The National Medical Products Administration (NMPA) has coordinated the revision and release of the In Vitro Diagnostic Reagents (IVDs) Classification List, which will come into effect from January 1, 2025. The list includes IVDs regulated as medical devices, excluding those used for blood source screening and those labeled with radioactive isotopes.
The document is organized into six sections: “First level serial number, first level product category, second level serial number, second level product category, expected use, and management category.” The “First level product category” is established according to the “Classification Rules,” totaling 25 categories. The “Second level product category” further refines the first level, based on detection targets, and does not generally include methods or principles, totaling 1852 categories. The “expected use” content outlines the tested substance and its main clinical application, primarily to determine the product’s management category, without representing a complete description of the product registration content. The classification code 6840 will continue to be used. For products with multiple expected uses falling under the same management category, the primary clinical use and specific use should be prioritized when classifying “primary product categories.”
Following the release of the document, several previous notices related to IVDs will be abolished. For IVD registration certificates already approved and in effect before January 1, 2025, they will remain valid within their approved validity period. From January 1, 2025, new IVD registrations will be accepted according to the Classification List. Until June 30, 2024, the registration of Class I IVDs can still be processed according to the original Classification List, although early adoption of the new list is encouraged. From July 1, 2024, Class I IVD registration must comply with the Classification List.- Flcube.com
