Recently，The State Administration of Food and Drug Administration announced the "Amendment to the Administrative Measures for Registration of Eye Diagnosis Reagents"，Measures for the Registration Administration of in vitro My stake betting appdiagnostic reagents (State Food and Drug Administration Order No. 5) Article 20 (No. 5)，The original "State Food and Drug Administration is responsible for the formulation and adjustment of the classification directory of the in vitro diagnostic reagent product"，Modified to: "Article 17 of these Measures、Article 18、Classification rules of in vitro diagnostic reagents described in Article 19，It is used to formulate and adjust the classification directory of instructive external diagnostic reagents，and determine the management category of the new in vitro diagnostic reagent。The State Food and Drug Administration can be based on the risk change of in vitro diagnostic reagents，Adjust the classification rules。"Amendment will be implemented from the date of announcement。

2014，The General Administration of Food and Drug Administration released the "Administrative Measures for the Registration of Diagnostic reagents"，Among them, Article 17、Article 18、Article 19 Clear the classification rules of in vitro diagnostic reagents，It is used to formulate and adjust the classification directory of instructive external diagnostic reagents，and determine the management category of the new in vitro diagnostic reagent。

In recent years，With the My stake betting appdevelopment of in vitro diagnostic technology、Increase in usage，According to Article 17、Article 18、Article 19 Classification of in vitro diagnostic reagents，The classification of some products does not match its risk，If the diagnosis of tumors，The results of the examination of an in vitro diagnostic reagent of immunohistochemistry are just one of the reference indicators for doctors，Doctors also need to comprehensively consider other large quantities of diagnostic testing indicators to confirm the diagnosis，But in accordance with the above clauses，Anyone in vitro diagnostic reagent related to tumor -assisted diagnosis as the third category of medical device management，Classification is not reasonable。Due to the lack of adjustment space for the content of the above clauses，Make the relevant product category adjustment and risk do not match，Can't meet the requirements of medical device supervision。

This amendment specifies that the State Food and Drug Administration can be based on the risk changes of in vitro diagnostic reagents，Adjust the classification rules，Leaves space for future classification rules and directory adjustments。stake online sports bettingIn the future work，The State Food and Drug Administration will strictly follow the requirements of the "Regulations on the Supervision and Administration of Medical Device"，Based on the risk of in vitro diagnostic reagents，In full research and argument、Based on the public solicitation of opinions，Development of classification rules and directory adjustments，Make the management category of internal diagnostic reagents more scientific、Reasonable，Further promote the review and approval reform of medical device review，The requirements for the development of the medical device industry and the requirements of clinical use and regulation。