Izin Distribusi Alat Kesehatan (IDAK) is managed under Indonesia’s Perizinan Berusaha Berbasis Risiko (PBBR) framework through the OSS system. In accordance with Permenkes 11/2025 and the Ministry of Health’s 2026 IDAK implementation guidance, distributors should ensure that their business locations, responsible personnel, facilities, product groups, and other licensing information remain consistent with their OSS records.
Distributors still holding a Sertifikat Distribusi Alat Kesehatan (SDAK) or an Izin Penyalur Alat Kesehatan (IPAK), as well as businesses operating multiple locations under a single IDAK, should reassess their licensing status.
Key Takeaways
- IDAK is managed under Indonesia’s PBBR framework, and licensing records must stay aligned with actual business activities and operating conditions.
- IPAK and older licensing records may need to be updated via OSS to align with the current IDAK framework.
- Each applicable business location requires its own IDAK, including when operations expand to additional locations.
- IDAK now uses KBLI 46791, while older KBLI 46691 licenses generally remain valid under transition rules.
- IDAK is only one part of compliance; distributors must also maintain PJT, CDB/CDAKB, facility, reporting, and product-registration requirements.
Izin Distribusi Alat Kesehatan in 2026: The overview
| Area | 2026 Position | What Businesses Should Do |
| PBBR Framework | IDAK is managed through OSS under Indonesia’s risk-based licensing framework | Keep licensing data aligned with actual operations |
| IDAK Validity | The focus is on ongoing compliance rather than a fixed renewal cycle | Update OSS records when business or licensing data changes |
| Legacy Licenses | Older IPAK and certain legacy records may need alignment with the current IDAK framework | Assess existing licenses before making updates |
| Business Locations | Each applicable business location requires the appropriate IDAK | Review additional locations and relocations |
| Application Corrections | Additional data is limited to 2 rounds of 10 working days | Prepare complete documents before submission |
| Current KBLI | Medical device distribution now uses KBLI 46791 | Verify OSS alignment with KBLI 2025 |
| Ongoing Compliance | PJT, CDB/CDAKB, facilities, reporting, and product registration remain relevant | Maintain compliance after IDAK is issued |
What is Izin Distribusi Alat Kesehatan?
Izin Distribusi Alat Kesehatan (IDAK) is the commonly used term for the business license required to distribute medical devices in Indonesia.
IDAK should not be confused with a medical device (Izin Edar). IDAK covers the distributor, while Izin Edar applies to each medical device product placed on the Indonesian market.
Companies may therefore need both the appropriate distribution license and valid product registrations before starting commercial distribution.
What changed for Izin Distribusi Alat Kesehatan in 2026?
The 2026 updates change how medical device distributors should manage IDAK validity, business locations, application corrections, and KBLI alignment. Existing license holders should assess these areas before operational changes create licensing gaps.
IDAK is no longer based on a fixed renewal cycle
The current PBBR framework changes how distributors should manage IDAK validity, legacy licenses, business locations, application corrections, and KBLI alignment. Existing license holders should assess these areas whenever their licensing records or operations change.
IPAK and SDAK licenses must be updated to IDAK
Medical device distributors still using IPAK or SDAK should update their licenses to IDAK through OSS under the current risk-based licensing framework.
Each applicable business location requires an IDAK
Businesses operating from more than one applicable location must hold an IDAK for each location. A relocation that changes the registered location coordinates also requires a new IDAK application.
Application correction time is shorter
The Ministry of Health reduced the additional data period to two rounds of 10 working days each. Incomplete or inconsistent applications therefore have less time for correction.
IDAK now uses KBLI 46791
OSS now classifies medical device distribution under KBLI 46791. Existing licenses under the previous KBLI 46691 generally remain valid, so companies should verify their OSS alignment before making unnecessary licensing changes.
If you are still unsure how the changes apply to your current license or distribution setup, InCorp Indonesia (an Ascentium Company) can assess your IDAK position and identify any required updates before you proceed. Talk to our team ->
Who needs to apply for or update Izin Distribusi Alat Kesehatan?
Companies engaged in medical device distribution in Indonesia need the appropriate distributor business license. Under PBBR, a new application or licensing update may be required when a company:
- Plans to operate as a medical device distributor in Indonesia
- Still holds an older IPAK that needs to be aligned with the current IDAK framework
- Adds or changes an applicable business or distribution location;
- Relocates to an address that changes the registered location coordinates
- Changes its Penanggung Jawab Teknis (PJT)
- Adds or changes approved medical device product groups
- Needs to update its OSS or technical licensing data to reflect current operations
Foreign manufacturers entering Indonesia should also confirm their local distribution and registration structure. Imported medical devices may be registered and distributed through an appropriately licensed Indonesian distributor appointed by the manufacturer or product owner.
