The “Regulations on the Administration of Self-inspection of Medical Device Registration” organized by the State Drug Administration (National Drug Administration Announcement No. 126, which will come into force on the date of issuance, hereinafter referred to as the “Regulations”), has been issued on October 21, 2021. The background, main content and key issues of the Provisions are hereby explained as follows:
1. Development background
When registering a medical device, it is necessary to submit a product inspection report, which is an important evaluation material for the design verification of the medical device. In the 2014 version of the “Regulations on the Supervision and Administration of Medical Devices”, registration applicants must submit a registration inspection report issued by an inspection agency with medical device inspection qualifications. In order to implement the requirements of the Party Central Committee and the State Council to encourage the innovation and development of the medical device industry, and further deepen the reform of “decentralization, management and service”, Article 14 of the new version of the “Regulations on the Supervision and Administration of Medical Devices” clearly states that the product inspection report submitted during the registration of medical devices can be the self-inspection report of the applicant for medical device registration, the recorder, or the inspection report issued by a qualified medical device inspection agency. This regulation helps to further unleash the vitality of industrial innovation and development, and at the same time strengthens the main responsibility requirements of registration applicants.
2. Main content
The regulation consists of six parts, namely self-inspection capability requirements, self-inspection report requirements, entrusted inspection requirements, application materials requirements, on-site inspection requirements and responsibility requirements. Requirements for self-inspection capabilities specify general requirements, inspection capability requirements, management system requirements, and self-inspection basis. Self-inspection report requirements specify the format requirements, signature requirements, and product inspection model coverage requirements for self-inspection reports. The entrustment requirements specify the entrustment conditions, the evaluation requirements for the entrusted party, and the consistency of samples, etc. The requirements for application materials specify the self-inspection report, self-inspection capability statement, quality management system-related information, model coverage description, self-declaration of report authenticity, etc. that registration applicants should submit when applying for registration. The on-site inspection requirements specify that during the on-site inspection of the registration quality management system, the inspection status of the “self-inspection capability requirements” should be described in the on-site inspection report.
3. Description of key issues
(1) General description on self-inspection capability requirements
The product self-inspection report submitted by the registration applicant is an important basis to ensure the safety, effectiveness and quality controllability of the product. The scientificity and accuracy of the test will affect the evaluation of the safety and effectiveness of the product to be marketed. Therefore, when the registration applicant conducts self-inspection work, it shall incorporate the self-inspection work into the medical device quality management system in accordance with the requirements of relevant inspection work and declared product self-inspection. The regulations also require registration applicants to have self-inspection capabilities, which mainly include detailed requirements in terms of personnel, equipment and environmental facilities, sample management, inspection quality control, and record control. Ensure that the quality of the self-inspection work of the registration applicant is under control, and take the main responsibility for the content, process and results of the inspection report.
(2) Requirements for inspectors
In the requirements for inspection capabilities, inspection personnel and corresponding management personnel are one of the core elements. Registration applicants should conduct standard management in terms of personnel recruitment, professional ability, training, on-the-job assessment, authorization, etc. in light of the situation of the declared product self-inspection project. It is stipulated that inspectors can only work in the enterprise and engage in full-time inspection-related work under authorization.
(3) Requirements for special professional inspection laboratories
If the registration applicant conducts special professional inspections, such as laboratories involving biological evaluation, electromagnetic compatibility, biosafety, in vitro diagnostic reagents, etc., when carrying out self-inspection work, control requirements such as environmental facility conditions should be formulated according to professional requirements.
(4) Requirements for self-inspection of commissioned production
If the registration applicant entrusts the entrusted production enterprise to carry out self-inspection, the registration applicant’s quality agreement on the entrusted production shall specify the requirements for the production enterprise’s testing capabilities, etc. If the inspection capability of the entrusted production enterprise cannot cover all the terms of the product technical requirements, the registration applicant shall entrust the corresponding part of the terms to a qualified medical device inspection institution for inspection. Registration applicants should summarize all inspection reports and issue self-inspection reports in accordance with the requirements of these regulations.
