AKL (Imported Medical Devices)
Medical Device Distribution License Services
Obtain your medical device distribution license quickly, easily, and in full compliance with Ministry of Health regulations.
Are you planning to officially distribute imported medical devices in Indonesia?
Ensure that your products have obtained an AKL Distribution License (Imported Medical Devices) issued by the Indonesian Ministry of Health (MoH).
Through PT Multi Jasa Berjaya’s AKL Distribution License Services, you are not merely assisted — we manage the entire process on your behalf.
From preparing and completing any missing regulatory documents, submitting all required files through the official e-registration system, to directly following up with the Indonesian Ministry of Health (MoH) both online and offline, we ensure your distribution license is issued efficiently and in full compliance with the latest regulations.
What is an AKL License?
The AKL Distribution License (Imported Medical Devices) is an official authorization issued by the Indonesian Ministry of Health which is mandatory for all imported medical device products before they can be marketed in Indonesia.
Without an AKL distribution license, a product is deemed non-compliant with Indonesian legal requirements and cannot be legally sold, and may even be subject to administrative sanctions or market withdrawal.
The AKL certificate serves as official proof that your imported medical device meets the quality, safety, and performance standards in accordance with regulations issued by the Indonesian Ministry of Health.
Companies officially appointed by foreign principals or manufacturers
Distributors or importers of foreign-manufactured medical devices
Companies involved in the assembly, relabeling, or rebranding of medical devices
Legal Basis & Required Documents for AKD License
The registration process for domestic medical devices is governed by Ministry of Health regulations. Below are the legal references and required documents:
Legal References:
Regulation of the Minister of Health of the Republic of Indonesia Number 14 of 2021
OSS–RBA regulations related to medical device distribution
Key Requirements, There are 4 main aspects to ensure a complete submission:
- The company holds a valid IDAK and has implemented CDAKB (Good Distribution Practices for Medical Devices)
- A formal internal agreement between the manufacturer and the distributor
- The company is appointed as the sole distributor
- The company does not engage in cooperation with countries subject to conflict or international sanctions
AKL License Application Procedure
Consultation & Document Review
We conduct an initial review to ensure that all regulatory requirements are fully met. If any documents are incomplete or missing, our team will assist in preparing the required documentation.Online Submission through the Ministry of Health e-Registration System
All required documents are uploaded and submitted in accordance with the official procedures of the Indonesian Ministry of Health.Technical Evaluation Follow-Up
We closely monitor the progress of your application and conduct direct follow-ups with the Indonesian Ministry of Health, both online and offline.Issuance of the AKL Certificate
Once the application is deemed complete and compliant, the AKL certificate is issued in both digital and physical formats.
Why Choose Us?
Experienced and Trusted Partner
More than just consultants, we are your legal compliance partner — helping dozens of companies successfully obtain their AKD licenses.Experts Who Understand the Regulations
Our team has in-depth knowledge of the OSS-RBA system, Ministry of Health’s e-registration platform, and medical device risk classifications.Efficient & Transparent Process
We handle every stage professionally, ensuring clear communication and transparent progress updates throughout the process.Integrated Licensing Services
In addition to AKD licensing, we also handle CDAKB, CPAKB, IPAK/IDAK, and other essential permits for medical device companies.
Related Articles:
- Understanding the Difference Between Medical Devices and PKRT in the Healthcare Industry
- Legalitas Dulu, Baru Melaju: Kunci Sukses Bisnis Alkes di Indonesia
- Persyaratan Krusial untuk Mendapatkan Izin Edar AKL dalam Waktu Singkat
- Cara Mendapatkan Izin Edar Alat Kesehatan di Indonesia (AKL)
- Preparation Steps Before Applying for an IDAK License: A Practical Guide for Medical Device Distributors
FAQ – Frequently Asked Questions
- Is ISO 13485 mandatory for AKL application?
Yes, ISO 13485 certification from the foreign manufacturer is a core requirement to ensure that the products meet international manufacturing standards. - Do I need an appointment letter from the overseas principal?
Yes, an official appointment letter is required to confirm that you are authorized as a distributor in Indonesia by the foreign principal. - Can you support us from start to certificate issuance?
Absolutely. We provide full-service assistance — from initial consultation to final certificate issuance. - Is an initial consultation available free of charge?
Yes. We provide a free initial consultation to ensure that all required documents are properly prepared and compliant before submission to the Indonesian Ministry of Health system.
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Trust your licensing needs to our experienced professional team. Contact us now for a FREE consultation — whether it's for medical device distribution permits, PKRT, or other official business licenses.
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