ASEAN MedTech Insights: Cracking Singapore's HSA Code - A Deep Dive into Device Classification & Grouping with Pure Global's Local Experts

In this episode of ASEAN MedTech Insights, we demystify one of the most critical hurdles for entering Singapore's lucrative medical device market: device classification and grouping. A misstep here can lead to costly delays and outright rejections from the Health Sciences Authority (HSA). We explore how ASEAN innovators can navigate this complex landscape. We break down the four-tier risk classification system and reveal how a strategic approach to device grouping can save you hundreds of thousands of dollars and slash your time-to-market, turning a regulatory burden into a competitive edge. Consider this scenario: A Malaysian IVD company wants to launch a family of five diabetes test kits. Are they facing five separate, costly registration processes? We explore how they navigated this exact challenge, avoiding months of delays and a massively inflated budget by leveraging expert grouping advisory. Key Takeaways from this episode: * Why is Singapore's four-tier risk classification system more nuanced than it appears? * What common mistake in device classification can lead to a complete rejection of your HSA submission? * How can you legally bundle multiple medical devices into a single, cost-effective application? * What are the three essential criteria for successful device grouping in Singapore? * How does a product's intended use dramatically impact its classification and potential for grouping? * When should you seek local expert advisory before even starting your technical dossier? * What are the unwritten rules of the HSA that you won't find in the official guidelines? Tired of regulatory guesswork? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, leveraging local expertise and advanced AI to streamline market access in Singapore and over 30 markets worldwide. Whether it's developing a bulletproof registration strategy or acting as your official local representative, we clear the path for your innovation. Contact our experts today at [email protected] or learn more at https://pureglobal.com/.

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