What if I do not want to set up a company in Indonesia, will it still be possible to export medical devices?

  • InCorp Editorial Team
  • 13 October 2023
  • 1 minute reading time

Yes, there are 2 options you may choose. The first option is appointing an existing distributor and the second option is appointing InCorp Indonesia to be the license holder.

Pandu Biasramadhan

Senior Consulting Manager at InCorp Indonesia

An expert for more than 10 years, Pandu Biasramadhan, has an extensive background in providing top-quality and comprehensive business solutions for enterprises in Indonesia and managing regional partnership channels across Southeast Asia.

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Frequent Asked Questions

Yes, license holder and distributor of medical devices must have Medical Device Distribution License (Izin Penyalur Alat Kesehatan/IPAK).

There will be specific documents from Manufacturing/Factory, Indonesian Legal Entity, and Product documents. Contact InCorp Indonesia for more details.

The medical devices license called Izin Edar Alat Kesehatan (AKL) will be valid up to 5 years, depending on the Letter of Authorization from the Principle (product owner).

Yes, there are 2 options you may choose. The first option is appointing an existing distributor and the second option is appointing InCorp Indonesia to be the license holder.

In general, the registration will take between 3 to 6 months. However, it all depends on the classification of your medical device. Class 1A, it may take 3 - 4 months, class 2B and 2C may take 4-5 months and class 3D may take up to 6 months