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01 Notice issued by the State Food and Drug Administration on guidance on self-verification of medical device registration

       Recently, in order to strengthen the registration management of medical devices (including in vitro diagnostic reagents) , standardize the registration self-inspection of applicants, and
ensure the orderly development of the registration self-inspection of medical devices, the State Drug Administration has formulated the guidance for self-inspection and verification of medical device registration and issued it,
which has been implemented since September 12,2025.

                                                                                                               02 Contents of the guide

The guide consists of four main sections:

1. Purpose and basis

2. Scope of application

3. General requirements

4. Requirements for inspection capability

Among them, the overall requirements and inspection ability requirements are the core content of the enterprise concern.

3.General Requirements:

（1） System Integration: The applicant for registration shall incorporate the self-inspection into the quality management system of medical devices,
and comply with the requirements of

“Good manufacturing practice for medical devices”and supporting documents.

（2） Capabilities: Carrying out self-inspection requires the ability to adapt to the product's self-inspection, including equipment and facilities that match the inspection requirements, a quality inspection department or dedicated inspection personnel, strict control of the inspection process, ensuring that the results are true, accurate, complete, and traceable, and taking primary responsibility for the self-inspection report.
（3） Verification and Implementation: When necessary, the regulatory authorities will conduct verification in conjunction with the application materials, focusing on system contents related to self-inspection, such as personnel, equipment environment, sample management, inspection quality control, and record control; according to the inspection capability requirements and appendixes of the "Medical Device Registration Self-Inspection Management Regulations" and "Guidelines", combined with product technical requirements, verify each item, select familiar inspection personnel, and invite experts to participate when necessary.

（4）Flexible verification methods: data review system verification. If the laboratory meets the specific conditions such as CNAS accreditation and similar projects have passed verification,
self-inspection and data review can be carried out, and on-site inspection can be carried out when necessary. 

4.Requirements for inspection capability

（1）Quality Management System (QMS)

        According to the inspection and declaration of product requirements, the establishment of adaptation system, system documents including quality manuals, including risk management

and regulatory requirements, to ensure the effective
implementation of controlled. Identify the source of self-inspection risk, make risk management documents to retain records; consider the risks and opportunities of laboratory activities,
determine the effect of measures to ensure the system;
the top management promotes the improvement of the system. Self-inspection non-compliance, according to the procedures to deal with, correct and dispose, keep records; at least 1
comprehensive system audit, 1 system and Inspection Activities Management Review every year.

（2）Personnel requirements

        With inspection, management (including audit, approval) personnel, inspection personnel for full-time and only in the enterprise. Personnel education background, technical ability,

quantity and inspection match (if the inspectors need relevant
college degree or above or 5 years of relevant experience, key personnel have additional requirements) , after training and examination qualified, familiar with regulations and other
knowledge, relevant personnel authorized according to the regulations.

（3）Requirements for equipment and environmental facilities

        Equipped with environmental facilities to meet the inspection, special laboratory (such as clean, biosafety laboratory) to set special management methods, records, in line with professional

requirements. Equipment Matching, co-existing equipment files, etc. ,
according to the value of traceability management; control external products and services that affect the quality of inspection, standardize procurement and other aspects, evaluate suppliers.

（4）Sample management requirements

         Establish sample management procedure, define sampling, sample size, etc. , to ensure the whole process of sample control and retention status. If the product is not suitable for sample

retention, use alternative methods such as process verification to ensure traceability.

（5）Requirements for quality control of inspection

         Carry out inspection with appropriate methods, suitable for evaluation measurement uncertainty, use statistical techniques to analyze data; encourage participation in proficiency testing to

improve the level. Develop quality control procedures that include
internal (personnel comparison, etc.) and external (proficiency testing, etc.) control methods; prepare an annual plan covering all inspection items, implement according to the plan, and analyze
and improve problems, correction and verification are needed when external results are abnormal.

（6）Record control requirements

         Establish record control procedures to ensure sufficient information of laboratory activity records, traceable and repetitive activities, and cover the whole process of recording. Electronic records

should consider storage and other security. Inspection of raw data
such as records of true, accurate, complete, immediate, traceable, with the necessary information, in accordance with regulations and easy to search.

（7）Evidence of self-examination

        Inspection according to the technical requirements of the products to be declared. The standard method shall be verified before use, and the non-standard or modified standard method shall be

confirmed and reported In vitro diagnostic reagent test methods
need additional clear reference materials and so on.

（8）Other matters

        The applicant for entrusting production may entrust the entrusted enterprise with self-examination and self-report. The entrusted enterprise may not entrust a third party again. It is required to

meet the requirements of self-examination and verify the report, agreement
and the ability of the entrusted enterprise. There are qualified laboratories in the group which are authorized to conduct self-examination for the applicant. The applicant will issue a report and
verify the report, authorization and laboratory qualification ability.