Cracking the ASEAN Code: A Pure Global Deep Dive into Clinical Evidence Requirements for MedTech Success in Singapore, Malaysia & Vietnam

This episode of ASEAN MedTech Insights dives deep into one of the most critical and often misunderstood aspects of medical device registration in Southeast Asia: the requirements for clinical evidence. We unpack the ASEAN Consultative Committee for Standards and Quality (ACCSQ) guidance document ACCSQ/MDPWG/GL-1, explaining how to build a robust Clinical Evaluation Report (CER) for the Common Submission Dossier Template (CSDT). We explore how manufacturers can leverage existing clinical data from other major markets like the EU and US to support their ASEAN submissions. This episode provides practical, actionable insights to help you avoid common pitfalls, reduce time-to-market, and successfully navigate the regulatory expectations of different authorities across this dynamic region. A common challenge is faced by companies with established products in Europe trying to enter markets like Thailand and Indonesia. They possess extensive clinical data that secured their CE marking, but they are uncertain how much of it is relevant for their ASEAN submission. This leads to costly delays as they struggle to adapt their dossier, facing questions from regulators about the data's applicability to the local population, ultimately stalling their market entry. What You'll Learn: - What exactly is the ASEAN CSDT and why is it crucial for your submission dossier? - Can you use your existing clinical data from the US or EU for your ASEAN registration? - How do clinical evidence requirements differ for low-risk versus high-risk medical devices? - What are the most common mistakes manufacturers make when preparing their Clinical Evaluation Report for ASEAN markets? - Why do different ASEAN countries sometimes have different expectations despite using a harmonized guidance document? - What key sources of data are considered valid for demonstrating clinical safety and performance? - How can you effectively demonstrate the applicability of international data to the ASEAN population? At Pure Global, we specialize in transforming these challenges into opportunities. We offer end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. Let us help you prepare a winning submission. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.

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