Wednesday, 29 May 2024 / Published in Medical Device, News, NMPA Registration in China

China IVD Reagent Classification Catalogue issued by the NMPA

China IVD reagent classification catalogue has been issued by the National Medical Products Administration (NMPA) on May 10, 2024.

General Information

1. Scope:

The “Classification Catalogue” includes In Vitro Diagnostic reagents managed as medical devices but excludes those used for blood screening and those labeled with radionuclides.

2. Structure:

The catalogue is based on the “IVD Classification Rules” and includes six headings:

primary category
primary product type
secondary category
secondary product type
intended use
management category.

In total there are 25 primary product types and 1852 secondary product types.

3. Coding:

The overarching classification code 6840 continues to be used.

4. Different Uses:

Products with the same substance but different clinical uses and management categories are listed separately. Multiple-use products in the same management category are classified based on primary clinical use.

5. Specific subcategories are addressed:

Microbial Media:

Microbial identification or susceptibility test media, and cell culture media used for in vitro diagnostics with selectivity, induction, and differentiation functions, are managed as Class II, while low-risk selective culture media without these functions are managed as Class I according to the Classification Rules.

Cell Culture Media:

Class I cell culture media include only basic products like RPMI-1640 medium, with usage restricted to in vitro diagnostics and not allowed for cell therapy, cell transfusion, assisted reproduction, or other non-diagnostic purposes.

Sample Processing Products:

Class I sample processing products, as per Rules 6 and 7 of the “Classification Rules,” are general-purpose products used for pre-test sample preparation that do not participate in the reaction, and typically include only reagents common to instrument platforms or methodologies, excluding those specific to certain tests.

Staining Solutions:

Generic staining solutions are Class I, excluding specific substances like proteins or antibodies.

Flow Cytometry and Hybridization Products:

Single antibodies or probes for these products are managed as Class I; combinations are managed as Class II or III.

Combination Products:

Products combined for specific uses are classified by the highest management category among the components. New uses require reclassification.

Calibration and Quality Control Products:

These are not included in the catalog. Their management category matches the associated diagnostic reagent.

High-Risk Reagents:

IVD reagents used for clinical diagnosis related to the detection of narcotic drugs, psychotropic substances, or toxic drugs for medical use, and used in clinical institutions, are managed as Class III according to the Classification Rules and relevant regulations issued by the NMPA, Ministry of Public Security, and National Health Commission.

Dynamic Adjustments:

Based on the production, operation, and use of medical devices, and grounded in risk analysis and evaluation of medical devices, the Classification Catalog will be updated and adjusted promptly in accordance with the “Dynamic Adjustment Procedure for the Medical Device Classification Catalogue.”

Abolished documents:

Starting from January 1, 2025, the following documents will be abolished:

- Notice on Issuing the Sub-Catalogue of In Vitro Diagnostic Reagents (2013, No. 242),
- Notice on Adjusting Attributes and Categories of Allergen, Flow Cytometer, Immunohistochemistry, and In Situ Hybridization In Vitro Diagnostic Reagents (2017, No. 226),
- Notice on Adjusting Part of the Content of the Sub-Catalog of In Vitro Diagnostic Reagents (2013 Edition) (2020, No. 112).

Registration and Filing Policies

In Vitro Diagnostic Reagent Registration Certificates Validity

Certificates approved before January 1, 2025, remain valid within their approval period.
For first-time registrations from January 1, 2025, applications will follow the new Classification Catalogue.
For applications accepted before January 1, 2025, but not yet approved, the review may continue under the original Classification Catalogue:
- If approved without category adjustment, a certificate will be issued under the new Classification Catalogue.
- If category adjustment is involved, the certificate will be issued under the original Catalogue with remarks indicating the new category and will not exceed validity beyond January 1, 2027.

Renewal and Change of Registration Applications

Renewals accepted before January 1, 2025, but not yet approved will follow the original Classification Catalogue:

If approved without category adjustment, a certificate will be issued under the new Classification Catalogue.
If category adjustment is involved, the certificate will be issued under the original Catalogue with remarks indicating the new category and will not exceed validity beyond January 1, 2027.

Category Adjustments

For certificates effective before January 1, 2025:

If adjusted from high to low category, renewal or filing must be applied under the new category.

If adjusted from low to high category, registration must be applied under the new category. Extensions can be granted until January 1, 2027, if safety and efficacy are maintained.

First-time Registration, Renewal, and Change Applications

Applications accepted before January 1, 2025, but not yet approved will follow the original Classification Catalogue:

If approved without category adjustment, documents will be issued under the new Classification Catalogue.
If category adjustment is involved, documents will be issued under the original Catalogue with remarks indicating the new category.

Class I In Vitro Diagnostic Reagents

Filing of Class I reagents until June 30, 2024, can follow the original Classification Catalogue but is encouraged to follow the new one.
From July 1, 2024, filings must follow the new Classification Catalogue.
Self-examination of filings done before July 1, 2024, is required. If category adjustment is needed, filings must comply with the new regulations.
Unregistered products by January 1, 2027, cannot be produced, imported, or sold.

Products Not Included in the Classification Catalogue

Applicants must apply for classification and definition per relevant requirements and then proceed with registration or filing accordingly.

Medical device manufacturing and operating policies

Production Licenses: Domestic manufacturers must apply for production licenses or modify existing ones according to the product’s management category. Production scope is defined under the “6840 IVD reagent” format.
Operating Licenses: Domestic operators in China must apply for or modify licenses according to the management category of the IVD products they handle. The scope is similarly defined as “6840 IVD reagent.”

Provincial Medical Products Administration are tasked with organizing training and supervision to ensure the effective implementation of the new classification directory and associated policies.