Công văn 15/BYT-TB-CT

To Representative offices of medical equipment importing, manufacturing and trading plants and enterprises (hereinafter referred to as entity or entities)

On December 31, 2018, the Government promulgated the Decree No. 36/2016/ND-CP on medical device management">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. 36/2016/ND-CP on medical device management">169/2018/ND-CP), which entered into force from the signature date.

1. The Decree No. 36/2016/ND-CP on medical device management">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 operation of medical equipment;

- Implementation organization.

2. The Decree No. 36/2016/ND-CP on medical device management">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.

- 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 validity period specified on each marketing authorization certificate ends. 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 disinfecting 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 each marketing authorization certificate. In particular, if marketing authorization certificates expire after the effective date of this 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 entities to study and undertake the implementation of provisions 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: [email protected] or [email protected] to seek its timely review and solution. Any blockage in business, manufacturing and import activities of entities that may arise at the aforestated transitional dates must be prevented./.