China's Updated Classification Codes for IVD Reagents

In December 2024, China’s National Medical Products Administration (NMPA) issued a notice regarding adjustments to the classification codes for in vitro diagnostic reagents. This change is part of the NMPA’s broader implementation of the Catalogue for the Classification of In Vitro Diagnostic Reagents (Document No. 58), which will take effect on January 1, 2025.

Key Changes to the Registration Process

Starting on January 1, 2025, the classification codes for in vitro diagnostic reagents will follow a new format: “6840-XX (primary sequence number)-XXXXX (secondary sequence number).”The new system provides a more detailed categorization of products, and applicants will be able to select from refined product categories via the eRPS system. For example, the classification code for novel coronavirus nucleic acid testing reagents will be 6840-01-01152.

Handling Multiple-Test Products and Category Mismatches

For multi-test products, the primary sequence number should reflect the product’s intended use, while the secondary sequence number can either represent a specific product category or be listed as "00000" when necessary. If a product’s category does not match the new Catalogue exactly, applicants can manually adjust the classification code by using “00” or “00000,” ensuring the hyphen format remains intact.

Ensuring Smooth Registration for 2025

These updates are essential for companies looking to register in vitro diagnostic reagents in China in 2025. Compliance with the new classification system will ensure a smoother registration process and avoid potential delays.

Further Information

To read the updated NMPA classification codes for in vitro diagnostic reagents, please click here.If you are interested in how these medical device regulatory standards might impact your organization, please contact Cisema for more information.