REGULATORY UPDATE | ANNOUNCEMENT
Integration of the Medical Devices and PKRT (Regalkes) Licensing System with OSS RBA

The Directorate of Medical Device Assessment has conducted a trial of the integration between the Medical Device Licensing System and the Household Licensing System (Regalkes) with the OSS RBA – Electronically Integrated Business Licensing System. The results indicate that there are no obstacles in generating permit IDs for new applications for both imported and domestic Medical Devices and Household products. Below are key details regarding this integration:

Announcement Number: FR.03.01/5/0106/2022
Subject: Integration of the Medical Devices and Household (Regalkes) Licensing System with OSS RBA

In the context of accelerating the implementation of Risk-Based Business Licensing Regulations, the integration will take effect on Wednesday, February 9, 2022. Key points to note include:

1. The integration of the Medical Devices and Household Licensing System with OSS RBA will commence on Wednesday, February 9, 2022.
2. New applications for distribution permits for Medical Devices and Household products must be submitted through the OSS RBA application using the OSS RBA user ID and password via the following link: http://oss.go.id. Applications for extensions, changes, or extensions with changes should be submitted through the Regalkes application using the Regalkes user ID and password at http://regalkes.kemkes.go.id.
3. For submitting new applications for distribution permits for imported Medical Devices, business actors must change the KBLI code from 46693 to 46691 to apply for PB-UMKU for a circulation permit through OSS RBA.
4. When applying for a distribution permit for domestic Medical Devices and Household products, business actors must ensure that the KBLI for each industry associated with the distribution permit is listed in the OSS RBA system.
5. A socialization session on Medical Devices and Household Circular Licensing Registration through OSS RBA will be held online on Wednesday, February 9, 2022, at 09:00 WIB via Zoom (Meeting ID: 827 8496 6274, Password: KEMENKES) and will also be live-streamed on the Farmalkes TV YouTube channel.