『Pure Global's Guide to ASEAN Market Entry: Mastering Malaysia’s Medical Device Act 2012 for Full Registration』のカバーアート

Pure Global's Guide to ASEAN Market Entry: Mastering Malaysia’s Medical Device Act 2012 for Full Registration

Pure Global's Guide to ASEAN Market Entry: Mastering Malaysia’s Medical Device Act 2012 for Full Registration

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This episode of ASEAN MedTech Insights delves into the critical requirements of Malaysia's Medical Device Act 2012 (Act 737). We unpack the mandatory full registration process that every medical device must undergo, highlighting the specific and often underestimated hurdles that foreign manufacturers face when entering this key ASEAN market. We explore the entire journey, from the initial shock of regulatory requirements to the detailed steps for a successful submission. Learn why existing international approvals are not a direct passport to the Malaysian market and how local nuances in the registration process can lead to costly delays if overlooked. **Case In Point:** Imagine your advanced, CE-marked product launch in Malaysia is stalled for over nine months. Your submission was rejected before it even reached the authorities. The reason? A fundamental misunderstanding of two local requirements under Act 737: the non-negotiable need for an in-country Authorized Representative and the mandatory use of the CSDT dossier format. This common oversight is currently costing companies significant time, resources, and market opportunity. **Key Takeaways From This Episode:** * Why is Malaysia's Act 737 a critical gatekeeper for all MedTech devices? * Is your CE Mark or FDA approval enough for a smooth registration process in Malaysia? * What is the mandatory legal role of a Malaysia Authorized Representative and why can't foreign firms submit directly? * How does the MeDC@St online system actually work for foreign companies? * What is a Conformity Assessment Body (CAB) and how does its review impact your submission timeline? * What are the most common documentation errors that lead to immediate rejection? * How can you accurately budget for both time and costs when planning your Malaysian market entry? At Pure Global, we eliminate these uncertainties. We provide end-to-end regulatory solutions, acting as your local Authorized Representative in Malaysia and over 30 other markets. Our team of local experts, powered by advanced AI tools, reformats your technical dossiers, manages CAB reviews, and handles submissions through the MeDC@St portal to ensure compliance and accelerate your market access. Don't let regulatory hurdles slow your growth in ASEAN. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to streamline your global expansion.
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