Asia-Pacific Economic Cooperation

Medical Devices Regulatory Science Center of Excellence Pilot Workshop，2019

Aiming to enhance regulators’ scientific capacity to promote regulatory harmonization and convergence on medical devices, with the endorsement of Asia-Pacific Economic Cooperation (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 APEC CoE pilot workshop on medical devices was successfully held in Dec.8-10 in Chengdu, China.

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 including Buddy Rather-a member of American Academy of Engineering, experts from Singapore Health Sciences Authority, Korea Soonchunhyang University Hospital, directors from NMPA, professors from Washington University, University of Southern California. About 140 delegates from 11 APEC economies and 6 non-APEC economics attended the workshop. Sichuan University, as the host,  covered international transportation, the accommodation, and conference expenses for the speakers and invited guests or delegates who were nominated or recommended by APEC economics.

Professor Xu Weilin (executive vice president of SCU), Wang Xiangyu (director of the department of science and technology and international cooperation of the NMPA), He Li (vice chairman of RHSC), and Nicole Smith (medical devices PWA sub-champion), delivered a speech in concession at the opening ceremony. They congratulated on the successful open of the workshop and expected to promote the global harmonization of medical device regulatory by co-building such an international platform. In addition, more than 140 participants attended the opening ceremony.

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. At the end of workshop, we received volunteer reports from delegates from many countries, who highly rated the workshop and provides some useful feedback.

To sum up, this pilot CoE workshop was successful in six ways: 1) the large scale of the number of participants and the participants’ countries. This workshop attracted about 140 delegates from 11 APEC economies and 6 non-APEC economics to attend the workshop. 2) World-class trainers. The trainers included Buddy Rather-a member of American Academy of Engineering, senior experts from regulatory authorities in Singapore, Korea and NMPA, professors from world famous university. 3) High quality and comprehensiveness of curriculum. The curriculum topics covered the whole-life cycle of medical devices regulatory. 4) Diversity of the training approaches. In addition to lectures, the training included Q & A session after each presentation, group discussion, in-class mock submission and sites visits. 5) High rating of the workshop from delegates. From the course evaluation, volunteer report or in-person communication, the delegates rated highly on course content, quality of speakers, the convenience of registration provided, availability of organizing committee to assist them in attending the workshop and the comfortable venue. 6) A highly efficient work team. It only took the work team of the pilot less than 6 months from starting to apply for the CoE pilot to the end of pilot successful held.

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. In the long run, the training will facilitate the reform of the medical device regulatory system and accelerate the innovation and development of global medical device industry. Based on the achievement of this pilot workshop, SCU will apply for the official approval of SCU APEC CoE on regulatory science for medical devices in February 2020. SCU is committed to build an international platform on medical device regulatory, serving medical devices’ R&D and human use across China and even across the whole world.