Integration Announcement
On February 9, 2022, the Indonesian Ministry of Health officially announced the integration of REGALKES with the OSS RBA (Online Single Submission Risk-Based Approach). This integration currently involves new medical device application commercialization licenses. Business agents wishing to apply for new local or imported medical device registrations must apply through OSS RBA (login using an OSS RBA account) and will be directed to REGALKES to meet requirements. For renewals, changes, and renewal with change applications, these will still be fully accessed through REGALKES (login using a REGALKES account).
Upcoming Developments
In conjunction with this, during a recent socialization conducted by MS, it was announced that another of their licensing systems, E-SUKA, is currently in development for integration with the OSS RBA. However, a date for implementation has not yet been announced.
Additional Information
New link: Download News Article - http://esuka.binfar.kemkes.go.id/download/lib/NEWS-20220206111145-41665.pdf
Type Approval Details
Type Approval impacted: Medical
Approval Process impact: Yes
Importation process impact: N.A
Type of product impacted: Submission OSS
Country: Indonesia
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |