The Ministry of Health of the Republic of Indonesia has announced the temporary closing of the Online Medical Device Licensing System (Regalkes) and the Online Certification System (e-SUKA). This measure is carried out in accordance with Minister of Health Regulation No. 11 of 2025 concerning business and product/service standards within the health sub-sector.
To read the full notification letter: Ministry of Health Notification Letter No. FR.03.01/E.V/2159A/2025 [pdf]
Key Updates
A. Medical Device Distribution License (IDAK)
As stated in the Notification Letter:
- Submission for new, renewal, change notification, and renewal with variation applications will be temporarily closed from 15 December 2025 to 9 January 2026.
- Applications currently under evaluation will continue to be processed.
- Applications with “Additional Data” status will be put on hold until the system reopens.
B. Product Approval License (Marketing Authorization)
According to the Notification Letter:
- Submission for new, renewal, change notification, and renewal with variation applications will be temporarily closed from 15 December 2025 to 9 January 2026.
- Applications under evaluation will continue to proceed.
- Additional data submission and document review will be processed as is.
- For approvals expiring during the closure period, license holders must submit renewal applications no later than 12 December 2025.
- If not submitted by the deadline, the application must be re-applied as a new registration once the system reopens.
C. Online Certification (Surat Keterangan Online)
As outlined in the Notification Letter:
- Submission of certification applications will be temporarily closed from 22 December 2025 to 5 January 2026.
- Applications under evaluation will continue to be processed.
- Applications with a “Data Correction” status will remain on hold during the closure period.
Payment Requirements
The Notification Letter also stipulates that:
- All applications that have received a billing code or payment order must complete payment and submit proof of payment no later than 31 December 2025.
Implications to Clients
Based on the Notification Letter, the temporary closure may lead to minor delays in product approval and licensing processes. Clients intending to submit applications before the suspension period are strongly advised to finalize documentation promptly to avoid disruption.
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