy of the medical device.

3. Stage 3: The post-market research conducted after the medical device is placed on the market in order to assess the safety and efficacy of the medical device when it is broadly used in the communities under the appropriate usage conditions.

Article 13. Requirements for medical devices undergoing clinical research

1. They must meet quality standards specified in the clinical research application dossiers.

2. Their technical parameters have been duly inspected to ensure the quality and safety.

3. They must be labeled as “For clinical research only - not for any other purposes”. The labeling of medical devices shall comply with the law provisions on labeling of goods.

Article 14. Requirements for institutions conducting clinical research on medical devices

An institution conducting clinical research on medical devices (hereinafter referred to as “clinical research institution”) shall meet the following requirements:

1. It is a scientific research institution that is independent from the organization or individual whose medical devices undergo the clinical research.

2. It must have clinical research laboratory or site, quality control system and technical documents that meet the Good Clinical Practice (GCP) guidelines adopted by the Minister of Health.

3. It has adequate human resources to conduct the clinical research, including:

a) Principal investigator who must have appropriate professional qualifications and competence in research, and experience in clinical practice and use of medical devices, thoroughly grasp regulations on science and technology management and codes of ethics in research and be capable of conducting clinical research on medical devices.

b) Researchers who must have professional qualifications and competence meeting research requirements and have completed training courses in knowledge and skills in clinical research on medical devices.

Article 15. Dossiers of clinical research on medical devices

A clinical research dossier shall consist of the following application dossiers for approval to conduct clinical research, approval of changes to clinical research, and approval of clinical research results:

1. An application dossier for approval to conduct clinical research, consisting of:

a) A written request for approval to conduct clinical research.

b) Documents about the medical device undergoing the clinical research, including:

- Description of the product undergoing research (general information about the medical device undergoing research, including its name, specifications, uses and other relevant information);

- Documents about pre-clinical research on the medical device undergoing research, including the research report on its safety and efficacy, and recommendations for its use and storage;

- Documents about previous stages of the clinical research on the medical device (if the clinical research in the subsequent stages is requested and the medical device is not exempt from previous clinical research stages).

c) Legal documents about the medical device undergoing the clinical research, including:

- Technical documents for the medical device;

- Technical standards and records of testing/inspection of the medical device issued by competent authorities;

- The user manual permitted to be issued, in cases where the medical device undergoes stage-3 clinical research;

- Written confirmations of participation by research institutions in multi-center clinical research conducted in Vietnam;

- The cooperative agreement on clinical research between the authority, organization or individual whose medical device undergoes the clinical research and the clinical research service provider; the cooperative agreement between organization or individual whose medical device undergoes the clinical research and the sponsor of the clinical research (if any).

d) Clinical research protocol and its description, including the Description of the clinical research on the medical device and questionnaires or CRFs (Case Report Forms).

dd) Academic curriculum vitae and a copy of the certificate of completion of GCP training course, issued by the Ministry of Health or qualified GCP training program provider, of the principal investigator.

e) The forms of provided research information and the informed consent forms given by the medical device clinical research volunteers.

g) The minute of the meeting to review ethical and scientific aspects of the clinical research made by the grassroots-level Research Ethics Committee.

h) Label of the medical device as prescribed in Clause 3, Article 13 of this Decree, and instructions for use of the medical device undergoing research.

2. An application dossier for approval of changes to clinical research, consisting of:

a) A written request for approval of changes to clinical research.

b) Updated versions of the corresponding documents prescribed in Clause 1 of this Article, as changed.

c) Review record made by the grassroots-level Research Ethics Committee if changes to the clinical research may affect the health and benefits of the participants to the research on the medical device, or the design, process and procedures of the clinical research.

3. An application dossier for approval of clinical research results, consisting of:

a) The written request for approval of clinical research results.

b) A copy of the approved clinical research protocol;

c) A copy of the decision on approval of the clinical research protocol;

d) The minute of the meeting to review clinical research results made by the grassroots-level Research Ethics Committee;

dd) The full-text report on clinical research results.

4. Requirements for documents:

a) Documents included the clinical research dossier must be made in Vietnamese. Documents in a language other than Vietnamese must be enclosed with their notarized Vietnamese translations.

b) Documents issued by foreign authorities require consular legalization in accordance with the law provisions on consular legalization, unless otherwise the consular legalization is exempted in accordance with the law provisions.

Article 16. Procedures for approval of clinical research on medical devices

1. The medical device clinical research institution (the clinical research institution) shall send, directly or by post, 01 application dossier for approval to conduct clinical research to the Ministry of Health.

2. The Ministry of Health shall check the validity of the application dossier within 05 working days from the date on which the dossier is received. In cases where the application dossier is valid, within 02 working days, the Ministry of Health shall transfer it to the National Research Ethics Committee for review. In cases where the application dossier is not valid, a written notice which guides the modification of such application dossier shall be sent to the applicant.

The clinical research institution must complete the application dossier within 60 days from the date on which the notice is received. Pass this time limit, the procedures for approval of the clinical research shall be re-conducted.

3. Within 25 days from the date on which the valid application dossier is received, the National Research Ethics Committee shall hold a meeting to review the clinical research protocol, which must be duly recorded in a minute.

In cases where the clinical research protocol is satisfactory, the National Research Ethics Committee shall issue a Certificate of approval of the clinical research protocol.

In cases where the clinical research protocol is refused or requires modification, the National Research Ethics Committee shall send a written notice in which reasons for such refusal or modification must be specified. The clinical research institution shall complete and re-submit the modified application dossier to the National Research Ethics Committee within 90 days from the date on which the notice is received. Pass this time limit, the procedures for approval of the clinical research shall be re-conducted.

Within 07 working days from the date on which the modified application dossier is completely received, the National Research Ethics Committee shall hold a meeting to review the application dossier. In cases where the application dossier is satisfactory, the National Research Ethics Committee shall issue a Certificate of approval of the clinical research protocol. In cases where the application dossier is refused, the National Research Ethics Committee shall send a written notice in which reasons for such refusal must be specified.

Each application dossier shall not be modified more than 03 times.

4. Within 05 working days from the date on which the Certificate of approval of the clinical research protocol and documents enclosed therewith are received, the Ministry of Health shall issue a decision to approve the clinical research protocol.

Article 17. Procedures for approval of changes to clinical research on medical devices

1. The medical device clinical research institution (the clinical research institution) shall send, directly or by post, 01 application dossier for approval of changes to clinical research to the Ministry of Health.

2. The Ministry of Health shall check the validity of the application dossier within 05 working days from the date on which it is received. In cases where the application dossier is not valid, written notices which guide the modification of such application dossier shall be sent to the clinical research institution until the application dossier is considered valid. The clinical research institution shall complete the application dossier within 60 days from the date on which the notice is received. Pass this time limit, the procedures for approval of changes to the clinical research shall be re-conducted.

In cases where the application dossier is valid, within 02 working days, the Ministry of Health shall transfer the application dossier to the National Research Ethics Committee for review of changes to the clinical research protocol, which must be duly recorded in a minute.

3. Within 25 days from the date on which the valid application dossier is received, the National Research Ethics Committee shall hold a meeting to review changes to the clinical research protocol, which must be duly recorded in a minute.

In cases where the clinical research protocol is satisfactory, the National Research Ethics Committee shall issue a Certificate of approval of changes to the clinical research protocol.

In cases where the clinical research protocol is refused or requires modification, the National Research Ethics Committee shall send a written notice in which reasons for such refusal or modification must be specified. The clinical research institution shall complete and re-submit the modified application dossier to the National Research Ethics Committee within 60 days from the date on which the notice is received. Pass this time limit, the procedures for approval of changes to the clinical research shall be re-conducted.

Within 07 working days from the date on which the modified application dossier is completely received, the National Research Ethics Committee shall review the application dossier. In cases where the application dossier is valid, the National Research Ethics Committee shall issue a Certificate of approval of changes to the clinical research protocol. In cases where the application dossier is refused, the National Research Ethics Committee shall send a written notice, in which reasons for such refusal must be specified, to the clinical research institution.

Each application dossier shall not be modified more than 03 times.

4. Within 05 working days from the date on which the Certificate of approval of changes to the clinical research protocol and documents enclosed therewith are received, the Ministry of Health shall issue a decision to approve changes to the clinical research protocol.

Article 18. Procedures for approval of clinical research results for medical devices

1.The medical device clinical research institution (the clinical research institution) shall send, directly or by post, 01 application dossier for approval of clinical research results that is made in Vietnamese to the Ministry of Health.

2. The Ministry of Health shall check the validity of the application dossier within 05 working days from the date on which it is received. In cases where the application dossier is valid, within 02 working days, the Ministry of Health shall transfer it to the National Research Ethics Committee for review. In cases where the application dossier is not valid, a written notice which guides the modification of the application dossier shall be sent to the clinical research institution.

The clinical research institution shall complete the application dossier within 60 days from the date on which the notice is received. Pass this time limit, the procedures for approval of the clinical research results shall be re-conducted.

3. Within 25 days from the date on which the valid application dossier is received, the National Research Ethics Committee shall hold a meeting to review clinical research results, which must be duly recorded in a minute.

In cases where the application dossier is satisfactory, the National Research Ethics Committee shall issue a certificate of approval of clinical research results.

In cases where clinical research results are refused or require modification, the National Research Ethics Committee shall send a written notice, in which reasons for such refusal or modification must be specified, to the clinical research institution. The clinical research institution shall complete and re-submit the modified application dossier to the National Research Ethics Committee within 60 days from the date on which the notice is received. Pass this time limit, the procedures for approval of the clinical research results shall be re-conducted.

Within 07 working days from the date on which the complete application dossier is received, the National Research Ethics Committee shall review the application dossier. In cases where the application dossier is valid, the National Research Ethics Committee shall issue a Certificate of approval of clinical research results. In cases where the application dossier is refused, the National Research Ethics Committee shall send a written notice, in which reasons for such refusal must be specified, to the clinical research institution.

Each application shall not be modified more than 03 times.

4. Within 05 working days from the date on which the Certificate of approval of clinical research results and documents enclosed therewith are received, the Ministry of Health shall issue a decision to approve the clinical research results.

Article 19. Responsibilities of organizations or individuals whose medical devices undergo clinical research

1. Making compensations for participants to the clinical research for any risks incurred from the clinical research in accordance with the law provisions.

2. Signing agreements on clinical research on their medical devices with the clinical research institutions.

3. Taking accountability to the laws for the quality and safety of their medical devices.

Article 20. Responsibilities of clinical research institutions

1. Assuming responsibility for their provided clinical research results.

2. Assuming responsibility for the safety and ensuring rights and benefits of participants to the clinical research and making compensations for participants for any risks incurred from the clinical research due to their mistakes in accordance with the law provisions.

3. Ensuring the integrity and objectivity of the clinical research on medical devices.

4. Being independent in terms of economic benefits and human resources from the organizations or individuals whose medical devices undergoes the clinical research.

