blue-check Many regulations on medical device management are further amended

Decree No. 07/2023/ND-CP dated March 3rd, 2023 of the Government on providing amendments to the Government’s Decree No. 98/2021/ND-CPstatus2 dated November 08, 2021 prescribing medical device management
Posted: 6/3/2023 7:31:33 AM | Latest updated: 14/3/2023 9:06:47 AM (GMT+7) | LuatVietnam: 5650 | Vietlaw: 602

This Decree amends, supplements many important regulations on medical devices in Decree No. 98/2021/ND-CPstatus2 , 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.


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Effective date 3-Mar-2023
Expired date Unknown
Published Vietlaw's Newsletter No. 602

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