Clinical evaluation
Clinical evidence, exemption or trial
Depending on the device, clinical evidence may be provided through the exemption catalogue, through comparison with an equivalent device already registered in China, or through a clinical trial conducted in China.
We assess which route is open, and build the evaluation file accordingly.
What this covers
- Check against the catalogue of devices exempt from clinical evaluation
- Equivalence route: selection of the comparator and the difference analysis
- Clinical evaluation report compilation from existing data
- Clinical trial planning where a trial is unavoidable
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