The Circulation Permit for Medical Devices is better known as the AKL Circulation Permit (Overseas/Imported Medical Devices) and the AKD Circulation Permit (Domestic Medical Devices).
Circulation Permit is a permit for Medical Devices produced by Manufacturers, and/or imported by PAK or importers to be circulated in the territory of the Republic of Indonesia. How to apply for a medical device distribution permit is by completing 5 forms of administrative requirements and technical requirements from the Ministry of Health.
A. Form A – Administrative Data Requirements
B. Form B – Product Information Requirements
C. Form C – Specification and Quality Assurance Information
D. Form D – Instructions for Use
E. Form E – Post Market Evaluation
If you have any questions and inquiries regarding our medical device distribution license process, please feel free to ask us and our staff will be happy to assist and provide solutions for your needs.