Chinese Regulators Considering New Clinical Trial, Adverse Event Reporting Requirements

Chinese medical device market regulators are three years away from full implementation of a new adverse event reporting and monitoring system, and may also establish a new clinical trial approval process for high-risk devices.

First, the China Food and Drug Administration (CFDA) has begun requiring manufacturers of Class III medical devices to use the National Medical Device Adverse Event Monitoring Platform for reporting adverse events. The CFDA plans to fully launch a more comprehensive and standardized adverse event monitoring system by 2016 in an effort to boost public safety.

Second, CFDA officials are currently soliciting comment on a proposed new process for approving clinical trials for some Class III high-risk devices. Affected manufacturers would have to obtain CFDA approval to begin clinical trials in China; application materials would have to include device descriptions, research reports and clinical trial protocols.

Both the clinical trial proposal and the adverse event monitoring system project, though some time away from full implementation, should be carefully considered by companies planning on medical device registration in China.

Stewart Eisenhart

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