On 3–4 December 2025, EuroCham Vietnam contributed to a training and dialogue conference on medical device classification in Hue, organised by the Vietnam Infrastructure and Medical Devices Administration (VIMDA) under the Ministry of Health. The event gathered more than 150 representatives from provincial Departments of Health and regional hospitals.
In his opening remarks, Dr. Nguyễn Tử Hiếu, Deputy Director General of VIMDA, highlighted the importance of strengthening provincial capacity in medical device and IVD classification, especially as decentralisation gives local authorities increased responsibility for the registration and inspection of Class A and B devices. Officials also provided updates on regulatory requirements, market surveillance, and implementation challenges.
Representing EuroCham’s Medical Devices & Diagnostics Sector Committee (MDDSC), Ms. Ngô Thị Thu Trang, Member of the Government Affairs & Market Access Working Group, shared international best practices on device classification and practical references that could support Vietnam’s ongoing regulatory harmonisation. She also conveyed industry feedback in a constructive spirit, noting challenges such as differing clinical approaches that result in classification inconsistencies, and the need for clearer guidance on borderline products.
The conference concluded with open dialogue between regulators and stakeholders. EuroCham expressed its appreciation for the Ministry of Health’s continued engagement and reaffirmed its commitment to supporting capacity-building efforts and contributing to a more predictable, internationally aligned regulatory environment for medical devices in Vietnam. EU Delegation on diverse trade topics
