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

　　I. Self-inspection Capability Requirements

　　(1) General Requirements

　　When conducting self-inspection during registration, the registration applicant shall have self-inspection capabilities, incorporate self-inspection work into the medical device quality management system, equip inspection equipment and facilities suitable for product inspection requirements, have corresponding quality inspection departments or dedicated inspection personnel, strictly control the inspection process to ensure that inspection results are true, accurate, complete, and traceable, and bear primary responsibility for the self-inspection report.

　　(2) Inspection Capability Requirements

　　1. Personnel Requirements. The registration applicant shall have inspection personnel and management personnel (including reviewers and approvers) suitable for the inspection activities carried out. The registration applicant shall be equipped with dedicated inspection personnel, who must be formally employed and work exclusively for the enterprise.

　　The educational background, technical ability, and number of inspection personnel shall match the product inspection work. Inspection personnel should be familiar with relevant medical device laws and regulations, standards, and product technical requirements, master inspection method principles, testing operation skills, work instructions, quality control requirements, laboratory safety and protection knowledge, metrology and data processing knowledge, and must undergo training and assessment in relevant medical device laws and regulations, quality management, and related professional technologies.

　　Inspection personnel, reviewers, approvers, and others shall be authorized by the registration applicant according to regulations.

　　2. Equipment and Environmental Facility Requirements. The registration applicant shall be equipped with instruments, equipment, and environmental facilities that meet inspection method requirements, establish and maintain archives, operating procedures, metrology/calibration certificates, usage and maintenance records for equipment and environmental facilities, and conduct traceability of measurement values according to relevant regulations.

　　Laboratories conducting specialized inspections, such as biological evaluation, electromagnetic compatibility, biosafety, in vitro diagnostic reagent laboratories, etc., shall have environmental facility conditions that meet their specific professional requirements.

　　3. Sample Management Requirements. The registration applicant shall establish and implement inspection sample management procedures to ensure samples are controlled and maintained in appropriate conditions.

　　4. Inspection Quality Control Requirements. The registration applicant shall use appropriate methods and procedures to carry out all inspection activities. Where applicable, this includes the evaluation of measurement uncertainty and the use of statistical techniques for data analysis.

　　Registration applicants are encouraged to participate in relevant inspection capability verification/inter-laboratory comparison programs organized by proficiency testing institutions to improve testing capabilities and levels.

　　5. Record Control Requirements. All quality records, original test records, and related certificates/certificate copies and other technical records shall be archived and kept for an appropriate period. Records include but are not limited to equipment usage records, original inspection records, procurement and acceptance records of raw and auxiliary materials for inspection. The retention period of records shall comply with relevant regulatory requirements.

　　(3) Management System Requirements

　　Registration applicants conducting self-inspection shall establish and implement a management system suitable for the self-inspection work in accordance with relevant inspection work and product self-inspection requirements.

　　Self-inspection work shall be incorporated into the medical device quality management system. Registration applicants shall develop quality management system documents related to self-inspection work (including quality manuals, procedures, work instructions, etc.), risk management for inspection work carried out, and documents related to medical device regulations, and ensure their effective implementation and control.

　　(4) Basis for Self-inspection

　　Registration applicants shall conduct inspections based on the product technical requirements of the product to be registered.

　　The formulation of inspection methods shall be adapted to the corresponding performance indicators, with priority given to the use of published standard inspection methods or recognized inspection methods.

　　Inspection methods shall be validated or verified to ensure repeatability and operability of the inspection.

　　For in vitro diagnostic reagent products, inspection methods shall also clearly specify the reference materials/standards used, sample preparation methods, reagent batch numbers and quantities used, number of tests, calculation methods, etc.

　　(5) Other Matters

　　1. Registration applicants who outsource production may entrust the contracted manufacturing enterprise to carry out self-inspection, and the registration applicant shall issue the corresponding self-inspection report. The self-inspection capability of the contracted manufacturing enterprise shall meet the requirements of these regulations.

　　2. If the domestic group company or its subsidiary of a domestic registration applicant has a laboratory accredited by the China National Accreditation Service for Conformity Assessment, or if the overseas group company or its subsidiary of an overseas registration applicant has a laboratory accredited by a corresponding overseas government or government-recognized laboratory accreditation body, the authorized group company may have the corresponding laboratory conduct self-inspection for the registration applicant, and the registration applicant shall issue the corresponding self-inspection report.

　　II. 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 product technical requirements. For change registration and renewal registration, the corresponding self-inspection report shall be submitted in accordance with relevant regulations. The report format shall comply with the inspection report template (Attachment 1) requirements.

　　(2) The self-inspection report shall have accurate conclusions, be easy to understand, use standardized wording, concise language, and a neat layout. Alterations are not allowed. The signature and seal shall comply with the relevant requirements of the "Medical Device Registration Application Materials Requirements and Approval Document Format" and the "In Vitro Diagnostic Reagent Registration Application Materials Requirements and Approval Document Format."

