Medical Device Distribution License For Domestic (AKD) Services
Obtain your medical device distribution license quickly, easily, and in full compliance with Ministry of Health regulations.
Are You Manufacturing or Distributing Domestic Medical Devices and Looking to Market Them Legally in Indonesia?
Ensure your products are fully compliant by obtaining the AKD License (Domestic Distribution License) issued by the Ministry of Health of the Republic of Indonesia (Kemenkes RI).
Through the AKD licensing service from PT Multi Jasa Berjaya, your product registration process will be handled faster more efficiently, and in full compliance with the latest regulations. At PT Multi Jasa Berjaya, our service goes beyond mere consultation we take full responsibility for the entire process on behalf of our clients from document preparation and system submission to direct follow-up with the Ministry of Health, ensuring you receive your final license seamlessly and on time.
What is AKD (Domestic Distribution License for Medical Devices)?
The AKD License (Izin Edar Alat Kesehatan Dalam Negeri) is an official authorization issued by Indonesia’s Ministry of Health for every manufacturer, distributor, or importer of medical devices to legally market their products within the country.
Without this license, products cannot be sold or used commercially and may be subject to administrative sanctions.
Who Must Obtain an AKD License?
Domestic manufacturers or producers of medical devices
Authorized distributors of locally 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 five main aspects to ensure a complete submission:
- Valid CPAKB (Good Manufacturing Practice Certificate)
- Valid IDAK and implementation of CDAKB (Good Distribution Practice) if distributed
- Trademark Certificate
- Product test results from an accredited laboratory
- Certificate of Analysis (COA) for both raw materials and finished products
AKD License Application Procedure
- Step 1 – Preparation
Initial consultation to review all administrative and technical documents. If anything is missing or incomplete, our team will assist in compiling the necessary supporting documents. - Step 2 – Online Submission
Documents are submitted through the Ministry of Health’s online licensing system. Initial verification is conducted before technical review. - Step 3 – Evaluation & Certificate Issuance
Once the documents pass verification, the product will undergo technical evaluation. If approved, the AKD certificate will be issued digitally and physically.
Why Choose Us?
Experienced and Trusted Partner
Lebih dari sekadar konsultan, kami mitra legalitas bisnis alat kesehatan yang telah membantu ratusan lebih perusahaan mendapatkan izin edar dengan sukses.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
- The Development of the Domestic Medical Device Industry: Challenges and Opportunities
- Legalitas Dulu, Baru Melaju: Kunci Sukses Bisnis Alkes di Indonesia
- Achieving Self-Reliance in the Medical Device Industry: A Guide to Managing AKD Licensing
- Preparation Steps Before Applying for an IDAK License: A Practical Guide for Medical Device Distributors
FAQ – Frequently Asked Questions
- Can you help from start to finish?
Yes, we provide full-service AKD licensing – including document review, application submission, and follow-up until the certificate is issued. - Is CPAKB mandatory for AKD?
Yes. Under the new Ministry of Health regulations, a valid CPAKB certificate is mandatory to prove that the medical device is manufactured according to Indonesian quality standards. - Can you help with both CPAKB and AKD?
Yes. We offer integrated support for obtaining both CPAKB and AKD to ensure efficient and compliant licensing. - Can a local business directly apply for AKD?
Yes, provided the business has a production license and CPAKB. We assist in verifying and completing all necessary documents. - Do you provide consultation services?
Absolutely. We offer free consultations to review your documents before submission to help ensure a successful application.
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