Malaysia MedTech: Your Guide to Authorized Representatives & Registrants

Medical Device Global Market Access · Oct 18, 2025 · 3m

This episode delves into the essential roles of the Authorized Representative (AR) and Registrant for medical device market access in Malaysia. We clarify the legal requirements under the Medical Device Act 2012 (Act 737), explain the responsibilities of a Malaysian AR, and break down the critical strategic differences between appointing a distributor versus an independent third-party as your representative. Understanding this distinction is key to maintaining control over your device registration and ensuring long-term market flexibility. Key Questions: • What is a Malaysia Authorized…