Malaysia MedTech: The Risks and Rewards of Self-Licensing

Medical Device Global Market Access

This episode delves into the strategic option for foreign MedTech companies to use their own Malaysian subsidiary as the official license holder for their medical devices. We unpack the regulatory framework under the Medical Device Act 2012, highlighting the complete control this model offers over registrations and commercial activities. However, it also brings significant legal and operational responsibilities, including mandatory GDPMD certification and full liability for post-market surveillance and recalls. We explore the risks and what is required for a local entity to successfully take on this role. Key Questions: • Can our own Malaysian company legally hold the registration for our medical devices? • What is a Malaysia Authorized Holder (MAH) and what are its core duties? • What are the primary legal liabilities when holding your own device registration in Malaysia? • Is obtaining a Good Distribution Practice for Medical Devices (GDPMD) certificate mandatory for our local entity? • What specific post-market surveillance tasks must the license holder perform? • How does self-licensing provide greater control over commercial distributors? • What are the consequences if our local company fails to manage its regulatory obligations? • Is it possible to hire a consultant for registration tasks without appointing them as our official Authorized Representative? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.