Earlier this year, Indonesia MoH has implemented a notification scheme for certain class A medical devices in its REGALKES system. The class A medical devices that are allowed in this notification scheme must be home use, non-sterile, and non-IVDs, making up 34 class medical devices fit for this scheme. For more details on the 34 class medical devices and document requirements, please refer here.

Aside from the simplification of the documents required, the notification scheme also offers a much faster evaluation timeline compared to the regular class A registration as seen in the following table.


Regular Class A MD

Notification Class A MD


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

29 WD

12 WD

The evaluation process for renewal, change and change with renewal is also 6 working days. If there are additional comments from MoH during the notification scheme, the registrant is allowed to comply once within 10 days. There is also no difference in terms of fees for the notification scheme and regular class A registration.



Circular Permit Requirement for Class A Medical Device Notification