The Asia Pacific Economic Cooperation (APEC) has also developed the following document relating GRP to implementation of the World Trade Organization Technical Barriers to Trade Agreement:
To promote regulatory convergence, the Asia-Pacific Economic Cooperation (APEC), launched in 2018 the “Roadmap to Promote Regulatory Convergence for Medical Device Regulatory System”. This work item “aims to promote international harmonization initiatives (i.e., International Medical Device Regulators Forum (IMDRF) and former Global Harmonization Task Force (GHTF) Guidance Documents), build regulatory capacity and knowledge, and support harmonized implementation efforts among APEC economies.”
Based on this proposal, a “Core Curriculum for Medical Device” was developed to provide training and capacity building for regulators “to gain greater understanding of international best practices, achieve harmonized approaches, and facilitate regulatory convergence for medical devices in APEC economies.”
To learn more, see here: Core Curriculum for Medical Device and Promote Regulatory Convergence for Medical Device Regulatory Systems.
REGULATORY COALITION PRINCIPAL MEMBERS
