This article focuses on Vietnam’s IMDA medical device registration rules and introduces the requirements for registering medical devices in Vietnam.
From 1 January 2025, Vietnam formally transferred medical device management from the Department of Medical Equipment and Construction (DMEC) to the newly established Infrastructure and Medical Device Administration (IMDA).
The official website of Vietnam’s medical device regulator is https://imda.moh.gov.vn/. Operated by the IMDA, it is the only official platform for medical device registration, certification and regulatory matters.
In Vietnam, medical devices are regulated by risk: Class A (lowest risk), Class B (low risk), Class C (high risk) and Class D (highest risk). This follows the GHTF (Global Harmonization Task Force) classification, focusing on product risk and use scenarios.
3. Registration Routes and Fees
IMDA notice on adjusting medical device fees: from 1 July 2025 to 31 December 2026.
4. Recognition Mechanisms and Local Requirements
Approvals from 7 jurisdictions including China NMPA, US FDA and EU CE can be used as evidence for market access, allowing simplified technical review and cutting approval time by 30%. Vietnam’s IMDA rules require a local agent: foreign manufacturers must authorize a Vietnamese company to submit the registration application and act as registration holder. All documents, including IFUs and labels, must be translated into Vietnamese.
5. Business Opportunities
As of May 2024, Chinese companies held 9,923 valid medical device registrations in Vietnam, 12.93% of the total – far more than the 2,656 (only 3.46%) held by Vietnamese companies. Vietnam’s medical device market is highly dependent on imports, with 90% of devices imported, offering Chinese companies a vast market.
6. EVERBIZ – Your Expert for Medical Device Registration in Vietnam
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Local authorized representative (MAH) services: acting as your legal registration holder in Vietnam and handling all communication with the IMDA
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Classification and registration route planning: determining the class based on product characteristics and developing the optimal registration strategy
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Fast-track applications: for NMPA-approved products, making full use of expedited review and clinical trial waivers to greatly shorten registration time
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Import licenses: assistance with medical device import license applications and customs clearance
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Post-market compliance maintenance: tracking regulatory changes to keep products compliant over the long term
With extensive practical experience in quality systems and product registration, EVERBIZ is ready to support your medical devices’ entry into the Vietnamese market.
Conclusion
This series will continue to share knowledge of FDA, NMPA, GMP, CE MDR/IVDR, MDSAP and other regulations and standards – stay tuned.
EVERBIZ hopes our extensive practical experience in quality systems and product registration will be helpful to you.
Let’s contribute together to the development of the medical device industry – if you have any questions or needs, please contact us.
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Shanghai: Room 909, Building 1, Lane 111 Luxiang Road, Baoshan District, Shanghai, China; Germany: Landsberger Str. 155, 80687 München, Germany
Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria
Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong
Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520
