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Unlocking the Malaysian Medical Device Market: A 2024 Regulatory Guide
This episode provides a detailed guide to Malaysia's medical device registration process. We explore the role of the Medical Device Authority (MDA), the foundational Medical Device Act 2012, and the critical steps manufacturers must take, from risk classification and conformity assessments to submission via the MeDC@St online system, including recent 2024 updates. • What is the primary legislation governing medical devices in Malaysia? • How does the risk classification (A, B, C, D) impact your registration strategy? • Are all device classes required to undergo a Conformity Assessment? • What…
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