Update Your Izin Distribusi Alat Kesehatan Before Risks Grow

Under the new regulations, Izin Distribusi Alat Kesehatan (IDAK) is now fully integrated into Indonesia’s risk-based business licensing framework, Perizinan Berusaha Berbasis Risiko (PPBR). This integration requires active compliance and alignment with business locations, responsible personnel, facilities, and distribution activities. 

Distributors that still hold Sertifikat Distribusi Alat Kesehatan (SDAK) or Izin Penyalur Alat Kesehatan (IPAK) or currently list multiple warehouses under one Izin Distribusi Alat Kesehatan license, may need to update their licensing records to comply with the latest PBBR requirements. 

Izin Distribusi Alat Kesehatan in 2026: Key Changes at a Glance 

Aspect	Before PBBR Update	Under PBBR 2026
Validity period	5-year fixed expiry	Valid as long as the business operates and complies
Correction rounds	2 rounds × 20 working days each	2 rounds × 10 working days each (from 1 April 2026)
Licenses	SDAK and IPAK are still recognized	Must convert to IDAK via OSS
Multi-location coverage	One IDAK could list several sites	Separate IDAK required per business location
System integration	Standalone licensing	OSS-RBA, integrated with Regalkes

What is Izin Distribusi Alat Kesehatan in Indonesia? 

Izin Distribusi Alat Kesehatan is the official license, issued through the Online Single Submission (OSS) system with technical approval from the Ministry of Health, that authorizes a legal entity to import, store, market, and distribute medical devices in Indonesia.  

It applies to companies operating under KBLI 46691 (wholesale of pharmaceutical, laboratory, and medical equipment). It is conditional on meeting the requirements of the Good Distribution Practice or CDAKB for Medical Devices. 

Without a valid distributor license, a company cannot legally distribute medical devices, hold a product license (Izin Edar), or act as the appointed local license holder for a foreign manufacturer. 

How PBBR Reshapes Izin Distribusi Alat Kesehatan Compliance 

PPBBR classifies business licenses at risk level and processes them through OSS-RBA. Medical device distribution is a high-risk activity, which means KBLI classification, registered business address, technical personnel, warehouse facilities, and sectoral obligations must remain consistent across OSS, IDAK, and the medical device registration system (Regalkes) records. 

A mismatch in any one field can block license updates, freeze product registration, and surface as a finding during inspection. In practice, Izin Distribusi Alat Kesehatan can no longer be treated as a standalone certificate; it is a live record of how the business operates.

READ MORE:

• Navigating IDAK & CDAKB Requirements for Indonesia Market Entry: A Case Study
• Why You Need a Product License Holder to Import and Distribute to Indonesia
• A Simple Guide to Medical Device Registration in Indonesia

What Changed for Izin Distribusi Alat Kesehatan Under PBBR 2026? 

Izin Distribusi Alat Kesehatan administration became more clearly integrated into Indonesia’s risk-based licensing framework under PBBR. Based on the 2026 Ministry of Health announcement, Izin Distribusi Alat Kesehatan remains valid as long as the business continues its activities and complies with applicable regulations. 

License Validity is No Longer Treated as a Fixed Expiry Issue 

The licenses remain valid as long as the business continues operating and complies with applicable laws and regulations. However, companies with an active IDAK that has not been revoked but still shows an expiry date in the technical attachment must update the license validity period in the OSS system. 

SDAK and IPAK Must Be Adjusted to IDAK 

Medical device distributors that still hold older licenses, such as SDAK or IPAK, issued before OSS risk-based licensing, must adjust them to IDAK. 

This adjustment is submitted through the OSS system and will later be integrated with Regalkes to fulfill requirements.

Application Corrections are Now More Limited 

Previously, applicants could make up to 2 correction rounds, with 20 working days for each correction. Under the new rule, applicants still receive 2 correction opportunities, but each correction period is limited to 10 working days. 

If the data or documents remain incomplete after 2 rounds of corrections, the application will be rejected. This correction timeline takes effect on April 1, 2026. 

Each Business Location Must Have Its Own License 

Companies with more than one business location must hold a separate license for each location. If multiple locations are currently listed under one IDAK, the company must submit a new application for each additional business location. 

Who Needs to Apply and Update Izin Distribusi Alat Kesehatan? 

Companies that import, store, sell, market, or distribute medical devices in Indonesia must apply for or renew this license when their business activities, locations, or licensing records change. 

• Plans to distribute medical devices in Indonesia 
• Acts as the local distributor for foreign manufacturers 
• Changes its registered business address or warehouse location 
• Adds or changes medical device categories 
• Changes the technical person in charge 
• Updates its OSS or business licensing data 
• Holds an older license that must be aligned with PBBR requirements 

Foreign manufacturers should pay attention to the local entity structure. Medical device distribution and registration in Indonesia typically require an Indonesian legal entity or appointed local license holder to manage regulatory responsibilities.  

What Happens If Your Izin Distribusi Alat Kesehatan is Not Compliant with PBBR? 

Non-compliant licensing data can create practical business disruption. Possible consequences include: 

• Delay or rejection in license updates or related licensing processes 
• Mismatch between OSS, IDAK, and facility data 
• Difficulty supporting medical device registration or license holder arrangements 
• Problems during inspection, verification, or compliance review 
• Disruption to import, distribution, or tender participation 
• Reduced confidence from manufacturers, principals, or business partners

Align Your Izin Distribusi Alat Kesehatan with PBBR Before It Costs You 

Outdated licensing data can delay medical device distribution, product registration, or licensing updates. InCorp Indonesia (an Ascentium Company) can help medical device distributors close that gap with: 

• IDAK review and update assistance 
• OSS and Regalkes data alignment 
• Medical device distributor licensing support 
• Medical device product registration 
• Local license holder advisory 
• Document preparation and compliance guidance 

Fill out the form below to speak with our regulatory team and map out the right next step for your distribution activities in Indonesia.

Frequently Asked Questions