blue-check New regulations on granting import permit to and inspection of medical devices

Circular No. 05/2022/TT-BYT dated August 1st, 2022 of the Ministry of Health on elaborating Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices
Posted: 2/8/2022 7:33:27 AM | Latest updated: 10/8/2022 8:33:48 PM (GMT+7) | LuatVietnam: 5511

This regulates in details Decree No. 98/2021/ND-CP in terms of:

(i) Classification of medical devices (Appendixes I and II);

(ii) List of in vitro diagnostic medical devices that are not required to undergo quality inspection by Vietnam’s competent authorities (Article 3);

(iii) List of class B, class C, and class D medical devices purchased and sold as common commodities (Article 4);

(iv) List of medical devices to be inspected for safety and technical functions (Article 5);

(v) List of medical devices to be granted import permit (Article 6).

Accordingly, from January 1st, 2022, if imported medical devices belong to the List of 46 medical devices regulated at Article 6 of this Circular, it is required to apply for the import permit.

Medical devices, including ventilators, anaesthetic machines, electric scalpels, infant incubators, defibrillators, hemodialysis machines must be inspected for safety; the roadmap for mandatory inspection is regulated at Article 8.

However, medical devices such as personal blood pressure monitors, baby nasal aspirators, medical tape, gauze pads, etc. regulated at Article 4 shall be purchased and sold as common commodities.

This Circular comes into force from August 1st, 2022.

Provisions elaborating Decree No. 98/2021/ND-CP under this Circular comes into force from the effective date of Decree No. 98/2021/ND-CP (January 1st, 2022).

Form No. 13.01, Form No. 13.02 under Appendix I and the Form under Appendix V of Circular No. 19/2021/TT-BYT dated November 16th, 2021 shall be abrogated.

To replace Circular No. 39/2016/TT-BYTstatus1 dated October 28th, 2016; Circular No. 46/2017/TT-BYTstatus1 dated December 15th, 2017; Circular No. 33/2020/TT-BYTstatus1 dated December 31st, 2020; Clause 1 Article 1 of Circular No. 23/2021/TT-BYT dated December 9th, 2021.

Please be informed that the attachments are neither translated nor included in the English file.

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