Xu Jinghe, a 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 "High quality
development period", the reform and innovation of the review and approval system has entered the "period of further promotion", the supervision capacity construction has entered the "comprehensive strengthening period", and the quality supervision has entered the "high risk pressure period".
Xu Jinghe put forward five requirements for the supervision of medical devices: conduct thorough investigation and rectification of risks and hidden dangers; continuously strengthen the supervision of epidemic prevention devices; continue to deepen the reform of the review and approval system; comprehensively promote the implementation of risk management responsibilities; and make every effort to strengthen the infrastructure construction.
The meeting laid out the key work of medical device registration and management in 2022:
First, we will deepen the reform of the medical device evaluation 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 basic capacity building of medical device registration.We will continue to implement the standard improvement plan, continue to improve the standard system for medical devices, strengthen the classification, naming and coding work, strengthen the publicity and implementation of laws and regulations, vigorously carry out scientific regulatory research, and strengthen international exchanges and cooperation.
Third, we will fully support the high-quality and 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, constantly improve the level of medical device registration and management.We will standardize local registration and filing business, improve the connection mechanism for review and approval, improve the management of national bureau examination centers, strengthen the management of clinical trial institutions and trial projects, and severely punish illegal acts.
The meeting clarified the key work of medical device supervision in 2022:
First, we will further investigate and address potential risks and hidden dangers.Focus on key products, key enterprises and key links, carry out in-depth investigation of risks and hidden dangers, carry out regular risk consultation; carry out "online cleaning and offline standardization" governance of medical devices, and strengthen the monitoring of online sales.
Second, we will 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 sampling inspection of medical devices for epidemic prevention and control.
Third, we will continue to strengthen supervision, inspection, inspection, monitoring and evaluation.We will continue to carry out in-flight inspections, strengthen quality supervision and sampling inspection, and strengthen the monitoring of adverse events.
Fourth, continue to strengthen the investigation and punishment of illegal cases, and severely punish the violations of medical devices.
Fifth, we will continue to strengthen regulatory capacity building.We will improve the legal system for medical devices, strengthen the publicity and training of laws and regulations, strengthen the construction of inspectors and information systems, strengthen scientific research on supervision, and promote social co-governance.
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