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How to Compile Clinical Evaluation for Clinical Trial Required Medical Device Software

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Clinical evaluation documents compiling is based on clinical trial differences during the CFDA registration process.
There are three main category:
  • The medical devices included in the clinical trial exempted catalog
  • Compare with the similar CFDA registered products
  • Clinical trial
Medical devices that clinical trial required and not included in the clinical trial exempted catalog can follow step two or three listed above.

Conduct Clinical Trial
The most positive and safest way is having the clinical trials. And all the clinical trials relative items are subject to CFDA regulation ‘Medical Device Clinical Trial Quality Control Standard’ and other medical device related regulations.

Compare with the Similar CFDA Registered Products
According to ‘Medical Device Clinical Evaluation Technical Guideline’ issuned by CFDA on May 19th 2015, the medical devices can prepare clinical evaluation documents by using clinical trials or clinical trial data of the similar CFDA registered products. Our clients can follow the steps listed below.
I) Fill the comparison charts of similar products.
  • It should prove the declaring product is similar to the CFDA registered products.
  • Whether the products differences will influence the products safety and effectiveness or not, it should be verified by the declaring products data. EX: products non-clinical research data, clinical reference data, clinical experienced data, the clinical trial data from clinical trial conducted in China and based on the products differences.
II) Comparison charts of similar products and declaring products (sample)
Compared itemSimilar productDeclaring productsDifferenceSupporting
document
Basic principle
Structural components
……
……
……

III) The difficulty of finding similar products
How to get similar products?
One is the manucactures can get the similar products clinical trial data from the competitor, but it is really hard. The other possible situation is the manufactures update the old generation product, so they can use the old generation clinical data for the new one registration

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+86 571 8720 6559 （GMT+8 8:30~17:00）
md@cirs-group.com
Contact Us
+86 571 8720 6559 （GMT+8 8:30~17:00）
md@cirs-group.com