Xu Jinghe put forward seven requirements for the next step: to ensure the safety of epidemic prevention products by persisting in strict and efficient examination and approval; to administer according to law and accelerate the improvement of the supporting regulations and normative documents of the regulations; to persist in reform and innovation and promote the high-quality development of the industry through policy guidance, scientific supervision and optimization of services; to persist in risk management and focus on key links, We should strengthen the precise implementation of policies, build a solid defense line for risk prevention and control; adhere to responsible governance, establish and improve mechanisms, and fully implement the responsibilities of enterprises, local governments, regulatory authorities, and society; adhere to intelligent governance, and continuously improve governance efficiency; adhere to strengthening the foundation, and strengthen the construction of standard system, inspection ability, inspection ability, and monitoring and evaluation system.

The meeting made arrangements for the key work of medical device registration management in 2021: first, continuously deepen the reform of review and approval system. We should continue to encourage the innovation and development of medical devices, comprehensively summarize the pilot work of medical device registrant system, strengthen the supervision of clinical trials of medical devices, promote the construction of evaluation and inspection sub centers in Guangdong, Hong Kong, Macao and Yangtze River Delta, cooperate with the national key regional development strategy, and implement regional medical device supervision policies. The second is to do a good job in revising the registration management law. We should speed up the revision of the registration management law and organize publicity and implementation training. Third, further consolidate the foundation of registration management. Continue to improve the construction of medical device standard system, continuously improve the management level of medical device classification and naming, steadily promote the implementation of the unique identification system, and optimize the service level of registration management. Fourth, strengthen the supervision and management of registration. We will continue to do a good job in the review and approval of epidemic prevention and control products, improve the management of technical review, and standardize the registration management of class II medical devices and the filing management of class I medical devices.

The meeting made clear the key work of medical device supervision in 2021: first, make every effort to do a good job in the quality supervision of medical devices for epidemic prevention and control. Supervise and urge enterprises to implement their main responsibilities, strengthen supervision and inspection, supervision and random inspection, and do a good job in the quality supervision of export products. The second is to carry out large-scale investigation and management of potential risks. Organize enterprises to carry out self-examination and provincial bureaus to carry out major investigation. Third, we will continue to strengthen supervision and inspection. We should carry out special inspection of sterile and implantable devices, carry out flight inspection, strengthen supervision and inspection of operation and use, continue to promote the "net clearing" action of medical devices, and intensify the investigation and handling of cases. Fourth, give full play to the role of supervision and sampling. Adhere to the problem oriented, strengthen the coordination and linkage of sampling inspection. Fifthly, we should attach great importance to the monitoring of adverse events. Implement the main responsibility of enterprise monitoring, and actively take risk control measures. Sixth, carry out risk consultation in an all-round way. Organize and carry out safety situation analysis and risk consultation, strengthen the supervision and guidance of innovative approval products. Seven is to constantly improve the system. Revise departmental rules and regulations, improve the regulatory system, and strengthen the publicity and training of laws and regulations. Eighth, continuously improve the regulatory capacity.

News source: China food and drug network