Background: Implementation of the New Classification Catalog
On May 10, 2024, the National Medical Products Administration (NMPA) issued two key documents concerning the classification of in vitro diagnostic (IVD) reagents:
- The In Vitro Diagnostic Reagent Classification Catalog (Announcement No. 58 of 2024, hereinafter referred to as the "Classification Catalog").
- The Notice on the Implementation of the In Vitro Diagnostic Reagent Classification Catalog (Notice No. 17 of 2024, hereinafter referred to as the "Notice").
According to the Notice, the Classification Catalog will take effect on January 1, 2025, replacing the existing classification system. To ensure a smooth transition for registration applications, the NMPA has outlined adjustments to the classification coding format.
New Classification Code Format Effective January 1, 2025
From January 1, 2025, all IVD reagents must use a standardized classification code in the following format:
"6840-XX (Primary Serial Number)-XXXXX (Secondary Serial Number)"
Applicants must select the appropriate product category from the drop-down menu in the eRPS system and assign the classification code based on the Classification Catalog.
For example, under the new system, the classification code for a novel coronavirus nucleic acid detection reagent is 6840-01-01152.
Guidelines for Multiplex Detection Products
For products capable of detecting multiple analytes, the Primary Serial Number should be assigned based on the intended use of the product. The Secondary Serial Number should either reflect the most relevant product category from the Classification Catalog or be designated as "00000" if no exact match exists.
Procedure for New and Unclassified Products
For innovative IVD products that do not fit into the predefined classification structure, applicants may manually assign a classification code in the "6840-XX-XXXXX" format by using:
- "00" for the Primary Serial Number
- "00000" for the Secondary Serial Number
This ensures consistency in the coding system while maintaining flexibility for new product categories.
Conclusion: Ensuring a Smooth Transition
The implementation of the new Classification Catalog represents a significant shift in the regulatory framework for IVD reagents. Manufacturers and regulatory professionals should familiarize themselves with the updated classification system to ensure compliance and streamline the registration process. Early preparation and correct classification code selection will help prevent delays in regulatory approvals.
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