Indonesia Medical Device Online Registrations to Close Temporarily
The medical device online registration system in Indonesia, Kemkes, will be shut down temporarily, as of 20 December 2021 to 14 January 2022 for maintenance purposes. This was announced on 1 December 2021 by the Ministry of Health in letter No. UM.01.05/5/2046/2021.
This means that the online registration system (http://regalkes.kemkes.go.id) will be closed for the following applications:
- new submission,
- change notification or an amendment,
- renewal with an amendment.
For medical device applications already in process
For licensing documents that have already been submitted in 2021 that have received a billing code and/or have made a payment, applicants must send proof of payment no later than 23 December 2021.
For registration applications that have already entered the evaluation process then this will be continued accordingly. The registrant may still proceed to complete any additional documents needed during the compliance stage or during the review of license approval, using the same registration system.
Any medical device license that expires at the time of the temporary system closure, may apply for renewal once maintenance of the system has been completed (14 January 2022) and until 31 January 2022 (the latest date possible for renewal after which a new registration must be made).
Online certification system temporary closure
Additionally, the Ministry of Health will also temporarily close the online certification system at http://esuka.binfar.kemkes.go.id/ as of from 27 December 2021 to 7 January 2022. This online system is mainly used to issue Certificates of Free Sale (CFS), spare part certificates, product information certificates, sample import certificates for product registration and other certificates or statement letters used in the registration of medical devices and household supplies. For requests that are already submitted and in process of payment, please send proof of payment immediately or no later than 28 December 2021.
It is highly recommended to start submitting new registration applications or renewals of a medical device license before 20 December 2021.
If you require a certificate from the online certification system at http://esuka.binfar.kemkes.go.id/, it is better to submit requests before 25 December 2021.
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