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New Regulations on the Manufacturing and Operating Medical Devices Were Issued
New Regulations on the Manufacturing and Operating Medical Devices Were Issued

  On March 23, 2022, The State Administration for Market Regulation issued the revised Measures for The Supervision and Administration of Medical Device Production and the Supervision and Administration of Medical Device Operation, which will take effect on May 1, 2022. For the implementation of the 'production method', 'management method' requirement, make 'production method' the management measures for the implementation of supporting work, issued by the state food and drug administration on March 23, 2022, the state food and drug administration about the implementation of the medical device manufacturing supervision measures for the administration > < the supervision and administration of medical devices management way > related issues notice '(no. 18, 2022).

  The circular has five main contents: first, it requires the supervision departments and production and operation enterprises to implement the responsibility of local supervision and quality safety, and strengthen the publicity and implementation of the Production and operation Measures training; The second is to stipulate the time limit and requirements for recording the production and operation license of medical devices in the transitional period in accordance with the new measures, reflecting the spirit of 'delegating control and providing services' and providing convenience to enterprises; The third is to clarify the style and printing requirements of the license and filing certificate. The filing department can provide the filing certificate for the production of category I medical devices and the filing certificate for the operation of category II medical devices according to the needs of enterprises. Fourthly, the changes, extensions and reissues of the license record within the validity period, as well as whether the validity period and serial number of the relevant documents are changed shall be clarified; Fifth, drug regulatory departments at all levels are required to strengthen the application of license filing information management, actively promote the issuance and application of electronic licenses for production and operation of medical devices, and continuously optimize the query and sharing of production and operation license filing information.

  Medical equipment safety is closely related to people's health, two ways to strictly implement the 'four most strict' requirements, the implementation of the 'regulations on the supervision and administration of medical device regulation, the full implementation of medical apparatus and instruments registrant record filing system, optimize the administrative licensing transaction process, to strengthen the supervision and inspection measures, improve the supervision and inspection means, strengthen the enterprise's main body responsibility, And further increase the penalties for illegal acts.

  Implement the strictest regulatory requirements. The supervision and management of medical device registrants has been strengthened, the responsibilities of both registrants and entrusted manufacturers have been clarified, the related requirements of entrusted production management have been incorporated into the quality management system, and the supervision requirements of medical device production including inspection duties, inspection methods, results disposal, investigation and evidence collection have been further improved. Improve the management requirements of sales, transportation and storage in business links, refine the relevant provisions on the traceability management of purchase inspection and sales records, and strengthen the quality and safety responsibility of the registrant and the record keeper for selling the registered and recorded medical devices.

  Consolidate the main responsibility of medical device production and operation enterprises. Establish a production reporting system for medical devices, stipulate the requirements of product variety report, production dynamic report, and production condition change report. At the same time, the licensing filing process has been optimized, the business license and filing requirements under the medical device registration system have been adjusted, the business license and relevant supporting documents have been cancelled when the license is submitted,. The time limit for verification and approval has been further reduced, and the material submission and other procedural requirements have been simplified for those who apply for both the license and filing at the same time.

Compacting department supervision responsibility. We will refine and improve the functions of supervisory departments at all levels, and improve various forms of supervision and inspection, including key inspections, follow-up inspections, inspections for specific reasons, and special inspections. It clarified the responsibilities and requirements of drug regulatory departments in the case of cross-provincial entrusted production by registrants,  the provisions on joint and assistance in trans-regional supervision, inspection, investigation and evidence collection. It added relevant provisions on extended inspection and joint inspection in business links, and improved the management systems of overseas inspection, information disclosure and responsibility interview.

  We will strengthen quality and safety risk control. Combined with the actual supervision work to further refine and improve the production and operation of medical devices hierarchical management and risk control, causal inspection requirements. Strengthen quality and safety risk control, categorize and clarify the focus of production and operation supervision and inspection, and clarify quality responsibility and management requirements for providing transportation and storage services for medical device registrants, record holders and operating enterprises. At the same time, it is clear that drug regulatory authorities shall conduct regular risk consultation and judgment based on supervision and inspection, product sampling inspection, adverse event monitoring, complaints and reports, and administrative punishment, and do a good job in the investigation, prevention, control and disposal of potential quality and safety hazards of medical devices.


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