On Thursday and Friday, 18 and 19 September 2025, at the invitation of the Vietnam Infrastructure and Medical Devices Administration, Ministry of Health, EuroCham Vietnam participated in a Workshop Conference on the topic of medical device classification. Held in Can Tho, the workshop gathered more than 300 participants, including specialists and leaders from Southern provincial Departments of Health, as well as representatives from central and local hospitals in the region.
In his opening remarks, Dr. Nguyen Minh Loi, Director General of the Vietnam Infrastructure and Medical Devices, emphasised the urgency of disseminating knowledge on the classification of medical devices and in vitro diagnostic devices to provincial health authorities. This is especially relevant in the context of decentralisation, where the registration and inspection of Class A and B devices have been delegated to provincial Departments of Health. The training aimed to strengthen the capacity of provincial officials and support the process of market surveillance. Officials from various divisions also shared updates on current regulations related to classification, penalties, and inspection procedures.
Ms. Truong To Hoa, Head of the Regulatory Affairs Working Group of EuroCham’s Medical Devices and Diagnostics Sector Committee (MDDSC), delivered a presentation at the workshop. She highlighted international practices on medical device classification and references that Vietnam could adopt. She expressed appreciation for the Ministry of Health’s efforts in building the capacity of provincial officials and moving towards greater international harmonisation.
Ms. Hoa also noted that there remain areas for improvement. She shared challenges faced by the business community, such as differences in medical approaches in Vietnam leading to differences in classification compared to international standards, as well as the lack of clear regulations for borderline products.
The workshop fostered dialogue and mutual understanding between regulators and stakeholders. EuroCham remains committed to supporting the Ministry of Health and the Vietnam Infrastructure and Medical Devices Administration in strengthening the regulatory framework and improving Vietnamese people’s access to advanced healthcare services.
Thank you to Mr. Nguyen Trung Hieu – Head of Regulatory Affairs Working Group, MDDSC, and Mr. Luong Nguyen Thanh Trung – MDDSC Coordinator for their contributions.
Interested in joining EuroCham’s Medical Devices and Diagnostic Sector Committee (MDDSC)? Please contact Mr. Trung Luong at trung.luong@eurochamvn.org
