On 9th February 2022, Indonesia’s MoH has officially announced the integration of REGALKES with OSS RBA (Online Single Submission Risk-Based Approach). The current integration only involves new application marketing permit of medical devices, in which business actors who wish to apply for new registrations of local or imported medical devices must apply through OSS RBA (login using an OSS RBA account) and will be directed to REGALKES for requirement fulfillment. While for renewal, change and renewal with change applications, they are still fully accessed through REGALKES (login using a REGALKES account).

In conjunction to this, during a socialization conducted by the MoH, they announced that another of its licensing system, E-SUKA, is currently under development to integrate with the OSS RBA. However, a fix date on the implementation has not been announced yet.

The Business Process for New Applications of Marketing Permit (OSS RBA-REGALKES)

Announcement on Integration of Medical Devices Licensing System (REGALKES) with OSS RBA