The Quality Management Standard for Clinical Trials of Medical Devices (Announcement No. 28, 2022, hereinafter referred to as the "Standard") has been issued and will come into force on May 1, 2022. The background, main contents and key revision parts of the Code are interpreted as follows:
        
        1. revision background
         In 2016, the former State Food and Drug Administration, together with the former National Health and Family Planning Commission, issued the "Quality Management Standards for Clinical Trials of Medical Devices" (Order No. 25 of the State Food and Drug Administration) (hereinafter referred to as the "Standards 2016"). The implementation of this standard establishes the criteria for clinical trials of medical devices, and plays a positive role in strengthening the management of clinical trials of medical devices and safeguarding subjects' rights and interests.
         In recent years, with the deepening of the reform of the review and approval system of medical devices, a number of reform policies have been introduced such as the change of medical device clinical trial institutions from qualification recognition to record management, and some contents of the 2016 "Standard" can no longer meet the needs of the development of clinical trials. In order to implement the reform requirements of the medical device review and approval system, cooperate with the newly revised Regulations on the Supervision and Administration of Medical Devices, Measures for the Registration and Archival Management of Medical Devices and Measures for the Registration and Archival Management of in vitro diagnostic reagents, and actively transform and apply the international medical device regulatory coordination documents, it is necessary to revise and supplement the 2016 "Specifications". In order to meet the needs of current medical device clinical trial supervision work.
        
         2. Scope of application
        Within the territory of the People's Republic of China, activities related to clinical trials of medical devices for the purpose of applying for registration of medical devices (including in vitro diagnostic reagents) shall comply with the Specifications. The Specifications cover the whole process of clinical trials of medical devices, including the design, implementation, supervision, inspection, and inspection of clinical trials of medical devices, as well as data collection, recording, preservation, analysis, summary, and report.
         3. The main content
        
         The Code consists of nine chapters and 66 articles. The chapters are named General Provisions, Ethics Committee, clinical trial institutions for medical devices, researchers, sponsors, clinical trial protocols and reports, multi-center clinical trials, record requirements and supplementary provisions. The general provisions define the legal basis and scope of application; The ethics committee chapter stipulates the principles and requirements of ethical review; The chapter on clinical testing institutions of medical devices clarifies that clinical testing institutions of medical devices should have corresponding clinical trial management departments, which are responsible for the management of clinical trials of medical devices. The researcher chapter emphasizes the conditions and responsibilities that the researcher should have; The sponsor chapter emphasizes the main responsibility of the sponsor, which requires that the quality management system of the sponsor should cover the whole process of clinical trials of medical devices. The chapter of clinical trial plan and report summarizes the general requirements, main content, seal requirements of the plan and report; The multi-center clinical trial chapter clarifies the definition and requirements of multi-center; The chapter of record requirements defines the basic principles of clinical trial record, and makes requirements for case report form filling and electronic data collection. The supplementary section sets out the terms and the date of implementation.
        
         4. Key revisions
         (1) Adjusting the overall framework.
        The contents in the 2016 Specifications, such as preparation for clinical trials, protection of subjects' rights and interests, and management of experimental medical devices, are classified into the responsibilities of each participant in clinical trials.
        
        
        
         The adjustment structure is clearer and emphasis on the responsibilities of all parties. First, it highlights the main responsibility of the sponsor, introduces the concept of risk management, and clearly stipulates that the quality management system of the sponsor should cover the whole process of clinical trials of medical devices. Second, to strengthen the requirements of medical device clinical trial institutions, clinical trial institutions should establish clinical trial management organization structure and management system; Third, emphasize the responsibilities of researchers, who should carry out clinical trials of medical devices in accordance with the "Norms" and relevant laws and regulations.
        (2) In vitro diagnostic reagents shall be included in the management of the "Standard"
         In order to meet the needs of the in vitro diagnostic reagent industry and supervision, the quality management requirements of in vitro diagnostic reagents for clinical trials are included in the Standard in this revision, reflecting the unity of the concept and requirements of quality management of clinical trials.
         (3) Adjust the safety information reporting process.
        The "Standard" optimizes and adjusts the safety information reporting process.
        
         First, the "double report" is changed into "single report". The sponsor shall report to the provincial drug regulatory department, the provincial drug regulatory department and the health regulatory department where the medical device clinical testing institution is located. Second, the scope of the report shall be determined as serious adverse events related to the experimental medical devices. Third, the reporting time limit of death or life threatening is required to be 7 days after the sponsor is informed, and the reporting time limit of non-death or life threatening and other serious safety risks is 15 days after the sponsor is informed.
        
         (4) Simplification and optimization of relevant requirements "Norms" combined with industrial demand and regulatory reality, effectively solve the current reflection of more concentrated problems.
        
         The requirement that "clinical trials of medical devices shall be conducted in two or more clinical trials institutions for medical devices" has been deleted, and the problem that it is difficult and unnecessary for some medical devices to conduct clinical trials in two clinical trials institutions has been solved. The requirement that the inspection report be valid for one year was removed, which is conducive to the smooth development of clinical trials.
        
        (5) Reflect the latest international regulatory system requires the Specification to learn from the regulatory coordination documents of the International Medical Device Regulators Forum (IMDRF), such as absorbing the contents of IMDRF MDCE WG/N57 FINAL:2019 Clinical Trials,
        
         The introduction of the concept of multi-regional clinical trials in different countries or regions is conducive to the simultaneous implementation of global innovative products in medical device clinical trials in China. In the process of revision, relevant contents of ISO 14155:2020 "Quality Management Practice for Clinical Trials of Medical Devices" and ISO 20916:2019 "In vitro Diagnostic Medical Devices - Clinical Performance Studies using Human samples - Good Research Quality Management Practice" are fully referred to, and the content of the latest version of the international standard is reflected in the text and terminology.
        
         5. Connection between old and new system documents
                  The file about new old system cohesion "specification" shall enter into force as of May 1, 2022, 2016, "the specifications" according to the state administration of market supervision and management on modifying part and abolished the rules of the decision "(national market supervision and administration of administration makes no. 55), on May 1, 2022.
        
         As of May 1, 2022, clinical trials of medical devices that have not passed ethical review shall be carried out after adjustment in accordance with the Code; Projects that have passed the first ethical review can be carried out in accordance with the requirements of the original relevant documents.
        6. Supporting documents of the "Specifications"
        
        In order to cooperate with the implementation of the Code and further guide the development of clinical trials, Our bureau has formulated six documents: Model of Clinical Trial Protocol for Medical Devices, Model of Clinical Trial Report for Medical Devices, Model of Clinical Trial Protocol for In Vitro Diagnostic Reagents, Model of Clinical Trial Report for in Vitro Diagnostic Reagents, Model of Serious Adverse Events Report Form for Clinical Trials of Medical Devices/In Vitro Diagnostic Reagents, and Basic Document Catalog for Clinical Trials of Medical Devices/In Vitro Diagnostic Reagents , and the "Standard" synchronous implementation.

Content source: State Medical Products Administration