Creates a New Registration Path for Low Risk Medical Devices

On January 10, 2022, Indonesia’s Ministry of Health released Indonesia Class A Notification Announcement 01.05500242022 establishing a new registration route for some low risk medical devices effective immediately. These product categories are exempt from the AKL licensing process and requires license holders apply for Notifications through the online registration system found here. Approval time is expected to be between 6 and 14 working days and will need to be renewed every 2-5 years. From Asia Actual’s experience, Class A medical device AKL applications are reviewed in under 15 working days and sometimes as quickly as 8 days. To learn more about the registration process in Indonesia, please click here.

Documents Required for Notification

At this time, only a select number of low risk medical devices are eligible for the new Notification process. The new process reduces the number of documents required as part of the application but does require 1 document be translated and 1 document legalized.

Documents required:

1. Letter of Authorization
2. Free Sale Certificate or equivalent
3. ISO 13485, CE cert.
4. Declaration of Conformity
5. Raw materials used
6. Final product specification / brochure
7. Labeling
8. Instructions For Use
9. List of accessories / variant sizes / variant volumes

Registration Timelines

Compared to other markets in the region, Indonesia has an efficient registration process with all classifications of products being reviewed in under 60 days. Asia Actual has been tracking our clients’ experience and have included our experienced ranges below as well as the official response time. Official review times do not include additional time needed should the MOH have questions. Low risk medical devices are typically approved within 2-3 weeks while Class C and D can require up to 7-8 weeks with questions.