Nghị định 36/2016/NĐ-CP về quản lý trang thiết bị y tế

THE GOVERNMENT

DecreeNo. 36/2016/ND-CP dated May 15, 2016 of the Governmenton medical equipment management

Pursuant to the Law on Government organization dated December 25, 2001;

Pursuant to the Law on Investment dated November 26, 2014;

At the request of the Minister of Health;

The Government hereby promulgates the Decree on medical equipment management.

Chapter I

GENERAL PROVISIONS

Article 1. Scope ofadjustment

This Decree provides for the management of medical equipment, including the classification of medical equipment; the manufacture, sale of medical equipment and provision of services related to medical equipment; information and label of medical equipment and the management and use of medical equipment at medical facility.

Article 2. Interpretation of terms

1. ”Medical equipment” are all kinds of equipment, tools, materials for implanting activities, reagents and in vitro calibration solutions, software which are used seperately or in association with each other according to the instruction of their owners for human use for one or more of the following purposes:

a) To diagnose, prevent, supervise, treat and eliminate the illness or to make up for pains;

b) To examine, replace, adjust or assist surgery activities or phisiology processes;

c) To support or sustain life;

d) To control the conception;

dd) To sterilize medical equipment, including chemicals used in testing;

e) To serve the specialized transport or use for healthcare activities;

g) Provide information serving the diagnosis, supervision and treatment through the examination of samples taken from human body.

2.“In vitro diagnosis medical device” includes reagents,calibrationsolutions, control materials, tools, machinery, devices and systems which are used separately or together according to the instruction of their ownersto serve the examination of samples taken from human body.

3. “Fittings”are products which are decided by the owner of the medical equipment to be used for a specific purpose together with a specific medical equipment to facilitate or assist such equipment to be used for its intended use.

4.The owner of the medical equipment is an organization or an individual that:

a) Provide medical equipment using its/his/her name or any label, design, trade name or other name or code within the possession of such individual/organization;

b) Take responsibility for the design, production, assembly, processing, labelling, packaging or the repair of medical equipment or the determination of the use of such medical equipment.

Article 3. Rules on management of medical equipment

1.Assure the quality and safety of medical equipment and assure the effective use thereof.

2.Promptly provide sufficient and accurate information about specifications and uses of medical equipment and possible risks thereby to the users.

3.Ensure thetraceability ofthe origin of the medical equipment.

4.The management of medical equipment must be based on the classification according to levels of risks and the respective national standards and National technical regulations which are issued or recognized by competent authorities or published and applied by organizations/individuals according to laws.

5.Medical equipment being measurement instruments or radiological equipment must be managed according to laws on measuring and laws on atomic energy and the provisions of this Decree.

Chemicals and preparations which are used only forsterilizingmedical equipment shall be managed according to regulations in this Decree. Chemicals and preparations which are used not only for sterilizing medical equipment but also for other purposes shall be managed according to laws pertaining to chemicals and/or preparations killing insects and bacteria for domestic and medical use.

Chapter II

CLASSIFICATION OF MEDICAL EQUIPMENT

Article 4. Medical equipment’s types

Medical equipment shall be classified into 2 groups which are divided into 4 types depending on the possible levels of risks related to the design and production of such medical equipment:

1.Group 1comprises Type Amedical equipment which is medical equipment with low level of risks.

2.Group 2comprises Type B, C and Dmedical equipment, where:

a)Type B medicalequipment is medical equipment with lower average level of risks;

b)Type C medicalequipment is medical equipment with upper average level of risks;

c) Medical equipment ofTypeB is medical equipment with high level of risks.

Article 5. Rules on classification of medical equipment

1.The classification of medical equipment must be based on the classification of levels of risks.

2.If medical equipment can be classifiedintomultiple levels of risks, its highest level of risks shall prevail.

3.If the medical equipment is intended tobeused together with other medical equipment, such equipment shall be classified separately.

4.If the medical equipment is intended tobeused together with other medical equipment or the medical equipment has multiple uses, the classification must be based on its most important use.

5.The Minister of Health shall be responsible for detailing the classification of medical equipment according to international treaties on classification of medical equipment by Association of Southeast Asian Nations to which Vietnam is a signatory.

Article 6. Conduct of classification of medical equipment

1.The classification of medical equipment must be conducted by an organization satisfying conditions specified in Article 7 of this Decree.

