Kong Fanpu, party branch secretary and director of Department of Medical Device Supervision of CFDA
Grasp the main contradiction of medical device regulation: among the contradictions of high expectation of the masses, poor industry basis and weak supervision, the main contradiction is between the regulation and industry development, especially the regulation. Therefore, the “Four Most Stringent” requirements shall be implemented and the medical devices supervision shall be strengthened unwaveringly to promote the development and quality increase of medical device industry, so as to ensure the safety of device use.
Plan the target path of medical device supervision: we strive to basically realize modernization of regulation of medical devices by 2035, holding scientific regulation system, enough regulation power, strong risk control capability and high quality regulation service level, and ranking in the international first-class list; and then based on which ranking in the global leading list of medical device regulation by 2050, after another 15 years of endeavor.
Implement reform of medical device regulation: General Secretary Xi Jinping points out that the people’s health is an important symbol of national prosperity and strength. In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued the Advice on Deepening Reform of Examination and Approval System and Encouraging Innovation in Drugs and Medical Devices (“the Advice”). The Advice brings unprecedented historical development opportunities both for structure adjustment and technical innovation of medical devices in China, and for sharp increase of regulation of medical devices. We should combine the learning and promotion of the spirit of 19th National Congress of the CPC with the implementation of the Advice, grasping the basic characteristics of the change of China's economy from high speed to high quality, seizing the historical opportunity and innovating the concept of supervision, promoting the transformation of regulation from “Nanny” to supervisory mode with implemented entity responsibility, and strengthen the full life cycle management of medical devices to increase the safety level of medical devices.