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The Ministry of Health of Indonesia has temporarily closed the Medical Device Licensing and Online Certification Systems for scheduled maintenance and end-of-year financial processes. These temporary suspensions will affect the following systems:
Medical Device Licensing and PKRT Registration System
Online Certification System (e-SUKA)
The suspension will occur from 16 December 2024 to 3 January 2025.
A. Submission of Medical Devices Distribution Licenses (IDAK)
New Applications and Renewals
All new applications, renewals, changes, or renewals with changes for IDAK will not be accepted during the temporary closure
Ongoing Evaluations
Applications already under evaluation will continue to be processed as usual
Pending Additional Data
Applications requiring additional data will not be processed during this period. Applicants may submit the data required once the systems reopen
Payment Submissions
If you have received a billing code of payment order (SPB), ensure payment is completed and the proof of payment is submitted by 31 December 2024
B. Submission of Medical Devices and PKRT Distribution Permits
New Applications and Renewals
The system will not accept new applications, renewals, changes, or renewals with changes during the suspension period
Payment Submission Deadline
Payments for applications submitted in 2024 must be completed, and proof of payment must be submitted by 31 December 2024
Ongoing Evaluations
Applications currently under evaluation will proceed as normal
Document Review
Reviews for additional data and updates to distribution permits (NIE) will continue to be processed as usual
Extension Requirements
Permit holders must apply for renewal at least nine (9) months before the expiration date, as per Regulation No. 62 of 2017, Article 26
Permits expiring during the system closure should be renewed by 13 December 2024
C. Submission of Online Certification Requests
Temporary Suspensions
Certification requests will be temporarily suspended from 23 December to 31 December 2024
Ongoing Evaluations
Applications under evaluation will continue to be processed
Pending Corrections
Applications requiring data corrections will not be processed during the closure period
Payment Submission Deadline
Payments for applications submitted in 2024 must be completed, and proof of payment must be submitted by 31 December 2024
The Ministry of Health encourages all stakeholders to plan submissions and payments accordingly to avoid delays. While the system is undergoing maintenance and financial closure, existing applications already under evaluation will be processed without interruption.
For further inquiries, contact the respective system administrators or refer to the official guidelines on the Ministry of Health’s website.
Source: Kementerian Kesehatan (Kemenkes)
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