On March 22, the State Administration for Market Regulation issued the revised Measures for the Supervision and Administration of Medical Device Production (hereinafter referred to as the “Production Measures”) and the “Measures for the Supervision and Administration of Medical Device Operations” (hereinafter referred to as the “Operation Measures”), which will be effective from May 1, 2022.
The State Administration for Market Regulation proposed that the above two measures must strictly implement the “four most stringent” requirements, implement the provisions of the “Regulations on the Supervision and Administration of Medical Devices” (hereinafter referred to as the “Regulations”), fully implement the medical device registrant and recorder system, optimize the administrative licensing process, strengthen supervision and inspection measures, improve supervision and inspection methods, consolidate the main responsibilities of enterprises, and further increase penalties for illegal activities.
Implement 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 for 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 medical device production link. Improve the management requirements for sales, transportation, storage and other aspects of the business process, refine the relevant regulations on traceability management such as incoming inspection and sales records, and strengthen the quality and safety responsibilities of registrants and filers selling their registered and filed medical devices.
Consolidate the main responsibilities of medical device production and operation enterprises.
Establish a medical device production reporting system and stipulate requirements for production product variety reporting, production dynamics reporting, production condition change reporting, and annual self-examination reports on the operation of the quality management system. At the same time, the licensing and filing process has been optimized, and the requirements for business licenses and filings under the medical device registrant system have been adjusted. The requirements for submitting business licenses and relevant supporting documents when canceling licenses have been further reduced. The time limit for verification and approval has been further shortened. The specific circumstances of exemption from submission of application materials and business filings have been clarified. For those who apply for licenses and filings at the same time, the procedural requirements such as material submission have been simplified.
Consolidate departmental supervision responsibilities.
Refine and improve the responsibilities of regulatory authorities at all levels, and improve various forms of supervision and inspection such as supervision and inspection, key inspection, follow-up inspection, reasoned inspection and special inspection. It clarifies the responsibilities and requirements of drug regulatory authorities when registrants entrust production across provinces, clarifies the regulations on joint and assistance in cross-regional supervision and inspection, investigation and evidence collection, adds new regulations on extended inspections and joint inspections of business links, and improves the management systems for overseas inspections, information disclosure and responsibility interviews.
Strengthen quality and safety risk management and control.
Based on the actual supervision work, the hierarchical management, risk control, and reasoned inspection requirements for medical device production and operation have been further refined and 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 responsibilities and management requirements for medical device registrants, filers and operating companies that specialize in providing transportation and storage services. At the same time, it is clarified that the drug regulatory authorities should conduct regular risk consultations and judgments based on supervision and inspection, product sampling, adverse event monitoring, complaints and reports, administrative penalties, etc., and do a good job in the investigation, prevention, control and disposal of medical device quality and safety hazards.