Changes to Labelling


Category (Significant, non-significant)

All changes to the labelling of medical devices that involve addition, removal and/or revision of warnings, precautions and/or contraindications not arising due to safety and/or performance concerns.

Labelling changes that modify the approved method of use; or involve a change from ‘professional use only’ to ‘home use’.


Change involves a reduction of intended use/indication of use not arising due to medical device safety and/or performance concerns.

Non - Significant, but generally reportable
Changes to the label due to typo error.

Non - Significant