On 25 September 2024, EuroCham Vietnam convened with the Infrastructure and Medical Device Administration (IMDA), part of the Ministry of Health, to continue fostering collaboration on medical device regulations. This significant meeting was attended by EuroCham representatives, including Mrs. Van Nguyen, Head of the Hanoi Office, along with MDDSC leaders Mr. Qadeer Raza, Mr. Duong Hong Duc, and Mr. Gaurav Chillar, alongside 28 other members from the MDDSC.
Dr. Nguyen Minh Loi, Director General of IMDA, provided essential updates on the evolving landscape of medical device regulations in Vietnam. He highlighted the ongoing development of the Law on Medical Devices and announced the forthcoming revision of Decree 96. Although EuroCham had previously requested an extension for medical device licenses, Dr. Loi confirmed that no extension is currently planned. However, priority may be given to products with existing import licenses once the decree is revised. IMDA has also strengthened its workforce by hiring 10 legal specialists to accelerate the review process for dossiers.
A key topic of discussion was the significant backlog of over 1,400 pending dossiers submitted by EuroCham members. In response, Dr. Loi offered two potential solutions: either prioritizing submissions after the revision of Decree 96 or allowing for the submission of new dossiers for immediate review. While the latter could increase the workload for both parties, he reassured attendees that the IMDA is enhancing its efficiency by holding more frequent committee meetings, aiming to process 1,200 dossiers monthly.
The meeting underscored the importance of EuroCham’s ongoing involvement in shaping regulations and addressing post-market challenges. Discussions also touched on the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) and the potential for further regulatory adjustments. The IMDA expressed appreciation for EuroCham’s support, indicating that the partnership has been instrumental in navigating the complexities of the medical device landscape in Vietnam.
Overall, the meeting was a productive step forward in strengthening the collaboration between EuroCham and IMDA, with both sides committed to working together to enhance the regulatory framework for medical devices in Vietnam, ultimately benefiting the healthcare industry and patients alike.
