China IVD IFU Guidelines have been released by the National Medical Products Administration (NMPA). They came into effect on January 3, 2024.
The “Guidelines for the Preparation of Instructions for Use (IFU) of In Vitro Diagnostic (IVD) Reagents (Revised 2023 Edition)” is a comprehensive document that provides detailed guidance for regulatory affairs professionals involved in the preparation of product instructions for in vitro diagnostic reagents. These guidelines are essential for ensuring compliance with relevant regulations and standards, as well as for maintaining the accuracy and clarity of product instructions.
The guidelines emphasize the importance of adhering to regulatory requirements, including those related to the supervision and administration of medical devices, registration and filing of in vitro diagnostic reagents, and the format and content of approval certificates. The primary objective of these guidelines is to offer structured guidance for creating in vitro diagnostic reagent instructions while serving as a technical reference for regulatory authorities during the review process.
Due to the diverse nature of in vitro diagnostic reagent products, with varying intended clinical uses and methodologies, these guidelines focus on general requirements for product instructions. Specialized products may require adherence to additional, specific guidelines. Manufacturers are encouraged to tailor the IFU to the unique characteristics and intended clinical use of their products, ensuring that users receive accurate information.
The guidelines outline the format for China IVD IFU, including key sections such as:
- Product Name: Guidance for naming the product, emphasizing adherence to regulatory naming principles, and incorporating reference to classification catalogs and industry standards when necessary.
- Packing Specifications: It is of importance to specify the number of samples or amount of samples that can be tested and the guidelines suggest including component names and article numbers for products with multiple components.
- Intended Use: The guidelines stress the necessity of detailing the analyte to be tested, the type of test (qualitative/quantitative/semi-quantitative), sample types, and any special use cases. Background information on the analyte and its relationship to clinical indications should also be included.
- Test Principle: Manufacturers are required to provide an in-depth explanation of the testing principles and methods, with the option to use graphical representations if necessary.
- Main Components: Detailed descriptions of reagent components, including names, quantities, loading amounts, and information about core reaction components, other bioactive materials, solid phase carriers, and more should be provided. The guidelines also address multi-component kits, consumables, and separately registered reagents or software.
- Storage Conditions and Expiration Date: Storage conditions, expiration dates, and special storage requirements, along with information on component-specific storage conditions and expiration dates must be provided.
- Applicable Instruments: Manufacturers must describe the applicable instruments and models to help users make informed choices.
- Sample Requirements: The guidelines outline requirements for sample types, collection and preservation methods, anticoagulants, and other necessary sample components. Information on sample stability, including cryopreservation conditions, should be provided.
- Test Method: Detailed explanations for sample processing, reagent preparation, reaction steps, calibration, quality control, and result interpretation must be given. Self-test products should also include easy-to-understand operation steps.
- Positive Judgment Value or Reference Range: Specifications for positive judgment values or reference intervals, along with the underlying research methods and data, including sample size, population characteristics, and statistical methods used must be provided.
- Interpretation of Test Results: Manufacturers must provide clear interpretation of test results based on positive judgment values or reference intervals, factors influencing results, and any retesting or confirmatory testing requirements.
- Limitations of the Test Method: Explanations of the test method’s limitations are to be given.
- Product Performance Index: A summary of performance study and clinical evaluation data, covering accuracy, precision, sensitivity, specificity, inclusiveness, and more must be provided.
- Precautions: Provide necessary precautions, such as limitations to in vitro use and warnings for products containing substances of human or animal origin.
- Explanation of the Logo: If any symbols or graphics appear in the instructions, explanations should be provided.
- References: List cited references.
- Basic Information: Information about the registrant, manufacturer, after-sales service, and, for imported products, the local authorized representative must be provided. Also, the document outlines the format for including medical device registration or record numbers and approval dates.
These guidelines aim to ensure that in vitro diagnostic reagent instructions are comprehensive, accurate, and user-friendly. As regulations and standards evolve, the content of these guidelines will be adjusted accordingly. These guidelines create compliant and informative product instructions in the rapidly evolving field of in vitro diagnostics.
Read the original CMDE announcement on China IVD IFU guideline.
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