Revised Measures for Supervision and Administration of Medical Device Production and Measures for Supervision and Administration of Medical Device Operation are Issued and will Come into Force on May 1, 2022
The revised Measures for Supervision and Administration of Medical Device Production and Measures for Supervision and Administration of Medical Device Operation (collectively, “Documents”) have recently been issued by the State Administration for Market Regulation of China, which will come into force on May 1, 2022.
Medical device safety is closely linked with people’s health. The Documents strictly implement the “Four Strictest (strictest standards, regulation, punishment and accountability)” requirements and the Regulation on the Supervision and Administration of Medical Devices, require comprehensive implementation of the system of medical device registrants and filing entities, optimize the administrative licensing process, strengthen the supervision and inspection measures, improve the supervision and inspection means, strengthen enterprises’ entity responsibilities, and further increase punishment for illegal acts.
Implementing the strictest regulatory requirements. The Documents strengthen supervision and administration of medical device registrants, define the responsibilities of registrants and entrusted manufacturers, include requirements for management of entrusted production in the quality management system, and further improve regulatory requirements for inspection responsibilities, inspection methods, results handling, and investigation and evidence collection related to medical device production. The Documents improve requirements for management of sales, transportation, storage, etc. involved in the operation, refine provisions on traceability management in terms of purchase inspections and sales records, and strengthen the quality safety responsibilities of registrants or filing entities in selling the medical devices registered or filed by them.
Strengthening the entity responsibilities of medical device producing and operating enterprises. The Documents establish a medical device production reporting system and stipulate requirements including product variety reporting, production dynamics reporting, production condition change reporting, and annual reporting of self-inspections of quality management system operation. The Documents also optimize the licensing and filing process, adjust operation licensing and filing requirements under the medical device registrant system, cancel requirements for submitting business licenses and related supporting documents at the time of licensing, further shorten the time limit for review and approval, identify specific circumstances where the submission of application data and operation filing can be exempted, and simplify procedural requirements for material submission if licensing and filing are applied for at the same time.
Strengthening regulators’ responsibilities. The Documents refine and improve the responsibilities of regulators at different levels and improve supervision and inspection forms such as supervisory inspection, key inspection, follow-up inspection, for-cause inspection, and special inspection. The Documents define responsibility requirements for drug regulators under the circumstance of trans-provincial production entrusted by registrants, define provisions on joint efforts and assistance in terms of cross-regional supervision and inspection and investigation and evidence collection, and improve systems for administering overseas inspections and information disclosure and regulatory talks with responsible persons.
Strengthening control over quality safety risks. The Documents further refine and improve requirements for level management, risk control and for-cause inspection of medical device production and operation. The Documents strengthen control over quality safety risks, define the key points for supervision and inspection of production and operation by category, and define requirements for quality responsibilities and management of those specialized in providing transportation and storage services to medical device registrants, filing entities and operating enterprises. The Documents also stipulate that drug regulators shall conduct regular risk-related consultation and assessment according to the situations of supervision and inspection, product sampling inspection, adverse event monitoring, complaint reporting, and administrative punishment and inspect, prevent, control and handle hidden dangers with respect to medical device quality safety.
Measures for Supervision and Administration of Medical Device Production March 22, 2022
Measures for Supervision and Administration of Medical Device Operation March 22, 2022
Source: National Medical Productions Administration