Hello. This is INSIGHTOF Consulting, your partner for successful market entry into Indonesia. Business growth often leads to office relocation. However, for companies holding Medical Device Marketing Authorizations (Izin Edar), moving offices is not just a logistical task—it is a regulatory trigger.
If the address listed on your license does not match your actual location, you may face compliance issues during post-market surveillance. The Ministry of Health (Kemenkes) requires you to update this information through a process called Registration for Variation (Permohonan Perubahan).
About INSIGHTOF Consulting
INSIGHTOF is a professional consulting firm specializing in Indonesian RA (Regulatory Affairs). We have successfully managed over 1,000 product registrations. We assist not only with new registrations but also with license maintenance, including variations (perubahan) and renewals (perpanjangan).
1. Identify the Scenario: Who Moved?
The requirements for the variation application differ depending on which entity in the supply chain has changed its address.
- Scenario A: The Distributor/License Holder Moved.
First update your Medical Device Distributor License (IDAK/IPAK) via OSS. Only after IDAK is updated can you proceed with the product license update. - Scenario B: The Principal/Product Owner Moved.
If the brand owner moves, this is considered a variation and must be updated in the NIE. - Scenario C: The Manufacturer (Factory) Moved.
⚠️ Caution: If the manufacturing site changes, this may require a new registration because it affects the QMS (ISO 13485).
2. Prerequisites: Mandatory Reporting (E-Report)
Before submitting any variation, Kemenkes requires the following:
Mandatory Prerequisite: Complete your e-report reporting at
e-report.alkes.kemkes.go.id. If not updated, the system will block the application.
3. Required Documents for Address Change
Documents required for uploading to the REGALKES system:
| Document Name | Description |
|---|---|
| 1. Application Letter | Formal request letter stating the address change. |
| 2. Previous License | Scan of the valid Marketing Authorization (NIE). |
| 3. New Labeling Artwork | Packaging/label design showing the new address. |
| 4. Statement Letter | Statement confirming only the address changed (Materai required). |
| 5. Updated Legal Docs |
– If Distributor moved: Updated IDAK. – If Principal moved: Updated LoA or CFS. |
4. Timeline and Costs
- Evaluation Timeline: 45 Working Days.
- Government Fee (PNBP) – Class A: Rp 500,000.
- Government Fee (PNBP) – Class B, C, D: Rp 1,000,000.
Note: The validity period of the updated license remains the same as the original.
5. Why Choose INSIGHTOF?
- ✔ IDAK Assistance: We help update your distributor license on OSS.
- ✔ Label Compliance: We ensure your new label meets current Kemenkes standards.
- ✔ System Management: We manage E-Report verification and online submission.
6. Conclusion
Updating your office address in your medical device license is mandatory under the Variation (Perubahan) process. Make sure your IDAK is updated and your e-report is complete to avoid system blocks or audit issues.
Need to Update Your Medical Device License?
Contact INSIGHTOF Consulting for a quick and compliant variation process.
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