The “Quality Management Regulations for Clinical Trials of Medical Devices” (Announcement No. 28 of 2022, hereinafter referred to as “the Regulations”) has been released and will come into force on May 1, 2022. The revision background, main content and key revisions of the Specification are now interpreted as follows:
1. Amendment background
In 2016, the former State Food and Drug Administration and the former National Health and Family Planning Commission issued the “Quality Management Standards for Clinical Trials of Medical Devices” (State Food and Drug Administration Order No. 25) (hereinafter referred to as “2016 “Specifications”) “). The implementation of this specification has established the guidelines for clinical trials of medical devices, which has played a positive role in strengthening the management of clinical trials of medical devices and safeguarding the rights and interests of subjects.
In recent years, with the continuous deepening of the reform of the medical device review and approval system, a number of reform policies have been introduced one after another, such as the transformation of medical device clinical trial institutions from qualification accreditation to filing management. development needs. In order to implement the reform requirements of the medical device review and approval system, cooperate with the implementation of the newly revised “Regulations on the Supervision and Administration of Medical Devices”, “Administrative Measures for Registration and Filing of Medical Devices”, and “Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents”, actively transform and apply international medical device supervision Coordination documents, it is necessary to modify and supplement the 2016 “Specifications” to meet the needs of the current supervision of clinical trials of medical devices.
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 entire process of medical device clinical trials, including the design, implementation, monitoring, inspection, inspection, data collection, recording, storage, analysis, summary and reporting of medical device clinical trials.
3. Main content
The “Specifications” has 66 articles in nine chapters. The titles of the chapters are General Provisions, Ethics Committee, Medical Device Clinical Trial Institutions, Investigators, Sponsors, Clinical Trial Protocols and Test Reports, Multi-center Clinical Trials, Recording Requirements and Supplementary Regulations. The chapter of general provisions clarifies the legal basis and scope of application, etc.; the chapter of the ethics committee stipulates the principles and requirements of ethical review; the chapter of medical device clinical trial institutions specifies that medical device clinical trial institutions should have corresponding clinical trial management departments to undertake the management of medical device clinical trials work; the chapter on investigators emphasizes the conditions and responsibilities that investigators should have; the chapter on sponsors highlights the main responsibilities of sponsors, and requires that the quality management system of sponsors should cover the entire process of clinical trials of medical devices; clinical trial protocols and trial reports The chapter outlines the general requirements, main content, signature requirements, etc. of the protocol and report; the multi-center clinical trial chapter clarifies the definition and requirements of multi-center; Data collection sets out requirements; by-laws chapters set out terminology and implementation dates.
4. Key revisions
(1) Adjust the overall framework
In the 2016 “Standards”, the chapters of pre-clinical trial preparation, protection of subjects’ rights and interests, and management of experimental medical devices are included in the chapters on the responsibilities of each participant in the clinical trial. The structure of this adjustment is more clear and emphasizes 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 entire process of clinical trials of medical devices; According to the requirements of the testing institution, the clinical trial institution should establish a clinical trial management organizational structure and management system; the third is to emphasize the responsibilities of researchers, and researchers should implement clinical trials of medical devices in accordance with the provisions of the “Standards” and relevant laws and regulations.
(2) Incorporating in vitro diagnostic reagents into the management of the “Standards”
In order to meet the needs of the in vitro diagnostic reagent industry and supervision, this revision incorporates the clinical trial quality management requirements for in vitro diagnostic reagents into the “Specifications”, reflecting the unity of clinical trial quality management concepts and requirements.
(3) Adjusting the safety information reporting process
The “Specifications” have optimized and adjusted the safety information reporting process. One is to change “double report” to “single report”. The sponsor shall report to the local provincial drug regulatory department, the provincial drug regulatory department and the health management department where the medical device clinical trial institution is located. The second is to determine the reporting scope as serious adverse events related to experimental medical devices. The third is that the time limit for reporting of death or life-threatening is within 7 days after the sponsor is informed, and the time limit for reporting non-death or non-life-threatening and other serious safety risks is within 15 days after the sponsor is informed.
(4) Simplify and optimize related requirements
The “Specifications” combine the needs of the industry and the regulatory reality to effectively solve the current problems that are relatively concentrated. The requirement that “medical device clinical trials should be conducted in two or more medical device clinical trial institutions” is deleted, which solves the problem that it is difficult and unnecessary for some medical devices to carry out clinical trials in two clinical trial institutions. Cancellation of the one-year validity period requirement for test reports is conducive to the smooth development of clinical trials.
(5) Reflect the requirements of the latest international regulatory system
The “Specifications” draw on the relevant content of the regulatory coordination documents of the International Medical Device Regulators Forum (IMDRF), such as absorbing the content of IMDRF MDCE WG/N57 FINAL: 2019 “Clinical Trials”, and introducing the concept of multi-regional clinical trials conducted in different countries or regions , which is conducive to the simultaneous development of clinical trials of medical devices in China for global innovative products. During the revision process, the relevant content of ISO 14155:2020 “Quality Management Practice for Clinical Trials of Medical Devices” and ISO 20916:2019 “In Vitro Diagnostic Medical Devices-Using Human Samples for Clinical Performance Studies-Good Research Quality Management Practices” was fully referred to in the text. The terms and terms reflect the latest version of the international standard.
5.Convergence of documents between the old and new systems
The “Standards” will come into effect on May 1, 2022. The 2016 “Standards” will be issued in May 2022 in accordance with the “Decision of the State Administration for Market Regulation on Amending and Abolishing Some Regulations” (Decree No. Repealed on 1st. From May 1, 2022, medical device clinical trial projects that have not passed the ethical review should be adjusted in accordance with the “Standards” to carry out clinical trials; for projects that have passed the first ethical review, work can be carried out in accordance with the requirements of the original relevant documents.
6. Supporting documents about the “Specification”
In order to cooperate with the implementation of the “Standards” and further guide the development of clinical trials, our bureau has formulated the “Medical Device Clinical Trial Protocol Template”, “Medical Device Clinical Trial Report Template”, “In vitro Diagnostic Reagent Clinical Trial Protocol Template” and “In vitro Diagnostic Reagent Clinical Trial Report Template” The six documents of “Reporting Form for Serious Adverse Events in Clinical Trials of Medical Devices/In vitro Diagnostic Reagents” and “Catalogue of Basic Documents for Clinical Trials of Medical Devices/In vitro Diagnostic Reagents” are implemented simultaneously with the “Specifications”.