Starting from 10th Jan 2022, Indonesia MoH has officially implemented a notification scheme for certain class A medical devices in its REGALKES system (a system for registering medical devices products in Indonesia). Previously, MoH has socialized this scheme and has explained that only certain class A medical devices that are home-use, non-sterile, and non-IVD are eligible for this scheme. For details on the 34 class A medical devices and the requirements, please refer here.

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Notification Menu on REGALKES: The Indonesia MoH has added a new menu for notification scheme in its REGALKES system


Announcement on Enforcement of Notification Scheme for Distribution License of Medical Devices and PKRT