The NMPA Issues Three Normative Documents,Including the Guidelines for the Preparation of Annual Self -inspection Report of Medical Device Quality Management System

In order to strengthen the supervision of medical device production and ensure the safety and effectiveness of medical devices, according to the relevant provisions of the regulations on the supervision and administration of medical devices and the measures for the supervision and administration of medical device production, the NMPA recently has revised and issued the Guidelines for the Preparation of Annual Self- inspection Report of Medical Device Quality Management System and the Catalogue of Medical Devices Prohibited from Commissioned Production, and formulated and issued the Guidelines for the Preparation of Commissioned Production Quality Agreement of Medical Devices. The above three normative documents shall come into force as of May 1, 2022.

The Guidelines for the Preparation of Annual Self -inspection Report of Medical Device Quality Management System has been revised on the basis of the Notice on Issuing the Guidelines for the Preparation of Annual Self -inspection Report of Quality Management System of Medical Device Manufacturers (former CFDA No. 76, 2016). The main contents are as follows: first, fully implement the latest requirements of the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Production, supplement and improve relevant requirements for the annual self-examination report submitted by the registrant of medical devices, the registrant of entrusted production and the registrant of import. Second, refine the filling requirements of the self- inspection report guide, give more detailed and clear guidance to the filling person, answer the doubts of the filling person in the filling process of the self- inspection report, and consolidate the main responsibility of the enterprise. At the same time, a more standardized and high-quality self-examination report is convenient for the regulatory authorities to grasp the operation of the enterprise, prevent and control potential risk points and carry out targeted supervision. Third, the self-examination report is prepared and filled in in a tabular, modular and data-based mode. The recorders of domestic medical device registrants, entrusted manufacturing enterprises and imported medical device registrants fill in according to different templates, so as to further strengthen the implementation of the main responsibility for product quality and safety.

The Catalogue of Medical Devices Prohibited from Commissioned Production is revised on the basis of the Notice on Issuing the Catalogue of Medical Devices prohibited from commissioned production (formerly No. 18 of the CFDA in 2014). The revision adheres to three principles: first, implements the “four strictest” requirements, adheres to risk management, adheres to the safety bottom line, and effectively ensures the safety of people’s use of machinery; Second, adheres to dynamic adjustment and improves the scientificity and operability of the catalogue; third, implements the reform spirit of the State Council on decentralization, management and service, adheres to the combination of decentralization and management, and pay equal attention to decentralization and management. The main amendments are reflected in two aspects: first, on the basis of the original catalogue, combing according to the Classification Catalogue of Medical Devices (revised in 2017), further clarifying the variety range and determining the classification catalogue code, so as to enhance the operability. The second is to modify the contents of the catalogue and deletes products such as implantable insulin pump and absorbable surgical hemostatic materials with relatively mature production technology and relatively low risk.

At the same time, in order to guide the medical device registrant, the filer and the entrusted production enterprise to jointly do a good job in the production quality management of medical devices, and in combination with the full implementation of the medical device registrant filer system, the guidelines for the preparation of entrusted production quality agreement of medical devices are formulated and issued. At the same time, in order to guide the medical device registrant, the filer and the entrusted production enterprise to jointly do a good job in the production quality management of medical devices, and in combination with the full implementation of the medical device registrant filer system, the guidelines for the preparation of entrusted production quality agreement of medical devices are formulated and issued. The guide provides guidance for the medical device registrants, recorders and entrusted manufacturers with corresponding conditions to sign quality agreements, reflecting the main characteristics of three aspects: first, payes attention to comprehensiveness. The guide covers the regulatory requirements, division of responsibilities, quality documents, quality records and key points of operation that should be considered in the drafting of agreements between enterprises; the second is to pay attention to balance. The guide not only implements the relevant requirements of regulatory documents, but also refines some experience and practices in practice. At the same time, it is clarified that enterprises can choose the applicable content to negotiate and sign according to the actual situation.

Source：NMPA

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