Legal Documents

Circular 05/2022/TT-BYT: Elaborating Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on Management of Medical Devices

Circular No. 05/2022/TT-BYT, issued on August 01, 2022, provides Elaborating Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on Management of Medical Devices. The circular includes the following contents:

1. Declaration of the invalidity of the implementation of several legal documents, such as:

    • Circular No. 39/2016/TT-BYT issued on October 28, 2016: Detailed regulations on the classification of medical device
    • Circular No. 46/2017/TT-BYT issued on December 15, 2017: Detailed regulations for the implementation of some provisions of Decree No. 36/2016/ND-CP dated May 15, 2016, of the Government on the management of medical device
    • Paragraph 1, Article 1 of Circular No. 23/2021/TT-BYT issued on December 09, 2021: Amendments and supplements to certain legal documents issued by the Minister of Health.
    • Circular No. 33/2020/TT-BYT issued on December 31, 2020: Regulations on the list of medical device subject to safety and technical performance testing.

2. In addition, Circular No. 05/2022/TT-BYT also provides Elaborating Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on Management of Medical Devices :

a) Classification of medical device as stipulated in Clause 5, Article 5 of Decree No. 98/2021/ND-CP.

b) Supplementing the list of in vitro diagnostic medical device that does not require quality assessment by competent authorities of Vietnam, as specified in Point d, Clause 3, Article 30 of Decree No. 98/2021/ND-CP.

c) The list of medical device in categories B, C, D can be bought and sold like regular goods, as regulated in Clause 1, Article 42 of Decree No. 98/2021/ND-CP.

d) The list of medical device that must be tested for safety and technical performance, as specified in Clause 10, Article 70 of Decree No. 98/2021/ND-CP.

e) The list of medical device requiring an import license, as stipulated in Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP

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– English Version: https://medgate.vn/wp-content/uploads/2023/12/Thong-tu-05_2022_TT-BYT_English-1.pdf