Reasons for the Backlog in the Medical Device Licensing Process

According to the regulations of Decree No. 98/2021/ND-CP issued on November 8, 2021 by the...

Decree 07/2023/ND-CP amending and supplementing a number of articles of Decree 98/2021/ND-CP on medical devices management

Decree No. 07/2023/NĐ-CP, issued on March 3, 2023, by the Government, represents a significant step...

Decision 2426/QĐ-BYT: On promulgation of guidance on the preparation of asean common submission dossier for medical devices

Decision 2426/QĐ-BYT, issued on May 15, 2021: On promulgation of guidance on the preparation of...

Official dispatch No. 15/BYT-TB-CT: Implementation of the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018.

On December 31, 2018, the government issued Decree No. 169/2018/ND-CP to amend and supplement Decree...

Official Dispatch No. 8329/BYT-HTTP: inspecting and reviewing the procedures for declaring medical devices

On December 30, 2023, the Ministry of Health issued Official Dispatch No. 8329/BYT-HTTB inspecting and...

Official Dispatch No. 7165/BYT-TB-CT – Regarding Implement the content of Resolution No. 131/NQ-CP dated December 6, 2017 of the Government

Official Dispatch No. 7165/BYT-TB-CT: includes the following contents: – Postponing of the valid period for...

Decree No. 98/2021/NĐ-CP: Prescribing medical device management

On November 8, 2021, the Government issued Decree No. 98/2021/NĐ-CP Prescribing medical device management. This...

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...