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The Chinese Food and Drug Administration (“CFDA”) recently announced its first update to the medical device clinical trial guidelines in 12 years. The finalized revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”) is titled Good Clinical Practice for Medical Device (“Device GCP”) and becomes effective on June 1, 2016. The Device GCP guidelines apply to medical device clinical studies performed for the purpose of obtaining regulatory approval.
The new Device GCP includes several major changes to the 2004 MDCSR, adding 11 new chapters and 96 articles. The guidelines cover such topics as patient safety, clinical study protocols, retention and documentation of records and reports, device management, and additional sponsor and investigator responsibilities.
Overall, the changes reflect increased regulatory oversight by the CFDA, particularly in regards to patient safety and record-keeping practices. A few changes are highlighted below.
Patient safety protections include enhanced sponsor monitoring requirements and additional requirements for patient informed consent. The guidelines provide stricter sponsor monitoring requirements and strengthen the role of ethics committees in study design and monitoring. The additional requirements for patient informed consent include the types of information that must be provided as well as acceptable methods for obtaining informed consent.
The guidelines also provide additional requirements for multicenter studies. Under the revised Device GCP, the lead site principal investigator and ethics committee will be required to actively coordinate implementation of the study and ethics reviews for all study sites.
Record-keeping requirements have also been significantly heightened. The new guidelines require that each study site maintain all data and records for at least ten years after the completion of the studies. The study sponsors are also required to maintain additional copies of all study records while the device remains in use. Study sponsors are further required to contact and register with the provincial CFDAs prior to commencement of the study.
Companies seeking to obtain regulatory approval for new medical devices in China are highly encouraged to review the revised Device GCP and update their practices.