An official letter 6698/BYT-TB-CT was released on November 21, 2022, by the Vietnam Ministry of Health (MOH) to collect comments for a draft decree amendment of decree 98/2021/ND-CP.
The draft decree amends and supplements the following main contents:
1. A new reviewing process is supplemented, whereby the MOH will assign conformity assessment bodies to evaluate dossiers. The MOH only receives dossiers certified by the conformity assessment bodies (CABs). The CABs will receive registration dossiers from September 01, 2023, and the certificates issued by those bodies will be effective from January 01, 2024.
2. Regarding the prices of medical devices, price publishing is not required anymore. However, price declaration is still applicable with less content which includes information on medical devices, packaging units, and prices in VND. Furthermore, the MOH will provide a list of medical devices that are mandatory to be declared marketing prices. The regulation on price declaration will go into effect from July 01, 2023.
3. Amendment of transition terms
- Import licenses for general medical devices and in-vitro medical devices issued from January 01, 2018, will be extended until December 31, 2023.
- Registration numbers of in-vitro medical devices issued between January 01, 2014, to December 31, 2017, will be valid until December 31, 2023. In-vitro medical device registration numbers issued from January 01, 2018, will be valid until the date mentioned in the registration certificate.
- Medical devices that do not require import licenses, except for disinfectants for medical devices, can be imported to Vietnam unlimitedly via a classified confirmation letter until December 31, 2023.
- Dossiers of import licenses that were submitted before January 01, 2022, will be reviewed and processed. The import licenses will be effective until December 31, 2023.
- CSDT will be applied as of January 01, 2024. Therefore, if dossiers are submitted before this time, CSDT will be replaced by Product Brief description, Instruction for Uses, and Product Labeling.
- Review time of normal route applications will be updated. If there are no input requests, the MOH will review and evaluate submitted dossiers then issue the registration certificate within 90 days from the date of receiving a sufficient dossier. In case there are a compliance request, they will issue a compliance letter within 70 days from the date of receiving a sufficient dossier.
- The number of compliances will be reduced from 05 times to 03 times.
4. For medical devices whose registration number is revoked, except for medical devices with defects that adversely affect users' health, medical facilities or users will continue to use them until liquidated according to regulations or until the expiry date.