Recently, the State Administration for Market Regulation issued the revised "Measures for the Supervision and Administration of Medical Device Production" and "Measures for the Supervision and Administration of Medical Device Operation", which will come into force on May 1, 2022
The safety of medical devices is closely related to the health of the people.
The two measures strictly implement the "four strictest" requirements, implement the "Regulations on the Supervision and Administration of Medical Devices", fully implement the medical device registrant filer system, optimize the administrative licensing process, strengthen Supervision and inspection measures, improve supervision and inspection methods, consolidate the main responsibility of enterprises, and further increase the punishment for illegal acts
.
Enforce the strictest regulatory requirements
Strengthen the supervision and management of medical device registrants, clarify the responsibilities of both the registrant and the entrusted production enterprise, incorporate the relevant requirements of entrusted production management into the quality management system, and further improve the inspection responsibilities, inspection methods, results disposal, and investigation of medical device production.
Forensics and other regulatory requirements
.
Improve the management requirements for sales, transportation, storage and other aspects of the business process, refine the relevant provisions on the traceability management of purchase inspection, sales records, etc.
, and strengthen the registrant and filer's responsibility for the quality and safety of medical devices that are registered and filed
.
Consolidate the main responsibility of production and operation enterprises
Establish a medical device production reporting system, and stipulate the requirements for production product variety report, production dynamic report, production condition change report, and annual report on self-inspection of the operation of the quality management system
.
At the same time, optimize the license filing process, adjust the requirements for business licenses and filings under the medical device registrant system, submit business licenses and relevant certification documents when canceling licenses, further shorten the time limit for verification and approval, and clarify the exemption from submitting application materials and It is exempted from the specific circumstances of business filing, and for those who apply for license and filing at the same time, the procedural requirements such as material submission are simplified
.
Compaction Department Regulatory Responsibilities
Refine and improve the responsibilities of regulatory departments at all levels, and improve various forms of supervision and inspection, such as supervision and inspection, key inspection, follow-up inspection, cause-based inspection and special inspection
.
Clarified the responsibilities and requirements of the drug regulatory department in the case of the registrant's cross-provincial entrusted production, clarified the cross-regional supervision and inspection, investigation and evidence collection and other aspects of joint and assistance provisions, added relevant provisions on extended inspection and joint inspection of business links, and improved overseas inspections And management systems such as information disclosure and responsibility interviews
.
Strengthen quality and safety risk control
Combined with the actual supervision work, the hierarchical management and risk control of medical device production and operation have been further refined and improved, and the requirements for cause-based inspection have been further refined
.
Strengthen the control of quality and safety risks, clarify the key points of production and operation supervision and inspection, and clarify the quality responsibilities and management requirements for the provision of transportation and storage services for medical device registrants, filers, and operating enterprises
.
At the same time, it is clarified that the drug regulatory department should conduct regular risk consultations and judgments based on supervision and inspection, product sampling inspection, adverse event monitoring, complaints and reports, administrative penalties,
etc.
