1) There is no fixed number of clinical cases, (previously stipulated, but now there is no such number). Enterprises calculate the number of cases through a formula based on the expected effect they need to achieve in the clinic, with reference to the value of the difference allowed by the enterprise, changing the effective rate of the product and other values.
2) Clinical testing requirements of the device must meet the basic requirements of the product's national standard, line standard, or through the standard. The testing organization must be a nationally recognized medical device testing organization.
3) 6 months of claims: some.
After getting the test report, clinical trials must be conducted within 6 months.
For more questions, you can consult Shenzhen Landa Business Consulting Co., Ltd, a professional medical device regulatory consulting organization.