Recently, the 2022 National Medical Device Supervision and Administration Work Conference was held in Beijing. The meeting made it clear that in 2022, it is necessary to fully implement the electronic review and approval of medical devices, accelerate the review and approval of innovative products; carry out “online clearing and offline standardization” management of medical devices, and increase the intensity of random inspections of medical devices for epidemic prevention and control.
The meeting deployed key tasks for medical device registration management in 2022:
First, deepen the reform of the medical device review and approval system. Comprehensively implement the registrant system, promote the research and transformation of laws and regulations, and fully implement electronic review and approval.
The second is to continue to strengthen the basic capacity building of medical device registration. Continue to implement the standard improvement plan, continue to improve the medical device standard system, strengthen classification, naming and coding work, strengthen the publicity and implementation of regulations, vigorously carry out regulatory scientific research, and strengthen international exchanges and cooperation.
The third is to fully support the high-quality innovative development of the medical device industry. Speed up 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.
The fourth is to continuously improve the level of medical device registration management. Standardize the local registration and filing business, improve the review and approval linkage mechanism, improve the management of the national device review center, strengthen the management of clinical trial institutions and trial projects, and severely punish illegal activities.
The meeting clarified the key tasks for medical device supervision in 2022:
First, carry out in-depth investigation and rectification of hidden risks. Focus on key products, key enterprises and key links, carry out in-depth risk investigation and regular risk consultations; carry out “online clearing and offline standardization” management of medical devices, and increase online sales monitoring.
The second is to continue to strengthen the supervision of medical devices for epidemic prevention and control. Strengthen the supervision of the production, operation and use of medical devices for epidemic prevention and control, and increase the intensity of random inspections of medical devices for epidemic prevention and control.
The third is to continuously strengthen supervision, inspection, inspection and monitoring and evaluation. We will continue to carry out unannounced inspections, strengthen quality supervision and random inspections, and strengthen adverse event monitoring.
The fourth is to continue to increase the intensity of investigating illegal cases and severely punish serious medical device violations.
Fifth, we will continue to strengthen regulatory capacity building. Improve the medical device regulatory system, strengthen regulatory publicity and training, strengthen the inspector team and information system construction, strengthen regulatory scientific research, and promote social co-governance.