To further strengthen the supervision and management of clinical trials of medical devices, China Food and Drug Administration (CFDA) and National Health and Family Planning Commission of China (NHFPC) recently issued “The Good Clinical Practice for Medical Devices” (CFDA Decree No. 25)—implementation starts June 1, 2016. “The Good Clinical Practice for Medical Devices” is comprised of 96 articles in 11 chapters, including general provisions, preparation before clinical trials, protection of rights and benefits of trial subjects, clinical trials protocol, responsibilities of ethics committee, responsibilities of sponsors, responsibilities of clinical trial institutions and investigators, records and reports, management of investigational medical devices, management of essential documents, and supplementary provisions.
- The new Good Clinical Practices (GCPs) removed the sub-definition for “Medical Device Clinical Trials” and “Medical Device Clinical Validation” as the current international regulatory practice does not distinguish clinical trials and clinical validation, and they are difficult to operate in practice. But in order to fully protect the interests of the subject, the provision stipulates a small test sample feasibility trial shall be conducted during the clinical trial protocol design as long as the device is not to be listed in the China or International Market, and it’s safety and performance has not been medically proven.
- This provision strengthens the responsibilities of sponsors, ethics committee, clinical trial institutions, and investigators. Take Sponsors for example, sponsors are responsible for monitoring the study and shall appoint qualified monitors to perform monitoring activities. In addition, if there was any information affecting the study, the sponsor would be responsible for revising the investigator brochure and obtaining an approval from the ethics committee for the revision.
- This version of GCPs also specifies requirements for multicenter studies, the type of information that must be included in an informed consent form, and how to obtain informed consent from study subjects. Any revised informed consent forms must be approved by the ethics committee prior to its communication with study subjects as long as the revision can potentially affect the subjects.
It is highly recommended for companies intending to launch new devices in China to review current practices and upgrade compliance standards to the necessary extent.
China Food and Drug Administration and People’s Republic of China National Health and Family Planning Commission. (2016, March 23). “Clinical trials of medical devices quality management practices” Retrieved April 1, 2016, from http://www.cfda.gov.cn/WS01/CL0053/148101.html