General Administration of Market Supervision: the New Regulations on the Supervision and Management of the Production and Operation of Medical Devices Have Been Issued, Emphasizing the Four Strictest and Five Key Points!

Recently, the State Administration of Market Supervision issued the revised Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Operation, which will come into force on May 1, 2022.

The relevant person in charge of the State Administration of Market Supervision said that 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 provisions of the regulations on the supervision and administration of medical devices, fully implement the filing system of medical device registrants, optimize the administrative licensing process, strengthen supervision and inspection measures, improve supervision and inspection means, and consolidate the main responsibility of enterprises, and further increase the punishment for illegal acts.

It is understood that the two supervision and management measures issued this time will implement the most stringent regulatory requirements. The new regulations strengthen the supervision and management of medical device registrants, clarify the responsibilities of both registrants and entrusted production enterprises, incorporate the relevant requirements of entrusted production management into the quality management system, and further improve the inspection responsibilities, inspection methods, result handling, investigation and evidence collection and other regulatory requirements of medical device production. At the same time, the new regulations also improve the management requirements of sales, transportation, storage and other aspects of business links, refine the relevant provisions on traceability management such as purchase inspection and sales records, and strengthen the quality and safety responsibility of registrants and filers in selling their registered and filed medical devices.

According to the relevant person in charge of the State Administration of Market Supervision, the two supervision and management measures released this time also consolidate the main responsibility of medical device production and operation enterprises. At the same time, the license filing process has been optimized, the requirements for business license and filing under the medical device registrant system have been adjusted, the requirements for submitting business license and relevant supporting documents when canceling the license have been further reduced, the time limit for verification and approval has been further reduced, the specific circumstances for exemption from submitting application materials and business filing have been clarified, and the procedural requirements for material submission have been simplified for those applying for license and filing at the same time.

At the same time, the two supervision and management measures released this time also require the supervision responsibilities of compaction departments, refine and improve the responsibilities of supervision departments at all levels, and improve various forms of supervision and inspection, such as supervision and inspection, key inspection, follow-up inspection, causal inspection and special inspection. It defines the responsibilities and requirements of the drug regulatory authorities in the case of cross provincial entrusted production of the registrant, defines the provisions on joint and assistance in cross regional sup设置特色图像ervision and inspection, investigation and evidence collection, adds relevant provisions on extended inspection and joint inspection in business links, and improves the management systems of overseas inspection, information disclosure and responsibility interview.

It is reported that the two supervision and management measures released this time also strengthen the quality and safety risk control. The two measures further refined and improved the requirements for hierarchical management, risk control and causal inspection of medical device production and operation in combination with the actual situation of supervision. 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, and administrative penalties, and do a good job in the investigation and prevention and control of medical device quality and safety hazards.

Source：NMPA

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