Summary of "Classification Rules for In Vitro Diagnostic Reagents"

Purpose of drafting: To standardize the classification management of in vitro diagnostic reagents, to guide the formulation and adjustment of the classification catalog of in vitro diagnostic reagents, and to determine the management categories of new in vitro diagnostic reagents.

Management category: In vitro diagnostic reagents are divided into the first category, the second category and the third category according to the degree of risk from low to high.

Classification factors: The management category of in vitro diagnostic reagents should be determined according to the degree of product risk. Factors that affect the risk level of in vitro diagnostic reagents include but are not limited to the following:

(1) The product’s intended use, indications, intended use environment and user’s professional knowledge;

(2) The degree of impact of test result information on medical diagnosis and treatment;

(3) The impact of test results on personal and/or public health.

Classification definition:For newly developed in vitro diagnostic reagents that have not yet been included in the classification catalog of in vitro diagnostic reagents, applicants can directly apply for registration of Class III in vitro diagnostic reagent products, or they can determine the product category based on this classification rule and define the workflow according to the medical device classification Application classification definition.

Management department: The classification catalog of in vitro diagnostic reagents is formulated and published by the State Food and Drug Administration. The State Drug Administration shall promptly analyze and evaluate the risk changes of in vitro diagnostic reagents based on the production, operation, and use of in vitro diagnostic reagents, and adjust the classification catalog of in vitro diagnostic reagents.

Others: In addition to the above, the rules also mention other situation judgments during classification.

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