In order to strengthen the supervision of medical device production and ensure the safety and effectiveness of medical devices, in accordance with 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 State Food and Drug Administration has recently revised and issued the Annual Self-Inspection of the Medical Device Quality Management System. Report Compilation Guidelines" and "Catalogue of Prohibited Entrusted Production of Medical Devices", and formulated and issued "Guidelines for the Compilation of Quality Agreements for Entrusted Production of Medical Devices". The above three normative documents will be implemented from May 1, 2022.

"Guidelines for Compiling Annual Self-inspection Reports for Medical Device Quality Management System" is based on the "Notice on Issuing Guidelines for Compiling Annual Self-inspection Reports for Quality Management System of Medical Device Manufacturers" (former State Food and Drug Administration, No. 76, 2016) It has been revised, the main contents are as follows: First, fully implement the latest requirements of the "Regulations on the Supervision and Administration of Medical Devices" and "Measures for the Supervision and Administration of Medical Device Production". The annual self-examination report supplements and improves the relevant requirements. The second is to refine the requirements for filling in the self-inspection report guidelines, give the applicants more detailed and clear guidelines, answer their doubts in the process of filling out the self-inspection report, and consolidate the main responsibility of the enterprise. At the same time, a more standardized and high-quality self-inspection report will help the regulatory authorities to grasp the operation of the enterprise, prevent and control potential risk points, and carry out targeted supervision work. The third is to prepare and fill out the self-inspection report in a tabular, modular, and data-based mode. The domestic medical device registrant filer, the entrusted manufacturer and the imported medical device registrant filer fill in according to different templates to further strengthen the main responsibility of product quality and safety. implement.

The "Catalogue of Medical Devices Prohibited from Entrusted Production" is revised on the basis of the "Notice on Issuing the Catalogue of Medical Devices Prohibited from Entrusted Production of Medical Devices" (former State Food and Drug Administration, No. 18, 2014). This revision adheres to three principles: first, to implement the "four strictest" requirements, adhere to risk management, adhere to the bottom line of safety, and effectively protect the safety of people's equipment; The third is to implement the reform spirit of the State Council, delegating power, delegating power, regulating services, and insisting on combining power with power and power with equal emphasis. The main revisions are reflected in two aspects: First, on the basis of the original catalogue, combing with the "Medical Device Classification Catalog" (revised in 2017), further clarifying the range of varieties, determining the coding of the classification catalogue, and enhancing the operability. The second is to revise the content of the catalog, and delete products such as implantable insulin pumps and absorbable surgical hemostatic materials with relatively mature production processes and relatively low risks.

At the same time, in order to guide the medical device registrant filer and the entrusted manufacturer to jointly do a good job of medical device production quality management, combined with the full implementation of the medical device registrant filer system, the "Guidelines for the Compilation of Medical Device Entrusted Production Quality Agreement" has been formulated and released. The guidelines provide guidance for medical device registrants to sign quality agreements with entrusted manufacturers with corresponding conditions, and reflect the main characteristics of three aspects: First, focus on comprehensiveness. The guidelines cover the regulatory requirements, division of responsibilities, quality documents, quality records and operational points that should be considered in the drafting of agreements between enterprises; the second is to pay attention to balance. While providing guidance for writing, the guide designed the "Contracted Production Quality Agreement Template" to provide guidance and reference for enterprises of different types and management levels; the third is to focus on operability. 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.

  【Related Links】

Announcement on the issuance of guidelines for the preparation of annual self-inspection reports of the medical device quality management system (No. 13 of 2022)
Notice of the State Food and Drug Administration on Issuing the Catalogue of Medical Devices Prohibited from Entrusted Production (No. 17 of 2022)
Circular of the State Food and Drug Administration on Issuing Guidelines for the Preparation of Quality Agreements for Medical Device Entrusted Manufacturing (No. 20, 2022)