2.The organization conducting the classification of medical equipment must take legal responsibility for the classification of such medical equipment.

3.If there is difference in the classification of medical equipment, such classification shall be decided by the Ministry of Health.

Article 7. Requirements to be satisfied by organizations conducting classification of medical equipment

1.Any organization must satisfy the following requirements to conducttheclassification of medical equipment

a) Legally established as prescribed by laws;

b) Havingqualifiedmedical equipment-classifying employeesaccording toclause 2 of this Article.

2.Conditions of medical equipment-classifying employees:

a) Havingat least a bachelor’s degree in technologyor medicine/pharmacy;

b) Havingat least 24 months’ experience of workinginthefield of medical equipmenttechnologiesat hospitals, medical facilities having beds, training institutions specified in medical equipment, facilities researching medical equipment, establishments producing medical equipment, organizations conducting the classification of medical equipment, agencies managing medical equipment (hereinafter referred to as “medical equipment facilities”);

c) Having beentestedand recognized byatraining institutionascapable of classifying medical equipment according to the training program issued by the Ministry of Health.

3.Such organizations shall conduct the classification of medical equipment only when it has obtained the receipt noteforthedeclarationofeligibility to classifymedical equipment from the Ministry of Health according to provisions of point b clause 1 Article 9 of this Decree.

Article 8. Declaration of eligibility to classify medical equipment

1. A declaration of elibility to classifymedical equipment shall consist of:

a) A writtendocument declaring the eligibility to classifymedical equipment using the form No. 01 specified in Appendix I enclosed with this Decree;

b) Alist of employeesusing the form specified in Appendix II enclosed with this Decree; accompanied by a written certificate of working time using the form in Appendix III enclosed with this Decree and qualifications of each employee conducting the classification of medical equipment.

2.Requirements for documents in thedeclaration:

a)Original copies orcertified true copiesofthe certificates of working time;

b) Certified true copiesofqualifications of employees conducting the classification of medical equipment.

Article 9. Procedures for declaring eligibility to classify medical equipment

1.Procedures fordeclaring the eligibility to classifymedical equipment:

a) Before classifying medical equipment, the organization conducting the classification of medical equipment shall send thedeclaration of eligibility to classifymedical equipment specified in clause 1 Article 8 of this Decree to the Ministry of Health;

b) If thedeclarationis satisfactory, the Ministry of Health shall issue the organization conducting the classification with the receipt note using the form No. 01 specified in Appendix IV enclosed herewith;

c) Within 03 working days from the date written on the receipt note, the Ministry of Health shall publish the following information onitswebportal: name, address, phone number of the organization conducting the classification of medical equipment and thedeclaration of eligibility to classifymedical equipment.

2.If there is any modification in thedeclarationduring its operation, the organization conducting the classification of medical equipment shall re-conduct the procedures fordeclaration of eligibility to classifymedical equipment.

Article 10. Recognition of classification of medical equipment

1. Medical equipment are not required to be reclassified in Vietnam if it has been classified by a competent regulatory body of a country recognized by Vietnam on the basis of international treaties or international arrangements to which Vietnam is a party or of a country which adopts a medical equipment classification system similar to that adopted by Vietnam.

2. The Minister of Health shall publish the list of countries whose medical equipment classifications have been recognized by Vietnam.

Chapter III

PRODUCTION OF MEDICAL EQUIPMENT

Article 11. Investment incentives for the production of medical equipment

1. Reduction or exemption from rents for State owned land:

a) Any investor having a project of producing Type B medical equipment that leases state-owned land shall be eligible for the rental rate prescribed by People’s Committees of provinces/central-affiliated cities and shall be eligible for exemption from land rents according to laws;

b) Any investor having a project of producing Type C or D medical equipment shall be eligible for exemption from land rents from the day on which the project is launched;

c) Any investor having a project of producing medical equipment shall be eligible for exemption from rents for land used for the construction of accommodations for employees or for planting public trees.

2. Apart from investment incentives specified in clause 1 of this Article, the project of producing medical equipment shall be eligible for other investment incentives as prescribed by laws on investment and science and technology.

Article 12. Requirements for employees of producers of medical equipment

1. The professionals must:

a) Have qualifications specified in medical equipment technology of college level or higher or having qualifications specified in technique or medicine of university level or higher;

b) Have at least 24 months experience of working in the field of technique of medical equipment at a medical equipment-providing facility for at least 24 months;

c) Be a full-time worker at the producer’s factory. The assignment and appointment of professionals producershall be made in writing.

