Q: How to calculate the one-year validity period for the type testing report issued by the inspection institution?
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:
For inquiries on clinical trial and CER in China, please email info@ChinaMedDevice.com.
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