Pure Global's Guide to Singapore's MedTech Regulations: Unlocking ASEAN Market Access Through Technical Specifications

In this episode of ASEAN MedTech Insights, we demystify the core technical specifications required under Singapore's Health Products (Medical Devices) Regulations 2010. We explore why Singapore serves as a crucial launchpad for the broader ASEAN market and break down the specific documentation demands of the Health Sciences Authority (HSA). We delve into the ASEAN Common Submission Dossier Template (CSDT), detailing the critical elements that manufacturers often overlook, from granular device descriptions and material specifications to the rigorous standards for labelling and clinical evidence. This episode is essential listening for any MedTech company planning a Southeast Asian market entry strategy. Case Study: Imagine launching a revolutionary Class C cardiovascular device, only to face months of delays because your clinical evidence dossier didn't meet the HSA's specific expectations for local population data. This common pitfall can cost millions in lost revenue and market opportunity, a challenge we help you understand and avoid. Key Takeaways: 1. What is the ASEAN CSDT and why is it the backbone of your Singapore submission? 2. How do Singapore's risk classifications (Class A, B, C, D) directly impact your technical documentation requirements? 3. What are the specific labelling and Instructions For Use (IFU) requirements you absolutely cannot ignore? 4. Does your existing clinical data from the US or EU meet the Health Sciences Authority's standards? 5. How can you leverage Singapore's registration as a stepping stone for other ASEAN markets? 6. What are the essential elements of a robust ISO 14971 risk management file that the HSA expects to see? 7. Beyond product testing, what specific details on manufacturing processes must be included in the dossier? Struggling to align your technical documentation with the demands of multiple markets? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise with advanced AI and data tools to streamline global market access. Let us help you turn a single, robust registration process into access for over 30 countries. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.

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