On 21 November 2022, the Ministry of Health (MoH) of Indonesia announced that a new development and improvement plan will be applied to the 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:
- Online Submission of Medical Devices Distribution License (IDAK)
- Online submission will be temporarily closed between 19 – 30 December 2022.
- IDAK application that has undergone evaluation process will be processed as it is.
- IDAK application that has received a payment order, and has already completed the payment, shall send the proof of payment no later than 23 December 2022.
- IDAK application whose status is “Registrants – On Process of Completing Compliances” and has not yet received a payment order, will have its status changed to Expired.
- Online Submission of Medical Devices and Household Supplies Registration
- Application for product registration, renewal, change notification, and renewal with change notification will be temporarily closed between 19 – 30 December 2022.
- All application submitted in 2022 that has received a payment order and has completed the payment, shall send the proof of payment no later than 23 December 2022.
- Application that has undergone evaluation process will be processed as it is.
- In cases where additional data is needed or document review process is still on-going, applicants may still proceed until 30 December 2022.
- Medical Device registration license that expires during the temporary closing, will be given an extended time to process the renewal until 31 January 2023.
- Submission of Other Online Certificates
- Application will be temporarily closed between 26 – 30 December 2022.
- Application that has undergone evaluation process will be processed as it is.
- All application submitted in 2022 that has received a payment order shall proceed to complete the payment and send the proof of payment no later than 28 December 2022.
- Downtime of Regalkes and Esuka System
The following website will be temporarily inactive starting 01 – 13 January 2023, for the purpose of development and improvement of the licensing service:
All stakeholders are advised to be aware of this new timeline. If you have any queries regarding the announcement, please get in touch or click the button below.