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

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 is it essential for selling medical devices in Vietnam? • Which key Vietnamese regulation defines the responsibilities of the Registration Number Holder? • What are the holder's primary duties regarding post-market surveillance and traceability? • Who is legally responsible for managing adverse events and product recalls in the Vietnamese market? • How is the price of a medical device controlled and declared to the Ministry of Health? • What are the rules for advertising medical devices in Vietnam? • What are the warranty and service obligations of the Registration Number Holder? • How does the choice of a Registration Number Holder impact a manufacturer's compliance and success? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.