When the performance indicators of in vitro diagnostic reagents change, how should the registrant submit a change declaration?
When a registrant applies for a change in the performance indicators of a product, the change declaration must clearly state the reasons and purposes for the changes in the product's performance indicators, provide a detailed description of the specific changes to the product, and analyze the impact of those changes on the product's performance. If the registrant claims that the product itself has not changed, they must explain in detail from the perspective of product design and development why the performance indicators have changed even though the product has not. Supporting documentation must also be provided.