China's NMPA Issues New Guidelines for In Vitro Diagnostic Reagent Classification
The National Medical Products Administration (NMPA) has issued Notification No. 17 of 2024 concerning the implementation of the "Catalogue of In Vitro Diagnostic Reagent Classification." This notification is intended to streamline the classification of in vitro diagnostic reagents in accordance with the "Regulations on the Supervision and Management of Medical Devices" (State Council Order No. 739) and other related guidelines. Key points from the notification include:
1. Scope and Structure of the Catalogue: The Catalogue covers in vitro diagnostic reagents managed as medical devices, excluding those used for legally mandated blood screening and those labeled with radioactive isotopes. The structure of the Catalogue is based on the "Classification Rules" and includes six components: first-level serial number, first-level product category, second-level serial number, second-level product category, intended use, and management category.
2. Classification Details: The first-level product categories are established based on the Classification Rules, totaling 25 categories. The second-level categories, which number 1,852, provide further refinement based on detection targets and do not include methods or principles.
3. Management of New Products: For newly developed medical devices not yet included in the Catalogue, applicants can directly apply for Class III registration or determine the product category according to the Classification Rules before applying for classification determination and then registration or filing.
4. Specific Regulations: The notification details the management of various specific products, including culture media used for microbial identification or antimicrobial susceptibility tests, cell culture media used for in vitro diagnostics, and general reagents used in sample processing and reaction systems.
5. Regulatory Updates: The notification also announces the repeal of previous notices and announcements related to the classification of in vitro diagnostic reagents, effective January 1, 2025. These include earlier versions of the classification sub-catalogue and adjustments to the categories of certain products.
6. Dynamic Adjustment: The Catalogue will be dynamically adjusted based on risk analysis and evaluation of medical devices, ensuring timely updates to reflect the current understanding and use of these products in medical practice.
This notification aims to clarify and standardize the classification and management of in vitro diagnostic reagents to ensure compliance with regulatory standards and to facilitate the registration and filing processes for these products.