IMDA (Infrastructure and Medical Device Administration)

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?

IIMDA was established in January 2025, when it officially replaced the Department of Medical Equipment and Construction (DMEC).

What medical device regulations does IMDA enforce?

Vietnam's Decree No. 98/2021/ND-CP is the primary regulation on medical equipment management, which went into effect January 1, 2022. It established the regulatory framework, including the classification of medical devices into four risk-based categories (A through D), requirements for manufacturing, clinical research, circulation registration, import/export, pricing, and post-market surveillance.

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 via their public service system, email, or phone:

Website: Infrastructure and Medical Device Administration (IMDA)
Address: 138A Giang Vo, Giang Vo Ward, Hanoi
Email: dmec@moh.gov.vn
Phone: 02462732272

‍

‍