The China NMPA recently announced that the updated China Good Clinical Practice (GCP) for Medical Devices will come into effect on May 1, 2022. The GCP was promulgated in 2016 in order to ensure the quality of medical device clinical trial management, standardize the process of medical device clinical trials, and protect subjects involved in such clinical trials.
One of the main updates of the GCP is that it spells out the responsibilities of all parties in a clinical trial. It emphasizes the role of the sponsor in the risk management of the clinical trial. In order to strengthen risk management, penalties for misconduct and illegal acts are increased.
The supervision and reporting system is also enriched by stipulating different forms of reporting to the provincial pharmaceutical regulatory departments. Serious adverse events that are life-threatening or result in death must be reported no later than 7 days, and serious adverse events that do not result in death or are non-life-threatening must be reported no later than 15 days.
The GCP simplifies and streamlines documentation and procedural requirements. It abolishes the requirement that medical device clinical trials have to be implemented in at least two clinical trial institutions. It also removes the requirement of 1-year validity for test reports. The timeframe for the review of medical device production license applications has also been decreased to 20 working days, from 30 working days.
If a clinical trial has not received an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approval by May 1, it should proceed in accordance with the new GCP. If a clinical trial has received IRB/IEC approval, it can proceed according to the old version of the GCP.