Indonesia: Temporary Closure of Medical Devices Licensing System, PKRT, and Online Certificates

ARQon
Dec 19, 2023
2 min read

Updated: Dec 26, 2023

Due to the scheduled maintenance system, the Ministry of Health (MOH) announced the temporary closure of the medical device licensing system, PKRT system, and online certification system. The closure is expected to affect 3 systems, Application for Medical Devices Distribution Permit (IDAK), Application for Medical Devices Marketing Authorization, and Online PKRT, and Application of Online Certification.

Manufacturers, responsible persons, or any party engaged in the documentation process should take note of the important dates outlined below.

A. Application for Medical Devices Distribution Permit (IDAK)

(** Company license to distribute medical devices)

All matters concerning the submission of the new application registration documents, extensions, amendments, or extensions with amendments will be under temporary closure starting from 18 December 2023 – 5 January 2024.
IDAK applications under the evaluation process will continue to be processed.
IDAK applications under the status of Registrant – Additional Data, will not be processed during the closure and the estimated time will be frozen.
IDAK applications with approved billing codes/payment orders (SPB) must submit the payment proof before 29 December 2023.

B. Application for Medical Devices Marketing Authorization and Online PKRT

(** Product license to import and sell to the market)

All matters concerning submitting the new registration application for marketing authorization, extensions, amendments, or extensions with amendments will be temporarily closed from 18 December 2023 – 5 January 2024.
Applications under the evaluation process, documents with additional data, and NIE document reviews will continue to be processed.
All applications with approved billing codes/payment orders (SPB) for 2023 are required to submit the payment proof before 29 December 2023.
Applications for distribution permits that have entered the evaluation process will continue to be processed as appropriate.
If there are additional data documents and review of NIE documents, they can still be processed as appropriate.
Any marketing authorization that will expire during the temporary closure period is required to request extensions before 15 December 2023, or a new application should be submitted after the expiry.

C. Application for Online Certificates

Submission of online certificate applications will be temporarily closed from 20 December 2023 – 29 December 2023.
All applications that are undergoing the evaluation process will continue to be processed.
Application with the status Registrant – Additional Data will be closed temporarily and the estimation time will be frozen.
All application submissions in 2023 with approved billing codes/payment orders (SPB), are required to settle the payment, check the payment status, and submit the payment proof before 29 December 2023.