IDAK License Indonesia: Requirements, Process & Compliance Guide (2026)

Why IDAK is the First Barrier to Enter Indonesia 

If you are planning to distribute medical devices in Indonesia, the IDAK (Izin Distributor Alat Kesehatan) license is not just a formality—it is the legal foundation of your entire market entry strategy. 

Many foreign manufacturers focus heavily on product registration (NIE), but in reality, most delays happen much earlier—at the distributor licensing stage. 

Without a valid IDAK (Izin Distributor Alat Kesehatan): 

This guide explains the real-world requirements, process, costs, and pitfalls of obtaining an IDAK license in Indonesia. 

What is IDAK (Izin Distributor Alat Kesehatan) and Why It Matters in Practice 

The IDAK (Izin Distributor Alat Kesehatan) is a license issued by the Indonesian Ministry of Health that authorizes a company to store, handle, and distribute medical devices. 

But in practice, it does much more than that. 

It confirms that your company: 

👉 In short: IDAK is not just a license—it is a compliance checkpoint for your entire supply chain. 

Who Actually Needs an IDAK License? 

This is where many companies misunderstand the regulation. 

You need an IDAK if you are: 

You do NOT need IDAK if: 

👉 However, you must appoint an IDAK-holding entity to enter the market. 

Deep Dive: IDAK Requirements (What Authorities Actually Check) 

Instead of just listing documents, let’s look at what regulators actually evaluate during approval. 

1. Legal Structure & OSS Alignment (Most Common Failure Point) 

Your company must be registered through Indonesia’s OSS-RBA system, but approval depends on correct classification. 

What MoH Verifies: 

⚠️ Real Issue: 
Many applications fail because: 

2. Warehouse Compliance (Not Just a Physical Space) 

Indonesia requires functional, audit-ready storage facilities. 

What Inspectors Look For: 

👉 This is not theoretical—your warehouse must reflect real operations. 

3. PJT Requirement (Often Underestimated) 

The PJT (Technical Person in Charge) is a regulatory requirement that carries legal responsibility. 

What Authorities Expect: 

⚠️ Common mistake: 

4. Documentation & SOP System 

Even for IDAK, authorities expect structured documentation. 

Typical Expectations: 

👉 This becomes even more critical later during CDAKB audits. 

Step-by-Step IDAK Process (Real-World Execution) 

Obtaining an IDAK (Izin Distributor Alat Kesehatan) license is not a simple document submission—it is a structured regulatory process where Indonesian authorities assess whether your company is legally, operationally, and technically capable of distributing medical devices safely. 

Below is a detailed breakdown of how the process works in practice. 

Step 1: Business Registration via OSS-RBA System 

The process begins with registering your company through Indonesia’s Online Single Submission – Risk-Based Approach (OSS-RBA) system. 

At this stage, your company is issued a NIB (Nomor Induk Berusaha – Business Identification Number), which acts as your primary business license. 

However, the most critical factor here is selecting the correct KBLI code (Indonesian Standard Industrial Classification)—typically KBLI 46691 for medical device distribution. 

If the KBLI code does not match your intended activity, your IDAK application may be rejected or delayed later during Ministry of Health verification. 

This step also defines whether your entity is: 

👉 In practice, many applications fail at this early stage due to misalignment between declared business activity and regulatory expectations. 

Step 2: Warehouse & Facility Compliance Preparation 

Before applying for IDAK, your company must demonstrate that it has a functional and compliant storage facility. 

This is not just a requirement on paper—authorities expect a real, operational warehouse setup. 

The facility must include: 

The layout should reflect a logical product flow, ensuring that non-compliant or damaged products are isolated and cannot enter the supply chain. 

👉 This step is critical because the same facility will later be evaluated under stricter compliance standards. 

Step 3: Appointment of PJT (Technical Person in Charge) 

An IDAK license requires a designated PJT (Penanggung Jawab Teknis)—a qualified professional responsible for ensuring regulatory compliance. 

The PJT must: 

Authorities may verify whether the PJT is genuinely involved in operations. Appointing a “nominee” without real responsibility can create compliance risks during inspections. 

Step 4: Documentation Preparation & IDAK Submission 

Once the legal, facility, and personnel requirements are in place, the IDAK application is submitted to the Ministry of Health. 

The submission typically includes: 

At this stage, consistency across all documents is crucial. Any mismatch between OSS data, facility details, and submitted documents can trigger queries. 

Step 5: Ministry of Health Review & Verification 

After submission, the Ministry of Health conducts a compliance review. 

This may involve: 

In some cases, authorities may assess whether the declared facility and operational setup are realistic and compliant. 

👉 Delays usually occur here due to incomplete documentation or inconsistencies. 

Step 6: IDAK Approval & License Issuance 

Once all requirements are satisfied, the IDAK license is issued. 

At this point, your company is legally authorized to distribute medical devices in Indonesia and can proceed to the next regulatory phase (CDAKB – Cara Distribusi Alat Kesehatan yang Baik, or Good Distribution Practice certification), which focuses on quality and operational compliance. 

While reaching this stage is a major milestone, many companies misunderstand what comes next. 

A common assumption is that once the IDAK license is obtained, the company can directly proceed to product registration. In reality, Indonesia’s regulatory framework introduces an additional and mandatory compliance layer that focuses not just on permission to operate, but on how medical devices are handled, stored, and distributed in practice. 

To fully understand this transition, it is essential to clearly distinguish between IDAK and CDAKB, as both play critical but different roles in the overall approval pathway. 

IDAK vs CDAKB: What’s the Difference? 

One of the most common areas of confusion in Indonesia’s medical device regulations is the difference between IDAK (Izin Distributor Alat Kesehatan) and CDAKB (Cara Distribusi Alat Kesehatan yang Baik). 

Although both are mandatory, they serve distinct regulatory purposes and must be obtained in the correct sequence. 

How They Work Together 

These two are not interchangeable—they are sequential requirements: 

How OMC Medical Simplifies IDAK Licensing 

Obtaining an IDAK (Izin Distributor Alat Kesehatan) license requires alignment between legal registration, facility setup, and regulatory compliance. OMC Medical simplifies this process through a structured and proactive approach: 

With vs Without OMC Medical 

Ready to Get Your IDAK License?

Avoid delays and get it right from the start. 
👉 Contact OMC Medical today to begin your IDAK licensing process.