Indonesia: Temporary Closing of the Online System for Submission of Medical Devices and Household Supplies Registration, Online Certificates, and Distribution License by the Ministry of Health of Indonesia

On 5 December 2023, the Ministry of Health (MoH) of Indonesia released an announcement letter No: FR.03.01/E.V/2510/2023 regarding the maintenance process of the MoH platform for online licensing system of medical devices and household supplies registration, issuance of online certificates, and issuance of medical devices distribution license (IDAK).

Therefore, the following changes will be applied:
A. Online Submission of Medical Devices Distribution License (IDAK)

1. Online submission will be temporarily closed starting 18 December 2023 until 05 January 2024.
2. IDAK application that has undergone evaluation process will be processed as it is.
3. IDAK application with status “Registrants – On Process of Completing Compliances” will not be processed during the closing period, and the estimated processed time will be freezed.
4. Proof of payment shall be sent no later than 29 December 2023 for IDAK application that has received a payment order and has already completed the payment.

B. Online Submission of Medical Devices and Household Supplies Registration

1. Application for product registration, renewal, change notification, and renewal with change notification will be temporarily closed between 18 December 2023 – 5 January 2024.
2. Proof of payment shall be sent no later than 29 December 2023 for all application submitted in 2023 that has received a payment order and has completed the payment.
3. Application that is already in the evaluation process will be processed as it is.
4. Process of additional data fulfilment and review process of license draft will be continued accordingly.
5. Medical Device registration license that expires during the temporary closing shall register for a renewal maximum on 15 December 2023. Otherwise, will be considered as expired and should register the product as a new registration.

C. Submission of Other Online Certificates

1. Application will be temporarily closed between 20-29 December 2023.
2. Application that has undergone evaluation process will be processed as it is.
3. Application with status “Registrants – On Process of Completing Compliances” will not be processed during the closing period, and the estimated processed time will be frozen.
4. Proof of payment shall be sent no later than 29 December 2023 for all application submitted in 2023 that has received a payment order and has completed the payment.

The announcement letter can be accessed here (in Bahasa Indonesian).

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