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blue-check It is allowable to circulate Class-C or D medical devices right after the import

Official letter No. 4090/BYT-TB-CT dated August 2nd, 2022 of the Ministry of Health regarding guidelines on application of the regulations at point d clause 2 Article 76 of Decree No. 98/2021/ND-CP on temporary import of medical devices
Posted: 3/8/2022 1:13:18 PM | Latest updated: 10/8/2022 8:05:03 PM (GMT+7) | LuatVietnam: 5510
VietlawOnline

According to point d clause 2 Article 76 of Decree No. 98/2021/ND-CP, medical devices which are not subject to import license requirements and have been classified as Class-C or D medical devices as published on the Ministry of Health’s Portal may continue to be imported until December 31st, 2022 without limits on quantities and confirmation as medical devices from the Ministry of Health upon following customs procedures.

According to the Ministry of Health, the above provision does not regulate that the classification result of Class-C or D medical devices published on the Ministry of Health’s Portal must be before January 1st, 2022.

At the same time, medical devices imported under this mode shall be allowable to be circulated in Vietnam right after they are imported without any procedures.

Regarding the temporary import of medical devices without fee sale number for displaying at a fair, exhibition or for product introduction, they are not required the import license according to the regulations at point c clause 1 Article 48 of Decree No. 98/2021/ND-CP.

Ms Phuong Thao (VietlawOnline.com)
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