2. Other employees must satisfy requirements for producing medical equipment producermanufactured.

Article 13. Requirements for infrastructures, equipment and quality control of producers of medical equipment

1. Having conditions of location, area and factory in conformity with the medical equipment that such producer produces.

2. Having equipment and procedures of production and quality inspection in conformity with the medical equipment that such producer produces. In case there is no equipment for quality inspection, a contract with an establishment capable of conducting quality inspection for the medical equipment shall be concluded.

3. Having storage facilities at least conformable to the following conditions:

a) Having area in accordance with the type and the quantity of the medical equipment to be stored;

b) Being airy, dry, clean, separate from sources of pollution;

c) Satisfying other storing requirements applicable to medical equipment according to the instruction.

4. Having vehicles for delivering medical equipment from producing establishments in accordance with the medical equipment.

5. Applying the quality control system prescribed in clause 1 Article 68 of this Decree.

6. If the establishment does not have storage facilities and vehicles for transporting medical equipment, a contract with an establishment satisfying requirements for storage facilities and transport of medical equipment as prescribed in clauses 3 and 4 of this Article shall be concluded.

Article 14. Declaration of eligibility to produce medical equipment

A declaration of eligibility to produce medical equipment shall consist of the following documents:

1. A declaration of eligibility to produce medical equipment using the form No. 02 specified in Appendix I enclosed with this Decree.

2. A list of employees using the form specified in Appendix II enclosed with this Decree.

3. A document on assignment/appointment of professionals of the producing establishment, enclosed with the certificates of working time using the form in Appendix III enclosed with this Decree and qualifications of the professionals.

4. A certificate of conformity with quality control standards.

In case of unavailability of the certificate of conformity with quality control standards, documents proving facilities satisfying requirements specified in clauses 1, 2, 3 and 4 Article 13 of this Decree are required.

In case the establishment fails to conduct the product quality inspection itself, or in case the establishment does not have storage facilities or transport vehicle and sign a contract with another establishment for quality inspection, storage and transport, documents proving that such contracting establishment is capable of conducting quality inspection, storing and transporting medical equipment produced by the producing establishment must be enclosed.

Article 15. Requirements for declaration of eligibility to produce medical equipment

1. The declaration of eligibility to produce medical equipment shall be made in 1 copy, where:

a) Documents  shall be readable and arranged according to the order provided for in Article 14 of this Decree; there shall be separators between different parts, there shall be cover pages and the table of contents;

b) Documents must be made in either English or Vietnamese.

2. Requirements for documents in the declaration of eligibility to produce medical equipment:

a) An original copy or a certified true copy of the written assignment/appointment or qualifications of professionals of the producing establishment;

b) The original copies or the certified true copies of documents proving that the establishment satisfying requirements specified in clauses 1, 2, 3 and 4 Article 13 of this Decree;

c) An original copy or a certified true copy or a copy certified by the applicant establishment of the Certificate of conformity with quality control standards.

Article 16. Procedures for making declaration of eligibility to produce medical equipment

1. The establishment shall carry out the production of medical equipment only when it has obtained the receipt note prescribed in point b clause 2 of this Article.

2. Procedures for making declaration of eligibility to produce medical equipment:

a) Before producing medical equipment, heads of medical equipment producing establishments shall send a declaration of eligibility to produce medical equipment specified in Article 14 of this Decree to the Department of Health of the area where the producing establishment is headquartered;

b) If the declaration is satisfactory, the Department of Health shall issue the establishment with the receipt note using the form No. 02 in Appendix IV enclosed with this Decree;

c) Within 03 working days from the date written on the receipt note, the Department of Health shall publish the following information on its web portal: name of the establishment; the professionals in charge; medical equipment produced by the establishment; contact address and phone number and the declaration of eligibility to produce medical equipment, except for the producing procedures and the quality inspection prodedures.

3. During its operation, if there is any change related to the accepted declaration, the producing establishment shall re-conduct the procedures for declaration of eligibility to produce medical equipment.

4. If the producing establishment has its producing site relocated to another province, is must notify the Department of Health where it has make the declaration of eligibility to produce medical equipment within 10 working days from the date of relocation.

