From May 1! Major adjustment of medical device supervision in all cities
2022-05-06 10:09:57
The state pointed out that the two measures strictly implement the "four strictest" requirements. We will implement the provisions of the regulations on the supervision and administration of medical devices, fully implement the system of medical device registrants and recorders, optimize the administrative licensing process, strengthen supervision and inspection measures, improve supervision and inspection means, strengthen the main responsibility of enterprises, and further strengthen the punishment of illegal acts.
Implement the most stringent regulatory requirements. Strengthen the supervision and management of the medical device registrant, clarify the responsibilities of both the registrant and the entrusted manufacturer, incorporate the relevant requirements of entrusted production management into the quality management system, and further improve the inspection responsibilities, inspection methods, result disposal, investigation and evidence collection and other regulatory requirements for the production of medical devices. Improve the management requirements for sales, transportation, storage, etc. in the business process, refine the relevant provisions for traceability management such as purchase inspection and sales records, and strengthen the quality and safety responsibilities of registrants and filers for selling their registered and filed medical devices.
Establish a medical device production reporting system, and specify the requirements for product variety report, production dynamic report, production condition change report and annual self inspection report on the operation of the quality management system.
Optimize the licensing and filing process, adjust the requirements for business license and filing under the medical device registrant system, submit the requirements for business license and relevant supporting documents when canceling the license, further reduce the time limit for verification and approval, clarify the specific circumstances of exemption from submission of application materials and exemption from business filing, and simplify the procedural requirements for submission of materials when applying for license and filing at the same time.
Supervision responsibility of compaction department. Refine and improve the responsibilities of regulatory departments at all levels, and improve various forms of supervision and inspection, including supervision and inspection, key inspection, follow-up inspection, causal inspection and special inspection. The requirements for the responsibilities of the drug regulatory authorities in the case of the registrant's Cross provincial entrusted production have been clarified, the provisions on joint and assistance in cross regional supervision and inspection, investigation and evidence collection have been clarified, the relevant provisions on extended inspection and joint inspection of business links have been added, and the management systems for overseas inspection, information disclosure and responsibility interview have been improved.
Strengthen the control of quality and safety risks, clarify the key points of production and operation supervision and inspection by classification, and clarify the quality responsibility and management requirements for providing transportation and storage services for medical device registrants, recorders and operating enterprises.
Implement the most stringent regulatory requirements. Strengthen the supervision and management of the medical device registrant, clarify the responsibilities of both the registrant and the entrusted manufacturer, incorporate the relevant requirements of entrusted production management into the quality management system, and further improve the inspection responsibilities, inspection methods, result disposal, investigation and evidence collection and other regulatory requirements for the production of medical devices. Improve the management requirements for sales, transportation, storage, etc. in the business process, refine the relevant provisions for traceability management such as purchase inspection and sales records, and strengthen the quality and safety responsibilities of registrants and filers for selling their registered and filed medical devices.
Establish a medical device production reporting system, and specify the requirements for product variety report, production dynamic report, production condition change report and annual self inspection report on the operation of the quality management system.
Optimize the licensing and filing process, adjust the requirements for business license and filing under the medical device registrant system, submit the requirements for business license and relevant supporting documents when canceling the license, further reduce the time limit for verification and approval, clarify the specific circumstances of exemption from submission of application materials and exemption from business filing, and simplify the procedural requirements for submission of materials when applying for license and filing at the same time.
Supervision responsibility of compaction department. Refine and improve the responsibilities of regulatory departments at all levels, and improve various forms of supervision and inspection, including supervision and inspection, key inspection, follow-up inspection, causal inspection and special inspection. The requirements for the responsibilities of the drug regulatory authorities in the case of the registrant's Cross provincial entrusted production have been clarified, the provisions on joint and assistance in cross regional supervision and inspection, investigation and evidence collection have been clarified, the relevant provisions on extended inspection and joint inspection of business links have been added, and the management systems for overseas inspection, information disclosure and responsibility interview have been improved.
Strengthen the control of quality and safety risks, clarify the key points of production and operation supervision and inspection by classification, and clarify the quality responsibility and management requirements for providing transportation and storage services for medical device registrants, recorders and operating enterprises.
