Vietnam's MedTech Gatekeeper: The Crucial Role of the Registration Number Holder

Medical Device Global Market Access · Oct 17, 2025 · 2m

This episode provides a detailed overview of the mandatory Registration Number Holder (Tổ chức đứng tên đăng ký) in Vietnam for foreign medical device manufacturers. We explore the critical legal, post-market, and commercial responsibilities assigned to this local entity under the governing regulation, Decree 98/2021/ND-CP, which came into effect on January 1, 2022. Key obligations discussed include post-market surveillance, adverse event reporting, product recalls, price declaration, advertising compliance, and warranty provision. Key Questions: • What is a Registration Number Holder and why…