Within 03 working days from the day on which the notification of the relocation of producing site is received, the Department of Health receiving the declaration of eligibility to produce medical equipment shall terminate the publication of information relevant to such establishment.

Chapter IV

SALE OF MEDICAL EQUIPMENT

Section 1. REQUIREMENTS FOR SALE, REGISTRATION NUMBER AND REQUIREMENTS FOR ORGANIZATION DECLARING APPLICABLE STANDARDS OR CONDUCTING REGISTRATION

Article 17. Requirements for selling medical equipment

1. Any medical equipment to be sold must satisfy the following requirements:

a) Having effective registration number or having obtained permission for import according to provisions of this Decree;

b) Having label or supplementary label containing sufficiently information specified in Article 54 of this Decree;

c) Having technical documents serving the repair and maintenance of medical equipment, excluding disposable medical equipment prescribed by its owner;

d) Having Vietnamese instruction of how to use the medical equipment;

dd) Having information about warranty establishments, conditions and duration, unless the equipment is disposable as decided by its owner.

2. The information specified in points c, d and dd clause 1 of this Article which is not enclosed with the equipment must be provided in form of electronic information; guidelines for accessing to such information must be clearly stated on the label of the medical equipment.

Article 18. Conditions for declaring applicable standards of application or issuance of certificate of registration for medical equipment

1.Conditions for declaring the applicable standards or the issuing the certificate of registration for medical equipment

a) Such equipment shall be manufactured at the producing establishment which has declared its eligibility to produce domestically produced medical equipment;

b) Such equipment shall be manufactured at an establishment which has been issued with the Certificate of conformity with quality control standards and permitted to be sold in any country in the world, applicable to imported medical equipment;

c) Such equipment shall be conformable to National technical regulation or the standard that the producer has declared to be applied.

2.The re-conduct of the procedures for declaring the applicable standards or conducting registration shall not be applicable to:

a) Medical equipment specified in clause 1 Article 34 of this Decree;

b)Medicalequipmentthatisrecalled according to regulations in clauses 1 and 3 Article 35 of this Decree.

3.The declaration of applicable standard or the application for registration of medical equipment of any of cases specified in clauses 2 and 8 Article 35 of this Decree shall not be accepted for 12 months from the day on which the decision to revoke the registration number is issued.

Article 19. Medical equipment exempt from declaring applicable standards or registering

1.Medical equipment that is used solely for researching, testing or repairing medical equipment or guiding the use thereof.

2.Medical equipment imported into Vietnam for assisting purpose or for displaying at a fair, exhibition or for product introduction or as a gift.

3.Medical equipment produced in Vietnam solely for export or for displaying at an overseas fair or exhibition.

Article 20. Registration number of medical equipment

1.Registration number of medical equipment means:

a)The number of the receipt note of the declaration of applicable standard, applicable to Type A medical equipment, using the form No. 03 provided in Appendix IV enclosed with this Decree;

b) The number of thecertificate of registration, applicable to type B, C or Dmedical equipment,using the form No. 09 provided in Appendix IV enclosed with this Decree.

2.The registration number of medical equipment may be issued to one or a group of medical equipment type.

3.The holder of the registration number is the organization declaring the applicable standards, applicable to type A medical equipment, or the organization obtaining the registration number, applicable to type B, C or D medical equipment.

4.Effect of the registration number:

a) The registration number of type A medical equipment shall be permanently effective;

b) The registration number of type B, C or D medical equipment shall be effective for 05 years from the date of issue. In case where the effect of the registration number is extended, the registration number shall be retained.

Article 21. Requirements for organizations declaring applicable standards or applying for registration of medical equipment

1.The following organizations are allowed to declare the applicable standards or applying for the registration of medical equipment:

a) Vietnamese enterprises, cooperatives or business households that are in possession of medical equipment;

b) Vietnamese enterprises, cooperatives or business households trading medical equipment that are authorized by medical equipment s owners to follow the registration procedures;

c) Standing representative offices in Vietnam of foreign traders who are the owners of the medical equipment or who are authorized by the owners of the medical equipment.

2.Any organization declaring the applicable standard or registering for selling medical equipment must have warranty establishments in Vietnam or sign a contract with an organization capable of providing warranty services on medical equipment which is registered by its name, except for disposable medical equipment as prescribed by the owners of such medical equipment.

