Pure Global: Malaysia & Thailand's MedTech Shortcut - A New Regulatory Reliance Shake-Up.

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Pure Global: Malaysia & Thailand's MedTech Shortcut - A New Regulatory Reliance Shake-Up.

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This week, we unpack the major regulatory announcement from Malaysia and Thailand that's set to reshape market access in ASEAN. The MDA and Thai FDA have launched a pilot program for regulatory reliance, creating a new, faster pathway for Class B, C, and D medical devices. This move promises to slash approval times and costs for manufacturers. We explore what this "sandbox" for ASEAN collaboration means for your business. Imagine you are launching a new cardiovascular device. Instead of two lengthy, independent reviews, you can now leverage your approval in one country to accelerate registration in the other. But this opportunity comes with strategic questions: which market should you prioritize for the initial review, and how do you prepare a submission that satisfies both regulators from the outset? Key Takeaways: - What specific device classes are included in the new Malaysia-Thailand regulatory reliance pilot? - How does this program change the traditional market entry strategy for MedTech companies in ASEAN? - Could this pilot program be the first step towards a unified ASEAN-wide approval system? - What are the potential risks or hidden complexities companies should watch out for? - How does this initiative affect local Malaysian and Thai manufacturers compared to international ones? - What documentation from the first approval is required to qualify for the fast-track process in the second country? - Are there lessons to be learned from similar reliance programs in other regions, like Europe? Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. We act as your local representative in over 30 markets, developing efficient pathways for regulatory approval. For help navigating the new ASEAN regulatory landscape, contact Pure Global at info@pureglobal.com or visit https://pureglobal.com/.

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