The Asia-Pacific Economic Cooperation (APEC) Center of Excellence pilot workshop on medical devices was successfully held in Dec.8-10 in Chengdu, China, with the endorsement of APEC Regulatory Harmonization Steering Committee (RHSC) and the support from Medical Device PWA, RHSC Center of excellence (CoE) Coalition, National Medical Products of Administration (NMPA), Chinese Society for Biomaterials (CSBM) and National Engineering Research Center for Biomaterials (NERCB).

The workshop was hosted by Sichuan University (SCU) and co-organized by the Institute of Regulatory Science for Medical Devices, SCU (RSMD)- the first NMPA Research Base of Regulatory Science for Medical Devices, and West China Hospital, SCU (WCH). More than 10 leading experts worldwide in the field of medical devices were invited to present as trainers. About 140 delegates from 11 APEC economies and 6 non-APEC economics attended the workshop. Sichuan University, as the host, covered the international transportation, the accommodation, and conference expenses for the speakers and invited guests or delegates who were nominated or recommended by APEC economics.

The workshop focused on “internationally regulatory convergence for medical devices” by presenting the principle and guidance from IMDRF/GHTF documents and latest regulatory issues or best practices. The curriculum topics covered the whole-life cycle of medical devices regulatory, mainly involving basic concept, effectiveness and evaluation, safety and risk, clinical evaluation, market access, quality management system (QMS), unique identification of medical devices (UDI) and post-market vigilance of medical devices. Q & A session after each presentation, group discussion, in-class mock submission and sites visit of NERCB and WCH were organized to improve close interaction between speakers and delegates, and between delegates from different countries.

As the first CoE workshop on medical devices in China, the workshop confirmed the active support and effort from Chinese government, scientific agency and society of industry to promote the global regulatory convergence of medical devices. The success of this pilot demonstrated the qualification and ability of SCU to host such international workshop.