Announcement from the Indonesian Ministry of Health
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). The current integration involves new medical device application commercialization licenses, where 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. Renewal applications, change applications, and renewals with changes are still fully accessed through REGALKES (login using a REGALKES account).
Additional Development
In conjunction with this, during socialization conducted by MS, it was announced that their other licensing system, E-SUKA, is currently in development for integration with OSS RBA. However, a date for implementation has not yet been announced.
Important Details
Type Approval impacted: Medical
Approval Process impact: yes
Importation process impact: N.A
Type of product impacted: Submission OSS
Further Information
New link: http://esuka.binfar.kemkes.go.id/download/lib/NEWS-20220206111145-41665.pdf
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |