China NMPA: IVD IFU Guideline Issued for Feedback

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The NMPA issued the “Guideline on Instructions for Use of In Vitro Diagnostic Reagents (draft)” for feedback. The guideline stipulates drug information such as the intended use, test methods, interpretation of test results, and precautions, which are important technical documents that direct users and clinicians to operate correctly, and accurately understand and apply test results.

The draft guideline says that, in principle, the contents of the product manual should be all expressed in Chinese; if there are English abbreviations that are commonly used internationally or generally recognized in the industry, they can be marked after Chinese in brackets; for words that are not properly expressed in Chinese, they can be expressed in English or their abbreviations.

Product Names of IVD IFU Guideline

Generic names should be named in accordance with the naming principles stipulated in the “Administrative Measures for the Registration of In Vitro Diagnostic Reagents” (Order No. 5 of the State Food and Drug Administration), and appropriate reference may be made to the relevant “categories” and/or national standards and industry standards.

Except for special-purpose products, which can indicate the sample type in the generic name, the generic name of other products should not include the sample type, qualitative/quantitative content, etc.

Packaging Specifications

Indicate the number of samples or filling volume that can be tested, such as ××test/box, ××person/box, ××mL. Except for the international common measurement unit, the rest of the content should be expressed in Chinese. If the product has different components, the name of the component can be written. If there is an item number, you can add the item number information.

Intended Use

The first paragraph shall detail the intended use of the product, such as qualitative or quantitative testing, self-testing, confirmation, etc., the type of sample and the substance to be tested, etc. The specific form of expression should be adjusted appropriately according to the characteristics of the product. If the sample is from a special test population, such as pregnant women, newborns, etc., it should be indicated.

The second paragraph shall describes the clinical indications and background information related to the intended use, as well as the relevant clinical or laboratory diagnostic methods.

Ingredients

1. For reagent components included in the product:

(1) State the name, quantity, and proportion or concentration in the reaction system, and if important for proper operation, provide its biological origin, activity, and other characteristics.

(2) For multi-component kits, clearly indicate whether the components in different batches of kits are interchangeable.

(3) If the box contains consumables, the name and quantity of the consumables should be listed. Such as plastic dropper, sealing film, self-sealing bag, etc.

2. For the reagent components not included in the product but necessary for the test, the name and purity of such reagents should be listed in the instructions, and the dilution or mixing method and other relevant information should be provided.

3. For calibrators and controls:

(1) Describe the main components and their biological origins.

(2) Indicate the fixed value of the calibrator and its traceability.

(3) Indicate the target value range of the quality control product. If the target value range is batch-specific, batch-specific can be indicated, and a separate target value list can be attached.

Basic Information on IVD IFU Guideline

1. Domestic in vitro diagnostic reagents

(1) If the registrant (or filing person) and the production enterprise are the same enterprise, the basic information shall be marked in the following format:

  • Registrant (or filing person)/name of manufacturer
  • Residence
  • Contact details
  • After-sales service unit name
  • Contact details
  • Production address
  • Production license number or production record certificate number

(2) The basic information of the entrusted production shall be marked in the following format:

  • Registrant (or filing person) name
  • Residence
  • Contact details
  • After-sales service unit name
  • contact details
  • The name of the trustee
  • Residence
  • Production address
  • Production license number or production record certificate number

2. Imported in vitro diagnostic reagents

Label basic information in the following format:

  • Registrant (or filing person)/name of manufacturer
  • residence
  • Production address
  • contact details
  • After-sales service unit name
  • contact details
  • agent’s name
  • residence
  • contact details
  • registration certificate number or filing certificate number of the product.

For more information on the following, please email info@ChinaMedDevice.com.

  • Storage conditions and validity period
  • Applicable instruments
  • Sample Requirements
  • Testing method
  • Explanation of test results
  • Limitations of test methods
  • Product performance index
  • Precautions
  • References and Approval date and revision date of the manual

Read more about clinical evaluation and clinical trial guidelines for IVDs.

Look over information for overseas clinical data guideline for IVDs.