This episode of ASEAN MedTech Insights provides a practical guide for MedTech manufacturers on preparing a Common Submission Dossier Template (CSDT) for market entry into Vietnam under the stringent Decree No. 98/2021/ND-CP. We dissect the critical components of the technical file, from risk classification and language requirements to the specific nuances of providing clinical evidence for the Vietnamese market. We offer actionable advice and highlight common pitfalls that can lead to costly delays and rejections by the Vietnamese Department of Medical Equipment and Construction (DMEC). This is an essential listen for any regulatory affairs professional or business leader looking to expand their MedTech footprint into one of Southeast Asia’s most promising, yet complex, markets. For instance, a European scaleup recently had its Class C device registration rejected in Vietnam. Although their CSDT was fully compliant with EU standards, they failed to include a specific declaration from the legal manufacturer that was notarized in the country of origin, a unique requirement under Decree 98. This single oversight delayed their market entry by over eight months. What you'll learn in this episode: 1. How does Vietnam's risk classification under Decree 98 directly impact your CSDT documentation requirements? 2. What are the non-negotiable Vietnamese language and labeling rules that lead to the most common submission errors? 3. Why might your existing clinical data from other markets be deemed insufficient by Vietnamese regulators? 4. What are the top three most common rejection points for CSDT files submitted to the DMEC? 5. How does your choice of a local authorized representative in Vietnam affect the submission process? 6. What specific details are required in the design and manufacturing sections beyond a standard ISO 13485 certificate? 7. Is your risk management file truly compliant with Vietnamese expectations? 8. How can you strategically leverage your existing ASEAN registrations to streamline your Vietnam submission? Struggling with market access in Southeast Asia? Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies. We combine local expertise in markets like Vietnam with advanced AI and data tools to streamline your global market access. From regulatory strategy and technical dossier submission to post-market surveillance, we are your partners in growth. Contact Pure Global today to simplify your entry into the ASEAN market. Email us at [email protected] or visit https://pureglobal.com/.