IDAK Certification Service

IDAK Certification for Medical Device Distribution in Indonesia

Legal Compliance

Mandatory for all medical device distribution in Indonesia.

Market Access

Open doors to Indonesia's expansive healthcare market.

Consumer Protection

Play a role in safeguarding the health of Indonesian consumers.

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.

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How to Get IDAK Certification in Indonesia

Identify Your Product Category and Class

Based on medical device category (Electromedic Radiation, Electromedic Non-Radiation, Non-Electromedic Sterile, Non-Electromedic Non-Sterile, Diagnostic In-Vitro)

Prepare the Necessary Documents

Company registration, Product specifications, Risk assessment reports, And other required documentation

Ensure Warehouse Compliance

Meet storage, labeling, and traceability standards.

Submit Your Application

Apply through the Directorate General of Pharmaceutical and Medical Devices (Regalkes)

Pay the PNBP Fee

Complete payment of the Non-Tax State Revenue fee.

Receive Your IDAK Certificate

Obtain certification after your application is approved.

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.

INSIGHTOF Consulting

Your Regulatory Experts

Address

Wisma PMI 6th Floor Jl. Wijaya I No.63, RT.8/RW.1, Petogogan, Kec. Kby. Baru, Kota Jakarta Selatan, Daerah Khusus Ibukota Jakarta 12160

Mail Address

marketing@insightof.co.id

+62 897 6470 070

Phone

(021) 7279 3812

Working Hours

Mon to Fri : 08:00 AM – 17:00 PM

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