Services for Medical Device Distribution Permit (AKL)

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
   Indications
   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.