The Vietnam Ministry of Health (MOH) issued decree 07/2023/ND-CP on March 3, 2023, to amend and supplement decree 98/2021/ND-CP on medical device management.
The main content of the decree are as follows:
1. Amendment of Transition Terms
- Import licenses for general medical devices and in-vitro medical devices issued from January 1, 2018, to December 31, 2021, will be extended until December 31, 2024.
- Registration numbers of in-vitro medical devices issued between January 1, 2014, and December 31, 2019, will be valid until December 31, 2024.
- In-vitro medical device registration numbers issued from January 1, 2020, to December 31, 2021, 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, 2024.
- Registration numbers issued before January 1, 2022, will be valid permanently following the decree 36/2016/ND-CP.
- As for dossiers of import licenses that were submitted before January 1, 2022, and that have not been approved yet, the Vietnamese MoH has the responsibility to instruct those businesses on how to complete the dossiers according to Decree 98/2021/ND-CP. The dossiers will be given priority to be reviewed and processed. If the registrant would still like MOH to continue to process their import permit reviewing, the MoH will review the application and issue an import license in accordance with the regulations. The import license will be effective until December 31, 2024.
- CSDT will be applied as of January 1, 2024. Therefore, if dossiers are submitted before this time, the CSDT will be replaced by a brief product description, instructions for use, and product labeling.
- For full evaluation registrations submitted before Jan 1st 2024, the maximum number of compliances will be reduced from five to three.
- The requirement pertaining to "not to buy and sell without the declared price and that the selling price cannot be higher than the price that is published in DMEC-MOH" is not required for bids opened before April 1, 2022.
2. Regarding the prices of medical devices, businesses need to list prices at the locations specified in Article 17 of Decree 177/2013/ND-CP or on the website of the MoH.
In addition, MOH will add the list and guidance on medical equipment subject to price declaration.
3. For cases in which registration numbers are revoked, an additional case was added: "Documentation of registration dossiers is consumed due to failure to follow regulations by the authorities". Medical devices whose registration number is revoked, except for medical devices with defects that adversely affect users' health, medical facilities or users can continue to use them until liquidated according to regulations or until the expiry date.
If the registration number is revoked but the medical devices have not been sold to users or medical facilities, the license holder must stop circulating those devices and take appropriate recall measures.
4. The maximum number of compliances for fast-track registration has been adjusted from five to three.