In accordance with the requirements of “the Decision on the Revision of the Medical Device Supervision and Management Regulations” issued by on State Council of P. R. China, the qualification confirmation of medical device clinical trial sites will be changed to filing management. In order to implement the relevant work, China Food and Drug Administration drafted the “Conditions and Filing Management Measures of Medical Device Clinical Trial Sites”. You can leave your feedback via e-mail or fax as CFDA is soliciting public opinion.
Medical device trial sites acceptable to CFDA must have clinical trial management systems and principal investigators experienced in running device studies. They must meet good clinical practices. CFDA is also to restrict the testing of Class III devices to tertiary-level medical institutions. In vitro diagnostic trials adhere to a strict set of rules.
The guidance also calls on trial sites to submit self-inspection reports. Reports should include overviews of the clinical trial management personnel and system. They should also include ethical review setup and arrangements for dealing with serious adverse events/emergencies. Sites must connect to and submit the reports along with documents such as their medical qualifications and licenses to a CFDA filing system. CFDA will publicly disclose basic information shared by the trial sites.
Trial sites must update CFDA with information in a timely fashion with information regarding change in personnel or operations. Sites that continue running studies must submit annual summaries of their clinical trial activities.
As stated, CFDA is working to update its infrastructure and team to facilitate reporting enforce its rules. CFDA is also working in enforcing their oversight of medical device clinical trials. CFDA will blacklist any trial sites found hiding information or providing false records.
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