The China Food and Drug Administration is proposing to require medical devicemakers to file clinical trial record forms, as the agency strengthens its oversight of devices.
Under the plan, companies would need to submit detailed information about the device’s classification and the testing facility, as well as copies of the sponsor’s business license, the ethics committee’s opinion and the researcher’s contact information.
The record would need to be filed with the provincial CFDA where the company registered before the trial kicks off. A number would be assigned to the record as soon as it’s submitted. Filings would be accepted within 10 business days after the provincial CFDA notifies its municipal counterpart where the trial site is located.