 

Chapter V
PLACEMENT OF MEDICAL DEVICES ON THE MARKET

 

Section 1
REGISTRATION NUMBER, CONDITIONS FOR PLACEMENT ON THE MARKET AND REQUIREMENTS FOR ORGANIZATIONS DECLARING APPLICABLE STANDARDS OR APPLYING FOR REGISTRATION NUMBER

 

Article 21. Registration numbers of medical devices

1. Registration number of a medical device is:

a) The number of the declaration of applicable standards of Type-A or Type-B medical device;

b) The number of the certificate of registration of Type-C or Type-D medical device.

2. Registration number holder is the organization that declares applicable standards for Type-A or Type-B medical device or that is granted the certificate of registration of Type-C or Type-D medical device.

3. Validity of registration number: The registration number of a medical device shall be valid for indefinite term, unless otherwise the registration number is issued in accordance with the provisions on issuance of emergency-use registration number for medical devices to serve pandemic prevention and control, catastrophe and disaster relief purposes. Based on the actual application dossier for issuance of emergency-use registration number for the medical device, the Minister of Health shall decide the specific validity of the issued registration number.

Article 22. Conditions for placement of medical devices on the market

1. A medical device may be placed on the market if it meets the following conditions:

a) It has been granted a registration number or import license in accordance with this Decree, unless otherwise prescribed in Clause 8, Article 3 and Article 24 of this Decree;

b) Its label contains adequate information in accordance with the law provisions on labeling of goods;

c) Instructions for use of the medical device are given in Vietnamese;

d) It has information about the warranty center, conditions, and time for warranty, unless otherwise such medical device is single-use medical device as defined by product owners or there are documents proving that it is not under warranty.

2. In cases where the information prescribed at Point c and Point d, Clause 1 of this Article is not provided upon the medical device itself, it must be provided in the form of electronic information for which instructions for search must be available on the label of the medical device.

Article 23. Requirements for making declarations of applicable standards or issuing certificates of registration for medical devices

1. Requirements for making declarations of applicable standards or issuing certificates of registration for a medical device:

a) The medical device is manufactured domestically by a manufacturer that has made declaration of eligibility for manufacture of medical devices;

b) In cases where the medical device is imported, it must be manufactured by a manufacturer that is granted a certificate of conformity with ISO 13485, and permitted to be sold in every country in the world;

c) The medical device shall comply with national technical regulations or standards declared by the manufacturer.

2. Procedures for declaration of applicable standards or registration of medical devices shall not be re-conducted in the following cases:

a) The medical device falls in any of the cases prescribed in Clause 1, Article 37 of this Decree;

b) The medical device is recalled in accordance with Clauses 1 and 3, Article 38 of this Decree.

3. Any application dossier for declaration of applicable standards or registration of such medical device submitted within 12 months from the date on which a medical device registration number is revoked under a decision as prescribed in Clause 2, Article 38 of this Decree shall be rejected.

Article 24. Cases of exemption from requirements for declaration of applicable standards and circulation registration

1. The medical device, which is used for research, testing, inspection, experiment, performance evaluation, instruction for use or device modification only.

2. The medical device is imported into Vietnam to serve the purposes of emergency aid or provision of humanitarian medical services or to be displayed at trade fair, exhibition, or product launch event, to be used as gift given to a health facility, to be used for medical treatment of a particular individual, or to serve special diagnosis of a health facility.

3. Unregistered medical devices which are imported to serve pandemic prevention and control, or catastrophe and disaster relief and cannot be replaced by any other medical devices sold on the market.

4. Medical devices which are manufactured in Vietnam to serve the purposes of export or display at an overseas trade fair or exhibition only.

Article 25. Requirements for organizations declaring applicable standards or applying for registration number for medical devices

1. Organizations that declare applicable standards or apply for registration number for medical devices include:

a) Vietnamese enterprises, cooperatives or household businesses that are product owners;

b) Vietnamese enterprises, cooperatives or household businesses that are authorized by product owners;

c) Permanent representative offices in Vietnam of foreign traders that are product owners or authorized by product owners.

2. The organization declaring applicable standards or applying for registration of a medical device must establish and maintain a warranty center in Vietnam or sign a contract with a qualified warranty center, unless otherwise such medical device is single-use medical device as defined by its product owner or there are documents proving that it is not under warranty.

In cases where the organization declaring applicable standards or applying for registration of a medical device is any of the entities prescribed at Point c, Clause 1 of this Article, the product owner must establish and maintain a warranty center in Vietnam or sign a contract with a qualified warranty center, unless otherwise such medical device is single-use medical device as defined by the product owner or there are documents proving that it is not under warranty.

The warranty center must be granted a certificate of eligibility for providing warranty services by the product owner.

 

Section 2
DECLARATION OF APPLICABLE STANDARDS FOR TYPE-A OR TYPE-B MEDICAL DEVICES

 

Article 26. Application dossiers for declaration of applicable standards

An application dossier for declaration of applicable standards for Type-A or Type-B medical device consists of:

1. A written declaration of applicable standards for Type-A or Type-B medical device.

2. A certificate of conformity with ISO 13485, which remains valid when the dossier is submitted.

3. A letter of authorization, which remains valid when the dossier is submitted, given by the product owner to the organization that applies for declaration of applicable standards, unless otherwise prescribed at Point a, Clause 1, Article 25 of this Decree.

4. A certificate of eligibility for providing warranty services granted by the product owner, unless otherwise such medical device is single-use medical device as defined by the product owner or there are documents proving that it is not under warranty.

5. A synopsis of technical description of the medical device in Vietnamese, enclosed with technical documents describing functions and specifications of such medical device issued by the product owner.

For an in-vitro reagent, calibration solution, or control material, the synopsis of technical description in Vietnamese must be enclosed with documents on materials and safety of such product, manufacturing process, pre-clinical and clinical research reports, including the report on its stability.

6. A certificate of conformity as prescribed or a product standard sheet provided by the product owner.

For a domestically manufactured medical device, the assessment record of chemical, physical and microbiological indicators and other indicators provided by a qualified conformity assessment body in accordance with the law provisions on conformity assessment is required; or, for an in vitro diagnostic medical device, the certificate of quality assessment issued by a competent authority of Vietnam is required. The assessment result must be conformable to the standards declared by the product owner.

7. User manual of the medical device.

8. A sample of the label for the medical device if it is sold in Vietnam.

9. A certificate of free sale (CFS) for imported medical devices which remains valid when the dossier is submitted.

Article 27. Requirements for application dossiers for declaration of applicable standards

1. An application dossier for declaration of applicable standards shall be prepared as 01 set.

2. Requirements for several documents included in the application dossier:

a) For the Certificate of conformity with quality control standards: its original, certified true copy, or a copy certified by the organization declaring the applicable standards.

In cases where the Certificate of conformity with quality control standards is not made in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be notarized in accordance with the law provisions.

b) For the product owner’s letter of authorization and certificate of eligibility for providing warranty services:

- For a domestically manufactured medical device: Its original or a certified true copy;

- For an imported medical device: A copy with consular legalization or a certified true copy thereof.

c) For the certificate of conformity or the product standard sheet provided by the product owner: Its original or a copy certified by the organization declaring the applicable standards.

In cases where the product standard sheet is not made in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be notarized in accordance with the law provisions.

d) For user manual of the medical device: A Vietnamese copy certified of the organization declaring the applicable standards, enclosed with its English version issued by the product owner, for an imported medical device. In cases where the user manual is not made in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be notarized in accordance with the law provisions.

dd) For the sample label: the sample label certified by the organization declaring the applicable standards. The sample label must meet requirements prescribed by the law provisions on labeling of goods.

e) For the CFS: A copy with consular legalization or a certified true copy thereof.

In cases where the CFS is not made in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be notarized in accordance with the law provisions.

g) For the record of chemical, physical and microbiological indicators and other indicators provided by a qualified conformity assessment body in accordance with the law provisions on conformity assessment or the certificate of quality assessment issued by a competent agency of Vietnam, for an in vitro diagnostic medical device: Its original or a certified true copy.

Article 28. Procedures for declaration of applicable standards

1. Before placing any Type-A or Type-B medical device on the market, the organization declaring applicable standards shall submit an application dossier for declaration to the Department of Health of the province where it is headquartered.

2. After receiving the application dossier (including the receipt of application fee as prescribed by the Ministry of Finance), the Department of Health of the province where the organization declaring the applicable standards is headquartered shall publish the number of the declaration of applicable standards for such Type-A or Type-B medical device on the Portal on Management of Medical Devices and the dossier of declaration of applicable standards, other than those prescribed in Clause 5, Article 26 of this Decree.

3. In cases where there are changes in the product owner, the type of the medical device, its category, intended purposes or indications for use, or additional information about the manufacturer or product code is provided, the registration number holder shall re-apply for declaration of applicable standards in accordance with this Decree.

4. During the placement of the medical device on the market, the product owner that has declared applicable standards for such medical device shall send a written notice of changes, enclosed with documents related to such changes, and update them to its application dossier for declaration of applicable standards published on the Portal on Management of Medical Devices within 05 working days from the occurrence of any of the following changes:

a) Change in address of the product owner or registration number holder;

b) Change in name of the registration number holder or product owner;

c) Change in name or address of the medical device manufacturer;

d) Change in packaging specifications;

dd) Change in the warranty center;

e) Change in the label or user manual without changing its intended purposes or indications for use. If the medical device has been manufactured before the product owner declaring the applicable standards makes a written notice of change in the label, it may be placed on the market with the information declared at the date of manufacture;

g) Reduction of factories, category, or product code.

 

Section 3
REGISTRATION OF TYPE-C OR TYPE-D MEDICAL DEVICES

 

Article 29. Methods of registration

1. A new registration number shall be issued in any of the following cases:

a) The medical device does not have any registration number.

b) The medical device has been granted registration number but has any of the following changes:

- A change in the product owner; its type; category, intended purposes or indications for use; quality standards; addition of factories or product code; the raw materials that affect the functions of in vitro diagnostic medical device or single-use medical device; the concentration, content, composition of raw materials that are active ingredients combined in one medical device to support the medical treatment;

- A change other than those prescribed in Clause 7, Article 32 of this Decree.

2. A new registration number shall be issued with quick procedures in any of the following cases:

a) The medical device has been granted the CFS (Certificate of Free Sale) or marketing authorization by one of the following authorities or countries: the US Food and Drug Administration (FDA), Australian Therapeutic Goods Administration (TGA), Health Canada, Japanese Ministry of Health, Labor and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA), EU state members, the UK, Switzerland, Chinese National Medical Products Administration (NMPA), RoK Ministry of Food & Drug Safety (MFDS), or other CFS issuing authorities recognized by Vietnam (hereinafter referred to as “reference countries”);

b) The medical device has been granted the import license, registration number, or certificate of registration in the commercial form in Vietnam, unless revoked before the effective date of this Decree;

3. An emergency-use registration number shall be issued to a medical device to serve pandemic prevention and control, catastrophe and disaster relief purposes in the emergency cases listed by the Minister of Health and any of the following cases:

a) The medical device has been placed on the market or granted registration number for emergency use in one of the reference countries;

b) The medical device is included in the list of products for emergency use announced by the World Health Organization (WHO);

c) The medical device is included in the list of common products announced by the EU Health Security Committee (EUHSC);

d) The medical device has been granted the registration number or import license in the commercial form in Vietnam, unless revoked before the effective date of this Decree;

dd) The medical device is domestically manufactured in the form of technology transfer for medical devices in any of the cases prescribed at Points a, b, c or d of this Clause;

e) The medical device is domestically manufactured in the form of medical device processing in any of the cases prescribed at Points a, b, c or d of this Clause.

