Regulatory Affairs

Part of the impetus behind the creation of the APACMed in 2014, was the need to help MedTech industry navigate the increasingly complex and fragmented regulatory landscape. APACMed provides access to actionable regulatory intelligence for its members, advocates for harmonised regulatory requirements where possible across Asia Pacific countries through capacity building and best practice sharing, and promotes regional and global convergence by securing a seat at the table with key harmonisation platforms, building thought leadership in prioritized areas, as well as fostering long-term partnership with regulatory authorities, peer associations, academia and industry.

APACMed’s Regulatory Affairs Committee is the Association’s largest committee, counting over 350 dynamic and engaged senior regulatory professionals.

Much of the regulatory advocacy efforts across the region coalesce around in market based Centres of Excellence, covering: China, South Korea, South East Asia, and  India. Separate Regional Working Groups are dedicated to Regulatory Intelligence (RI), Digital Health (DH), Capacity Building Group (CBG), and In-Vitro Diagnostics (IVD). Through its Centres of Excellence and Working Groups, APACMed has successfully engaged members and fostered its networks at the local level across the region