CFDA Q&A: Clinical Trial Quality Management for Medical Devices

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CFDA Q&A: Clinical Trial Quality Management for Medical Devices

Q: How to calculate the one-year validity period for the type testing report issued by the inspection institution?

A:

  1. For the multi-center clinical trials, the one-year validity period is calculated from the date of the test report to the date of ethical committee approval by the lead site of the clinical trial.
  2. For non-multi-center clinical trials, the one-year validity period is calculated from the date of the test report to the date of ethical committee approval by each site.

 

For 2018 first clinical inspection announced in June, please click HERE.

 

Q: How to file a medical device clinical trial?

A: After signing an agreement or contract with each clinical trial site, the sponsor can file with the provincial drug administration department where the sponsor/agent is located. After the record is filed, clinical trials can be conducted.

When the same clinical trial project was filed for multiple times, the sponsor shall provide all the records obtained previously. The provincial drug administration department shall indicate in the “recording number” column of the “Medical Device Clinical Trial Record Form”, so that the clinical trial record number of the same project can be consistent.

 

Q: How to conduct quality management for multi-center clinical trials?

A: For the quality management of multi-center clinical trials, the following points should be followed:

  1. The study design should meet the requirements of the multi-center clinical trial in the “China Good Clinical Practice”.
  2. One clinical trial site should be identified as the lead site. The same protocol should be used for each site to ensure the consistency of trial implementation.
  3. The lead site shall organize and summarize the clinical trial summary from each site and complete the clinical study report (CSR). The CSR should be sealed by each site.

 

For inquiries on clinical trial and CER in China, please email info@ChinaMedDevice.com.

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About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are certified as legal agent. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies’ success.