Article 30. Application dossiers for issuance of new registration numbers

1. An application dossier for issuance of a new registration number of a medical device corresponding to a national technical regulation consists of:

a) A written request for issuance of a new registration number.

b) A certificate of conformity with ISO 13845, which remains valid when the dossier is submitted.

c) A letter of authorization, which remains valid when the dossier is submitted, given by the product owner to the organization that applies for registration, unless otherwise prescribed at Point a, Clause 1, Article 25 of this Decree.

d) A certificate of eligibility for providing warranty services granted by the product owner, unless otherwise such medical device is single-use medical device as defined by the product owner or there are documents proving that it is not under warranty.

dd) A CFS, which remains valid when the dossier is submitted, for an imported medical device.

e) An ASEAN Common Submission Dossier Template (hereinafter referred to as “CSDT”).

g) A certificate of conformity.

2. An application dossier for issuance of a new registration number for the medical device that is a measuring device whose sample requires approval as prescribed by the law provisions on measurement consists of:

a) A written request for issuance of a new registration number.

b) The decision on approval of the sample medical device.

c) Documents prescribed at Points b, c, d, dd and e, Clause 1 of this Article.

3. An application dossier for quick issuance of a new registration number for the medical device as prescribed in Clause 2, Article 29 of this Decree consists of:

a) A written request for issuance of a new registration number.

b) Documents prescribed at Points b, c, and d Clause 1 of this Article.

c) A CFS issued by one of the reference countries in the case prescribed at Point a, Clause 2, Article 29 of this Decree.

d) A CFS for an imported medical device, and an import license, registration number, or certificate of registration in the case prescribed at Point b, Clause 2, Article 29 of this Decree.

dd) A certificate of quality assessment issued by a competent agency of Vietnam for an in vitro diagnostic medical device, except the following cases:

- The medical device is included in List A or List B of Annex 2 to the EU In Vitro Diagnostic Medical Devices Regulation and has been granted a CFS by one of EU member states, the UK or Switzerland;

- The medical device is included in List A or List B of Annex 2 to the EU In Vitro Diagnostic Medical Devices Regulation and has been granted a Marketing Authorization by one of the reference countries;

- The medical device is not included in List A or List B of Annex 2 to the EU In Vitro Diagnostic Medical Devices Regulation but has been granted a Marketing Authorization by one of the reference countries;

- The medical device is included in the list of medical devices announced by the Minister of Health.

e) A CSDT.

4. An application dossier for issuance of a new registration number for the medical device in an emergency case prescribed in Clause 3 Article 29 of this Decree consists of:

a) A written request for issuance of a new registration number.

b) Documents prescribed at Points b, c, and d, Clause 1 of this Article.

c) A CFS or license for emergency use of the imported medical device.

d) The contract for technology transfer for the case prescribed at Point dd, Clause 3, Article 29 of this Decree.

dd) The processing contract in the case prescribed at Point e, Clause 3, Article 29 of this Decree.

e) A certificate of inspection or a certificate of product quality assessment issued by one of entities listed on the Ministry of Health’s portal if the medical device falls in one of the following cases:

- The medical device is domestically manufactured;

- The medical device has been granted a permit for placement on the market or emergency use by a competent authority of one of EU member states, the UK or Switzerland but is not included in the EUHSC’s list of common products.

g) A CSDT.

5. An application dossier for issuance of a new registration number for the medical device in other cases consists of:

a) A written request for issuance of a new registration number.

b) Documents prescribed at Points b, c, d and dd Clause 1 of this Article.

c) A record of the CSDT inspection given by the agency designated by the Minister of Health, enclosed with the CSDT.

d) For an in vitro diagnostic medical device that is reagent, calibration solution or control material: A certificate of quality issued by a competent agency of Vietnam.

dd) For chemicals or preparations only used for disinfection of medical devices: A report on testing for active ingredients in the disinfectants and the contents thereof given by the entity that has declared its eligibility for providing testing services in accordance with the law provisions on management of insecticidal and germicidal chemicals and preparations for medical and household use; a report on trials to evaluate biological efficacy and side effects of the product on trial participants given by the entity that has declared its eligibility to conduct trials in accordance with the law provisions on management of insecticidal and germicidal chemicals and preparations for medical and household use.

Article 31. Requirements for application dossier for new registration number

1. Requirements for a number of documents included in the dossier for registration:

a) With regard to the certificate of conformity with quality control standards: the original copy or a certified true copy or a copy bearing the applicant’s certification is required.

In cases where the certificate of conformity with quality control standards is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

b) With regard to the power of attorney of the owner of medical equipment and the certificate of eligibility to provide warranty:

- Regarding a domestically produced medical device: the original copy or a certified true copy is required;

- Regarding an imported medical device: a consularly legalized copy or a certified true copy of the consularly legalized copy is required.

c) With regard to a marketing authorization: a consularly legalized copy or a certified true copy of the consularly legalized copy is required.

In cases where the marketing authorization is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

d) With regard to a quality assessment certificate, testing report, trial report and record of appraisal of CSDT dossiers: the original copy or a certified true copy or a copy bearing the applicant’s certification is required.

dd) With regard to a CSDT dossier: a copy bearing the applicant’s certification is required. In cases where the CSDT dossier is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

2. Requirements for a number of documents included in the dossier for registration of medical devices for emergency use as prescribed in Clause 3, Article 29 of this Decree:

Documents issued by foreign competent agencies must be consularly legalized. In cases where a document does not bear consular legalization:

a) With regard to the letter of authorization: the original copy accompanied by certification must be submitted.

b) With regard to the documents prescribed at Point c, Clause 4, Article 30 of this Decree: it must indicate the link for searching information on the circulation or license for use of medical devices on the licensing agency’s website, enclosed with a document providing the link for searching information of the applicant. The results of searching information on circulation license found on the website must include at least the following information in English: name, type, manufacturer and manufacturing country.

Article 32. Receipt and appraisal of dossiers for registration of medical devices

1. The applicant shall submit an application dossier for registration number to the Ministry of Health through the portal on management of medical devices.

2. With regard to a dossier for registration of medical devices prescribed in Clause 1 and Clause 2, Article 30 of this Decree:

a) In cases where the dossier is satisfactory, the Minister of Health shall be responsible for appraising such dossier to issue a registration number within 30 days from the receipt of the complete and valid dossier (including fee receipts for appraisal and issuance of marketing authorization as prescribed by the Ministry of Finance). In cases of refusal, a written response indicating reasons for such refusal shall be provided.

b) In cases where the dossier is not satisfactory, the Ministry of Health shall send a request for supplementing or amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant within 25 days from the receipt of the dossier.

c) When receiving a request for supplementing or amending the dossier, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has supplemented or amended the dossier but it fails to comply with the request, the Ministry of Health shall send the applicant a request for continuing to complete the dossier as prescribed at Point b, Clause 2 of this Article.

In cases where the applicant fails to supplement and amend the dossier within 90 days from the receipt of the Ministry of Health’s request for modification or the dossier is still unsatisfactory after 05 modification times, the applicant shall re-perform the procedure for applying a registration number.

3. With regard to a dossier for registration of medical devices prescribed in Clause 3, Article 30 of this Decree:

a) In cases where the dossier is satisfactory, the Minister of Health shall be responsible for appraising such dossier to issue a registration number within 10 working days from the receipt of the complete and valid dossier (including fee receipts for appraisal and issuance of marketing authorization as prescribed by the Ministry of Finance). In cases of refusal, a written response indicating reasons for such refusal shall be provided.

The Ministry of Health shall only appraise the legal documents specified at Points b, c, d and dd Clause 1, Article 30 of this Decree. The applicant shall be accountable for the accuracy and legitimacy of other documents included in the dossier which may be inspected by the Ministry of Health after issuing the registration number.

b) In cases where the dossier is not satisfactory, the Ministry of Health shall send a request for supplementing or amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant within 10 days from the receipt of the dossier.

c) When receiving a request for supplementing or amending the dossier, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has supplemented or amended the dossier but it fails to comply with the request, the Ministry of Health shall send the applicant a request for continuing to complete the dossier as prescribed at Point b, Clause 3 of this Article.

In cases where the applicant fails to supplement and amend the dossier within 90 days from the receipt of the Ministry of Health’s request for modification or the dossier is still unsatisfactory after 05 modification times, the applicant shall re-perform the procedure for applying a registration number.

4. With regard to a dossier for registration of medical devices prescribed in Clause 4, Article 30 of this Decree:

a) In cases where the application dossier is satisfactory, the Minister of Health shall be responsible for appraising such dossier to issue a registration number within 10 working days from the receipt of the complete and valid dossier (including fee receipts for appraisal and issuance of marketing authorization as prescribed by the Ministry of Finance). In cases of refusal, a written response indicating reasons for such refusal shall be provided.

The Ministry of Health shall only appraise the legal documents specified at Points b, c, d, dd and e, Clause 4, Article 30 of this Decree. The applicant shall be accountable for the accuracy and legitimacy of other documents included in the dossier which may be inspected by the Ministry of Health after issuing the registration number.

b) In cases where the dossier is not satisfactory, the Ministry of Health shall send a request for supplementing or amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant within 08 days from the receipt of the dossier.

c) When receiving a request for supplementing or amending the dossier, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has supplemented or amended the dossier but it fails to comply with the request, the Ministry of Health shall send the applicant a request for continuing to complete the dossier as prescribed at Point b, Clause 4 of this Article.

In cases where the applicant fails to supplement and amend the dossier within 90 days from the receipt of the Ministry of Health’s request for modification, the applicant shall re-perform the procedure for applying a registration number.

5. With regard to a dossier for registration of medical devices prescribed in Clause 5, Article 30 of this Decree:

a) In cases where the application dossier is satisfactory, the Minister of Health shall be responsible for appraising such dossier to issue a registration number within 45 days from the receipt of the complete and valid dossier (including fee receipts for appraisal and issuance of marketing authorization as prescribed by the Ministry of Finance). In cases of refusal, a written response indicating reasons for such refusal shall be provided.

b) In cases where the dossier is not satisfactory, the Ministry of Health shall send a request for supplementing or amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant within 40 days from the receipt of the dossier.

c) When receiving a request for supplementing or amending the dossier, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has supplemented or amended the dossier but it fails to comply with the request, the Ministry of Health shall send the applicant a request for continuing to complete the dossier as prescribed at Point b, Clause 5 of this Article.

