On January 17, the CFDA held the Expert Symposium on Reform of Medical Devices Evaluation and Approval System, listening to the suggestions and comments of deputies to the National People's Congress, members of the national committee of CPPCC in medical devices field and specialists and scholars in the field of clinical and scientific research, Chinese Society of Biomedical Engineering, Chinese Society for Biomaterials, China Association for Medical Devices Industry and some enterprise representatives. Jiao Hong, Deputy Director of CFDA, took the chair and gave a speech.
At the meeting, the heads of Department of Medical Device Registration, Department of Medical Device Supervision, and Center for Medical Device Evaluation reported the progress of the reform and supervision of medical devices evaluation and approval system. The participating experts agreed that the initiatives of CFDA to promote the reform of medical devices evaluation and approval system are implementable and down to earth, the increase of efficiency and strength of evaluation and approval greatly boosts the innovation and R&D of medical devices and healthy industrial development, solving some of the problems long troubled the enterprises. Experts suggested, under the premise of complying with national evaluation and approval system, to continuously optimize and simplify registration procedures, further strengthen capacity building for evaluation of medical devices, increase the number of reviewer, and speed up the reform of evaluation and approval.
Jiao Hong pointed out that the reform shall be clinical demand-oriented to meet the needs of the masses to use high-level and high-performance medical devices and to increase the sense of gain of scientific researchers, enterprises and the masses. The increase of capacity of CFDA on evaluation and approval of medical devices requires not only regulatory efforts but also the joint participation and support of scientific institutions, enterprises and industry associations. Comprehensive in-depth reform involves both reform of evaluation and approval and update of regulation idea, matching of full life cycle management, strengthening of risk management, clarification of regulatory power, and construction of professional inspector team, all these are the priority of the work in the future. The implementation of the “Four Most Stringent” requires more professional supervision and the industry associations shall drive the enterprises to implement the entity responsibility, so as to implement the quality management system. As the rotating presidency of 2018 International Medical Device Regulators Forum (IMDRF), China will hold international meetings in March and September in Shanghai and Beijing respectively, which is a rare opportunity for China to increase the supervision level of medical devices, and the medical device enterprises are welcome to the meetings. The CFDA will also increase international exchanges to make better conditions for export of domestic medical devices.
The responsible persons of relevant departments and directly controlled organs of CFDA attended the symposium. Zhao Yixin, chairman of CAMDI, was also invited to attend the conference and proposed active suggestions and comments on relevant issues on behalf of the industry and enterprises.
At the meeting, the heads of Department of Medical Device Registration, Department of Medical Device Supervision, and Center for Medical Device Evaluation reported the progress of the reform and supervision of medical devices evaluation and approval system. The participating experts agreed that the initiatives of CFDA to promote the reform of medical devices evaluation and approval system are implementable and down to earth, the increase of efficiency and strength of evaluation and approval greatly boosts the innovation and R&D of medical devices and healthy industrial development, solving some of the problems long troubled the enterprises. Experts suggested, under the premise of complying with national evaluation and approval system, to continuously optimize and simplify registration procedures, further strengthen capacity building for evaluation of medical devices, increase the number of reviewer, and speed up the reform of evaluation and approval.
Jiao Hong pointed out that the reform shall be clinical demand-oriented to meet the needs of the masses to use high-level and high-performance medical devices and to increase the sense of gain of scientific researchers, enterprises and the masses. The increase of capacity of CFDA on evaluation and approval of medical devices requires not only regulatory efforts but also the joint participation and support of scientific institutions, enterprises and industry associations. Comprehensive in-depth reform involves both reform of evaluation and approval and update of regulation idea, matching of full life cycle management, strengthening of risk management, clarification of regulatory power, and construction of professional inspector team, all these are the priority of the work in the future. The implementation of the “Four Most Stringent” requires more professional supervision and the industry associations shall drive the enterprises to implement the entity responsibility, so as to implement the quality management system. As the rotating presidency of 2018 International Medical Device Regulators Forum (IMDRF), China will hold international meetings in March and September in Shanghai and Beijing respectively, which is a rare opportunity for China to increase the supervision level of medical devices, and the medical device enterprises are welcome to the meetings. The CFDA will also increase international exchanges to make better conditions for export of domestic medical devices.
The responsible persons of relevant departments and directly controlled organs of CFDA attended the symposium. Zhao Yixin, chairman of CAMDI, was also invited to attend the conference and proposed active suggestions and comments on relevant issues on behalf of the industry and enterprises.