What happens if your Izin Distribusi Alat Kesehatan is non-compliant with the PBBR?
Outdated or inconsistent IDAK data can cause practical business disruption, especially when licensing records no longer align with actual operations.
Possible impacts include:
- Delays in license updates or related regulatory processes
- Mismatches between OSS, IDAK, and facility information
- Complications in supporting medical device registration or license-holder arrangements
- Issues during inspections, verification, or compliance reviews
- Disruption to import, distribution, or tender activities
- Reduced confidence from manufacturers, principals, or business partners
Keeping your IDAK data aligned with current PBBR requirements can help reduce these risks before they affect commercial activities.
Clear Paths to Product Registration in Indonesia
Keep your Izin Distribusi Alat Kesehatan aligned with PBBR
Under the current PBBR framework, Izin Distribusi Alat Kesehatan should be treated as an ongoing compliance requirement rather than a license that only needs attention when its validity period approaches.
Companies should confirm that their IDAK, OSS data, KBLI, locations, PJT, product groups, facilities, and CDB/CDAKB position continue to match their actual distribution activities.
InCorp Indonesia (an Ascentium Company) supports medical device businesses with:
- IDAK applications, updates, and licensing assessments
- OSS and KBLI alignment
- Location and PJT changes
- CDB/CDAKB preparation and regulatory compliance
- Medical device product registration and local license-holder support
For foreign medical device manufacturers, our team can also assess the Indonesian entity, distributor, import, and product registration structure before market entry.
Assess your IDAK position before a licensing gap affects your medical device operations in Indonesia. Fill out the form below.
Frequently Asked Questions
What is Izin Distribusi Alat Kesehatan?
Izin Distribusi Alat Kesehatan (IDAK) is the business license used for medical device distribution activities in Indonesia.
How does PBBR affect IDAK?
Under PBBR, IDAK is managed through OSS and should stay aligned with the distributor’s actual business activities, locations, and licensing data.
Does IDAK still need to be renewed every five years?
The current framework focuses more on keeping the license and supporting data up to date rather than following a fixed renewal cycle.
Do IPAK holders need to update their license?
Yes. Businesses that are still holding an older IPAK should align their licensing status with the current IDAK framework via OSS.
Does each business location need its own IDAK?
Yes. Each applicable business location must have the appropriate IDAK. A relocation that changes the registered coordinates may also require a new IDAK application.
What is the current KBLI for medical device distribution?
Medical device distribution now uses KBLI 46791 under KBLI 2025. Older KBLI 46691 licenses generally remain valid under the transition rules.
What changes may require an IDAK update?
Common triggers include changes to the business location, PJT, product groups, facilities, or OSS licensing data.
Is CDAKB required in addition to IDAK?
Yes. Distributors must also meet the applicable CDB/CDAKB requirements before carrying out medical device distribution activities.
Can foreign manufacturers distribute medical devices directly in Indonesia?
Foreign manufacturers generally need an appropriately licensed Indonesian distributor or local license-holder structure to support registration and distribution.
How can InCorp Indonesia help?
InCorp Indonesia (an Ascentium Company) can support IDAK applications and updates, OSS and KBLI alignment, PJT and location changes, CDB/CDAKB preparation, and medical device product registration.
Get in touch with us.
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A prompt response to your inquiry
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Disclaimer
The information is provided by PT. Cekindo Business International (“InCorp Indonesia/ we”) for general purpose only and we make no representations or warranties of any kind.
We do not act as an authorized government or non-government provider for official documents and services, which is issued by the Government of the Republic of Indonesia or its appointed officials. We do not promote any official government document or services of the Government of the Republic of Indonesia, including but not limited to, business identifiers, health and welfare assistance programs and benefits, unclaimed tax rebate, electronic travel visa and authorization, passports in this website.
Verified by
Hotdo Nauli
Senior Legal & Delivery Manager at InCorp Indonesia
Hotdo heads the Legal and Delivery team at InCorp Indonesia, managing Product Registration, Legal Advisory, and Business Licensing. With over 8 years of experience, she focuses on compliance and integrity, ensuring all client operations align with Indonesian laws and regulatory standards, including contract reviews and sector-specific licenses. She is also a licensed advocate and a member of the Indonesian Advocates Association (PERADI).
