The last time the NMPA In Vitro Diagnostic Reagents Classification Catalog was announced was in 2013 with two supplemental updates in 2017 and 2020 respectively. NMPA issued the “Draft Classification Catalog for IVD Reagents” on March 14, 2023 and finalized it on May 11, 2024.
The new Catalog is the result of several years in effort to standardize the classification and streamline the IVD registration process. It is to “keep up with the regulatory and industry development needs brought by new technologies, methods and biomarkers.”
From January 1, 2025, registration application for IVD reagents should follow the new classifications.
Compared with the previous catalogs, key changes are:
- The number of IVDs catalogs is increased to 25:
- There are 1852 subcategories, classified by biomarkers. Among them are 349 Class III and 719 Class II IVD reagents.
- Except for gene testing, human leukocyte antigen B27 (HLA-B27) test reagents are reclassified from Class III to Class II.
- Media used for microbial identification or susceptibility testing, as well as media for cell proliferation culture that has selective, inductive, or differentiation functions and is used for IVD cell culture, are managed as Class II. Low-risk microbial culture media used only for selective culture and lacking microbial identification and susceptibility functions are managed as Class I.
- Cell culture medias managed as Class I only include basic culture media products, such as RPMI-1640 medium, with clearly defined usage restrictions (not for cell therapy, cell transfusion, assisted reproduction, etc., but limited to IVD purposes).
- Sample processing products managed as Class I mainly refer to general-purpose products used in the sample pre-treatment stage before the detection reaction occurs and do not participate in the reaction. In principle, such products only include reagents for general sample processing used with instrument platforms or methodologies and do not include sample processing reagents for specific detection items.
- General-purpose reagents for the reaction system managed as Class I mainly refer to reagents that maintain the reaction system environment during the detection reaction stage. These include only reagents for general reaction systems used with instrument platforms or methodologies and do not target specific detection items. Complete products cannot be split and registered/filed separately.
- Staining solutions managed as Class I mainly refer to general products and do not contain specific proteins, antigens, antibodies, enzymes, etc. They are named according to their main chemical components or common names.
- Antibodies or probes involved in flow cytometry, immunohistochemistry, and in situ hybridization products managed as Class I are all “single antibodies” or “single probes.” For in situ hybridization products that detect a single gene, break-apart gene probes, and fusion gene probes require two probes to work together for gene detection, these are considered “single probes.” For in situ hybridization products that detect a single gene and include an additional probe for “auxiliary positioning,” this is also considered a “single probe.”
- Combined uses of the aforementioned “single antibodies” or “single probes” are managed as Class II or III
- “Single antibodies for flow cytometry used only to provide auxiliary diagnostic information to professional doctors” refer specifically to single antibodies and isotype control antibodies used to analyze and provide auxiliary information on suspended cells in body fluids. IVD reagents that detect other components in body fluids by forming bioparticles for flow cytometry do not meet the requirements for “single antibodies for flow cytometry” as per the Classification Rules. For example, on a flow platform, reagents that detect and analyze substances such as interleukins, interferons, and tumor necrosis factors using specific “microspheres” or “microbeads” based on antigen-antibody reactions.
- The Classification Catalog does not include calibrators and quality control materials. The category of calibrators and quality control materials used with Class II and III IVD reagents corresponds to that of the reagent; those used with Class I IVD reagents are managed as Class II.
- IVD reagents related to the detection of narcotic drugs, psychotropic substances, and toxic drugs for medical use, with clinical diagnostic purposes and used in clinical institutions, are managed as Class III.
For an English copy of the IVD Classification Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For IVD Classification Rules released in October 2021, please click HERE