Vietnam: New circular regulating the issuance of circulation numbers for medical equipment

Vietnam: New circular regulating the issuance of circulation numbers for medical equipment
Bảo Ngọc

On September 16, 2021, the Ministry of Health of Vietnam promulgated Circular 13/2021/TT-BYT regulations on granting circulation numbers and importing medical equipment for COVID-19 prevention and control in urgent cases.

According to this Circular, Medical equipment shall be eligible for rapid issuance of registration if the medical equipment::

(1) is specified under the list in Annex 1 attached to Circular 13/2021/TT-BYT ;

(2)  Falls under any of the following circumstances:

- Has been licensed for circulation or emergency use by: Food and Drug Administration (FDA) - United States of America; Therapeutic Goods Administration (TGA) - Australia; Health Canada; Ministry of Health, Labor, and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency – Japan;

- Has been permitted for circulation and/or emergency use by competent authority of European countries under Annex 2 attached to Circular 13/2021/TT-BYT of Vietnam.

- Falls under list of SARS-CoV-2 testing equipment for emergency use publicized by World Health Organization (WHO) on;

-  Falls under list of popular products for testing SARS-CoV-2 publicized by Health Security Committee (EUHSC);

-  Has been licensed for import for commercial purposes in Vietnam  before September 16, 2021;…

For details, see Circular 13/2021/TT-BYT of Vietnam effective from September 16, 2021 to the end of December 31, 2022.



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