1.      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.

2.      The IDAK license is valid for 5 years and must be renewed 9 months before the expiration date.

3.      The IDAK license is categorized based on the type of product as follows:

a.      License for Radiation Electronic Medical Devices (Alat Kesehatan Elektromedik Radiasi)

b.      License for Non-Radiation Electronic Medical Devices (Alat Kesehatan Elektromedik Non Radiasi)

c.      License for Sterile Non-Electronic Medical Devices (Alat Kesehatan Non Elektromedik Steril)

d.      License for Non-Sterile Non-Electronic Medical Devices (Alat Kesehatan Non Elektromedik Non Steril)

e.      License for In Vitro Diagnostic Products (IVD) (Produk Diagnostik In Vitro)

4.      Important Notes:

a.      The office and warehouse addresses must be listed on the NIB (both can use the same address);

b.      Office and warehouse addresses cannot be virtual addresses; if leased, the lease term must be at least 2 years;

c.      The NIB must include the business activity code 46691;

d.      Depending on the type of products to be distributed, the company must have a PJT technical manager or mechanical engineer;

e.      After obtaining the IDAK license, the company must obtain CDAKB certification (Good Distribution Practices for Medical Devices) within 1 year.

5.      Without the IDAK license, a company cannot register for CDAKB and AKL/AKD, nor can it legally import and distribute medical device products in Indonesia.