Decision 04/QĐ-BYT: The Designation of Units for Assessment of The Common Technical Dossier on Medical Devices According to The ASEAN Regulations

On January 2, 2024, the Ministry of Health issued Decision No. 04/QD-BYT regarding The Designation of Units for Assessment of The Common Technical Dossier on Medical Devices According to The ASEAN Regulations.

The decision includes the following contents:

1. The Designation of units to conduct assessments of general technical documentation on medical  in accordance with ASEAN regulations.

  • For documentation requesting the issuance of circulation numbers for medical  that is not in vitro diagnostic medical devices: Institute of Equipment and Health Construction.
  • For documentation requesting the issuance of circulation numbers for in vitro diagnostic medical devices: National Testing Institute for Vaccine and Biological Products.

2. The effective date of this decision is January 2, 2024.

Readers download the content below:

– English Version: https://medgate.vn/wp-content/uploads/2023/12/EN_-QD-04-BYT.pdf