Decree 98/2021/ND-CP on management of medical devices

On November 8, 2021, the Government has just signed and promulgated Decree 98/2021/ND-CP on Management of Medical Devices. Accordingly, Decree 98/2021/ND-CP will take effect from January 1, 2022 and replace all Decrees 36/2016/ND-CP, Decree 169/2018/ND-CP, Decree 03 2020/ND-CP.

A few new points to note of the Decree:

1. Class B medical equipment will change to apply for a Standard Announcement Number applicable to medical equipment such as Class A from the Department of Health, and Class C and D will still apply for a free-sale registration number.
2. The import license from 2018 to now is continued to be extended until December 31, 2022.
3. For medical equipment of class C and D that are not included in Circular 30: only need to classify (publicize on Dmec portal) to be able to import goods. However, the deadline is only until December 31, 2022.
4. The duration of the circulation number is changed from 5 years to indefinite.
5. The classification of medical equipment must be carried out by a classification establishment which is an establishment that declares applicable standards or registers for free sale under its name.
6. Expand the group of reference countries (applied in the rapid issuance of circulation numbers): Add the National Medical Products Administration (NMPA) – China; Ministry of Food and Drug Safety (MFDS) – Korea or on the list of marketing authorization organizations recognized by Vietnamese authorities
7. Change of conditions for fast issuance of circulation numbers. Only 1 of the following conditions must be met:
–  Only 1 certificate of free sale (Certificate of Free Sale) or certificate of circulation (Market Authorization) (hereinafter referred to as circulation certificate) of the reference country is required.
Having been granted an import license or a free-sale registration number or a certificate of registration of commercial circulation in Vietnam.
– Compulsory application of the Common Technical Dossier for medical equipment in accordance with ASEAN regulations (CSDT) from January 1, 2023.
Disclosure of content and advertising of medical equipment will be applied from July 1, 2022.
8. About price disclosure
– Do not buy or sell medical equipment without the declared price and must not buy or sell higher than the price declared on the website of the Ministry of Health at the time of purchase and sale.
– Only the owner of the free-sale registration number can publish the price, unless the owner of the free-sale registration number is a resident representative office in Vietnam of a foreign trader of which that trader is the owner of the equipment. medical device or authorized by the owner of the medical device. At that time, the CSH of the circulation number appoints the distributor to make the price public.
– In case there are many distributors distributing the same product, the holder of the free sale registration number of medical equipment must appoint a distributor to declare the price. Other distributors are not required to declare a price but may not sell above the price declared by the designated distributor.

9. ASEAN Common Technical Dossier (CSDT)

– Applied from January 1, 2023.

10. Advertisement of medical devices

– Valid from 1/7/2022.

– Units that are allowed to register advertising content: Company is the owner of the circulation number or the enterprise is authorized from the owner of the circulation number.