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

　　III. Entrusted Inspection Requirements

　　(1) Entrustment Conditions

　　If the registration applicant submits a self-inspection report but lacks the inspection capability for some items in the product technical requirements, the relevant items may be entrusted to a qualified medical device inspection institution 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 Entrusted Party

　　The registration applicant shall evaluate the qualifications and inspection capability compliance of the entrusted party in the medical device production quality management system documents, establish a list of qualified entrusted parties, and keep evaluation records and evaluation reports.

　　(3) Sample Consistency

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

　　The registrant shall summarize the reports issued by the entrusted party and combine them with the inspection items completed by the registrant itself 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 Declaration Materials

　　If the registrant submits the product inspection report through self-inspection, the following declaration materials shall be submitted:

　　(1) Self-inspection report. For items involving entrusted inspection, relevant qualification documents of the inspection agency shall also be provided.

　　(2) Declaration of corresponding self-inspection capability. The registrant shall commit to having the ability to self-inspect the specific clauses in the product technical requirements, including having the corresponding personnel, equipment, facilities, environment, etc., and conducting inspections according to quality management system requirements.

　　(3) Quality management system related materials. Including the configuration list of inspection equipment (including standard items) (see Attachment 2); for software used in medical device inspection, its name, release version number, release date, supplier or agent information should be clearly stated (format reference Attachment 2); medical device registration self-inspection personnel information form (see Attachment 3); list of quality management system documents related to inspection, such as quality manuals, procedure documents, work instructions, etc., with document names containing document number information.

　　(4) Explanation regarding model coverage. Provide relevant materials on model coverage, including typical explanations, analysis of differences between covered models/configurations and main inspection models/configurations.

　　(5) Self-guarantee statement on report authenticity. If the registrant entrusts related items for inspection, the self-guarantee statement shall include a declaration of consistency between the samples submitted for self-inspection and those for entrusted inspection.

　　If the laboratory conducting self-inspection by a domestic registrant is accredited by the China National Accreditation Service for Conformity Assessment (CNAS), or if the laboratory conducting self-inspection by a foreign registrant is accredited by the foreign government or a government-recognized laboratory accreditation body, items (2) and (3) of this article may not need to be submitted, but corresponding accreditation documents and supporting materials for the scope of inspection should be submitted. If a group company or its subsidiary is authorized by the group company to conduct self-inspection through the corresponding laboratory, an authorization letter shall be submitted.

　　5. On-site Inspection Requirements

　　For those submitting self-inspection reports, when the drug regulatory authority conducts on-site verification of the medical device registration quality management system, in addition to handling according to the relevant medical device registration quality management system verification guidelines, it shall also verify each item according to the "Self-inspection Capability Requirements" in the first part of this document and explain it in the on-site inspection report. Inspectors familiar with inspection personnel should be assigned to participate in the inspection.

　　On-site inspections can be conducted by reference to, but not limited to, the following methods:

　　(1) Qualification requirements for inspection personnel: Review employment certificates of inspection personnel, training records of inspection and approval personnel in relevant personnel information forms, personal files, etc., and conduct face-to-face communication with relevant personnel to verify whether qualifications and capabilities meet the requirements of the quality management system.

　　(2) Inspection personnel operational skills: Conduct random checks on items claimed to be self-inspected. The corresponding inspection personnel listed in the medical device registration self-inspection personnel information form should perform on-site operations on retained or self-inspection samples according to work instructions (or operating procedures), be able to repeat the entire inspection process, ensure inspection methods meet requirements, and that inspection results are consistent with conclusions in the company's registration application materials.

　　(3) Facilities and environment: For laboratories conducting 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 product inspection requirements.

　　(4) Inspection equipment: Verify whether the information in the self-inspection equipment configuration list submitted in the declaration materials matches the on-site equipment. Review calibration/verification records and metrological confirmation data of inspection equipment to ensure they meet inspection requirements. Check the list of inspection equipment, which should indicate the source of equipment (purchased/rented), and review corresponding contract documents.

　　For enterprises using self-made calibration items, quality control items, sample processing reagents, etc., relevant operating procedures, quality standards, preparation and inspection records should be reviewed, focusing on calibration item preparation, value transfer procedures, uncertainty requirements, stability studies, quality control item preparation, value assignment operating procedures, target value range determination, stability studies, and other related content.

　　(5) Inspection records: Review original records, inspection equipment usage, calibration, maintenance and repair records, inspection environmental condition records, materials related to sample validity, audit and evaluation records and reports of entrusted parties (if any), entrusted inspection reports (if any), entrusted inspection agreements (if any), etc.

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

　　If the laboratory conducting self-inspection by a domestic registrant is accredited by the China National Accreditation Service for Conformity Assessment, or if the laboratory conducting self-inspection by a foreign registrant is accredited by a foreign government or government-recognized laboratory accreditation body, the process can be handled according to the medical device registration quality management system verification guidelines.

　　6. Responsibility Requirements

　　The registrant shall strengthen quality management throughout the entire lifecycle of the medical device in accordance with the "Regulations on the Supervision and Administration of Medical Devices," and shall be legally responsible for the safety, effectiveness, and authenticity of inspection reports throughout the research, production, inspection, and other processes.

　　If the self-inspection report provided by the registrant is false, penalties shall be imposed 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, penalties shall be imposed in accordance with Article 96 of the same regulations.

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