Standing at the historical intersection of the “two centenary” goals, Chinese medical device industry and regulatory undertakings are facing a new situation. Wang Zhexiong, Director of the Medical Device Supervision Department of the State Drug Administration, stated that in 2021, in order to ensure a good start and a good start in the “14th Five-Year Plan”, the medical device supervision department will implement the newly revised “Regulations on the Supervision and Administration of Medical Devices” and continue to Strengthen the construction of laws and regulations, take the “four most stringent” requirements as the fundamental orientation, make every effort to supervise the quality of medical devices for epidemic prevention and control, strengthen risk management and control with high-risk products as the focus, make all efforts to supervise medical devices, and maintain medical device safety The situation is stable, and the high-quality development of the medical device industry is promoted.
In 2021, the State Food and Drug Administration will intensify investigation and handling of cases, and severely crack down on illegal activities such as unlicensed production and production of unlicensed products, non-compliance with mandatory standards or product technical requirements. At the same time, establish a smooth investigation and handling mechanism.
The enterprise is the first person responsible for product quality. The provincial drug regulatory bureaus shall supervise and guide the medical device manufacturers in the area of epidemic prevention and control to fully perform their main corporate responsibilities, organize production in strict accordance with laws, standards and technical specifications, strengthen the construction of the enterprise quality management system, strengthen the internal management of the enterprise and the training of employees Production process control and factory inspection.
Wang Zhexiong pointed out that to improve the efficiency of medical device supervision, it is necessary to promote social co-governance and strengthen coordination among all parties, but also to strengthen the linkage between the upper and lower levels, promote close contact between the regulatory authorities at all levels, and strengthen the quality supervision of the production, operation, and use of medical devices throughout the life cycle. Comprehensively strengthen the supervision system and supervision capacity building.
Post time: Mar-18-2021