On May 31, the Medical Device Supervision Department of the State Food and Drug Administration organized a report meeting on the investigation and rectification of potential quality and safety risks in the operation and use of medical devices. If there are problems, study the next steps, further strengthen the supervision of the operation and use of medical devices, and improve the quality and safety assurance level of medical devices.
The meeting pointed out that the safety and effectiveness of medical devices are closely related to public health and life safety. The drug administration departments at all levels must be strict and practical, and further promote the quality supervision of the operation and use of medical devices. Under the current situation of epidemic prevention and control, drug regulatory departments at all levels must keep in mind their responsibilities and missions, implement various tasks, and ensure the effectiveness of supervision.
It is reported that in order to promote the solid development of the rectification of medical devices, the local drug regulatory departments actively plan, innovate in the regulatory system and form, and make solid progress. The Jiangsu Provincial Bureau has launched the "Li Jian 2022" special action, and the Guangdong Provincial Bureau has included it in the "Work Style Construction Promotion Year" project. Provincial epidemic prevention and control equipment, carry out full coverage sampling inspections in stages, at different levels, and by varieties. The Market Bureau of Weihai City, Shandong Province included the investigation and management of hidden dangers and special drug rectification actions into the "top-ranking project". The High-tech Branch of the Market Bureau of Baoji City, Shaanxi Province established a work task ledger, explored the implementation of the "monthly plan, weekly notification, quarterly evaluation" system, and solidly promoted the investigation and rectification action. For business entities and supervisory units, the Market Bureau of Chengguan District, Lanzhou City, Gansu Province, the Market Bureau of Chengdu High-tech Zone, Sichuan Province, and the Market Bureau of Weihai City, Shandong Province have formulated a double-check on the "risk of medical device products" and "risk of regulatory responsibility". Procedures or lists, to promote the implementation of the responsibilities of both business entities and regulators.
For the next step, the meeting put forward requirements: drug administration departments at all levels should strengthen communication and cooperation with health, public security and other departments under the leadership of local party committees and governments and the joint epidemic prevention and control mechanism to form a joint supervision force. Make every effort to build a solid bottom line on the safety of medical device products for epidemic prevention and control, and make new contributions to epidemic prevention and control.
The Medical Device Supervision Department of the State Food and Drug Administration, the China Inspection Institute, the Inspection Center, the Evaluation Center, the Acceptance and Reporting Center, and the responsible comrades of the drug regulatory departments of more than ten provinces and cities including Jiangsu Province and Guangdong Province attended the meeting in the main venue and branch venues respectively. .
Strict, practical and meticulous, and in-depth promotion of quality supervision in the operation and use of medical devices
2022 06/06