In cases where the applicant fails to supplement and amend the dossier within 90 days from the date the Ministry of Health notifies the modification request, or after 5 times of modifying, supplementing dossier from the receipt of the Ministry of Health’s first request for modification, the applicant shall re-perform the procedure for applying a registration number.

6. Within 01 working day from the issuance of the registration number, the Ministry of Health shall publish the following information on the portal on management of medical devices, including:

a) Name, type, manufacturer and manufacturing country of medical devices;

b) Registration number of medical devices;

c) Name and address of the owner of medical devices;

d) Name and address of the registration number holder;

dd) Name and address of the warranty provider of medical devices;

e) The documents included in the dossier for registration of medical devices, except the documents prescribed at Point e, Clause 1 and Point c, Clause 5 of Article 30;

g) Intended purposes of medical devices.

7. During the circulation of medical devices, the registration number holder shall assume responsibility for making a written notice of changes accompanied by supporting documents, and updating them to the dossier for registration number published on the portal on management of medical devices within 10 working days from the occurrence of any of the following changes:

a) Change in address of the owner of medical devices or a registration number holder;

b) Change in name of the registration number holder or the owner of medical devices;

c) Change in the medical device manufacturer’s name or address;

d) Change in packaging specifications;

dd) Change of the warranty provider of medical devices;

e) Change in the label or user manual without changing intended purposes, indications for use, functions or performance of medical devices. Where the medical device has been manufactured before the registration number holder makes a notice of change in the label, the device may be placed on the market with information registered and updated at the date of manufacture.

 

Section 4.

POST-MARKET MANAGEMENT OF MEDICAL DEVICES AND HANDLING OF MEDICAL DEVICES IN SOME SPECIFIC CASES

 

Article 33. Requirements for dossiers of post-market management of medical devices

The registration number holder shall establish, organize and manage the tracing of origin of medical devices on the market and fully retain dossiers of medical device management, including at least the following documents:

1. Dossiers for issuance of registration number for medical devices, in which the following documents shall be retained in physical form:

a) The letter of authorization from the owner of medical devices, except for the cases specified at Point a, Clause 1 Article 25 of this Decree;

b) The certificate of eligibility to provide warranty granted by the owner of medical devices, except for disposable medical devices as decided by the owner of medical devices or cases where there are documents proving that the medical devices are not under warranty;

c) The certificate of free sale or marketing authorization.

2. Distribution records (in cases where the registration number holder is a representative office, it shall not be required to retain these records but must request the entity that it authorizes to import medical devices to perform this responsibility).

3. Records of adverse events, complaints and remedial measures that indicate name, type, quantity and batch number of medical devices, especially those that are defective or unsafe for users.

4. Dossiers of medical device quality management, including:

a) The certificate of origin made in accordance with law provisions on origin of goods;

b) The certificate of quality of each medical device batch issued by the owner of medical devices or manufacturer whose name is specified in the dossier for registration of medical devices;

c) Inspection results of medical devices in the cases specified in Clause 1, Article 55 of this Decree;

d) Technical documents serving the repair and maintenance of medical devices, except for disposable medical devices as decided by the owner of medical devices or cases where there are documents proving that the medical devices are not under warranty;

dd) Vietnamese instructions for use of medical devices;

e) Information about warranty establishment, conditions and duration, except for disposable medical devices as decided by the owner of medical devices or cases where there are documents proving that the medical devices are not under warranty.

Article 34. Handling of medical devices with warnings about potential risks of seriously threatening public health or possibly leading to death of users

1. In cases where a medical device has a warning from a Vietnamese or international competent agency about a potential risk that poses a serious threat to public health or may cause death of users, the registration number holder shall inform health establishments using such medical devices of the warned risk and carry out investigation and identification within 30 days from the receipt of such warning. In cases where the investigation and identification takes more than 30 days, a written report clearly stating reasons and solutions for ensuring safety of users shall be submitted to the Ministry of Health.

2. In cases where the medical devices specified in Clause 1 of this Article is found to have a defect which may affect the health of users, the registration number holder shall:

a) Suspend the circulation of the medical device batch on the market.

b) Send a written notice to the Ministry of Health, distributors and users of such medical devices. The notice shall clearly state the batch number and the defect which may adversely affect the health of users, and whether or not such defect can be repaired.

c) Formulate a plan for remedying or recalling the batch of defective medical devices.

d) Send a report to the Ministry of Health after the remedy or recall of defective medical devices are completed.

3. In cases where the defect of medical devices can be remedied:

a) Within 03 working days from the receipt of the notice from the registration number holder, the Ministry of Health shall be responsible for issuing a decision to suspend the circulation of the batch of defective medical devices on the market.

A suspension decision shall contain the following information:

- Name of the suspended medical devices;

- Batch number of the suspended medical devices;

- Registration number of the suspended medical devices.

b) After a suspension decision is issued, the registration number holder shall be responsible for remedying the defect, which causes adverse effects to the health of users.

c) After completing the remedy of the defect, the registration number holder shall send a report to the Ministry of Health, accompanied by the inspection record for the medical devices specified in Clause 1, Article 55 of this Decree or commitment to maintain quality of the medical devices after the defect has been remedied for other medical devices.

d) Within 20 days from the receipt of the report on remedying the defect sent by the registration number owner, the Ministry of Health shall issue a decision to lift the suspension. In cases of refusals, the Ministry of Health shall send a written response clearly stating the reasons to the applicant.

4. In cases where the defect cannot be remedied:

a) The Ministry of Health shall issue a decision to recall the entire batch of defective medical devices.

A recall decision shall contain the following information:

- Name of the recalled medical devices;

- Batch number of the recalled medical devices;

- Registration number of the medical devices.

b) The registration number holder shall recall the entire batch of defective medical devices by the deadline imposed by a competent agency and bear all costs for the recall of the batch of defective medical devices.

c) In cases where the registration number holder fails to complete the recall by the deadline imposed by the competent agency, the recall will be enforced in accordance with law provisions on handling of administrative violations.

Article 35. Handling of cases where an adverse event has affected the health of users

1. In cases where a medical device has an adverse event that poses a serious threat to public health or has caused death of a user, the registration number holder shall assume responsibility for:

a) Posting a notice of the adverse event on the registration number holder’s website (if any) and sending written notices of the adverse event to the Ministry of Health, traders and users of that batch of medical devices;

b) Suspending the circulation of the medical device batch involving the adverse event on the market;

c) Conducting an investigation and verifying the cause of the adverse event;

d) Sending a report to the Ministry of Health after the investigation and verification results are available. In cases where the adverse event is caused by a defect in the medical devices, the report shall describe the defect and whether it can be remedied. Carrying out the remedy or recall of the batch of defective medical devices, submit a report to the Ministry of Health after completing the remedy or recall.

2. In cases where the adverse event does not cause death but has caused serious harm to the health of users, the registration number holder shall assume responsibility for:

a) Sending a written notice of the adverse event to the Ministry of Health;

b) Conducting an investigation and verifying the cause of the adverse event;

c) Sending a report to the Ministry of Health after the investigation and verification results are available. In cases where the adverse event is caused by a defect in the medical devices, the report shall describe the defect and whether it can be remedied. Carrying out the remedy or recall of the batch of defective medical devices, submit a report to the Ministry of Health after completing the remedy or recall.

3. The handling of defective medical devices that adversely affect the health of users shall comply with the provisions of Clauses 3 and 4, Article 34 of this Decree.

Article 36. Forms of handling, remedying and recalling defective medical devices

1. Forms of handling the defective medical devices:

a) Providing instructions on measures to remedy the defect;

b) Remedying the defect of medical devices;

c) Replacing the defective medical devices with equivalent devices;

d) Recalling the defective medical devices for re-export or destruction;

2. Forms of recalling the defective medical devices:

a) Voluntary recall by the registration number holder;

b) Compulsory recall in the cases specified in Article 39 of this Decree.

Article 37. Handling of medical devices in cases where the owner of medical devices or registration number holder no longer carries out manufacturing or goes bankrupt or is dissolved

1. In cases where the owner of medical devices declares termination of manufacturing of medical devices which has been granted the registration number or goes bankrupt or is dissolved, the medical devices may continue its circulation on the market for a maximum period of 24 months from the date of the owner’s declaration of manufacturing termination, bankruptcy or dissolution provided that the registration number holder in Vietnam provides a commitment to provide warranty or materials for replacing or serving the use of the medical devices for 08 years, unless the registration number holder is a permanent representative office in Vietnam of a foreign trader that is the product of medical devices.

2. In cases where the registration number holder of a medical device goes bankrupt or is dissolved, the medical device may continue its circulation on the market for a maximum period of 24 months from the date of the registration number holder’s declaration of bankruptcy or dissolution provided that the distributor provides a commitment to provide warranty or materials for replacing or serving the use of the medical devices for 08 years.

3. The registration number holder or distributor shall assume responsibility for sending their commitment to the Ministry of Health through the portal on management of medical devices within 60 days from the date on which the owner of medical devices or registration number holder declares termination of manufacturing or goes bankrupt or is dissolved.

4. The commitment shall include the following documents:

a) The written commitment to provide warranty and materials serving the use of the medical devices;

b) The list of medical devices with the registration number that the applicant is holding but the owner of medical devices or registration number holder declares termination of manufacturing or goes bankrupt or is dissolved.

5. Within 15 working days from the receipt of the commitment as prescribed in Clause 4 of this Article, the Ministry of Health shall send a written response indicating whether or not the medical devices may be placed on the market. In cases of refusals, a written response clearly stating the reasons shall be given.

6. In cases where the Ministry of Health refuses to permit the circulation of the medical devices specified in Clause 1 of this Article on the market, the registration number holder or distributor shall recall all medical devices circulated on the market, except for those sold to users.

 

Section 5.

REVOCATION OF REGISTRATION NUMBER OF MEDICAL DEVICES

 

Article 38. Cases where registration number is revoked

1. The applicant uses fraudulent documents to apply for registration.

2. In cases where 03 batches of the medical devices are recalled during the validity of the registration number, except for registration number holder’s voluntary recall of the medical devices.

3. The applicant falsifies the contents of the registration number without permission.

4. The registration number holder terminates its operation or is no longer authorized by the owner of medical devices and no substitute organization has been appointed, except for the cases specified in Article 37 of this Decree.

5. Quality of the medical devices being circulated on the market is not consistent with the registered quality.

6. The registration number has been issued against regulations of this Decree.

7. The registration number holder or distributor has not provided commitment for the medical devices as prescribed in Clauses 1 and 2, Article 37 of this Decree.

8. The period for circulation of the medical devices on the market has expired as prescribed in Clauses 1 or 2, Article 37 of this Decree.

9. The medical devices have been manufactured at a factory that fails to satisfy eligibility requirements prescribed in this Decree.

