It is informed that on February 7, 2022 the Registration System for Licensing Medical Devices and Household Health Supplies will be temporarily closed in order to conduct a Trial of the Integration of the Licensing System for Medical Devices and (Regalkes) with OSS – RBA Until February 8, 2022. Read more at below:

Announcement

NUMBER: UM.01.05/5/0101/2022
ABOUT: Temporary Closing of the Medical Devices and Supplies Licensing Registration System
Household Health

In connection with the Trial of Integration of the Medical Device Licensing System and HouseHold (Regalkes) with OSS – RBA, we hereby inform that:

1. Submission of distribution permit registration documents for new applications, extensions, amendments and extensions with changes to be closed temporarily starting February 7, 2022 s.d. February 8, 2022.
2. Applications for marketing permits that have entered the evaluation process will still be processed as they should.
3. In the event that there are additional data documents and a review of NIE documents, the registrant can still do it properly.

Thus this notification is conveyed, please all parties can understand the existence of this notification. Thank You