If the organization declaring the applicable standard or conducting the registation for selling medical equipment is of those specified in point c clause 1 of this Article, the owners of the medical equipment sign a contract with an organization capable of providing warranty services on medical equipment which is declared by its name, except for disposable medical equipment as prescribed by the owners of such medical equipment.

The warranty establishment shall be certified by the owner of the medical equipment to be capable of providing warranty on products which are registered by such organization.

Section 2. PUBLICATION OF APPLICABLE STANDARDS OF TYPE A MEDICAL EQUIPMENT

Article 22. Declaration of applicable standard

The declaration of applicable standard for type A medical equipment shall consist of:

1.A declaration of the applicable standard of type A medical equipment using the form No. 03 provided in Appendix I enclosed with this Decree.

2.A classification table using the form in Appendix V enclosed with this Decree.

3.A receipt note of the declaration of eligibility to produce medical equipment, applicable to domestically produced equipment, or the Certificate of conformity with quality control standards which is effective by the time of declaration, applicable to imported equipment.

4.The power of attorney by the owner of the medical equipment for the organization declaring the applicable standard using the form in Appendix VI enclosed with this Decree which is effective by the time of declaration, except for cases specified in point a clause 1 Article 21 of this Decree.

5.The certificate of eligibility to provide warranty issued by the owner of the medical equipment using the form provided in Appendix II enclosed with this Decree, excluding disposable medical equipment prescribed by its owner.

6.Documents that give brief description of medical equipment technology using the form No. 01 in Appendix VIII enclosed with this Decree.

7.The standard which the owner of the medical equipment declares to apply or the Certificate of conformity.

8.Written instruction for the medical equipment.

9.The label of the medical equipment which is intended to be used when it is sold in Vietnam.

Article 23. Requirements for declaration of applicable standards

1.The declaration of applicable standard shall be made in 01 dossier.

2.Requirements for a number of documents in the declaration of applicable standard:

a) Regarding the receipt note of the declaration of eligibility to produce medical equipment: a copy which is certified by the organization declaring the applicable standard is required.

b)Regarding the Certificate of conformity with quality control standard: an original copy or a certified true copy or a copy certified by the establishmentdeclaring the applicable standard is required;

If the copy certified by the organization declaring the applicable standard is used, at the time of submission of the declaration, the original copy shall be presented for comparison or data sources shall be provided so that the receiving body checks the validity of such documents;

Any Certificate of conformity with quality control standard which is not made in English nor Vietnamese shall be translated into Vietnamese. The translation must be authenticated according to laws.

c) Regarding the power of attorney of the owner of medical equipment and the Certificate of eligibility to provide warranty:

-Regarding domestically produced medical equipment: an original copy of a certified true copy is required;

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

d) Regarding the Certificate of conformity or the standard declared by the owner of the medical equipment: a copy certified by the organizartion declaring the applicable standard is required.

Any Standard which is not made in English nor Vietnamese shall be translated into Vietnamese. The translation must be authenticated according to laws;

dd) Regarding the instructions for the medical equipment: a Vietnamese copy certified by the organization declaring the applicable standard is required;

e) Regardingthe label model: a copy which is certified by the organizationdeclaringthe applicable standardis required.The label model must satisfy requirements specified in Article 54 of this Decree.

Article 24. Procedures for declaring applicable standard

1.Type A medical equipment shall be sold only when the receipt note for the declaration of applicable standard has been issued by the Department of Health as prescribed in point b clause 2 of this Article.

2.Procedures for declaring applicable standard:

a) Before releasing type A medical equipment, the establishment in charge of selling medical equipment shall send the declaration of applicable standard specified in Article 22 of this Decree to the Department of Health of the area where such establishment is headquartered;

b) If thedeclarationis satisfactory, the Department of Health shall issue the establishment with theReceipt noteusing the form No. 03 in Appendix IV enclosed with this Decree;

c) Within 03 working days from the date written on thereceipt note, the Ministry of Health shall publish the following information onitsweb portal: name,classification, producer, country of origin of medical equipment; registration number of the medical equipment; name,addressof the owner of the medical equipment; name, address of the holder of the registration number; name, address of the establishment providing warranty services on medical equipment and the declaration of applicable standard for medical equipment.

3.If the owner of the medical equipment or the producer of the medical equipment is changed, the holder of the registration number shall re-conduct the procedures for declaration of the applicable standard according to provisions of this Decree.

