China to Allow Use of Overseas Trial Data in Device Applications
In a significant policy shift, China plans to accept data from foreign clinical trials in its medical device approval process if the device is already approved overseas.
The new policy will help the China Food and Drug Administration stretch its clinical research resources, replacing the current clinical trial center qualification system with a clinical trial filing system.
The change will “improve the efficiency of ethical reviews at the same time,” according to Grace Palma, founder and CEO of Boston-based China Med Device, a firm specializing in assisting medtech companies entering China.
China recently tightened up on its policing of clinical trials, with the Supreme People’s Court requiring stricter punishments for companies that falsify clinical trial reports.