Submission requirements for in vitro diagnostic reagent declaration data sheets/labels

The state continues to strengthen the registration management of medical devices, and the requirements for the materials submitted by our applicants are "complete materials and meet the statutory form requirements". Today, let's talk about the submission requirements of the instructions/label materials in the in vitro diagnostic reagent application materials.





Status analysis of registration management of in vitro diagnostic reagent products in China

In vitro diagnostic reagents refer to reagent products used for in vitro testing of human samples. Except for in vitro diagnostic reagents used for blood source screening and radionuclide labeling, all of them belong to the supervision of medical devices. It includes reagents, kits, calibrators, quality control products, etc., with the ability to predict diseases, diagnose diseases and prognosis observation and health status evaluation, which plays an important role in improving the quality of medical care and reducing medical costs. Therefore, it is very important to establish a sound regulatory system to ensure the standardization of in vitro diagnostic reagent filing and registration and product safety and effectiveness.





The growth rate of global in vitro diagnostics comes from emerging markets, and China's market size has exceeded 120 billion yuan.

In vitro diagnosis is a branch of the medical device industry. It refers to a unified detection system composed of relevant medical clinical diagnostic instruments and supporting detection reagents outside the human body. Through the detection of human samples (blood, body fluids, tissues, etc.) to obtain clinical diagnostic information, and then to judge the disease or body function of products and services.





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