Additional forms to implement Decree 98/2021/ND-CP on management of medical device in Vietnam

Additional forms to implement Decree 98/2021/ND-CP on management of medical device in Vietnam

supplementing Form No. 05.A - A written request for a license to import medical device to comply with the provisions of Clause 18, Article 1 of Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP on management of medical device.

Form No. 05.B - Order to import in vitro diagnostic biologicals to comply with the provisions of Clause 18, Article 1 of Decree 07/2023/ND-CP.

From May 11, 2023, the form of the document to announce, publicize, declare, notify, and request a new issuance of the circulation number, import license, and certificate of free sale includes:

- Form No. 02.01: Declaration of applicable standards for medical device of type A

- Form No. 02.02: Declaration of applicable standards for medical device of type B

- Form No. 03.01: A written request for a new grant of free-sale registration numbers for medical device of categories C, D with national technical regulations

- Form No. 03.02: A written request for a new grant of free-sale registration numbers for medical device of categories C and D that are measuring instruments subject to sample approval.

- Form No. 03.03: A written request for a new grant of free-sale registration numbers for medical device of categories C and D in the case of fast issuance.

- Form No. 03.04: A written request for a new grant of free-sale registration numbers for medical device of categories C and D in case of emergency.

- Form No. 03.05: A written request for a new grant of free-sale registration numbers for other medical device of types C, D

- Form No. 05.A: A written request for a license to import medical device to comply with the provisions of Clause 18, Article 1 of Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP on management of medical device.

- Form No. 05.B: Orders for importing in vitro diagnostic biologicals to comply with the provisions of Clause 18, Article 1 of Decree 07/2023/ND-CP.

Circular 10/2023/TT-BYT takes effect from the date of signing and promulgation.

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