Vietnam Medical Devices: MOH, IMDA and Provincial Health Departments

Q: Which authority regulates medical devices in Vietnam?

A: The Ministry of Health (Bộ Y tế, MOH). Implementation sits at two levels. At national level, the Department of Medical Infrastructure and Medical Equipment (Cục Hạ tầng và Thiết bị y tế, IMDA) handles the work under the MOH. At provincial level, the Department of Health (Sở Y tế) of each province or centrally governed city is responsible. IMDA was renamed in January 2025 from the former Department of Medical Equipment and Construction (Cục Trang thiết bị và Công trình y tế, DMEC); both names refer to the same body, so older documents should be read with this in mind.

Q: How are responsibilities divided between the two levels?

A: The dividing line is the risk class:

• Class A and Class B: file a Declaration of Applicable Standards (Bản công bố tiêu chuẩn áp dụng) with the provincial Department of Health;
• Class C and Class D: apply to the MOH (processed by IMDA) for a Circulation Registration Number (số lưu hành);
• Trading Eligibility Declaration (Bản công bố đủ điều kiện mua bán, required for Class B/C/D trading): file with the provincial Department of Health where the trading premises are located.

In recent years the MOH has also issued delegation decisions signed by the Deputy Minister, expressly assigning IMDA to handle matters including the issuance of Class C/D circulation numbers, post-licensing inspections, suspension of circulation for specific batches, batch recalls, the Article 37 confirmation on whether a device may remain on the market, revocation of circulation numbers under Article 39, and issuance of import licences under Article 48.

Q: What is the top-level legal basis?

A: Decree 98/2021/NĐ-CP (issued 8 November 2021, in force from 1 January 2022), which replaced Decree 36/2016 and Decree 169/2018 and is the parent decree for device regulation in Vietnam. It has since been amended three times: by Decree 07/2023/NĐ-CP (3 March 2023), Decree 96/2023/NĐ-CP (30 December 2023, whose Article 147 amends Decree 98 as a package), and Decree 04/2025/NĐ-CP (1 January 2025). Classification rules are set separately by Circular 05/2022/TT-BYT (1 August 2022).

Q: What is the first thing a manufacturer outside Vietnam needs to understand?

A: Vietnam operates a two-tier structure: product authorisation plus trading authorisation, and both tiers are tied to a Vietnamese legal entity. At product level, the circulation number or the Declaration of Applicable Standards must be held by a locally registered MAH. At trading level, any Class B/C/D trading activity requires a separate Trading Eligibility Declaration. An overseas manufacturer cannot hold the registration or file in its own name. This looks similar to the EU authorised representative model but works differently: the Vietnamese MAH is not a “representative” but the rights holder named on the certificate.

Practical note: to judge whether a Vietnamese partner can actually deliver, check four things: (1) a valid business licence whose scope covers medical devices; (2) a completed Trading Eligibility Declaration for Class B/C/D, verifiable on the MOH portal; (3) circulation numbers actually held in its name; (4) technical staff and warehousing and transport evidence meeting Article 40. Only when all four are in place does the partner have genuine licence-holding capability; a brochure alone proves nothing.

Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP (8 November 2021, in force 1 January 2022); (2) Decree No. 07/2023/NĐ-CP (3 March 2023); (3) Decree No. 96/2023/NĐ-CP (30 December 2023), Article 147; (4) Decree No. 04/2025/NĐ-CP (1 January 2025); (5) Circular No. 05/2022/TT-BYT (1 August 2022); (6) the MOH/IMDA website imda.moh.gov.vn for the department’s mandate and published information.