The Ministry of Health in Indonesia has announced a temporary closure of its medical devices licensing system and online certification platform for maintenance purposes, as outlined in Announcement No. FR.03.01/E.V/2653/2024, dated December 11, 2024.
System Closure Details
Medical Device Licensing System
The medical device online registration system (REGALKES) available at https://regalkes.kemkes.go.id will be temporarily closed during the following period:
- December 16, 2024 to January 3, 2025
During this time, the system will not process the following applications:
- New submissions
- Renewals
- Change notifications or amendments
- Renewals with variations
Important Instructions:
- For applications submitted before the system closure:
- If a billing code has been issued and/or payment has been made, applicants must submit proof of payment no later than December 31, 2024.
- Applications under evaluation will continue to be processed as usual. Registrants may proceed to provide any additional documents required during the compliance stage.
- For licenses expiring during the temporary closure:
- Renewal applications must be submitted no later than December 13, 2024.
Online Certification System
The online certification system (ESUKA) available at https://esuka.kemkes.go.id will also be temporarily closed during the following period:
- December 23 to December 31, 2024
This system is primarily used to issue the following certificates:
- Certificates of Free Sale (CFS)
- Spare part certificates
- Product information certificates
- Sample import certificates for product registration
- Other related certificates
For further details, you can access the official announcement here (document in Indonesian; no English translation available).
For any inquiries or assistance, please contact us at sales@andamanmed.com or click the button below.
For any inquiries or assistance, please contact us at sales@andamanmed.com or click the button below.