On 13 July, EuroCham’s Medical Devices & Diagnostic Sector Committee (MDDSC) attended the 2026 Business Dialogue with Medical Devices Businesses. Hosted by Vice Minister of Health Do Xuan Tuyen, the dialogue welcomed officials from the Vietnam Infrastructure and Medical Device Administration (VIMDA), together with business representatives.
Ministry of Health’s four priorities for medical devices regulations
Vice Minister Do Xuan Tuyen reaffirmed the Ministry of Health’s commitment to improving the regulatory environment while ensuring patient safety and effective state management. He highlighted that more than 10,000 previously backlogged marketing authorisation and licensing dossiers had been reviewed by the end of 2025. The Ministry had approved qualified applications and returned incomplete dossiers for supplementation.
Looking ahead, the Ministry of Health will focus on four priorities:
- Streamlining administrative procedures through greater decentralisation and digitalisation,
- Strengthening risk-based regulation,
- Enhancing quality management throughout the entire medical device lifecycle,
- Developing a national medical device database.
Recognising that Vietnam remains heavily dependent on imported medical devices and that the current legal framework is fragmented, the Ministry is accelerating the drafting of a dedicated Medical Devices Law and amendments to existing decrees to create a more transparent, predictable, and business-friendly regulatory system. The Government also announced plans to modernise the medical device supply chain, implement Unique Device Identification (UDI), integrate regulatory systems with customs, tax, procurement and health insurance authorities, and promote digital transformation.
Business inputs on streamlining market authorisation & regulation procedures
During the dialogue, businesses and associations raised concerns on market authorisation, classification, origin labelling, procurement and public tendering. The Ministry committed to carefully reviewing these recommendations and incorporating urgent issues into upcoming amendments to Decree 96/2023/ND-CP, while encouraging stakeholders to continue contributing to the development of the future Medical Devices Law.
Representing EuroCham, MDDSC’s Head of Regulatory Affairs Working Group, Ms. To-Hoa highlighted MDDSC’s advocacy efforts over 2025–2026, including more than 21 advocacy letters and regular dialogues with the Ministry of Health and VIMDA. MDDSC welcomed recent regulatory progress, particularly the issuance of key circulars, accelerated marketing authorisation, and the Government’s commitment to national health screening and digital transformation. MDDSC also outlined recommendations for amending Decree 98/2021/ND-CP, focusing on simplifying administrative procedures, improving post-market management, establishing a regulatory framework for Software as a Medical Device (SaMD), and implementing the Apostille Convention.
EuroCham Vietnam and our Medical Devices & Diagnostic Sector Committee (MDDSC) reaffirmed our commitment to supporting the Government in developing a transparent, internationally harmonised, and innovation-friendly regulatory framework for the medical device sector.
Special thanks to EuroCham representatives for their contributions:
- Ms. Chau Nguyen, Vice-Chair, Medical Devices and Diagnostics Sector Committee
- Mr. Duc Duong, Vice-Chair, Medical Devices and Diagnostics Sector Committee
- Ms. To Hoa, Co-head of Regulatory Affairs Working Group, Medical Devices and Diagnostics Sector Committee
- Mr. Trung Hieu, Co-head of Regulatory Affairs Working Group, Medical Devices and Diagnostics Sector Committee
- Ms. Thu Hang, Co-head of Government Affairs and Market Access Working Group, Medical Devices and Diagnostics Sector Committee
- Ms. Thanh Thuy, Co-head of Government Affairs and Market Access Working Group, Medical Devices and Diagnostics Sector Committee
- Ms. Mai Chi, Sector Committee Coordinator, EuroCham Vietnam
