In the past years, Vietnam had published a total of three decree on Medical Device (MD) Management including Decree 36/2016/NĐ-CP dated on 15/05/2016, Decree 169/NĐ-CP dated on 31/12/2018 and Decree 03/2020/NĐ-CP dated on 01/01/2020. On November, VN MOH has finally published Decree 98/2021/NĐ-CP with the purpose of unifying regulations on managing medical device. Decree is implemented from 1/1/2022.
Some of major amendments are as follows:
- MOH puts in the definition of custom-made medical device.
- Risk classification of MD will be determined by license holder.
- MOH adds clinical research.
- Class B MD shall apply for a Declaration of Applicable Standard, instead of a Certificate of MD Registration (Reg. No.).
- MOH amends the requirement for quick issue from 2 CFS to 1 CFS of reference countries. Reference countries now include China and Korea, next to Japan, Australia, US, Canada, UK, Switzerland, and EU countries.
- MD that has been granted an Import Permit (IP) can also apply for quick issue.
- MOH adds emergency issue, its requirement and dossier.
- Reviewing period for Reg. No. class C & D with the normal route is changed from 90 days to 40 days.
- MOH adds new section for Change notification submission dossier and reviewing time, managing price of MD, managing material used to manufacture MD incorporating drugs and precursors.
In line with these changes, the following terms will be enforced.
1. Specific regulations on validity of Reg. No, IP that had been issued before 1/1/2022:
+ With MD that had been granted a Reg. No. under Decree36/2016, Reg. No. is valid forever.
+ With General MD that had been issued an IP between 1/1/2018 and 1/1/2022, IP is valid until 31/12/2022.
+ With IVD MD that had been issued an Reg. No between 1/1/2014 and 31/12/2017, Reg. No is valid until 31/12/2022.
+ With IVD MD that had been issued an Reg. No from 1/1/2018, Reg. No is valid until expiration date of the certificate.
+ With IVD MD that had been granted an IP before 1/1/2018, IP is valid until 31/12/2022.
2. Registration application submitted under Decree36/2016 before 1/1/2022:
+ Class B Registration will change to Declaration of Applicable Standard without additional fee.
+ Class C and D Registration can apply for quick issue if applicable.
3. Application for Import Permit that is submitted before 1/1/2022 will be reviewed and granted IP is valid until 31/12/2022.
4. CSDT will be implemented from 1/1/2023.
5. Content of MD advertise will be published from 1/7/2022.
6. License holder must complete price publishment before 1/4/2022.