For quantitative detection products, appropriate statistical analysis methods such as regression analysis should be selected according to the detection performance of the products for clinical trial results. Within a reasonable confidence interval, investigate whether there was a significant correlation and whether there is a significant statistical difference in the results of quantitative values. If possible, the recommendation should be taken into account that the possible differences in the performance of reagents in different sample concentration intervals, the overall concentration range is subject to interval stratified statistics, and the results in different concentration intervals were analyzed for correlation to better verify the correlation between the two reagents.

1 Whether the non-Chinese clinical trial data of the product must fully meet the requirements of the corresponding Chinese guidelines or not? 2 Can I select similar products as the control products according to Chinese regulations? 3 Is it necessary to include the Chinese trial data in the non-Chinese clinical trial data ? 4 Are the medical devices required to carry out clinical trials in China?

A single-group target value design can be considered when test device is technically mature and the disease for which it is intended is well understood, or when it is objectively infeasible to set up a control group We recommend choosing RCT trial design for clinical trial, according to technical development and clinical application status of intracranial drug-coated balloon dilatation catheter, which does not conform to the basic principle of single-group target value design.

When different anticoagulants are involved in the test samples of in vitro diagnostic reagents, different anticoagulants should be studied in the preclinical research stage to verify the applicability of anticoagulants and their impact on the test.

Guideline on Market Access for Medical Device in China is a report drafted by CIRS Group- Medical Device BU to help companies and individuals who would like to sell their medical devices to the People’s Republic of China and get their medical device products registered with NMPA. The guide describes key definitions, main regulations, authorities of the medical devices in China, and also the requirements of the whole life-cycle of medical devices including pre-registration preparatioin, registration process, testing/inspection, clinical evaluation, QMS and post-market management.

Adverse events (AE) refer to unfavorable medical events that occur during clinical trials, regardless of whether they are related to experimental medical devices. A serious adverse event (SAE) refers to a death or serious deterioration in health that occurs during a clinical trial, including fatal diseases or injuries, permanent defects in body structure or body function, requiring hospitalization or prolonged hospitalization, and the need to undergo Medical or surgical inte