The Trial of Integration of the Medical Device Licensing System and HouseHold (Regalkes) has been carried out by the Directorate of Medical Device Assessment. And the results of the trial there are no obstacles in making a permit ID for new applications for imported Medical Devices and HouseHold, and making a permit ID for new applications for permits for domestic Medical Devices and HouseHold. There are a few more things you should know. For further information is below:

Announcement

NUMBER: FR.03.01/5/0106/2022
ABOUT: Integration of the Medical Devices and HouseHold (Regalkes) Licensing System with OSS RBA Electronically Integrated Business Licensing System

In the context of accelerating the Implementation of the Evaluation of Risk-Based Business Licensing Regulations, the Directorate for Assessment of Medical Devices and PKRT has carried out a Trial of Integration of the Medical Devices and HouseHold Licensing System (Regalkes) with OSS RBA – Electronically Integrated Business Licensing System. The results of the trial show that there are no problems in making a permit ID for new applications for imported Medical Devices and HouseHold, and in making a permit ID for new applications for permits for domestic Medical Devices and HouseHold. In relation to this integration, we can say:

1. Integration of the Medical Devices and HouseHold (Regalkes) Licensing System with OSS RBA – Electronically Integrated Business Licensing System will be carried out on Wednesday 9 February 2022.

2. Submission of a new application for a distribution permit for Medical Devices and HouseHoldis carried out through the OSS RBA application (using the OSS RBA user ID and password via the link: http://oss.go.id). The application for extension, change, and extension with changes is made through the Regalkes application (using the regalkes user ID and password, via the link: http://regalkes.kemkes.go.id/).

3. In the context of submitting a new application for a distribution permit for Imported Medical Devices, business actors must change KBLI 46693 to KBLI 46691 in order to apply for PB-UMKU for a circulation permit for imported Medical Devices through OSS RBA.
4. In the context of submitting a new application for a distribution permit for Domestic Medical Devices and HouseHold, business actors must ensure that the KBLI for each industry whose distribution permit will be registered is listed in the RBA OSS system.

5. Socialization of Medical Devices and HouseHold Circular Licensing Registration through OSS RBA was conducted online on Wednesday, February 9, 2022 at 09.00 WIB through the zoom meeting application (meeting ID: 827 8496 6274, password: KEMENKES) and via live streaming Youtube channel Farmalkes TV .

Thus we convey, thank you for your attention.