Announcement of the State Food and Drug Administration on the issuance of the "Regulations on the Administration of Medical Device Registration and Self-inspection" (No. 126 of 2021)

In order to strengthen the management of medical device registration, standardize the registration and self-inspection of registration applicants, and ensure the orderly development of medical device registration and inspection work, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. 739) and the "Administrative Measures for the Registration and Filing of Medical Devices" “Regulations for the Registration and Filing of In Vitro Diagnostic Reagents” (Order No. 47 of the State Administration for Market Regulation), “Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents” (Order No. 48 of the State Administration for Market Regulation). To be released, it will take effect from the date of release.

Special announcement.

State Drug Administration

October 21, 2021

Appendix:

Medical device registration self-inspection management regulations

In order to strengthen the registration management of medical devices (including in vitro diagnostic reagents), standardize the registration and self-inspection of registration applicants, and ensure the orderly development of medical device registration review work, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and the "Administrative Measures for the Registration and Filing of Medical Devices". The Regulations on the Registration and Filing of In Vitro Diagnostic Reagents are formulated.

1. Self-inspection capability requirements

(1) General requirements

If self-inspection is carried out during registration, the registration applicant shall have the self-inspection ability, incorporate the self-inspection work into the medical device quality management system, be equipped with inspection equipment and facilities that meet the product inspection requirements, and have corresponding quality inspection departments or full-time inspectors. Strictly control the inspection process to ensure that the inspection results are true, accurate, complete and traceable, and take the main responsibility for the self-inspection report.

(2) Inspection ability requirements

1. Personnel requirements. The registration applicant shall have inspectors and management personnel (including reviewers and approval personnel) suitable for the inspection activities carried out. Applicants for registration should be equipped with full-time inspectors, and inspectors should be officially hired and can only work in the enterprise.

The educational background, technical ability and quantity of the inspectors should match the product inspection work. Inspectors should be familiar with relevant laws and regulations, standards and product technical requirements for medical devices, master the principles of inspection methods, test operation skills, work instructions, quality control requirements, laboratory safety and protection knowledge, measurement and data processing knowledge, etc., and should pass Training and assessment of medical device-related laws and regulations, quality management and related professional technology.

Inspectors, reviewers, approval personnel, etc. shall be authorized by the registration applicant in accordance with regulations.

2. Equipment and environmental facility requirements. The registration applicant should be equipped with equipment and environmental facilities that meet the requirements of the inspection method, establish and save the equipment and environmental facilities' files, operating procedures, measurement/calibration certificates, use and maintenance records, and trace the value in accordance with relevant regulations.

For laboratories that carry out special professional inspections, such as biological evaluation, electromagnetic compatibility, biological safety, in vitro diagnostic reagent laboratories, etc., their environmental facilities should meet their specific professional requirements.

3. Sample management requirements. The registration applicant shall establish and implement inspection sample management procedures to ensure that the samples are controlled and maintained in a corresponding state.

4. Inspection quality control requirements. Registration applicants should use appropriate methods and procedures to carry out all inspection activities. When applicable, it includes the evaluation of measurement uncertainty and the use of statistical techniques for data analysis.

Encourage registered applicants to participate in related proficiency testing/inter-laboratory comparison projects organized by proficiency testing agencies to improve testing capabilities and levels.

5. Record control requirements. All quality records, original inspection records and relevant certificates/certificate copies and other technical records should be archived and kept for an appropriate period. Records include, but are not limited to, equipment usage records, original inspection records, purchase and acceptance records of raw and auxiliary materials for inspection, etc. The retention period of records shall meet the requirements of relevant laws and regulations.

(3) Management system requirements

Registration applicants who carry out self-inspection shall establish and implement a management system suitable for self-inspection in accordance with the requirements of relevant inspection work and self-inspection of declared products.

Self-inspection work should be incorporated into the medical device quality management system. Registration applicants should formulate quality management system documents related to self-inspection (including quality manuals, procedures, work instructions, etc.), risk management of inspections carried out, and documents related to medical device regulations, etc., and ensure their effective implementation And controlled.

(4) Basis for self-inspection

The registration applicant shall conduct inspections in accordance with the product technical requirements of the products to be registered.

