Vietnam’s Ministry of Health issued “Consolidated Document No. 08/VBHN-BYT” on medical device management on March 6, 2026. This brings together the provisions of Decree No. 98/2021 and its amendments, including Decree No. 07/2023, into one unified document. The consolidation simplifies how device companies should interpret and apply current rules. Instead of introducing new regulations, the document covers and provides additional details on the full regulatory lifecycle, including product classification, registration, licensing, distribution, and post-market surveillance. By replacing the need to review multiple legal texts, it provides medical device companies with a clearer and more efficient compliance framework.
Separately, Vietnam has introduced updates affecting medical device advertising. Decree No. 342/2025 removes the requirement to publicly disclose medical device advertising content on the national portal. Although this reduces administrative burden, companies remain responsible for ensuring that promotional materials comply with applicable advertising laws.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.