10. The registration number holder fails to comply with the provision at Point k, Clause 3, Article 74 of this Decree, except for the cases specified in Article 37 of this Decree.

11. The dossier for declaration or issuance of registration number fails to comply with regulations of this Decree.

12. The medical devices have been classified against regulations on classification of medical devices.

13. The registration number holder applies for voluntary revocation of the registration number.

Article 39. Procedures for revocation of registration number

1. During the course of inspection, if detecting any of the cases specified in Clauses 1 through 12, Article 38 of this Decree, the agency performing the examination and inspection shall prepare and send an inspection record to the Ministry of Health or provincial-level Department of Health that has issued the registration number (hereinafter referred to as “registration number issuer”).

2. Within 05 working days from the receipt of the inspection record specified in Clause 1 of this Article, the registration number issuer shall consider and decide on the revocation of registration number under their management.

3. After issuing the decision to revoke registration number, the registration number issuer shall assume responsibility for:

a) Publishing the decision to revoke registration number on its website and sending it to the registration number holder, the Ministry of Health, provincial-level Departments of Health and customs offices.

b) Removing all information related to the medical devices published on its website.

4. When receiving the registration number issuer's decision to revoke registration number, provincial-level Departments of Health shall publish the full text of the decision on their websites and direct specialized agencies to supervise the recall of relevant medical devices.

5. In cases of voluntarily applying for revocation of registration number, the registration number holder shall submit an application clearly stating the reasons for such revocation to the registration number issuer. After receiving the application, the registration number issuer shall carry out the procedures for revocation of registration number as prescribed in Clauses 2 and 3 of this Article.

 

Chapter VI

MANAGEMENT OF TRADING OF MEDICAL DEVICES

 

Section 1.

REQUIREMENTS FOR TRADING MEDICAL DEVICES

 

Article 40. Requirements for type-B, C or D medical device trading establishments

1. Having at least 01 technical staff with an associate degree, or higher, in technology, medicine, pharmacy, chemistry, biology or medical devices, or an associate degree, or higher, suitable for the medical devices which the establishment trade.

2. Having warehouse and vehicles for transporting medical devices that satisfy the following minimum requirements:

a) The warehouse must:

- Have an area suitable for the types and quantities of stored medical devices;

- Be well ventilated, dry and clean, and separated from sources of pollution;

- Meet other storage requirements for the medical devices in accordance with their user manuals.

b) The vehicles for transporting medical devices from trading establishments to buyers must be suitable for types of such medical devices;

In cases where a trading establishment does not have a warehouse or vehicle for transporting medical devices, the trading establishment may sign a contract with a qualified storage or transport service provider.

3. With regard to an establishment trading in medical devices containing narcotics and precursors:

a) The person in charge of expertise must have a bachelor’s degree in medical devices, medicine, pharmacy, pharmaceutical chemistry or biology.

b) The trading establishment must have a warehouse that satisfies the requirements as prescribed in Article 7 of the Government’s Decree No. 80/2001/ND-CP dated November 05, 2001.

c) There is a system to monitor and manage the export, import and inventory of medical devices containing narcotics and precursors.

Article 41. Dossiers and procedures for declaration of eligibility for medical device trading

1. A dossier for declaration of eligibility for medical device trading shall include:

a) A written declaration of eligibility for medical device trading;

b) A personnel list;

c) Documents proving that the warehouse and vehicle for transporting medical devices satisfy the requirements specified in Clause 2, Article 40 of this Decree. These documents must be certified by the applicant;

d) Documents proving that the warehouse and the system to monitor and manage the export, import and inventory of medical devices containing narcotics and precursors comply with the requirements as prescribed in Clause 3, Article 40 of this Decree. These documents must be certified by the establishment making declaration of eligibility for trading in medical devices that contain narcotics and precursors.

2. Procedures for declaration of eligibility for medical device trading:

a) Before trading medical devices, the trading establishment shall assume responsibility for submitting a dossier for declaration of eligibility for medical device trading to the Department of Health of province where the trading establishment is located.

b) After receiving the dossier (including fee receipts as prescribed by the Ministry of Finance), the Department of Health of province where the trading establishment’s head office is located shall publish on the portal on management of medical devices all information about and dossier for declaration of eligibility for medical device trading.

c) In the course of operation, the trading establishment shall assume responsibility for making a written notice of changes which is accompanied by supporting documents for such changes, and updating such documents to its application for declaration of eligibility for medical device trading published on the portal on management of medical devices within 03 working days from the occurrence of such changes.

Article 42. Trading in medical devices which is not required to satisfy requirements nor follow procedures for declaration of eligibility for medical device trading

1. Type B, C or D medical devices included in the list of medical devices issued by the Minister of Health shall be traded like other normal goods.

2. The trade of medical devices specified in Clause 1 of this Article is not required to satisfy requirements as prescribed in Article 40 of this Decree and is not required to follow the procedures for declaration of eligibility for medical device trading as prescribed in Article 41 of this Decree, provided that such trading is conformable to the requirements for storage and transport prescribed by the owner of medical devices.

 

Section 2.

MANAGEMENT OF MEDICAL DEVICE PRICES

 

Article 43. Principle for state management of medical device prices

1. Managing prices of medical devices according to the market mechanism; respecting the right to pricing and price competition of entities trading in medical devices in accordance with law provisions.

2. Ensuring the publicity and transparency of medical device prices during the circulation on the market.

3. Protecting the lawful rights and interests of medical device traders and users, and of the State.

4. Taking measures for ensuring management of medical device prices suitable to socio-economic development conditions in each period.

Article 44. Measures for management of medical device prices

1. Declaring the prices of medical devices before being traded on the market in Vietnam and declaring again whenever they are changed in accordance with the provisions of this Decree.

2. Posting up the wholesale and retail prices of medical devices in VND at transaction or selling locations of medical device trading establishments; such prices shall be publicly posted on a board, paper or in other forms.

3. Publicizing the winning bids for medical devices of public health establishments.

4. Trading establishments shall not be allowed to trade medical devices before their prices are declared or at prices higher than those available on the Ministry of Health’s portal on management of medical devices at the time of trading.

Article 45. Contents and responsibility for declaration of medical device prices

1. Contents of declaration of medical device prices:

a) Name and type of medical devices;

b) Manufacturing country;

c) Unit of calculation;

d) Import cost price of imported medical devices or manufacturing cost of domestically manufactured medical devices;

dd) Expected profits;

e) The highest price of medical devices corresponding to each design configuration, technical function and unit of calculation;

g) Prices of accessories and parts (if any);

h) Warranty or maintenance costs (if any);

i) Training costs (if any);

k) Other costs (if any);

2. Contents of publicizing medical device prices:

a) Name and type of medical devices;

b) Manufacturer and manufacturing country; product owner and country of product owner;

c) Unit of calculation;

d) The highest price of medical devices corresponding to each design configuration, technical function and unit of calculation;

dd) Prices of accessories and parts (if any);

e) Warranty or maintenance costs (if any);

g) Training costs (if any);

h) Other costs (if any);

3. Prices of medical devices shall be expressed in VND.

4. Registration number holders shall assume responsibility for:

a) Making declaration of medical device prices that includes all contents specified in Clause 1 of this Article and publish information on the Ministry of Health’s portal before such medical devices are traded on the market of Vietnam;

b) Updating prices of medical devices whenever they are changed;

c) Requesting distributors to comply with the provisions at Points a and b of this Article in the cases prescribed at Point c Clause 1, Article 25 of this Decree. In cases of multiple distributors of the same medical device, one distributor shall be appointed to declare the medical device price. Other distributors shall not be required to make price declaration but shall not sell the medical device at a price higher than that declared by the appointed distributor;

d) Making declaration and explaining price constituents to tax administration offices or at the request of state management agencies.

5. Prices posted on the Ministry of Health’s portal must include sufficient information as specified in Clause 2 of this Article.

 

Section 3.

EXPORT AND IMPORT OF MEDICAL DEVICES

 

Article 46. Principle for management of import and export of medical devices

1. Importers and exporters of medical devices must satisfy the requirements as prescribed in the law on import and export and assume responsibility for ensuring quality, quantities, types and intended purposes of their imported/exported medical devices.

2. Medical devices that have been granted registration numbers in Vietnam may be exported and imported without limits on quantities and without the Ministry of Health’s approval.

3. Issuance of certificates of free sale for medical devices shall comply with law provisions on foreign trade management.

4. Temporary import for re-export, temporary export for re-import, or transit of medical devices shall comply with law provisions.

5. Import of used medical devices shall comply with law provisions on foreign trade management.

Article 47. Export and import of medical devices

1. Domestic enterprises are encouraged to manufacture medical devices for export.

2. An organization or individual wishing to import the medical device that has been granted registration number shall satisfy the following conditions:

a) Being the registration number holder or having the authorization letter of the registration number holder. When authorizing import of medical devices, the registration number holder shall send a copy of the authorization letter to the registration number issuer and the customs office;

b) Having a warehouse and vehicles for transporting medical devices that satisfy the requirements prescribed in Clause 2, Article 40 of this Decree or having entered into a contract with a qualified storage and transport service provider;

c) Having a warehouse and system to monitor and manage the export, import and inventory of medical devices containing narcotics and precursors that meet the requirements prescribed in Clause 3 Article 40 of this Decree.

3. Procedures for import and export of medical devices shall comply with regulations of the law on customs. Importers of medical devices shall not be required to prove their satisfaction with the requirements laid down in Clause 2 of this Article when following customs procedures.

Article 48. Import license

1. An import license is required in the following cases:

a) Medical devices do not have the registration number and are imported to serve scientific research, testing, inspection, experiment, performance evaluation, or instruction for use or device modification only;

b) Medical devices do not have the registration number and are imported to serve disease prevention and control, or disaster recovery;

c) Medical devices do not have the registration number and are imported as assistance or humanitarian aid; gifts or presents given to health establishments; or to serve display at trade fair, exhibition or product launch event;

d) Medical devices do not have the registration number and are imported to serve charitable medical examination and treatment;

dd) Medical devices do not have the registration number and are imported for personal treatment of illness, including personalized medical devices, or to serve a health establishment’s special diagnosis demand;

e) Used medical devices:

- Being imported to serve research or training (no use on humans and for diagnostic and treatment purposes);

- Being temporarily imported for re-export to serve display, product launch event, trade fair or exhibition.

Dossiers, order and procedures for import, temporary import for re-export of medical devices shall comply with law provisions on foreign trade management.