Section 3. REGISTRATION FOR TYPE B, C OR D MEDICAL EQUIPMENT

Article 25. Forms of registration

1.A new registration number shall be issued to the following medical equipment:

a) Medical equipment which applies for registration number for the first time;

b) Medical equipment which has been issued with the registration number and has been modified in type or producing materials (that affects its functions, applicable to in vitro diagnosis device and disposable medical equipment);

c) Medical equipment which has been issued with registration number and its owner fails to apply for extension of its registration number within the time specified in clause 3 Article 27 of this Decree.

2.The registration number shall be re-issued if the Certificate of sale is lost or damaged.

3.The time limit of the registration number shall be extended of the registration number nearly expires as prescribed in clause 3 Article 27 of this Decree.

Article 26. Application for new registration number

1.An application for the registration number of medical equipment for which there is no applicable National technical regulation:

a) A written application form for a new registration number using the form No. 04 provided in Appendix I enclosed with this Decree;

b) Aclassification table using the form in Appendix V enclosed with this Decree;

c) The certificate of conformity with quality control standards which is effective at the time of application, unless the medical equipment has been issued with the Certificate of Free sale by the competent body of any of the following countries and organizations: EU member countries, Japan, Canada, Therapeutic Goods Administration (TGA) of Australia, Food and Drug Administration (FDA) of America;

d)The power of attorney by the owner of the medical equipment for theestablishment conducting the registrationusing the form in Appendix VI enclosed with this Decree which is effective by the time ofapplication, except for cases specified in point a clause 1 Article 21 of this Decree;

dd) The certificate of eligibility to provide warranty issued by the owner of the medical equipment using the form provided in Appendix II enclosed with this Decree, excluding disposable medical equipment prescribed by its owner;

e) The Certificate of free sale which is effective at the time of application, applicable to imported medical equipment;

g) Vietnamese documents that give brief description of medical equipment using the form No. 01 in Appendix VIII enclosed with this Decree;

h) A catalogue describing functions and specifications of medical equipment; technical information on reagents, calibration solutions, in vitro control materials using the form No. 02 provided in Appendix VIII enclosed with this Decree;

i) Written instruction for the medical equipment;

k) Regarding type C or D medical equipment which is used by putting into human body: the summary of clinically testing data using the form in Appendix IX enclosed with this Decree together with the clinically testing reseach results are required, unless:

-Medical equipment is manufactured or processed in Vietnam solely for export and the importing country does not request clinical testing;

-Such medical equipment has been sold and obtained the Certificate of Free sale by the competent body of any of the following countries and organizations: EU member countries, Japan, Canada, TGA of Australia, FDA of America;

-Other cases specified by the Minister of Health.

l) Type C or D medical equipment for in vitro diagnosis must have the certificate of inspection as prescribed by the Minister of Health, unless the medical equipment has been issued with the Certificate of Free sale by the competent body of any of the following countries and organizations: EU member countries, Japan, canada, TGA of Australia, FDA of America;

m) The label of the medical equipment which is intended to be used when it is sold in Vietnam.

2.Regarding the application for the registration number of medical equipment with applicable National technical regulations:

a) A written application form for a new registration number using the form No. 04 provided in Appendix I enclosed with this Decree;

b) The certificate of conformity;

c) Papers specified in points b, c, d, dd, e, g, h, i and m clause 1 of this Article.

3.Regarding the application for a new registration number of medical equipment being measurement instruments subject to obtaining the approval of the model according to laws on measuring:

a) A written application form for a new registration number using the form No. 04 provided in Appendix I enclosed with this Decree;

b) The decision to approve the model;

c) Papers specified in points b, c, d, dd, e, g, h, i and m clause 1 of this Article.

4.Regarding the application for a new registration number of medical equipment being measurement instruments which is not required to obtain the approval for the model as prescribed in laws on measuring, regulations in clause 1 of this Article shall be complied with.

Article 27. Application for reissuance/extension of registration number

1.The application for reissuance of the registration number which is lost or damaged shall include an application form using the form No. 05 provided in Appendix I enclosed with this Decree.

