Change Notification for Registered Devices
The obligation to notify before changing
Once a device is registered on the SMDR, the registrant must notify HSA before implementing any changes to the registered device. This applies to changes to the device itself (design, materials, manufacturing), changes to labelling, and changes arising from a Field Safety Corrective Action.
The obligation to notify before implementing changes (rather than after) is important — making a change without prior notification is a regulatory non-compliance.
Types of changes and their notification categories
HSA categorises changes into several types, each with different notification requirements:
| Change type | Description |
|---|---|
| Technical changes | Changes to device design, materials, components, software, or manufacturing process |
| Review changes | Changes that require HSA to review and assess before approval |
| Administrative changes | Changes to labelling, distributor details, or other administrative information |
| Notification changes | Minor changes that only require notification without HSA review |
| FSCA-related changes | Changes arising from a Field Safety Corrective Action |
The specific requirements for each category, including what documentation to submit and which changes require HSA approval before implementation, are detailed in HSA's change notification guidance.
How to submit a change notification
Change notifications are submitted through the SHARE portal.