Running, or planning, clinical trials in China for medical device or IVD?
The NMPA & NHC (National Health Commission) have released important updated clinical practice requirements for clinical trials in China for medical device and IVD.
China GCP
no. 28 [2022] was released on March 24: link (in Chinese).NMPA released a circular on March 31 "On matters related to the implementation of the good management practice for clinical trials of medical devices" (no. 21 [2022]):
link (in Chinese).
Key changes: The adjustment structure is more clear and emphasizes the responsibilities of all parties, one is to highlight the main responsibility of the sponsor, introduce the concept of risk management, and clearly stipulate that the quality management system of the sponsor should cover the whole process of clinical trials of medical devices; second, strengthen the requirements of clinical trial institutions for medical devices, clinical trial institutions should establish a clinical trial management organizational structure and management system; third, emphasize the responsibilities of researchers, and researchers should implement clinical trials of medical devices in accordance with the provisions of the Code and relevant laws and regulations.
Key documentation guidance for
clinical trial reports, adverse event reports and basic documentation are also important.
This is one of the critical regulations building upon Order No. 739 from last year, with the new GCP revision formally effective on May 1, 2022.
Manufacturers, sponsors, CROs and others involved in clinical trials in China should study the new guidelines closely.
#clinicaltrials #ChinaGCP #NMPA
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Hamish King
hamish.king@cisema.comwww.cisema.com------------------------------