On Wednesday, 4 June 2025, a consultation meeting took place between EuroCham, the Health Strategy and Policy Institute (HSPI) and the Infrastructure and Medical Device Administration under the Ministry of Health (MOH) to gather feedback from the business community during the drafting process of Vietnam’s first-ever Law on Medical Devices.
Participants included representatives from EuroCham, especially from the Medical Devices & Diagnostics Sector Committee (MDDSC), as well as officials from HSPI:
- Dr. Khuong Anh Tuan – Vice Director, Health Strategy and Policy Institute
- Dr. Nguyen Thi Minh Hieu – Head of the Department of Health Services Management, Health Strategy and Policy Institute
- MSc. Mai Xuan Thu – Researcher, Health Strategy and Policy Institute
- MD. Pham Thi Hue – Researcher, Health Strategy and Policy Institute
- Representatives of Infrastructure and Medical Device Administration
Vietnam’s Law on Medical Devices to align with international standards
During the meeting, the business community strongly recommended building the law upon internationally recognised frameworks, particularly those developed by the World Health Organization (WHO). This would harmonise Vietnam’s regulatory environment with global standards. In response, representatives from the Ministry of Health noted that the drafting process would align with international practices and welcomed continued support and inputs from the private sector.
Addressing current challenges
Industry stakeholders raised several current challenges, including overlapping administrative procedures, unclear licensing pathways, and limited transparency in regulatory enforcement. These obstacles have created barriers to market access and increased operational uncertainty for investors.
The discussion also addressed key technical issues such as:
- The classification of medical devices into Class A, B, C, and D;
- The respective roles of authorities in dossier reception, evaluation, and license issuance;
- Regulatory treatment of refurbished medical devices;
- The transition from pre-market to post-market surveillance mechanisms; and
- Legal clarity around Software as a Medical Device (SaMD).
Both sides had a fruitful exchange of views. EuroCham and MDDSC reaffirmed their willingness to work closely with the Vietnamese government to improve patient’s access to modern, safe, and high-quality medical devices.
EuroCham Vietnam would like to thank our participants for their valuable contributions:
- Ms. Nguyen Cam Van, Head of Hanoi Office cum External Relations Manager
- Ms. Truong Thi To Hoa, Co-Head of Regulatory Affairs Working Group, EuroCham’s MDDSC
- Mr. Nguyen Trung Hieu, Co-Head of Regulatory Affairs Working Group, EuroCham’s MDDSC
- Ms. Nguyen Thu Hang, Co-Head of Government Affairs and Market Access Working Group, EuroCham’s MDDSC
- Ms. Doan Thi Thanh Thuy, Co-Head of Government Affairs and Market Access Working Group, EuroCham’s MDDSC
- Representatives of 26 members of MDDSC online and offline