2.An application for extension of the registration number shall consist of:

a) A written application form forextension ofregistration number using the form No. 06 provided in Appendix I enclosed with this Decree;

b) A copy of the obtained certificate of sale;

c) The certificate of conformity with quality control standards which is effective at the time of application, unless the medical equipment has been issued with the Certificate of Free sale by the competent body of any of the following countries and organizations: EU member countries, Japan,Canada, Therapeutic Goods Administration (TGA) of Australia, Food and Drug Administration (FDA) of America;

d) The power of attorney by the owner of the medical equipment for the establishment conducting the registration using the form in Appendix VI enclosed with this Decree, except for cases specified in point a clause 1 Article 21 of this Decree;

dd) The Certificate of free sale which is effective at the time of application, applicable to imported medical equipment;

e) The income statement for the period when the registration is obtained using the form in Appendix X enclosed with this Decree.

3.Time limit for applying for extension of the registration number shall be at least 60 days before it expires.

Article 28. Requirements for application for new issuance/extension of registration number

1.An application for new issuance or extension of the registration number of medical equipment shall be made in 01 dossier and documents in such dossier shall be readable and shall be arranged according to the order specified in Article 26 of this Decree, applicable to applications for new inssuance of the registration number, or in clause 2 Article 27 of this Decree, applicable to applications for extension of the registration number; there shall be separators between different parts, there shall be cover pages and the table of contents.

2.Requirements for a number kinds of papers in the application for new issuance/extension of registration number:

a)Regarding the Certificate of conformity with quality control standards: the original copy or a certified true copy or a copy certified by the applicant establishment is required.

In case of including the copy certified by the applicant establishment, the original copy shall be presented for comparison or data sources shall be provided for checking the validity of such documents, at the time of submission of the application.

Any Certificate of conformity with quality control standard which is not made in English nor Vietnamese shall be translated into Vietnamese. The translation must be authenticated according to laws.

b) Regarding the power of attorney of the owner of medical equipment and the Certificate ofeliogibility to providewarranty:

-Regarding medical equipment manufactured in Vietnam: an original copy of a certified true copy is required;

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

c)Regardingthe Certificate of Free sale: a consularly-legalized copy or a certified true copy of the consularly-legalized copyis required.

Any Certificate of free sale which is not made in English nor Vietnamese shall be translated into Vietnamese. The translation must be authenticated according to laws.

If the certificate of free sale does not specify the date of expiry, such certificate shall expire after 36 months counted from the date of issue.

d) Regarding catalogue of the medical equipment: the copy certified by the applicant is required.

Any catalogue which is not made in English nor Vietnamese shall be translated into Vietnamese. The translation must be authenticated according to laws;

dd) Regarding the instructions for the medical equipment: a Vietnamese copy certified by the applicant establishment is required.

e) Regarding thecertificate of inspection: the original copy or a certified true copy or a copy certified by the applicant establishmentis required.

In case of including the copy certified by the applicant, the original copy shall be presented at the time of submitting the application for comparison.

g) Regarding the label model: a copy which is certified by the organization registering for selling medical equipment.The label model must satisfy requirements specified in Article 54 of this Decree.

Article 29. Receipt and inspection of application for registration number of medical equipment

1.Any establishment applying for the registration number shall submit the application at the Ministry of Health.

2.When receiving satisfactory application, the Ministry of Health shall issue the applicant establishment with the receipt note using the form No. 04 provided in Appendix IV enclosed with this Decree.

3.In case the application is satisfactory and not any modification is required, the Minister of Health shall:

a) Regarding medical equipment for which there is no applicable National technical regulation: Conduct inspection for new issuance of the registration number within 60 days or for extension of the registration number within 30 days from the date written on the receipt note. In case of refusal to issue or grant extension of the registration number, a written response containing explanation shall be made;

b) Regarding medical equipmentwithapplicable National technical regulation: Conduct inspection for new issuance of the registration number within 15 days or for extension of the registration number within 10 days from the date written on the receipt note.In case of refusal to issue or grant extension for the registration number, a written response containing explanation shall be made;

c) The re-issuance of the registration number shall be carried out within 05 working days from the date written on the receipt note. In case of refusal to re-issue the registration number, a written response containing explanation shall be made.

4.If the application for the registration number is not satisfactory, the Ministry of Health shall send a written notification to the establishment applying for new issuance, re-issuance or extension of the registration requesting the modification, detailing documents and information subject to modification within the periods specified as follows:

a)15 working days from the date written on the receipt note, applicable to applications for new issuance or extension of the registration;

b) 05 working days from the date written on the receipt note, applicable to applications forre-issuance of the registration.

