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Guideline on Modification Registration of IVD Reagents Asks Your Feedback


The NMPA issued the “Draft Guideline on Modification Registration IVD of In Vitro Diagnostic Reagent” on May 31, 2023, for feedback. Feedbacks need to be submitted by June 30, 2023.

Decision-making Modification Registration IVD Flowchart

Changes in IVD reagents should be controlled through the quality management system, and if the changes occur on medical device registration certificate and its annexes, modification filing or modification registration is required.

Modification Registration IVD flowchart

Changes in the name and address can be applied through modification filing, and other content changes shall be applied through modification registration.

Consideration to be Given

The following situations need to be considered in the process of risk control and technical evaluation. For details, please email

Circumstances that do not increase risks:

  • Textual changes in product names.
  • Changes in packaging specifications that do not affect performance or stability: the minimum packaging of the product composition remains unchanged, only the number of packaging changes.
  • Add warning information to the manual.
  • Delete the applicable model.
  • The text change of the production address of imported IVD reagents.
  • Other changes that do not affect the performance of the product.

Circumstances where there is potential risk:

  • Packaging specification changes
  • Changes in product storage conditions and expiration date
  • Applicable instrument changes
  • Positive judgment value or reference interval change
  • Changes in raw materials of Class III IVD reagents
  • Changes in the production process of Class III IVD reagents
  • Changes in the reaction system
  • Change of production address of imported IVD reagents
  • Applicable sample type change
  • Changes in applicable population and clinical indications
  • Changes in product technical requirements and instructions

Circumstances that are required to file a new application.

Modification Examples

The draft guideline takes the examples below to demonstrate the modification application, from the perspective of modification description, non-clinical and clinical trial:

  1. Changes to applicable instruments
  2. Changes in raw materials for Class III IVD reagent
  3. Changes in raw materials for Class III IVD reagent
  4. Changes in the reaction system
  5. Changes of clinical indications
  6. Changes to other products used in companion with the reagent
  7. Changes of reference interval
  8. Changes to the sample types and clinical indications
  9. Add calibrators

For the English version of the draft guideline on Modification Registration IVD, please contact us at We charge nominal fees for the translation.

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