Medical Device Certifications
IDAK Medical Device Distributor License New Registration
The Medical Device Distributor License (IDAK) is a certification that suppliers must obtain. It is reviewed and issued by the Indonesian Minister of Health to certify that the supplier is qualified and uses appropriate methods to distribute medical devices, ensuring the quality of their products and the safety of the entire distribution chain.
Recommendation for Medical Device Technical Responsible Person and/or Mechanical Engineer (PJT/Technician)
The Technical Responsible Person (PJT) is the individual in charge of technical matters related to product distribution. When a company applies for medical device-related certification, it is required to have a technical responsible person and/or a mechanical engineer (for example, if electronic medical devices are involved).
IDAK Additional Registration
Registration additions can be made in Adding product categories and Adding products
AKD Registration for Local Medical Product Distribution License
According to the regulations of the Indonesian Ministry of Health, all medical products manufactured and distributed in Indonesia must be registered with the AKD (License for Local Medical Product Distribution).
AKL Registration for Imported Medical Product Distribution License
According to the regulations of the Indonesian Ministry of Health, all imported and distributed medical products in Indonesia must be registered with the AKL (License for Imported Medical Product Distribution).
New Registration of PKL (Import Household Disinfectant Distribution License) / PKD (Local Household Disinfectant Distribution License)
According to the 2023 Indonesian Ministry of Health guidelines for the issuance and registration of licenses for Class 1 and Class 2 Household Health Supplies (PKRT), PKRT refers to tools, materials, or mixtures of materials used for maintenance and care in households and public places. Based on these regulations, every PKRT distributor must have a PKL/PKD license.
New Registration for CDAKB Certification of Medical Devices
The Good Distribution Practice for Medical Devices (CDAKB) is a guideline for the distribution activities and quality assurance of medical devices. The concept of CDAKB is equivalent to ISO.