NMPA newly revised the "Quality Management Practice for Clinical Trials of Medical Devices", which will be implemented from "May 1st"

A few days ago, the National Medical Products Administration in conjunction with the National Health Commission organized the revision of the "Quality Management Practice for Medical Device Clinical Trials" (hereinafter referred to as the "Code") released to the public
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The "Specification" has nine chapters and 66 articles, covering the whole process of clinical trials of medical devices, including the design, implementation, supervision, inspection, and inspection of clinical trials of medical devices, data collection, recording, preservation, analysis, summarization, and reporting
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It is reported that in 2016, the former State Food and Drug Administration, together with the former National Health and Family Planning Commission, issued the "Quality Management Practice for Clinical Trials of Medical Devices" (CFDA Order No.

25) (hereinafter referred to as "2016" "")

The official interpretation stated: This new revision of the "Specifications" makes it 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 sponsor's quality management system should cover the entire clinical trial of medical devices.
The second is to strengthen the requirements of medical device clinical trial institutions , and clinical trial institutions should establish a clinical trial management organizational structure and management system; the third is to emphasize the responsibility of researchers, and researchers should implement medical device clinical trials in accordance with the "Specifications" and relevant laws and regulations.

At the same time, in order to meet the needs of the in vitro diagnostic reagent industry and supervision, the quality management requirements for clinical trials of in vitro diagnostic reagents have been incorporated into the "Specifications", reflecting the unity of the concept and requirements of clinical trial quality management
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The "Specifications" also combine industrial needs and regulatory reality to effectively solve the problems that are currently reflected more intensively
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The requirement that "clinical trials of medical devices should be conducted in two or more clinical trial institutions for medical devices" has been deleted, and the one-year validity period of inspection reports has been cancelled, which is conducive to the smooth development of clinical trials

In order to cooperate with the implementation of the "Specification" and further guide the development of clinical trials, the State Food and Drug Administration has formulated the "Model Clinical Trial Protocol for Medical Devices", "Model Clinical Trial Report for Medical Devices", "Model Clinical Trial Protocol for In Vitro Diagnostic Reagents" and "Clinical Trials for In Vitro Diagnostic Reagents".

Six documents, including the Report Template, the Medical Device/In Vitro Diagnostic Reagent Clinical Trial Serious Adverse Event Report Form, and the Medical Device/In Vitro Diagnostic Reagent Clinical Trial Basic Document Catalog, will be implemented simultaneously with the Specification

On March 31, the State Food and Drug Administration's "Notice on Matters Concerning the Implementation of the "Quality Management Practice for Clinical Trials of Medical Devices" (No.

21, 2022) clarified that from May 1, 2022, medical treatment that has not passed the ethical review The clinical trial projects of devices shall be adjusted in accordance with the "Specifications" 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