IMDA (Infrastructure and Medical Device Administration)
The Infrastructure and Medical Device Administration (IMDA) is the specialized regulatory agency under Vietnam’s Ministry of Health tasked with managing the lifecycle of medical devices and IVDs.
The Infrastructure and Medical Device Administration (IMDA) (formerly the DMEC) is the specialized agency under Vietnam’s Ministry of Health that is responsible for regulatory oversight of medical devices and IVDs. It implements the MoH’s policies in this sector by overseeing device classification, registration, import licensing, and post-market surveillance, and enforcing current medical device regulations. IMDA functions as the operational arm of the MoH and acts as the primary point of contact for manufacturers, distributors, and healthcare providers engaged in Vietnam’s medtech market.
IMDA ensures that medical devices entering or circulating in Vietnam meet defined safety and performance standards. It administers market access procedures such as issuing marketing authorizations and it enforces compliance through inspections, recalls, and adverse event monitoring. The agency also regulates device labeling and advertising to align with national requirements.
When was the Vietnam IMDA established?
IMDA was established in January 2025, when it officially replaced the Department of Medical Equipment and Construction (DMEC).
What medical device regulations does IMDA enforce?
Decree No. 98/2021/ND-CP remains the foundation of Vietnam's medical device management framework, but it must be read with subsequent amendments, including Decree 07/2023/ND-CP, Decree 96/2023/ND-CP, and Decree 04/2025/ND-CP. Together, the current rules address risk classification (Classes A through D), manufacturing, clinical research, circulation numbers, import and export, pricing, and post-market controls. Applicants should use the consolidated requirements and current IMDA notices rather than an original 2021 checklist.
Does IMDA charge fees for regulatory activities related to medical devices?
Yes, IMDA charges fees per medical device registration application. Fees were temporarily reduced under Notification No. 645/TB-HTTB, but return to standard rates on December 31, 2026.
How can I contact IMDA in Vietnam?
IMDA can be contacted through its current public service portal, email, or phone. IMDA announced that administrative procedures moved to the VIMDA portal from 1 April 2026, with the former portal available only during a transition through 30 September 2026:
Website: Infrastructure and Medical Device Administration public service portal and IMDA information site
Address: 138A Giang Vo, Giang Vo Ward, Hanoi
Email: dmec@moh.gov.vn
Phone: 02462732272
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