Medical Device Distributor License in Indonesia (IDAK)
Overview
To properly market and sell medical devices in Indonesia, businesses must obtain a valid Medical Device Distributor License (Izin Distribusi Alat Kesehatan or IDAK). Business Hub Asia helps medical companies, suppliers, and manufacturers streamline this process from regulatory document preparation to official approval, ensuring compliance with the Ministry of Health regulations and allowing legal commercial distribution.
Key Features
IDAK (Medical Device Distributor License) Application
End-to-end management of the IDAK application through the Ministry of Health's system.
Document & Facility Compliance Review
Ensure that the business address, storage facilities, and documents meet regulatory standards.
Regulatory Consultation for Classification
Assistance in understanding risk-based classifications and applicable medical product categories.
Local Representation (if needed)
For foreign companies, we help appoint a local legal entity to act as a distributor or a license holder.
Minimum Requirements
Legal Entity Documents
Deed of Establishment & SK Kemenkumham
Business Registration
NPWP & NIB with correct KBLI (46691 or equivalent)
Office Location
Business domicile in a commercial zone
Facility
Adequate storage facility with documented SOPs
Personnel
Appointed pharmacist or qualified technical personnel
Operational Permit
Valid operational license
Product Information
Product classification & catalog (if available)
Process and Timeline
1
Pre-Assessment & Document Review
Review KBLI, facility requirements, legal entity documents, and prepare ASPAK (MOH’s online platform) registration. Estimated Time: 2-3 working days.
2
Application Submission to the Ministry of Health
Submit via ASPAK with supporting documents including SOPs, technical personnel data, and warehouse details. Estimated Time: 1-2 working days.
3
On-Site Facility Verification (if required)
MoH may schedule an inspection to validate the compliance of the office and storage facilities. Estimated Time: 5-10 working days.
4
Final Approval & IDAK Issuance
Upon approval, the medical distribution license is digitally issued and uploaded to the OSS system. Estimated Time: 1-2 working days.
*The total estimated time needed to obtain a medical distribution permit is approximately 2-4 weeks.
Important Consideration
- IDAK license is mandatory for companies involved in the marketing and sales of medical devices in Indonesia.
- The company must employ a licensed pharmacist or technical manager listed during registration.
- Virtual office addresses are not allowed to simultaneously act as a business domicile for this license.
- A storage facility must meet temperature, cleanliness, and monitoring requirements.
- Additional permits may be required depending on the risk class of the medical devices.
Frequently Asked Questions
Is IDAK required for both local and foreign companies?
Yes. Any company involved in the commercial distribution of medical devices in Indonesia must hold a medical distribution permit (IDAK).
Can foreign companies apply for the IDAK license directly?
No. Foreign entities must appoint an Indonesian-registered company as the distributor or establish a PT PMA for this purpose.
What kind of facility is required for the license?
A proper warehouse or storage room with SOPs for temperature control, sanitation, and inventory must be available.
Do I need a pharmacist to apply for the license?
Yes. A certified pharmacist or technical personnel with a relevant background must be registered in the application.
How long is the IDAK license valid?
Generally valid for 5 years, and must be updated or renewed if there are changes in address or management.
Secure the Right Licenses for Your Operations
Ensure compliance with Indonesian regulations by obtaining the necessary business permits and sector-specific licenses.