Regalkes Portal — Overview
What Is Regalkes?
Regalkes is the online portal operated by the Indonesian Ministry of Health (Kemenkes) for the registration and management of medical devices, IVDs, and household health products. All NIE applications, renewal requests, change notifications, and adverse event reports for medical devices are submitted through Regalkes.
- URL:
regalkes.kemkes.go.id - Operated by: Directorate General of Pharmaceutical and Medical Devices, Kemenkes
- Access: Indonesian language interface; accounts registered under the LAR/IDAK holder's credentials
What Regalkes Handles
| Function | Description |
|---|---|
| New NIE applications | Full registration dossier upload and submission |
| Administrative review | Kemenkes completeness check |
| PNBP fee payment | Billing notice generation and payment confirmation |
| Technical review | Evaluator queue, clarification issuance and response |
| NIE renewal | Renewal applications with updated documentation |
| Change notifications (Perubahan) | Minor and major change submissions |
| Adverse event reporting | Post-market safety reporting to Kemenkes |
| Application status tracking | Real-time visibility into where your application sits |
Regalkes-Specific Constraints
Indonesian-Language Templates
The Regalkes portal enforces Indonesian-language form templates and has strict requirements for:
- File naming conventions (non-compliant file names can cause upload failures)
- Document format (PDF preferred; specific size limits per document type)
- Form structure (fields must be completed in the system's format, not just via document upload)
Manufacturers accustomed to EU MDR or FDA submission formats will need to restructure their technical files to fit Regalkes requirements. This is a significant practical challenge that is frequently requirements and use the ASEAN Common Submission Dossier Template (CSDT) as the baseline. File naming conventions must strictly match Regalkes specifications, and all text-based documents must comply with Indonesian-language underestimated and should be budgeted for in timelines.
Maintenance Shutdowns
Regalkes undergoes periodic scheduled maintenance. For example, the portal had a planned closure in December 2024. These shutdowns halt all new submissions. Plan your submission timing with adequate buffer, particularly around year-end periods.
Clarification Queue
After technical review begins, queries from Kemenkes evaluators arrive through the Regalkes system. The response window is time-limited — late or incomplete responses delay your approval clock.
Relationship to OSS
The Regalkes account and submissions are linked to the LAR's OSS (Online Single Submission) identity and NIB. The IDAK status is verified via OSS connectivity — if the IDAK status changes in OSS, it is reflected in Regalkes.
"The LAR must have an active IDAK (medical device distribution licence) and CDAKB (Good Distribution Practice certificate) before registering in Regalkes. These licences are verified in real-time through OSS connectivity. If either licence expires or is suspended, the Regalkes account will be frozen and no new applications or renewals can be submitted."