Regulatory Affairs Update: Vietnam

Vietnam: Handling of Unapproved Medical Devices Import Application Submitted Before 2022

On September 12, 2024, the Ministry of Health (MoH) of Vietnam issued Official Letter No. 365/HTTB-ĐKKD concerning the handling of medical device import applications submitted before January 1, 2022, which have not been approved yet. The key points are as follows:


1. Review of Pending Applications: applicants must review their import dossiers submitted before January 1, 2022, that have not yet received import licenses. They should either submit new applications or complete their existing applications in accordance with the provisions of Decree No. 98/2021/ND-CP. Additionally, applicants shall send a letter to the IMDA requesting prioritized processing of these applications as stipulated in Clause 21, Article 147 of Decree No. 96/2023/ND-CP, dated December 30, 2023, which outlines certain provisions of the Law on Medical Examination and Treatment.


2. Documents Needed for Pursuing with the Application: if applicants wish to continue importing medical devices related to their pending applications, they must submit the hard copy of their dossiers in accordance with Clause 18, Article 1 of Decree No. 07/2023/ND-CP. These applications should be sent directly to the IMDA for review and processing per the regulations.


Applicants with pending import application shall determine the strategy to obtain the import license or to proceed with the registration application instead. In this case, they will be prioritized during the evaluation of registration applications.


For more details on the regulation, please refer to this link: 365/ HTTB-ĐKKD (in Vietnamese).

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