2. An application dossier for import license shall include:

a) A written request for import license;

b) A synopsis of the technical description of medical devices in Vietnamese;

c) The certificate of conformity with quality control standards of the manufacturer bearing the applicant’s certification;

d) In cases where medical devices are imported to serve research: a certified true copy of the decision to approve the research and documents bearing the applicant’s certification proving that the devices have been granted marketing authorization by a competent agency;

dd) In cases where medical devices are imported to serve training purposes: the original copy of the training program and documents bearing the applicant’s certification proving that the devices have been granted marketing authorization by a competent agency;

e) In cases where medical devices are imported to serve testing, inspection, experiment, or performance evaluation: the certification indicating the quantity of the imported devices given by the agency competent to carry out such testing, inspection, experiment, or performance evaluation;

g) In cases where medical devices are imported as aid: a copy of the decision to approve the aid and documents bearing the applicant’s certification proving that the devices have been granted marketing authorization by a competent agency;

h) In cases where medical devices are imported as gift or present given to a health establishment: the original copy of the training program and documents bearing the applicant’s certification proving that the devices have been granted marketing authorization by a competent agency;

i) In cases where medical devices are imported to serve charitable medical examination and treatment: documents bearing the applicant’s certification proving that the devices have been granted marketing authorization by a competent agency;

k) In cases where medical devices are imported to serve a health establishment’s special diagnosis demand: documents bearing the applicant’s certification proving that the devices have been granted marketing authorization by a competent agency;

l) In cases where medical devices are imported to serve personal treatment of illness, including personalized medical devices: a copy of the physician’s prescription which is consistent with the applicant’s illness;

m) In cases where medical devices are imported to serve a trade fair, exhibition, display or product launch event: copies of documents on the program, invitation letter and service contract;

n) In cases where medical devices are imported to serve the purposes of disease prevention and control or disaster recovery, the following documents are required:

- A written approval by a competent agency for urgent needs in disease prevention and control, and remediation of consequences of natural disasters or catastrophes;

- Documents bearing the applicant’s certification proving that the devices have been granted marketing authorization or license for emergency use by a competent agency.

3. Procedures for processing an application dossier for license to import medical devices:

a) In cases where the dossier is satisfactory, the Ministry of Health shall assume responsibility for appraising such dossier to issue the import license within 15 working days, or 02 working days for an unregistered medical device that is imported to serve disease prevention and control or disaster recovery, from the receipt of the adequate and valid dossier (including fee receipts for appraisal and issuance of import license as prescribed by the Ministry of Finance). In cases of refusal, a written response clearly stating the reasons for such refusal shall be sent to the applicant.

The import license shall be sent to the applicant and customs offices.

b) In cases where the dossier is not satisfactory, the Ministry of Health shall send a request for supplementing and amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant within 10 days, or 02 working days for an unregistered medical device that is imported to serve disease prevention and control or disaster recovery, from the receipt of the dossier.

c) When receiving a request for supplementing or amending the dossier, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has supplemented or amended the dossier but it fails to comply with the request, the Ministry of Health shall send the applicant a request for continuing to complete the dossier as prescribed.

d) In cases where the applicant fails to provide the modified dossier within 30 days from the receipt of the Ministry of Health’s request for modification, the applicant shall re-perform the application procedure for license to import medical devices.

dd) In cases where the modified dossier is satisfactory, the Ministry of Health shall issue an import license in accordance with Point a of this Clause. The import license shall be sent to the applicant and customs offices.

Article 49. Application dossiers for Certificate of Free Sale for medical devices

1. An application dossier for certificate of free sale for medical devices shall include:

a) A written request for certificate of free sale.

b) A certified true copy of the unexpired certificate of conformity with quality control standards issued by a conformity assessment agency as prescribed by law provisions.

2. Procedures for issuing a certificate of free sale shall comply with the Government’s Decree No. 69/2018/ND-CP dated May 15, 2018, detailing a number of articles of the Law on Foreign Trade Management.

Article 50. Competence and procedures for issuance, re-issuance and revocation of Certificate of Free Sale

1. The Minister of Health shall assume responsibility for the issuance, re-issuance and revocation of certificate of free sale for medical devices.

2. Procedures for the issuance, re-issuance and revocation of certificate of free sale shall comply with the Prime Minister’s regulations on issuance of certificate of free sale.

 

Section 4.

RIGHTS AND OBLIGATIONS OF ORGANIZATIONS AND INDIVIDUALS ENGAGED IN TRADING OF MEDICAL DEVICES

 

Article 51. Rights of medical device trading establishments

1. Requesting the medical device seller to provide adequate information and documents serving the tracing of origin and warranty on the medical devices.

2. Requesting importers, distributors and users to cooperate in recalling and handling defective medical devices.

3. Requesting the registration number holder or warranty establishment that is recognized by the owner of medical devices to provide warranty on the medical devices.

4. Being notified by the registration number holder about defective medical devices.

5. Exercising other rights as prescribed by law provisions.

Article 52. Obligations of medical device trading establishments

1. Implementing internal control measures to maintain the quality of medical devices as prescribed by the registration number holder.

2. Providing users with adequate and timely information about:

a) Instructions for use of medical devices; conditions for ensuring safety, storage, calibration, inspection and maintenance of medical devices;

b) Notices of defective medical devices.

3. Declaring and posting medical device prices in accordance with law provisions. Not trading medical devices before their prices are declared or at prices higher than those available on the Ministry of Health’s portal on management of medical devices at the time of trading.

4. Retaining records of medical device monitoring and carrying out tracing of origin and recall of medical devices in accordance with the provisions of this Decree.

5. Promptly notifying registration number holders and state management agencies of defective medical devices.

6. Complying with regulations of law and inspection decisions issued by competent agencies.

7. Performing other obligations as prescribed by law provisions.

 

Chapter VII

MEDICAL DEVICE-RELATED SERVICES

 

Section 1

MEDICAL DEVICE TECHNICAL CONSULTING

 

Article 53. Conditions for providing medical device technical consulting

1. The provision of services for consulting on listing and formulation of technical configuration and functions of medical devices must be conducted by individuals who have certificates of completion of training course in technical consulting on medical devices.

2. An individual who provides medical device technical consulting must satisfy the following conditions:

a) Having a bachelor’s degree, or higher, in technology, medicine or pharmacy;

b) Having at least 05 years’ experience of working in medical device technology in health establishments;

c) Having been examined and recognized by the training institution to be capable of providing medical device technical consulting according to the training program issued by the Ministry of Health.

3. A consultant shall only provide medical device technical consulting after the Ministry of Health publishes his/her information and dossier for declaration of eligibility to provide medical device technical consulting as prescribed at Point b, Clause 2, Article 54 of this Decree.

Article 54. Dossiers and procedures for declaration of eligibility to provide medical device technical consulting

1. An application dossier for declaration of eligibility to provide medical device technical consulting shall include:

a) A written request for declaration of eligibility to provide medical device technical consulting;

b) Certified true copies of qualifications/certificates as prescribed at Points a and c, Clause 2, Article 53 of this Decree;

c) A certificate of working time.

2. Procedures for declaration of eligibility to provide medical device technical consulting:

a) Before providing medical device technical consulting, the applicant shall assume responsibility for submitting an application dossier for declaration of eligibility to provide medical device technical consulting to the Ministry of Health.

b) After receiving the dossier (including fee receipts as prescribed by the Ministry of Finance), the Ministry of Health shall publish on the portal on management of medical devices all information about and dossier for declaration of eligibility to provide medical device technical consulting.

c) During its operation, the consultant shall assume responsibility for making a written notice of changes which is accompanied by supporting documents for such changes, and updating such documents to his/her dossier for declaration of eligibility to provide medical device technical consulting published on the portal on management of medical devices within 03 days from the occurrence of such changes.

 

Section 2

INSPECTION AND CALIBRATION OF MEDICAL DEVICES

 

Article 55. Principle for the inspection and calibration of medical devices

1. Medical devices on the list announced by the Minister of Health must undergo safety and function inspection before use (except for the cases prescribed in Article 57 of this Decree), periodically and after major overhaul. The inspection of medical devices that are measurement devices and radiological devices shall be carried out in accordance with regulations in Clause 2 of this Article.

2. Medical devices that are measurement devices and radiological devices must undergo inspection and calibration in accordance with law regulations on measurement and atomic energy.

Article 56. Requirements for the provision of medical devices inspection services

Requirements in terms of devices, personnel; the application dossier for the Certificate; the form of submitting the dossier; the procedure for issuing, revising, reissuing and revoking the Certificate of registration of medical devices inspection services shall be carried out in accordance with current law regulations on conformity assessment services;

Of which, the satisfaction with professional requirements for medical devices inspection shall be prescribed as follows: each inspection process registered by an inspecting organization must be handled by at least 02 inspectors who have certificates of training in such inspection process.

Article 57. Exemption of first inspection before use for medical devices

Medical devices shall be eligible for the exemption of first inspection before use in one of the following cases:

1. The medical devices already have the Certificate of conformity;

2. The unregistered medical devices are imported to serve scientific research or training in use, maintenance or repair of such devices;

3. The unregistered medical devices are imported for the importer’s personal treatment or charitable medical examination and treatment or serving special diagnostic purposes;

4. The unregistered medical devices are imported for display at an exhibition or introduction event.

Article 58. Handling of unqualified medical devices

1. In cases where the result of inspection before use of medical devices are not satisfactory:

a) Health facilities must not receive or use the medical devices;

b) The inspecting organization shall send a notice of the unsatisfactory result to the Ministry of Health;

c) If 03 medical devices in the same batch fail the safety and function inspection, the Ministry of Health shall request the registration number holder to send a written report on the quantity of medical devices being sold on the market and being used by health facilities;

Based on the report of the registration number holder and the unsatisfactory result, the Ministry of Health shall decide on the re-inspection, the quantity of medical devices that must undergo re-inspection, or suspend the use of such medical devices;

Based on the re-inspection result, the Ministry of Health shall decide on the implementation of another re-inspection, the quantity of medical devices that must undergo another re-inspection, or request the registration number holder to recall the whole batch;

In cases where 03 batches of medical devices are revoked during the effective period of the registration number, the registration number will be revoked. Medical devices that have been used by health facilities before the issuance of the decision on the revocation of such registration number may continue to be used if they satisfy the inspection requirements.

2. In the cases where the result of a periodic inspection or post-overhaul inspection is not satisfactory:

a) Health facilities must stop using such medical devices;

b) The marking of the previous inspection result shall be removed;

c) Health facilities shall cooperate with the registration number holder in implementing corrective measures and carrying out a re-inspection.

d) Medical devices shall only be used if the re-inspection result is satisfactory.

 

Chapter VIII

MANAGEMENT OF RAW MATERIALS FOR MANUFACTURE OF MEDICAL DEVICES, SUBSTANCES FOR EXTERNAL QUALITY ASSESSMENT THAT CONTAIN NARCOTIC SUBSTANCES AND PRECURSORS

 

Article 59. Principle for management of raw materials for manufacture of medical devices, substances for external quality assessment that contain narcotic substances and precursors

1. The concentration and content of raw materials for manufacture of medical devices, substances for external quality assessment that contain narcotic substances and precursors must be declared before they are imported to or exported from Vietnam.

2. The customs clearance must be in accordance with the declaration number and shall not require the import license issued by the Ministry of Health.