(5) Requirements for internal self-inspection of the group company
In view of the rapid development of the medical device industry, more and more group companies have emerged both domestically and overseas. Taking the domestic registration applicant as an example, if the laboratory within the group company it belongs to has been accredited by the CNAS laboratory, in order to effectively save testing resources, with the authorization of the group company, the registration applicant can send samples to the laboratory for self-inspection, and finally the registration applicant will issue a corresponding self-inspection report to reflect the main responsibility requirements of the registration applicant for the inspection report. This behavior needs to be authorized by the group company, mainly to avoid problems such as mutual entrustment between subsidiaries and unclear responsibilities. Inspection laboratories cannot be commissioned to inspect items beyond their own inspection scope.
Domestic or overseas group companies may have cross-border inspection laboratories. Considering the current regulatory reality, domestic registration applicants can only conduct self-inspection in domestic laboratories of their group companies; overseas registration applicants can only conduct self-inspection in overseas laboratories of their group companies.
Registration applicants should evaluate the inspection capabilities and inspection scope of the inspection laboratories within the group to ensure that the self-inspection reports comply with relevant management regulations.
(6) Requirements for self-inspection reports
The content of the self-inspection report should be an inspection report based on the technical requirements of the declared product for all items. The format should be submitted in accordance with the requirements of “Appendix 1 “Medical Device Registration Self-inspection Report” (Template)”. If entrusted inspection is involved, the reports issued by the entrusted party shall be summarized to form a complete inspection report, and the entrusted items shall be indicated in the remarks. At the same time, the original entrusted inspection report shall be attached to the self-inspection report.
(7) Questions about the qualifications of inspection agencies entrusted with inspections
According to Article 75 of the “Regulations on the Supervision and Administration of Medical Devices”, inspections of medical devices can only be carried out by inspection agencies that have been approved by the certification and accreditation supervision and management department of the State Council in conjunction with the drug supervision and management department of the State Council.
According to the relevant regulations on the qualification accreditation of national inspection and testing institutions, medical device inspection and testing institutions should obtain a certificate of qualification accreditation (CMA). The applicant for registration shall evaluate the qualification, inspection ability and inspection scope of the entrusted institution according to the characteristics of the product. The entrusted inspection report should be affixed with the official seal of CMA. If the inspection agency cannot affix the CMA official seal, it shall follow the notice of the General Department of the State Food and Drug Administration on clarifying the matters related to the marking of the qualification accreditation mark in the “Standards for Medical Device Inspection Work” (Drug Administration Comprehensive Department Wai Han [2020] No. 746).
(8) Requirements for product registration application materials
1. Instructions on the inspection personnel information form
In view of the fact that the inspector’s specialty and years of experience in the post are crucial to the quality of the self-inspection report, in order to better regulate the self-inspection work, it is required to submit the information sheet of the self-inspection inspector in the registration application materials, which will help the regulatory authorities understand the company’s inspection staffing situation.
2. Instructions for filling out the inspection equipment configuration form
The inspection items in the specified “Appendix 2 Medical Device Self-inspection Equipment (Including Standard Products/Reference Products) Configuration Table” should be consistent with the corresponding items in the product technical requirements.
3. Instructions on product model coverage
The registration applicant should conduct a difference analysis for all models of the declared product, and can prove that the performance indicators of the model in the self-inspection report can cover all models by testing the items of the difference.
(9) On-site inspection requirements
The regulations clearly require that during the on-site inspection of the registration quality management system, the “self-inspection capability requirements” should be verified item by item at the same time, and should be explained in the on-site inspection report. In order to better guide the actual operation of inspectors, the “Regulations” describe in detail the inspection methods in terms of the qualification requirements of inspectors, inspectors’ operating skills, facilities and environment, inspection equipment, inspection records, and inspection quality control capabilities. Drug supervision and management departments at all levels can refer to the inspection methods listed in the “Regulations” and combine the actual conditions of production enterprises and products in the administrative area to formulate corresponding specific inspection methods.