Change Notifications
Not Every Change Requires Re-Registration
Under Permenkes 62/2017, changes to a registered medical device are managed through the Regalkes system. The regulatory burden depends on the nature and significance of the change.
Change Categories
Minor Changes → Change Notification (Perubahan)
Minor changes can be notified via the faster, lower-cost Perubahan process in Regalkes:
| Change Type | Examples |
|---|---|
| Administrative updates | LAR address change, contact details update |
| Label layout changes | Reformatting that does not alter content |
| Minor labeling updates | Adding BI translation to a previously English-only section |
| Minor supplier changes | Material supplier change where material spec is unchanged |
| Packaging changes | Outer packaging aesthetic changes; pack size variants not affecting device |
| URL update for e-labeled IFU | Change of electronic IFU URL |
Major Changes → Full Re-Registration Required
Major changes require a new NIE application:
| Change Type | Why Re-Registration |
|---|---|
| New intended use | Changes the clinical scope of the device |
| New brand/trade name | New identity; different NIE required |
| Change of NIE holder | Transfer not permitted — new party must register |
| New manufacturing site | Different GMP status; new site validation |
| Significant design change | Changes safety/performance characteristics |
| New risk class | Reclassification requires new evaluation |
Decision Framework
When a change is planned, apply this test:
- Does the change affect the intended use, performance, or safety of the device? → Likely re-registration
- Does the change affect the NIE holder identity? → Re-registration required
- Does the change affect labeling content (not just layout)? → May require Regalkes notification or update
- Is the change purely administrative (addresses, contacts)? → Change Notification (Perubahan)
When in doubt, consult with your LAR and Kemenkes. Undisclosed major changes identified in market surveillance or inspections can result in NIE suspension.
Perubahan Process
Change notifications are submitted through Regalkes under the Perubahan category:
- LAR logs into Regalkes and selects the relevant NIE
- Initiates a Perubahan application
- Uploads supporting documentation for the change
- Kemenkes reviews (typically faster than full registration)
- Updated NIE certificate issued (same NIE number, updated approval)