The formulation of inspection methods should be compatible with the corresponding performance indicators, and priority should be given to the use of promulgated standard inspection methods or recognized inspection methods.

The inspection method should be verified or confirmed to ensure that the inspection is repeatable and operability.

For in vitro diagnostic reagent products, the test method should also clearly indicate the reference/standard substance used, the sample preparation method, the batch and quantity of the reagent used, the number of tests, the calculation method, etc.

(5) Other matters

1. The applicant for registration of entrusted production may entrust the entrusted production enterprise to carry out the self-inspection, and the registration applicant shall issue the corresponding self-inspection report. The self-inspection capability of the entrusted production enterprise shall meet the requirements of these regulations.

2. The domestic group company or its subsidiary where the domestic registration applicant is located has a laboratory accredited by the China National Accreditation Service for Conformity Assessment, or the overseas group company or its subsidiary where the overseas registration applicant is located has a laboratory accredited by the foreign government or government For laboratories accredited by the corresponding laboratory qualification certification body, with the authorization of the group company, the corresponding laboratory may carry out self-inspection for the registered applicant, and the registered applicant shall issue the corresponding self-inspection report.

2. Self-inspection report requirements

(1) The self-inspection report submitted when applying for product registration shall be a full-item inspection report that meets the technical requirements of the product. Submit the corresponding self-inspection report in accordance with relevant regulations for change of registration and renewal of registration. The report format should meet the requirements of the inspection report template (Annex 1).

(2) The self-inspection report should have accurate conclusions, be easy to understand, use standard words, concise language, neat and clean, and no alteration is allowed. The signature and seal shall comply with the relevant requirements of "Medical Device Registration Application Material Requirements and Approval Certificate Document Format", "In Vitro Diagnostic Reagent Registration Application Material Requirements and Approval Certificate Document Format".

(3) The products inspected in the same registration unit should be able to represent the safety and effectiveness of other products in this registration unit.

3. Commissioned inspection requirements

(1) Fiduciary conditions

If a registration applicant submits a self-inspection report, if it does not have the inspection capabilities for some items in the product technical requirements, the relevant items can be entrusted to a qualified medical device inspection agency for inspection. Qualified medical device inspection institutions shall comply with the relevant provisions of Article 75 of the Regulations on the Supervision and Administration of Medical Devices.

(2) Evaluation of the trustee

The applicant for registration shall evaluate the qualification and inspection capability conformity of the trustee in the medical device production quality management system documents, establish a directory of qualified trustees, and keep the evaluation records and evaluation reports.

(three) sample consistency

The registration applicant shall ensure the consistency between the self-inspected samples and the entrusted inspection samples, communicate with the entrusted party in a timely manner, report problems, and assist in the inspection work.

(4) Form a self-inspection report

The registration applicant shall summarize the reports issued by the trustee and combine the inspection items completed by the registration applicant to form a complete self-inspection report. For items involving entrusted inspection, in addition to indicating the entrusted inspection agency in the remarks column, the original entrusted inspection report shall also be attached.

4. Requirements for application materials

If the registration applicant submits the product inspection report through self-inspection, the following application materials shall be submitted:

(1) Self-inspection report. Where the commissioned inspection items are involved, the qualification certification documents of the relevant inspection agency shall also be provided.

(2) A statement of the corresponding self-inspection capability. The registration applicant shall promise to have the ability to self-inspect the corresponding specific items in the product technical requirements, including the corresponding personnel, equipment, facilities and environment, and carry out the inspection in accordance with the requirements of the quality management system.

(3) Related materials of the quality management system. Including the configuration table of inspection equipment (including standard products) (see appendix 2); the software used for medical device inspection should specify its name, release version number, release date, supplier or agent and other information (for format refer to appendix 2) ; Medical device registration self-inspection inspector information form (see Annex 3); Inspection-related quality management system document list, such as quality manuals, procedure documents, work instructions, etc. The document name should include document number information, etc.

(4) Explanation about model coverage. Provide relevant information on model coverage, including typical descriptions, analysis of differences between covered models/configurations and main inspection models/configurations, etc.

(5) Self-Guarantee Statement on the Authenticity of the Report. If the registration applicant entrusts relevant items for inspection, the self-assurance statement should include a declaration of the consistency of the self-inspected samples and the entrusted inspection samples.