Article 60. Application dossiers and procedures for the declaration of raw materials for manufacture of medical devices, substances for external quality assessment that contain narcotic substances and precursors

1. The application dossier for declaration shall include:

a) The written declaration of raw materials for manufacture of medical devices, substances for external quality assessment that contain narcotic substances and precursors;

b) The Certificate of conformity with quality control standards;

c) Technical documents.

2. Procedures for the declaration of concentration, content of narcotic substances and precursors:

a) Before importing raw materials for manufacture of medical devices and substances for external quality assessment that contain narcotic substances and precursors, the importer shall be required to publish the full and valid application dossier for declaration as prescribed in Clause 1 of this Article on the Portal on the management of medical devices;

b) After receiving a full and valid application dossier, the Ministry of Health shall publish on the Portal on the management of medical devices all information and the application dossier for declaration of raw materials for manufacture of medical devices and substances for external quality assessment that contain narcotic substances and precursors.

3. Importers/exporters shall be responsible for reapplying for the declaration of concentration/content of narcotic substances and precursors whenever there are any changes to their declaration dossiers.

 

Chapter IX
INFORMATION ON MEDICAL DEVICES

 

Article 61. Information on medical devices

1. Information about medical devices shall be for the purpose of providing healthcare practitioners and users with guidelines on the reasonable and safe use of medical devices.

2. Information about medical devices must be sufficient, objective, accurate, honest, understandable and must not cause any misunderstanding.

3. Responsibility to provide information on medical devices shall be prescribed as follows:

a) The registration number holders and trading establishments shall be responsible for publishing information on the levels of risks and other information related to the use of medical devices;

b) Health facilities shall be responsible for internally disseminating information on medical devices;

c) Health workers shall be responsible for disseminating information on the levels of risks of Class-C, D medical devices to patients;

d) Management agencies in charge of medical devices shall be responsible for making information on medical devices publicly available.

4. Organizations and individuals providing information on medical devices shall assume responsibility for their provided information.

5. The Minister of Health shall be responsible for organizing an information system on medical devices.

Article 62. Advertising of medical devices

1. Contents of an advertisement for a medical device must be consistent with one of the following documents:

a) The application dossier for declaration of applied standards of Class-A or Class-B medical devices;

b) The application dossier for registration number of Class-C or Class-D medical devices.

2. An advertisement for a medical device must include the following information:

a) The name, category, product code, manufacturer and manufacturing country of the medical devices;

b) The registration number;

c) The functions and uses;

d) The name and address of the registration number holder or the organization authorized by the registration number holder;

dd) Health warnings for medical devices users and storage conditions (if any).

3. Audio or video advertisement on medical devices must display clearly information specified in Clause 2 of this Article.

4. Before carrying out the advertising, the registration number holder or the organization authorized in writing by the registration number holder shall be responsible for publishing planned contents and form of advertising on the Portal on the management of medical devices.

5. The registration number holder or the organization authorized by the registration number holder shall take responsibility before law for the conformity of advertisement contents with the planned advertisement contents having been published and the application dossier for declaration of applied standards of Class-A or Class-B medical devices or the application for registration of Class-C or Class-D medical devices.

6. Documents or materials that do not mention the name of medical devices; those that contain only name and technical specifications of the medical devices without information on the functions or uses; scientific research documents; clinical documents; documents used for training in use of medical devices shall not be considered as advertising documents.

 

Chapter X

MANAGEMENT AND USE OF MEDICAL DEVICES AT MEDICAL FACILITIES

 

Article 63. Principle for the management and use medical devices

1. The management and use of medical devices must be conformable to the purposes, utilities, policies, economical and effective.

2. Medical devices must be inspected, maintained, repaired, used and must comply with other manufacturer's technical instructions and undergo inspection in accordance with regulations of this Decree to ensure quality.

For medical devices subject to strict occupational safety and health requirements, such devices must comply with regulations on quality control specified in this Decree and law regulations on occupational safety and health.

3. Dossiers on medical devices shall be compiled, managed and retained sufficiently; the settlement of medical devices in physical form or in value shall be conducted in accordance with current law regulations on accounting and statistics and other relevant law provisions; the funding for the performance of tasks specified in Clause 2 of this Article shall be ensured.

4. To undergo the inspection, monitoring and supervision of competent agencies in charge of managing medical devices.

Article 64. Management and use of medical devices in State-owned health facilities

State-owned health facilities, apart from complying with law regulations on management and use of medical devices specified in Article 63 of this Decree, shall manage medical devices in accordance with the following provisions:

1. Investment in, purchase, management and use of medical devices shall comply with law regulations on management and use of public assets.

2. The use of domestically manufactured medical devices shall be encouraged.

Article 65. Rights and responsibilities of health facilities for management and use of medical devices

1. Health facilities shall have the following rights:

a) To request the registration number holder or the warranty center recognized by the product owner to provide periodical maintenance of such medical devices during the warranty period;

b) To request the seller to provide technical documents of such medical devices;

c) To receive the used medical devices to serve their scientific research and training in use and repair of medical devices.

2. Health facilities shall be responsible for:

a) Using and operating the medical devices in accordance with the instructions of the product owner;

b) Carrying out periodical maintenance, inspection and calibration in accordance with the instructions of the product owner or as prescribed by the law;

c) Participating in testing for and assessment of quality of medical devices;

d) Reporting on cases of defective medical devices and other information at the request of competent State agencies.

 

Chapter XI
ONLINE DECLARATION AND REGISTRATION

 

Article 66. Procedures to be conducted online

1. Declaration of eligibility for manufacture of medical devices.

2. Declaration of applied standards for medical devices.

3. Application for registration of medical devices.

4. Declaration of eligibility for medical devices trading.

5. Declaration of eligibility to provide medical devices technical consulting.

6. Application for the Certificate of registration of medical devices inspection services.

7. Application for the License to import medical devices.

8. Application for the Certificate of free sale for domestically manufactured medical devices.

9. Declaration of prices of medical devices.

10. Declaration of concentration, content of raw materials for manufacture of medical devices and substances for external quality assessment that contain narcotic substances and precursors.

11. Declaration of contents and form of advertising of medical devices.

Article 67. Requirements for online application dossiers

The application dossiers for declaration, registration, and issuance of the Certificate of free sale (hereinafter referred to as “online application dossiers”) shall be considered valid when meeting the following requirements:

1. Containing adequate documents and the contents of such documents are declared as fully in accordance with law regulations as physical dossiers and are converted into electronic documents. The name of electronic documents must be relevant to the name of documents included in the physical dossiers.

2. Information on the declaration, registration and application for license must be compiled adequately and accurately in electronic documents.

Article 68. Procedures for online declaration

1. The legal representatives or their authorized persons shall declare information, upload electronic documents, make confirmation using digital signature (if any) and make online application fee payment in accordance with the prescribed procedures on the Portal on the management of medical devices.

2. The agencies in charge of receiving online application dossiers shall carry out administrative procedures relevant to the application dossiers in accordance with regulations of this Decree.

3. The results of online administrative procedures shall have the same legal effect as those of normal administrative procedures.

Article 69. Storage of online application dossiers

1. In cases of conducting online registration, the applying establishment shall be required to store physical documents of such application dossier in accordance with Clause 1 Article 33 of this Decree.

2. In cases where any physical documents included in the application dossier specified in Clause 1 of this Article is lost or damaged, the applying establishment shall be responsible for sending a written notice to the receiving agency, repreparing the dossier, sending a written notice to the receiving agency on the completion of such dossier, and updating the dossier after getting the approval from the receiving agency.

3. Within 35 days from the date on which the written notice on the loss of the dossier is received, if the applying organization fails to send a written notice on their completion of the dossier, the receiving agency shall be responsible for:

a) Removing all information published on the Portal about the medical device manufacturer, medical device trading establishment or medical devices consultant, raw materials for manufacture of medical devices, substances for external quality assessment that contain narcotic substances and precursors, medical devices inspection service provider, and registration number of the medical devices;

b) Revoking the registration number and License to import medical devices.

4. The applying establishment shall not be allowed to continue their operation and medical devices shall not be allowed to be put on the market from the date on which the receiving agency removes information in accordance with regulations in Clause 3 of this Article.

 

Chapter XII
ORGANIZATION OF IMPLEMENTATION

 

Article 70. Responsibility of the Ministry of Health

The Ministry of Health shall assume responsibility before the Government for state management on medical devices and shall have the following tasks and powers:

1. To submit to the Government or Prime Minister to promulgate, or promulgate within their jurisdiction legislative documents, national technical regulations, strategies, policies and plans on medical devices.

2. To direct and organize the implementation of legislative documents, national technical regulations, strategies, policies and plans on medical devices.

3. To organize information dissemination and communication on medical devices.

4. To provide training for human resources in the field of medical devices.

5. To publish the following information on the Ministry of Health’s Portal:

a) Prices of medical devices declared by enterprises;

b) Prices of winning bids for medical devices of State-owned health facilities nationwide;

c) List of medical devices whose registration number has been revoked.

6. To decide on the application or exemption of provisions of this Decree to products or goods which are considered as medical devices in some countries but may not be considered as such in other countries.

7. To carry out the inspection and settlement of complaints, denunciations and take actions against violations in the field of medical devices. During the inspection and control of medical device prices, if any establishment is found to inadequately declare medical device prices, the competent State management agency under the Ministry of Health shall notify the declaring establishment to review their price declaration and provide explanations.

8. To update and publish the list of organizations specified at Point a, Clause 2, Article 29 of this Decree.

9. To provide detailed regulations on classification of medical devices which must be conformable to ASEAN’s treaties on the classification of medical devices to which Vietnam is a signatory; to issue practical training programs on the classification of medical devices.

10. To issue the list of medical devices subject to inspection and class-based inspection procedures for listed medical devices.

11. To provide guidelines for the common submission dossier template on medical devices in accordance with ASEAN’s regulations.

12. To provide specific provisions on the forms providing details on the implementation of this Decree.

Article 71. Responsibility of the Ministry of Science and Technology

1. To promulgate the list of medical devices which are measuring devices subject to sample approval, inspection and calibration after obtaining the consent from the Ministry of Health.

2. To assume the prime responsibility and cooperate with the Ministry of Health in developing the national standards on medical devices; quality inspection of medical devices that are measuring devices and radiation devices.

Article 72. Responsibility of the Ministry of Finance

1. To provide guidelines for the management of public assets that are medical devices for State-owned health facilities after obtaining opinions from the Ministry of Health.

2. To provide specific provisions on the management and use of fees and charges in the field of medical devices in accordance with law regulations on fees and charges.

3. To carry out examination, inspection and take sanctions against violations in the field of medical devices.

Article 73. Responsibility of provincial People’s Committees

1. To assume responsibility to manage activities related to trading and use of medical devices in their locality.

2. To organize information dissemination and communication on medical devices in their locality.

3. To provide training for human resources in the field of medical devices in their locality.

4. To publish on the Portal of the provincial People's Committee and send to the Ministry of Health the following information:

a) Prices of winning bids for medical devices of State-owned health facilities in their locality.

b) List of medical devices whose registration number has been revoked in their locality

5. To carry out the inspection, examination and settlement of complaints, denunciations and handle violations in the field of medical devices in their locality

Article 74. Responsibility of organizations and individuals trading in medical devices

1. Organizations and individuals trading in medical devices must take responsibility for the safety and quality for the medical devices which they are traded.

