NMPA published the “Guideline on Core Raw Materials of In Vitro Diagnostic Reagents” on January 3, 2024, along with eleven IVD related guidance. It comes as the File No.1 released by NMPA CMDE (Center for Medical Device Evaluation) in 2024.

The core raw materials document first discusses various materials essential for the core reaction system in biological assays and the broader biological detection process. In the review key points section, it emphasizes transparency in providing information about the selected raw materials, their sources, and the quality standards applied, ensuring a thorough understanding of the product’s composition and performance during the registration review process.

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Application Scope

The guideline is mainly for Class III IVD products. The various core materials can be categorized into the following groups:

• Core Reaction System Raw Materials

It directly involved in reacting with the target substance include biologically active materials like antigens, antibodies, primers, probes, dNTPs, DNA polymerase, and reverse transcriptase. These are crucial for nucleic acid detection reactions, as well as substrates, enzymes, and cofactors for biochemical assays like blood typing and clotting tests.

• Other Biologically Active Materials in the Reaction System

It encompasses secondary antibodies for immunohistochemistry, enzymes for signal generation in immune detection, and materials targeting interference, such as anti-red blood cell antibodies and inhibitors for background signals.

• Solid Phase Carriers

It includes materials like nitrocellulose membranes, magnetic beads, and microplates used in various immunoassays, blood typing tests, and microfluidic devices.

• Signal Substances

It comprises colorimetric and turbidity agents like colloidal gold and latex, luminescent substances such as fluorescent dyes and microspheres, and agglutination-based reagents for blood typing.

• Biologically Active Materials in Quality Control and Internal Standards

It involves materials with specific nucleic acid fragments, antigens, antibodies, and biochemicals used in quality control and internal standards for assays like gene detection, immunochromatography, and biochemical testing.

Review Key Points

The document outlines key points for the review process in the IVD development. The focus is on the selection and sourcing of core raw materials, the quality standards for these materials, the inclusion of enterprise reference materials, and the content in the product technical requirement (PTR).

• Selection and Sourcing of Core Raw Materials

In the early stages of product design and development, the selection of core raw materials is crucial. This involves a comprehensive analysis and verification of factors such as product design requirements, performance indicators, basic information, parameter specifications, and supply sources. The process includes theoretical analysis and experimental validation, with theoretical analysis considering factors like antigen-antibody interactions for pathogen detection and primer-probe design for target genes. Experimental validation involves screening multiple materials based on design requirements.

• Quality Standards for Core Raw Materials

Once materials are selected and validated, the next step is to establish quality standards. This involves defining objective evaluation criteria and corresponding test methods. For core reaction system materials, the standards should encompass both intrinsic material properties and functional attributes such as sensitivity, specificity, precision, accuracy, linearity, and stability. The applicant is encouraged to conduct comprehensive testing, including batch-to-batch consistency assessments for materials with potential variability.

• Reference Materials

Manufacturers are advised to establish internal reference materials to aid in product design, development, and quality control. These reference materials can include positive/negative controls, detection limit references, repeatability references, and linear references. Detailed information about the composition, preparation, and determination of these reference materials should be submitted as part of the application.

• Core Raw Materials in PTR

The PTR for Class III IVDs should explicitly specify major raw materials in the appendix. For core reaction system materials, details such as name, source (self-made or purchased), basic information (biological origin, monoclonal/polyclonal, clone number for monoclonal antibodies, natural/recombinant origin, expression vector, gene locus/name, fragment size, sequence information, preparation, and identification methods), and quality standards should be clearly defined. For other major raw materials, names, basic information, and quality standards should also be included.

For an English copy of the complete guideline, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

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• Source: https://chinameddevice.com/ivd-core-raw-materials/