Regalkes Account Setup
Who Creates the Account?
The Regalkes account is created and owned by the Indonesian LAR/IDAK holder. Foreign manufacturers do not have direct accounts — all portal interactions occur under the LAR's credentials.
The account is linked to the LAR's:
- IDAK licence number
- NIB (Nomor Induk Berusaha) from OSS
- CDAKB certificate status
Account Prerequisites
Before a Regalkes account can be created and used for NIE submissions, the IDAK holder must have:
| Prerequisite | Source |
|---|---|
| Valid IDAK | OSS system |
| Valid CDAKB | Kemenkes inspection and certification |
| NIB | OSS registration |
| Active OSS account | oss.go.id |
Manufacturer Visibility
Foreign manufacturers typically do not have direct access to the Regalkes portal. You are dependent on your LAR for:
- Application status updates
- Clarification query content and responses
- Fee payment coordination
- Document upload confirmation
Best practice
Establish clear communication protocols with your LAR from the outset:
- Agree on turnaround times for your review of Regalkes-generated clarification queries
- Request screenshots or exports of the application status at regular intervals
- Agree on a document naming convention that your LAR implements consistently in Regalkes uploads
Common Account Issues
| Issue | Cause | Resolution |
|---|---|---|
| Account access denied | IDAK expired or suspended | Renew IDAK via OSS |
| Cannot submit new applications | CDAKB not in place | Obtain CDAKB before submission |
| Upload failures | Non-compliant file names or formats | Rename files per Regalkes convention; convert to PDF |
| Portal unavailable | Scheduled maintenance | Check Kemenkes announcements; wait for maintenance window to end |