Changes on a label: Are they annexes to the dossier or formal modifications?

For medical devices or reagents, label changes can either be minor updates or formal modifications, each with different reporting requirements for INVIMA.

If your label change is minor and does not impact the device's characteristics, you may notify INVIMA with a brief statement. This step ensures that your dossier remains current (examples include changes to label color, font style, or layout).

However, if the label change affects critical information about the product as presented to consumers, a formal modification filing is required. Such changes must be submitted to INVIMA as they impact the device’s or reagent’s registered details.