On 26 May 2026, EuroCham Vietnam and our Medical Devices and Diagnostics Sector Committee (MDDSC) met with the Vietnam Infrastructure and Medical Device Administration (VIMDA) under the Ministry of Health to discuss key regulatory developments and priorities for the medical devices sector.
VIMDA Director General Dr. Nguyen Minh Loi, Deputy Director Generals, senior officials, and specialists joined the meeting. Representing EuroCham were EuroCham Vice-Chair and MDDSC Vice-Chair Torben Minko, Head of Hanoi Office cum External Relations Manager Nguyen Cam Van, and leaders and representatives of the MDDSC Regulatory Affairs Working Group and Government Affairs & Market Access Working Group.
A key discussion point was the renewal of the Memorandum of Understanding (MoU) between VIMDA and MDDSC. Both parties agreed to begin preparations in June 2026 and aim to finalise the renewal by the end of the year in line with government approval procedures.
The MDDSC also raised recommendations on the supplementation of documents during technical dossier post-audits. VIMDA shared that it is developing a new decree to replace Decree 96 and plans to address this issue under the principle of avoiding additional administrative procedures.
VIMDA responded positively to several MDDSC recommendations and indicated that policymakers may incorporate them into the future Medical Device Law or the decree replacing Decree 98. These recommendations include:
- Changes during medical device lifecycle management;
- Withdrawal of circulation numbers;
- Regulation of medical software and AI-enabled devices;
- Refurbished medical devices; and
- Post-market surveillance.
VIMDA expects to issue the decree replacing Decree 98 in 2027, followed by the Medical Device Law in 2029.
The discussion also covered cross-sectoral topics such as artificial intelligence, health insurance, and value-based procurement. VIMDA explained that it will continue coordinating with relevant authorities to develop and refine the legal framework, with the aim of aligning regulations with international practices and ensuring a coherent management approach.
Regarding the management of narcotic substances used in medical devices, VIMDA announced that the Ministry of Health plans to issue a list of regulated narcotic substances used in medical devices and manufacturing materials later this year. VIMDA also invited EuroCham to contribute feedback during the drafting process.
The meeting reaffirmed the strong partnership between EuroCham, MDDSC, and VIMDA, as well as their shared commitment to fostering a transparent, predictable, and internationally aligned regulatory environment for Vietnam’s medical technology sector.
