Công văn 14/BYT-TB-CT 2019 hướng dẫn Nghị định 169/2018/NĐ-CP về trang thiết bị y tế

THE MINISTRY OF HEALTH

Official Dispatch No. 14/BYT-TB-CT dated January 2, 2019 of the Ministry of Health on guiding the implementation of the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018

To:Ministry of Finance (General Department of Customs)

On December 31, 2018, the Government promulgated the Decree No. 169/2018/ND-CP amending and supplementing certain Articles of the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical equipment (hereinafter referred to as Decree No. 169/2018/ND-CP),which entered into force from the signature date.

1. The Decree No. 169/2018/ND-CP amends and supplements regulations pertaining to management of medical equipment as follows:

- Interpretation of medical equipment terms;

- Classification of medical equipment;

- Requirements applied to medical equipment classification, manufacturing and trading establishments;

- Procedures for declaration and registration for marketing authorization and import of medical equipment;

- Medical equipment assessment and calibration activities;

- Management and usage of medical equipment;

- Implementation organization.

2. The Decree No. 169/2018/ND-CP amends and supplements transitional provisions in Article 68 of the Decree No. 36/2016/ND-CP, including the following noticeable contents:

- Permits for import of medical equipment classified into group B, C and D which were granted in 2018 have been invalid from December 31, 2018 while import permits granted in 2019 will continue its effect till end of December 31, 2019.

- Group-A medical equipment with notes of acknowledgement of application documentation for declaration of applied standards, issued by the Department of Health, may be imported depending on demands without being subject to any quota and having to enclose the written confirmation of medical equipment given by the Ministry of Health before customs clearance. Medical equipment not in the list of medical equipment that require import permits and already classified as group-B, C, and D medical equipment by classification bodies published by the Ministry of Health on its website may continue to be imported till end of December 31, 2019, depending on demands, without being subject to any quota and having to enclose the written confirmations of medical equipment by the Ministry of Health before customs clearance.

- With regard to medical equipment which are in-vitro diagnostic biological products already obtaining marketing authorization certificates under the provisions of the 2005 Law on Pharmacy and other documents guiding the implementation of this Law, previously-granted marketing authorization numbers will be valid until the end of the expiry date specified on each marketing authorization certificate. In particular, if numbers of marketing authorization for in-vitro diagnostic biological products expire after January 1, 2019 and before December 31, 2019, they may continue to be in use till the end of December 31, 2019.

If medical equipment which are in-vitro diagnostic biological products have applications for marketing authorization submitted in accordance with the 2005 Law on Pharmacy before January 1, 2019, these applications will be processed as per the 2005 Law on Pharmacy.

If medical equipment which are imported in-vitro diagnostic biological products have applications for marketing authorization within the period from January 1, 2019 to end of December 31, 2019, permits for import of these products will be awarded in accordance with the 2005 Law on Pharmacy and will be valid till end of December 31, 2019.

- If chemicals, pest control and antibacterial products for domestic and medical uses which serve the sole purpose of disinfection of medical equipment have already been granted marketing authorization certificates which expire after July 1, 2016 and before January 1, 2019, these certificates will continue to be used till end of December 31, 2019.

- If domestically-manufactured medical equipment has already obtained marketing authorization certificates, marketing authorization numbers will be valid till end of the expiry date specified on marketing authorization certificates. In particular, if marketing authorization certificates expire after the effective date of the Decree and before December 31, 2019, these certificates may continue to be in use till the end of December 31, 2019.

- All applications for declaration of applied standards of group-A medical equipment have been received since January 1, 2017 and the notes of acknowledgement of such application have been valid since July 1, 2017; all applications for registration of marketing authorization for group-B, C and D medical equipment have been received since July 1, 2017 and marketing authorization numbers of medical equipment have been valid since January 1, 2020.

- Medical equipment classification bodies shall be responsible to finish publishing results of classification of medical equipment already issued before December 31, 2018 on the website of the Ministry of Health at the address: www.dmec.moh.gov.vn before April 1, 2019.

- All certificates of completion of training in classification of medical equipment which were granted before December 31, 2018 are valid for only 3 years from the signature date;

- Holders of marketing authorization numbers must review results of classification of medical equipment in accordance with clause 2 of Article 4 in the Decree and must report to the Ministry of Health prior to July 1, 2019.

- ASEAN Common Submission Dossier Template will be applied from July 1, 2020.

- Medical gas manufacturing establishments must finish applying the quality control system ISO 9001 or equivalent from January 1, 2020. Other establishments must continue to comply with provisions laid down in the Decree No. 36/2016/ND-CP.

The Ministry of Health would like to request you to study, provide Customs Departments of cities and provinces with instructions and directions for implementation of the Decree. In the course of implementation, if there is any query and difficulty that arises, please contact the Ministry of Health (Department of Medical Equipment and Construction) via the telephone number: 024.62732272, email: dmec@moh.gov.vn or vuttbctyt@gmail.com for collaboration purposes.

Thanks for your collaboration./.

 For the Minister

Deputy Minister

Nguyen Viet Tien