Unlocking Your MedTech in Vietnam: The Registration Holder Dilemma

This episode delves into the critical process of changing a medical device registration holder in Vietnam. We clarify a common misconception: a direct license transfer between holders is not permitted by the Ministry of Health. Instead, manufacturers must navigate a full re-registration process. We outline the steps involved and highlight the significant strategic advantages of appointing an independent registration holder to maintain control and flexibility over your market access. Key Questions: • Thinking of changing your distributor in Vietnam? • Is your medical device registration currently held by your commercial partner? • What happens to your market access if that partnership ends? • Can you simply transfer a device registration from a distributor to a new company in Vietnam? • What is the official process for changing your registration holder with the MOH? • Why is appointing an independent registration holder a smarter long-term strategy? • How can you avoid being locked into an underperforming distributor? • What are the risks of a distributor refusing to cancel an existing registration? 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.