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Per Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU.
Vietnam has recently made significant amendments to its medical device registration process and technical documentation requirements. The Ministry of Health (MOH) issued Circular 10/2023/TT-BY on May 11, 2023, outlining the new guidelines for pre-market approval.
On April 15th the MEDLATEC Diagnostic Imaging Center (MEDIM) hosted a conference to discuss the current state of AI-based software in diagnostic imaging in Vietnam.
On March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (Decree 07/2023), which automatically extended the validity of import licenses to December 31, 2024.
On November 15th, the Vietnamese Ministry of Health (MOH) issued a draft decree to amend a number of articles from a previous decree related to the registration of medical devices.
On September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.
The conference was held to provide clarity to the Price Declaration process and announce the establishment of a new online portal for license holders to declare prices. This comes as many provincial health services, including Ninh Binh and Dak Nong, have not been able to purchase medical products since January 1, 2022.
All unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.
On September 9th, the Vietnamese Ministry of Health (MoH) officially opened the Information Portal of Medical Equipment Pricing. Under the new system, the list price of medical equipment will be published (by configuration) on this Ministry of Health hosted website.
Vietnam has been quietly transforming their economy of 100 million people into a regional powerhouse. Through a combination of significant private investment, the US-China trade war, and their highly successful handling of the Coronavirus, Vietnam’s economy is expected to rebound quickly, especially with regards to manufacturing.