New Reporting Scheme Implementation
Earlier this year, the Indonesian Ministry of Health implemented a reporting scheme for certain Class A medical devices in its REGALKES system. Class A medical devices that are permitted under this reporting scheme must be home-use, non-sterile, and non-IVDs, making 34 class medical devices eligible for this scheme. For more details on the 34 class medical devices and document requirements, see here - http://regalkes.kemkes.go.id/index.php/home/fileDownload/BERITA_FILE.pdf/1000863.
Evaluation Process
Aside from the simplification of required documents, the notification scheme also offers a much faster assessment schedule compared to regular Class A registration, as shown in the following table:
| Process | Regular Class A MD | Notification Class A MD |
|---|---|---|
| Evaluation | 15 Working Days (WD) | 6 Working Days (WD) |
| Product Permit Preview | 4 Working Days (WD) | 4 Working Days (WD) |
| E-sign Approval | 10 Working Days (WD) | 2 Working Days (WD) |
| Maximum Total Days | 29WD | 12WD |
The evaluation process for renewal, change, and change with renewal is also 6 business days. If there are additional comments from the MoH during the notification scheme, the registrant can comply once within 10 days. There is no difference in terms of fees for the notification scheme and regular Class A registration.
Additional Information
Based on the Regulator webpage:
Type Approval impacted: MEDICAL
Date published: 04/27/22