IDAK Certification Service

IDAK Certification for Medical Device Distribution in Indonesia 

Indonesia medical device distribution license

What is IDAK (Izin Distribusi Alat Kesehatan)?

IDAK, or the Medical Device Distribution Permit, is a government-mandated license essential for legally distributing medical devices in Indonesia. It guarantees that only safe and effective products reach the market. IDAK (Izin Distribusi Alat Kesehatan) is a mandatory license issued by the Indonesian Ministry of Health for any business distributing medical devices in Indonesia.

Our team helps both local and foreign companies navigate the process of obtaining the Indonesia medical device distribution license, including documentation, submission, and regulatory communication.
We assist with the IDAK license application for foreign distributors, ensuring smooth entry into Indonesia’s medical device market.

Medical Device Category

Electromedic Radiation

Medical devices that use radiation for diagnosis or treatment, such as X-ray or radiation therapy machines.

Electromedic Non-Radiation

Medical devices that use electrical energy but do not emit radiation, like ECG machines or ultrasound devices.

Non-Electromedic Sterile

Medical devices that do not use electricity and are sterile, such as surgical instruments or implants.

Non-Electromedic Non-Sterile

Non-electric medical devices that are not sterile, including bandages and splints

Diagnostic In-Vitro

Medical devices used to test samples outside the body, such as blood test kits or lab equipment.

Basic Document Requirement

IDAK License Requirements 

Notarial Deed of Company Establishment

Business Identification Number (NIB) – 46691

Taxpayer Identification Number (NPWP)

Building/Warehouse Floor Plan and Equipment

Pictures of Workspaces and Warehouse

SOP for Storage, Reception and Distribution of Goods

Technical Responsible Person (PJT)

Technician

Have any questions about IDAK Certification?

We’re here to help! Our team of experts provides clear guidance and support to ensure a seamless registration process, from understanding regulations to obtaining approval.