Services for Medical Device Distribution Permit (AKL)

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).

Jasa Pengurusan Izin Edar Alat Kesehatan

Table of Content

What is a Medical Device Circulation Permit?

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

  1. Medical Device Production Certificate (for domestic medical devices)
  2. Medical Device Distributor License/IPAK (for domestic and foreign medical device distributors)
  3. Sole Agency Letter
    Certificate of Free Sale (overseas products)
  4. Quality Management (ISO 9001, ISO 13485, CE Certificate)
  5. Product exclusive summary
  6. Standard of conformity/Declaration of Conformity
    Brand Certificate
    Affidavit of original document


B. Form B – Product Information Requirements

  1. Tool description
  2. Description and features of the Medical Device
  3. Intended Use
    Directions for use
    Contra-indication (if any)
  4. Warnings (if any)
  5. Precautions (if any)
  6. Potential unwanted effects (if any)
  7. Alternative therapy (if any)
  8. Material
    Manufacturer information
  9. Production process


C. Form C – Specification and Quality Assurance Information

  1. Characteristics and specifications
  2. Additional information
  3. Summary of design verification and Validation documents
  4. Pre-clinical study (class D)
  5. Software validation testing results (if applicable)
  6. Research results of devices containing biological material
  7. Clinical Evidence (class D)
  8. Risk analysis of the device (Class D)
  9. Risk analysis results (Class D)
  10. Specifications and/or raw material requirements (Class C & D)
  11. Packaging specifications (diagnostic products)
  12. Data from analysis and or clinical trials.
  13. Device safety test results


D. Form D – Instructions for Use

  1. Marking Example
  2. Explanation of the markings on the device
  3. Instructions for use, training materials & installation and maintenance instructions
  4. Production Code and its meaning
  5. Accessories list


E. Form E – Post Market Evaluation

  1. Procedures used and recording systems, complaint handling, etc.

Interested in Using Our AKL Circulation Permit Management Services?

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.

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