The self-inspection laboratory of the domestic registration applicant is accredited by the China National Accreditation Service for Conformity Assessment (CNAS), or the laboratory that the overseas registration applicant conducts the self-inspection is accredited by the foreign government or the corresponding laboratory qualification certification agency accredited by the government , It is not necessary to submit the content of items (2) and (3) of this article, but the corresponding recognized supporting documents and supporting materials for the corresponding inspection scope shall be submitted. If the group company or its subsidiary is authorized by the group company to carry out the self-inspection by the corresponding laboratory, it shall submit a letter of authorization.

5. On-site inspection requirements

For those submitting a self-inspection report, when conducting on-site inspections of the medical device registration quality management system, the drug regulatory authority shall not only follow the requirements of the relevant medical device registration quality management system verification guidelines, but also in accordance with the "Self-inspection Capability Requirements" in the first part of this article. Perform verification and explain it in the on-site verification report. During the inspection, personnel familiar with the inspection shall be selected to participate in the inspection.

On-site inspection can be referred to, but not limited to the following methods:

(1) Qualification requirements of inspectors: check the on-the-job certificate of inspectors, the training records of inspectors and approved personnel in the relevant personnel information table, personal files and other documents, and conduct face-to-face communication with the corresponding personnel to verify whether the qualifications and abilities meet the relevant quality management System requirements.

(2) Operational skills of inspectors: Randomly check the items claimed to be self-inspected, and require the corresponding inspectors in the medical device registration self-inspection inspector information form to check the reserved samples or self-inspection samples in accordance with the operation instructions (or operating procedures) During the on-site operation, the entire inspection process should be repeated, the inspection methods meet the requirements, and the inspection results are consistent with the conclusions in the company's registration documents.

(3) Facilities and environment: laboratories that carry out special professional inspections, such as biological laboratories, electromagnetic compatibility laboratories, in vitro diagnostic reagent laboratories, etc., check whether the laboratory's facilities, environment, and monitoring records meet the requirements of product inspection .

(4) Inspection equipment: Check whether the information in the self-inspection equipment configuration table submitted in the application materials is consistent with the relevant equipment on site. Check whether the verification/calibration records and measurement confirmation data of the inspection equipment meet the inspection requirements. Check the list of inspection equipment. The list should indicate the source of the equipment (self-purchased/leased), and check the corresponding contract documents.

If you use enterprise-made calibrators, quality control products, sample processing reagents, etc., you should check the relevant operating procedures, quality standards, preparation and inspection records, and pay attention to the preparation of calibrators, measurement value transfer procedures, uncertainty requirements, stability studies, etc. , Pay attention to the preparation of quality control products, assignment operating procedures, target value range determination, stability research, etc.

(5) Inspection records: check the original records, inspection equipment use, calibration, maintenance and repair records, inspection environmental conditions records, materials related to the effectiveness of the inspection samples, audit evaluation records and reports (if any) of the entrusted party, commissioned inspections Report (if any), commissioned inspection agreement (if any), etc.

(6) Inspection quality control ability: check inspection-related quality manuals, procedure documents, standards, work instructions (if applicable), operating procedures, inspection method verification/confirmation records, internal quality control records and other documents.

If the domestic registration applicant’s self-inspection laboratory is accredited by the China National Accreditation Service for Conformity Assessment, or the overseas registration applicant’s self-inspection laboratory is accredited by a foreign government or a government-recognized laboratory certification body, it can be approved as a medical device The registration quality management system verification guidelines require processing.

VI. Responsibility requirements

The registration applicant shall strengthen the quality management of the whole life cycle of medical devices in accordance with the requirements of the Regulations on the Supervision and Administration of Medical Devices, and be responsible for the safety, effectiveness and authenticity of inspection reports in the entire process of development, production, and inspection of medical devices. .

If the self-inspection report provided by the registration applicant is false, it shall be punished in accordance with Article 83 of the Regulations on the Supervision and Administration of Medical Devices. If the entrusted party issues a false inspection report, it shall be punished in accordance with Article 96 of the Regulations on the Supervision and Administration of Medical Devices.