2. Domestic medical devices manufacturers shall take responsibility to manage quality of medical devices during manufacture, transportation and storage process of medical devices in accordance with their application dossiers for registration number.

3. Registration number holders shall take responsibility:

a) To carry out classification of medical devices, publish on the Ministry of Health’s Portal and take responsibility before law for their classification results;

To take remedial measures for incorrect classification results that reduce the level of risks of classified medical devices or incorrect classification results in terms of competence specified in this Decree.

b) To conduct the declaration of applied standards or application for registration of medical devices in accordance with this Decree. To take responsibility before law for the accuracy and truthfulness of their application dossiers for registration number;

c) To establish and maintain operation of warranty centers for medical devices or sign service contracts with qualified warranty service providers, except for cases of disposable medical devices as defined by product owners or cases where there are documents proving that the medical devices are not under warranty;

d) To prepare and maintain documents on the management of medical devices and carry out the tracing of origin of medical devices as prescribed in this Decree, except for cases of disposable medical devices as defined by product owners; to report to the Public Security force upon the loss of medical devices or raw materials for manufacture of medical devices that contain narcotic substances and precursors;

dd) To provide adequate and accurate information about the product on the label and user manual of the medical devices in accordance with law regulations on goods labels and law regulations of this Decree;

e) To issue prompt, adequate and accurate warnings about the risks to users’ health and the environment; preventative measures for sellers and users to minimize the risks; provide information about requirements for transportation, storage and use of medical devices;

g) To promptly suspend placement on the market, notify relevant parties and take handling and remedial actions or recall defective medical devices in accordance with law regulations of this Decree. In cases of handling by destruction of defective medical devices, the destruction shall comply with law regulations on environmental protection and relevant law regulations and the registration number holders shall bear all the destruction costs;

h) To comply with law regulations and decisions on the inspection and examination issued by competent State management agencies;

i) To pay compensation for damage caused by defective medical inspection as prescribed by the law;

k) To ensure that the following documents are effective during the effective period of the registration number:

- The Certificate of free sale (for imported medical devices);

- The written authorization, except the case specified at Point a, Clause 1 Article 25 of this Decree;

- The Certificate of eligibility to provide warranty services, except for cases of disposable medical devices defined by product owners or cases where there are documents proving that the medical devices are not under warranty.

l) To take responsibility to ensure that the medical devices are only manufactured during the effective period of the Certificate of conformity with quality control standards;

m) To take responsibility before law for the legitimacy and accuracy of the documents posted while conducting the procedures specified in this Decree;

n) To provide health facilities that buy the medical devices with 01 set of quality control dossier specified in Clause 4, Article 33 of this Decree;

o) To directly or designate an organization to declare and update selling prices of medical devices;

p) To perform other obligations as prescribed by the law.

4. Trading, exporting, importing and transferring establishments of medical devices, substances for external quality assessment that contain narcotic substances and precursor shall be responsible for submitting annual reports to the Ministry of Health and the Ministry of Public Security by January 15 of the following year.

 

Chapter XIII
IMPLEMENTATION PROVISIONS

 

Article 75. Effect

1. This Decree takes effect from January 01, 2022.

2. The following Decrees shall cease to be effective from the date on which this Decree takes effect:

a) The Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on prescribing regulations on the management of medical devices;

b) The Government’s Decree No. 169/2018/ND-CP dated December 31, 2018 on amending and supplementing a number of articles of the Government's Decree No. 36/2016/ND-CP dated May 15, 2016 on the management of medical devices;

с) The Government’s Decree No. 03/2020/NĐ-CP dated January 01, 2020 on amending and supplementing Article 68 of the Government’s Decree No. 36/2016/ND-CP dated May 25, 2016 the management of medical devices which is amended and supplemented in the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018 on amending and supplementing a number of articles of the Government's Decree No. 36/2016/ND-CP dated May 15, 2016 on the management of medical devices;

3. To annul the regulations in Article 7 of the Government’s Decree No. 181/2013/ND-CP dated November 14, 2013 prescribing in detail a number of articles of the Law on Advertising from July 01, 2022.

Article 76. Transitional provisions

1. Medical devices which have been manufactured in Vietnam or imported into Vietnam before the date on which this Decree takes effect shall continue to be placed on the market until they are liquidated in accordance with law regulations on the management and use of public assets or the expiry date specified on the Certificate of registration or expiry date of the product.

2. Regulations on the validity of the registration number or import license issued before January 01, 2022:

a) Registration numbers of medical devices which have been issued in accordance with the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016, as amended and supplemented in the Government’s Decree No. 169/2018/ND-CP and the Government’s Decree No. 03/2020/ND-CP (hereinafter referred to as “the Decree No. 36/2016/ND-CP”) shall be valid for indefinite term;

b) For domestically manufactured medical devices which have been issued Certificates of registration, such Certificates of registration shall be valid until the expiry dates written on the Certificate;

c) For medical devices not being in vitro diagnostic reagents which have been issued the import license from January 01, 2018, their import license shall be valid until December 31, 2022;

d) Medical devices which are not required to obtain the import license (except for insecticidal and germicidal chemicals and preparations for medical and household use which are used solely for disinfection of medical devices) and have been classified as Class-C or D medical devices as announced on the Ministry of Health’s Portal may continue to be imported until December 31, 2022 without limits on quantities and written confirmation as medical devices from the Ministry of Health when conducting the customs clearance;

dd) Medical devices that are in vitro diagnostic reagents and have been granted registration number within the period from January 01, 2014 to December 31, 2017, such registration numbers shall be valid until December 31, 2022;

e) Medical devices that are in vitro diagnostic reagents and have been granted registration number from January 01, 2018, such registration numbers shall be valid until the expiry dates written on the registration;

g) Import licenses issued to medical devices that are in vitro diagnostic reagents from January 01, 2018 shall be valid until December 31, 2022 without limits on quantities. The Customs agencies shall not control the import quantities in such cases.

3. Application dossiers for registration number which are submitted in accordance with the Decree No. 36/2016/ND-CP before January 01, 2022 but have yet to be granted the registration number before the date on which this Decree takes effect shall be processed as follows:

a) For application dossiers for registration of Class-B medical devices, the Ministry of Health shall instruct the applying enterprises to review the application dossier to declare the applied standards in accordance with regulations in this Decree without re-paying fee for inspection and licensing;

b) For application dossiers for registration of Class-C or D medical devices if they meet the requirements specified in Clause 3, Article 30 of this Decree, the Ministry of Health shall issue the registration number in accordance with the procedures specified in Article 32 of this Decree;

c) It is possible to use the classification results provided by the classification organization that has been granted the receipt of the application for declaration of eligibility to classify medical devices before the effective date of this Decree in the application dossier for registration number.

4. The application dossiers for license to import medical devices which have been submitted before January 01, 2022 shall be processed in accordance with legislative documents promulgated by the Minister of Health before the date on which this Decree takes effect. The import license issued in accordance with the regulations in this Clause shall be valid until December 31, 2022.

5. Labels of medical devices which have been manufactured in Vietnam or imported into Vietnam before the dates specified in Clause 2 and Clause 4 of this Article shall continue to be used until the expiry date of such medical devices or until the medical devices are liquidated in accordance with law regulations on the management and use of public assets or until the expiry date specified on the Certificate of registration or the expiry date of the product.

6. Regulations on the application of CSDT:

a) CSDT shall be compulsory from January 01, 2023.

b) For application dossiers for issuance of registration number submitted before December 31, 2022, the dossier shall consist of the documents specified at Points a, b, d, dd, Clause 1, Article 30 of this Decree and the following documents:

- A synopsis of technical description of the medical devices in Vietnamese language, accompanied by technical documents describing functions and specifications of the medical devices issued by the product owner.

For in-vitro diagnostic reagents, calibrators and control materials, the synopsis of technical description in Vietnamese language must be accompanied with documents on the materials, the safety of the product, the manufacturing and safety control process, pre-clinical and clinical study reports including the stability report.

- User manual of the medical devices.

- Sample of the label for the medical devices sold in Vietnam.

The above-stated documents must satisfy the following requirements:

- For technical documents of the medical devices: submit the copy with the certification of the applying organization.

- For user manual of the medical device: submit the copy in Vietnamese with the certification of the applying organization, accompanied by the original copy in English issued by the product owner in case of imported medical device.

- For sample label: the sample label with the certification of the applying organization. The sample label must meet requirements in accordance with law regulations on labeling of goods.

c) The receipt, inspection of application dossiers for registration of a medical device prescribed at Point b of this Clause shall be conducted as follows:

- If there is no need to amend, supplement the application dossier for registration, the Minister of Health shall be responsible for: Organizing inspection to issue the registration number within 90 days from the date on which a full and valid dossier is received (including receipt of inspection application fee as prescribed by the Ministry of Finance). In cases of not issuing the registration number, there must be a written reply which clearly states the reason.

- If the application dossier is not satisfactory, the Ministry of Health shall send a written notice to request for amendment and supplement of such dossier, in which the documents and contents requiring amendment must be specified within 70 days from the date on which a full and valid dossier is received;

- Upon receiving the request for amending and supplementing the application dossier for registration number, the applying establishment must amend and supplement in accordance with the notified contents and send to the Ministry of Health.

In cases where the applying establishment has amended and supplemented such dossier but the modified application is still unsatisfactory, the Ministry of Health shall send a written notification to the applying establishment to continue to complete the dossier in accordance with regulations at Point b, Clause 6 of this Article.

Within 90 days from the date on which the Ministry of Health issues the written request, if such establishment fails to amend, supplement the dossier or if after 05 times of amendment and supplement of the dossier from the date on which the Ministry of Health issues the first written request, the dossier is still unsatisfactory, the procedure to request for the registration number must be conducted from the beginning.

7. The declaration of contents and form of advertising of medical devices shall be applied from July 01, 2022.

8. Holders of registration numbers or Licenses to import medical devices issued before the date on which this Decree takes effect shall be required to comply with the provisions of Clause 4, Article 45 of this Decree before April 01, 2022 for their medical devices being in circulation in Vietnam and before introducing their imported medical devices to the market of Vietnam.

Article 77. Responsibility for guidance and implementation

1. The Minister of Health shall be responsible for providing guidelines, organizing and inspecting the implementation of this Decree.

2. Ministers, Heads of ministerial agencies, Heads of Governmental agencies, Chairpersons of Provincial People’s Committees and relevant agencies, organizations and individuals shall be responsible for the implementation of this Decree.

For the Government

For the Prime Minister

          The Deputy Prime Minister

          Vu Duc Dam