5.After receiving the request for modification of the application for the registration number, the applicant establishment shall complete the documents according to the written notification and send them to the Ministry of Health. The date of receipt of the completed application shall be written on the receipt note.

In case where the applicant establishment has modified its application unconformably with the request, the Ministry of Health shall request the applicant establishment to continue completing the application according to regulations in clause 4 of this Article.

After 60 days from the day on which the written notification by the Ministry of Health is received, if the applicant establishment fails to complete its application, it shall re-conduct the procedures for applying for the registration number.

6.If the inspection council request the modification of the application, within 10 working days from the day on which the meeting minute of the council is made, the Ministry of Health shall send a written notification to the applicant establishment for modification of the application. The notification shall specify the information to be supplemented and the information to be adjusted.

After receiving the request for modification of the application for the registration number, the applicant establishment shall modify the documents according to the written notification and re-send the application to the Ministry of Health. The date of receipt of the completed application shall be written on the receipt note.

In case where the applicant establishment has modified its application unconformably with the request, the Ministry of Health shall request the applicant establishment to continue completing the application according to regulations in clauses 4 and 5 of this Article.

7.Within 03 working days from the day on which the registration number is issued, the Ministry of Health shall publish on its web portal the following information:

a) Name, classification, producer and country of origin of the medical equipment;

b)Registration number ofthemedical equipment;

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

d) Name and address of the holder of the registration number;

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

e)The application for registration number of the medical equipment, except for information specified in points g and h clause 1 Article 26 of this Decree.

8.During the period of selling medical equipment, the holder of the registration number shall send a written notification to the Ministry of Helath within 10 working days from the day on which any of the following activities is conducted:

a) The address of the owner of the medical equipment or of the holder of the registration number of the medical equipment is changed;

b) Name of theholderof the registration numberis changed. The holder of the registration number shall enclose with the written notification documents proving the ownership towards the medical equipment of the new owner and the label model prescribed in Article 54 of this Decree;

c) Information about name or address of the producer of the medical equipment is modified. The holder of the registration number shall enclose with the written notification of modification the following documents: the Certificate of Free sale and the Certificate of conformity with quality control standards which are effective at the time of application, unless the medical equipment has been issued with the Certificate of Free sale by the competent body of any of the following countries and organizations: EU member countries, Japan, canada, TGA of Australia, FDA of America;

d) The packing specifications are changed, applicable to in vitro diagnosis medical devices. The holder of the registration number shall enclose with the written notification documents specified in points h and m clause 1 Article 26 of this Decree;

dd) The warranty provider is changed. The holder of the registration number shall enclose with the written notification documents specified in points dd clause 1 Article 26 of this Decree.

9.Within 03 working days from the day on which the notificatioon by the holder of the registration number is issued, the Ministry of Health shall update the modifed information on its web portal the following information.

10.The Minister of Health shall issue regulations on the inspection of the application for registration number.

Section 4. TRACING ORIGIN AND HANDLING DEFECTIVE MEDICAL EQUIPMENT, SUSPENSION OF SALE OR RECALLING OF DEFECTIVE MEDICAL EQUIPMENT AND HANDLING OF MEDICAL EQUIPMENT IN SPECIFIC CASES

Article 30. Tracing the origin of defective medical equipment

1.Regarding defective medical equipment, the holder of the registration number shall trace the origin, including:

a) Determining name, type and amount of medical equipment in the defective batch;

b) Publishing on the web portal of the owner (if any) and the web portal of the Ministry of Health, and requesting establishments producing, trading or using such medical equipment in writing to provide information on name, type and the amount of medical equipment in the defective batch, the actual amount remained in the storage and the actual amount being on market;

c) Formulating plans on measures to be taken or on the recall of defective medical equipment;

d) Report to a competent agency the plans specified in point c of this Clause.

2.The competent agency shall conduct inspection and monitor the tracing of the origin of the defective medical equipment within its management.

Article 31. Handling and recalling defective medical equipment

1.Measures to be taken for defective medical equipment:

a) Providing guidelines on remedial measures;

b)Eliminating defects of the medical equipment;

c) Replacing the defective medical equipment with the equivalent one;

d) Recalling for re-exporting or destruction.

2.Defective medical equipment shall be recalled as follows: