New Record Keeping Requirements for Clinical Trial Institutions for Medical Devices in China

The Chinese Food and Drug Administration (CFDA) is the regulatory body in China that oversees the safety and efficiency of foods, pharmaceuticals, medical devices, and cosmetics. The CFDA recently issued regulations to enforce record-keeping of clinical trial institutions for medical devices.

The new regulations will go into effect on January 1, 2018.

The CFDA issued new regulations that apply to all institutions that carry out clinical trials of medical devices in China. The clinical trial institutions have to meet the quality management standards of clinical trials of medical devices along with the requirements for professionals leading the trial, technical requirements, requirements for organizational management and ethics committee.

The CFDA has established an electronic record management information system for medical device clinical trial institutions. There are no fees to use the electronic record filing system. The clinical trial facilities will be supervised by the provisional Food and Drug Supervision and Administration Departments.

Here are the types of information institutions will have to record:

  1. Licenses and information about medical institution, practitioners, researchers, and principal investigator.
  2. Proof of qualified management personnel, office conditions, and quality control
  3. Information related to qualification of clinical subjects
  4. Evidence to support all principal investigators have senior professional titles and former experience with three or more clinical trials with either medical devices or drugs
  5. Plan to address emergencies and serious adverse events
  6. Report of ethical review and information on ethical committee
  7. Self-inspection report
  8. Evidence to support the institutions has the ability to carry out relevant medical services to meet the requirements of the test population
  9. Qualification certificate issued by the corresponding competent department
  10. CFDA or provincial departments must provide annual reports on the clinical trial institutions to the Department of Health and Family Planning.

If the information being provided involves state secrets, trade secrets or privacy information, then institutions should comply with “State Secrets Avoidance Law of the People’s Republic of China.”

If an institution provides false materials or records or is unsuitable to undertake clinical trials, then the CFDA will inform the National Health and Family Planning Commission and make a public announcement.