What Should Be Paid Attention To When Composing Part (V) Of The Review In The Application Dossiers Of IVD Reagents?

The content of the review information Part (V) in the IVD reagent application dossiers is often neglected. This part is a summary of the innovativeness of the product and the approval status of similar products in China and abroad.

If similar products have been approved in China or abroad, the applicant should give a brief introduction to the similar products, including the information about manufacturers, product name, approved country or region, etc. Compare the investigational reagent with the similar products in technical methods, product performance, result reporting methods, etc. Briefly describe the market application of similar products in China and abroad.

For newly developed IVD reagents, if there is no similar product approved, or the applied product changes its conventional intended use and has a new clinical significance, the sponsor should provide proof to support the new marker or the new intended use, such as literatures, guidance documents, expert consensus, etc., which can interpret the relationship between the test result and the clinical endpoint. How the kit will be used in the disease diagnosis and treatment, and how to interpret the test result should also be detailed.