This Decree amends, supplements many important regulations on medical devices in Decree No. 98/2021/ND-CP , including:
- Definition of “Registration number holder at Clause 2 Article 21;
- Conditions for placement of medical devices on the market at Article 22;
- Requirements, time limit for modifying, supplementing to the application for registration number for the medical device at Point c Clause 3 Article 32;
- Responsibility to conduct the recall of medical devices placed on the market when the Ministry of Health has given a written response indicating its refusal to permit the placement of the medical device on the market at Clause 6 Article 37;
- Cases where registration number is revoked at Article 38;
This Decree takes effect from the date of its signing.
|Published||Vietlaw's Newsletter No. 602|