On the afternoon of 18 June 2025, representatives of EuroCham and its Medical Devices and Diagnostics Sector Committee (MDDSC) held an in-person working meeting with the Vietnam Infrastructure and Medical Device Administration (VIMDA) under the Ministry of Health in Hanoi. The meeting took place in a spirit of openness and constructive dialogue, with extensive discussions on key regulatory and technical issues.
Representing EuroCham were Head of the Hanoi Office cum External Relations Manager – Ms. Van Nguyen, Advocacy Manager – Ms. Diep Truong, and Sector Committee Coordinator – Mr. Trung Luong. Representing MDDSC were Chairman – Mr. Fabian Singer, along with Vice Chairs – Mr. Torben Minko, Mr. Ricky He, and Ms. Chau Nguyen. The meeting also welcomed members of the Regulatory Affairs Working Group and the Government Affairs & Market Access Working Group. The delegation from VIMDA, led by Director General – Dr. Loi Nguyen, included Deputy Director General – Mr. Hieu Nguyen, and technical officers of the administration.
Updates to draft law on Medical Devices
At the meeting, VIMDA provided updates on the draft Law on Medical Devices, which is expected to be submitted to the National Assembly in 2028, and called for EuroCham’s continued support through consultations, workshops, and international exchange activities. VIMDA outlined their 2025 regulatory roadmap, including the revision of Decree 96/2023/ND-CP, and plans to amend Circular 05/2022/TT-BYT, Decree 98/2021/ND-CP, and other related decrees, focusing on AI, Software as Medical Device (SaMD), and third-party classification for Class A/B devices.
Procurement reforms: a key focus
Procurement was another key focus, with plans to issue centralised procurement and device grouping regulations by mid-August 2025. MDDSC Chairman – Fabian Singer raised concerns over price-focused tender processes potentially limiting access to high-quality, innovative products. In response, VIMDA highlighted recent legal reforms allowing hospitals greater flexibility, while acknowledging the need for clearer guidance and mindset shifts among procurers.
National medical device information system under development
Looking toward the future, VIMDA shared their collaboration with international partners in developing a national medical device information system, expected to be operational by 2030. As part of this effort, VIMDA is working to standardize product nomenclature using GMDN, starting with ophthalmic and orthopaedic products, and may require English names in registration dossiers to ensure alignment with international practices. VIMDA welcomed EuroCham’s comments and support in this process. Discussions also covered challenges in post-market surveillance, borderline classifications, and improvements to the IMDA portal.
Re-affirming the MoU between EuroCham and VIMDA
On the operational side, EuroCham and VIMDA reaffirmed their commitment to implementing the 2023–2026 Memorandum of Understanding (MoU), which focuses on policy shaping, technical collaboration, and capacity building. Mr. Minko highlighted MDDSC’s support for regional activities such as the AMDC in Cambodia, GHWP in Thailand, and the upcoming industry forum in Nha Trang. Both sides also agreed to continue collaboration in law-making, training programs, and regulatory reform workshops.
The meeting concluded with a shared commitment to strengthening public–private cooperation, improving the legal and regulatory environment, advancing digital transformation, and promoting sustainable development of the medical device sector in Vietnam.
