State Food and Drug Administration: in 2022, strengthen the sampling inspection of medical devices for epidemic prevention and control
2022-01-28
According to the official website of the State Food and drug administration, on January 27, the 2022 national medical device supervision and management conference was held in Beijing. The meeting made it clear that in 2022, the electronic review and approval of medical devices should be fully implemented, and the review and approval of innovative products should be accelerated; We will carry out the "online cleaning and offline standardization" of medical devices, and intensify the sampling and inspection of medical devices for epidemic prevention and control. Xu Jinghe, member of the Party group and deputy director of the State Drug Administration, pointed out that at present, China's medical device industry has entered the "golden development period", the reform and innovation of the review and approval system has entered the "in-depth promotion period", the construction of regulatory capacity has entered the "comprehensive strengthening period", and the quality supervision has entered the "high-risk period". Xu Jinghe put forward five requirements for the supervision of medical devices: to carry out in-depth investigation and rectification of potential risks; Continue to strengthen the supervision of epidemic prevention equipment; Continue to deepen the reform of the review and approval system; Comprehensively promote the implementation of risk management responsibilities; Go all out to strengthen infrastructure construction. The meeting deployed the key work of medical device registration management in 2022: first, deepen the reform of medical device review and approval system. We will fully implement the registrant system, promote the research and transformation of laws and regulations, and fully implement the electronic review and approval. Second, we will continue to strengthen the building of basic capacity for medical device registration. Continue to implement the standard improvement plan, continue to improve the medical device standard system, strengthen the classification, naming and coding work, strengthen the publicity and implementation of laws and regulations, vigorously carry out regulatory scientific research, and strengthen international exchanges and cooperation. Third, fully support the high-quality innovative development of the medical device industry. We will accelerate the review and approval of innovative products, promote the transformation and application of scientific and technological achievements, implement major national strategies, and support the development of industries in key regions. Fourth, continuously improve the level of medical device registration management. Standardize the local registration and filing business, improve the connection mechanism of review and approval, improve the management of the National Bureau of medical examination center, strengthen the management of clinical trial institutions and test projects, and severely punish illegal acts. The meeting defined the key work of medical device supervision in 2022: first, carry out in-depth investigation and rectification of potential risks. Focus on key products, key enterprises and key links, carry out in-depth risk and hidden danger investigation, and regularly carry out risk consultation; Carry out the governance of "online cleaning and offline standardization" of medical devices, and strengthen the monitoring of online sales. Second, continue to strengthen the supervision of medical devices for epidemic prevention and control. We will strengthen supervision over the production, operation and use of medical devices for epidemic prevention and control, and intensify the random inspection of medical devices for epidemic prevention and control. Third, continuously strengthen supervision, inspection, monitoring and evaluation. Continue to carry out flight inspection, strengthen quality supervision and sampling inspection, and strengthen adverse event monitoring. Fourth, we will continue to intensify the investigation and handling of illegal cases, and severely punish and severely punish the illegal behaviors of medical devices. Fifth, continue to strengthen the building of regulatory capacity. Improve the legal system of medical devices, strengthen the publicity and training of laws and regulations, strengthen the construction of inspector team and information system, strengthen the scientific research of supervision, and promote the common governance of society. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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