China NMPA Implements Revised Classification Catalog For In Vitro Diagnostic Reagents


On May 21 2024, the China NMPA has announced the implementation of the revised Classification Catalog for In Vitro Diagnostic Reagents (the Catalog) in accordance with the Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 739). This revision, aimed at enhancing the regulatory framework for in vitro diagnostic (IVD) reagents, is set to take effect on January 1, 2025.

The revised catalog delineates the classification of IVD reagents managed as medical devices. It excludes IVD reagents used for blood screening and those labeled with radioactive nuclides. The catalog is structured into six parts: primary and secondary product categories, expected usage, and management categories. The primary categories are based on the Classification Rules (NMPA Announcement No. 129 of 2021) and consist of 25 categories, further detailed into 1,852 secondary categories based on testing targets.

Key highlights include:

Products with the same analytes but different clinical purposes will be listed under separate management categories if widely used in different clinical applications.

Reagents used for microbiological identification and drug sensitivity tests, cell culture media, and other specific reagents are categorized based on their risk and intended use.

The catalog will be updated dynamically based on risk analyses and evaluations of medical device production, operation, and usage.

By 2025, new registration applications must comply with the revised catalog. For applications submitted before this date but not yet approved, the original catalog may still be referenced for approval. Transition policies are in place to ensure smooth adaptation, including guidelines for extending the validity of existing registrations and handling changes in product management categories.

Effective immediately, entities can use either the original or revised catalog for filing IVD reagents until June 30, 2024. From July 1, 2024, the revised catalog must be used for all new filings. Existing products must be reviewed for compliance with the new catalog, and adjustments must be made accordingly by January 1, 2027.

The NMPA emphasizes that the catalog does not cover calibration and quality control materials, which are managed based on their association with second or third-category IVD reagents.

BradyKnows Medical stands at the forefront of medical device innovation, providing elite expertise in the regulatory landscape of IVD reagents. Our comprehensive knowledge and meticulous approach ensure seamless compliance with evolving regulations, making them an invaluable partner in navigating the complexities of medical device classification and registration. For further inquiries regarding medical device registration, please contact: