The NMPA and China Health Commission released the “Quality Management Practice Specification for Clinical Trials of Medical Devices”, implemented from May 1, 2022.
The “China GCP” covers the whole process of medical device clinical trials, including the design, implementation, supervision, inspection, inspection, data collection, recording, preservation, analysis, summary, and reporting.
Reflecting the latest international requirements, the “Specification” refers to the documents of the International Medical Device Regulators Forum (IMDRF), such as MDCE WG/N57 FINAL:2019, and introduces the concept of multi-regional clinical trials in different countries or regions, which facilitates the market access of imported innovative products.
Key Changes for Clinical Trial NMPA China
Compared to the China GCP published in 2016, the newer version has modified the following:
- Specify responsibilities of all parties
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 process of clinical trials of medical devices
It strengthens clinical trials of medical devices. The testing institution requires that the clinical trial institution shall establish a clinical trial management organizational structure and management system; it emphasizes the responsibility of the researcher, and the researcher shall conduct clinical trials of medical devices in accordance with the “Specifications” and relevant laws and regulations.
- Incorporate in vitro diagnostic reagents into the management
- Adjust safety information reporting process
The “Specification” optimizes and adjusts the safety information reporting process.
changed “dual report” to “single report”. The sponsor shall report to the provincial drug regulatory department, the provincial drug regulatory department and the health management department where the medical device clinical trial institution is located.
determine the scope of reporting as serious adverse events related to experimental medical devices.
the reporting time limit for death or life-threatening risks is required to be within 7 days after the sponsor is informed, and the reporting time limit for non-death or non-life-threatening and other serious safety risks is within 15 days after the sponsor is informed.
- Simplify requirements
The “Specification” combines industrial needs and regulatory reality to effectively solve the problems that are currently reflected more intensively. The requirement that “clinical trials of medical devices should be conducted in two or more clinical trial institutions for medical devices” is deleted, which solves the problem that it is difficult and unnecessary to conduct clinical trials in two clinical trial institutions for some medical devices. The one-year validity period of the inspection report has been cancelled, which is conducive to the smooth development of clinical trials.
For the English version of “Quality Management Practice Specification for Clinical Trials of Medical Devices” and any documents below that NMPA issued as Annexes, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
- Model Clinical Trial Protocol for Medical Devices
- Model Clinical Trial Report for Medical Devices
- Model Clinical Trial Protocol for In Vitro Diagnostic Reagents
- Model Clinical Trial Report for In Vitro Diagnostic Reagents
- Severe Adverse Event Report Form for Clinical Trials of Medical Devices/In Vitro Diagnostic Reagents
- Catalogue of Basic Documents for Clinical Trials of Medical Devices/In Vitro Diagnostic Reagents