If your company distributes medical devices in Indonesia — or plans to — the rules governing your business license just got a significant update. The Ministry of Health’s Directorate of Medical Device Production and Distribution has rolled out a revised framework for the Izin Distribusi Alat Kesehatan (IDAK), Indonesia’s official Medical Device Distribution Permit, aligned with the country’s broader risk-based business licensing reform. Here’s what changed, why it matters, and what distributors need to do next.
Table of Contents
- The Legal Foundation Behind IDAK
- How Business Licensing (PB) Works for Distributors
- Business Classification: Two Types of Distributors
- Types of IDAK Applications
- What’s Inside the IDAK Certificate
- Transitional Provisions
- Key Changes at a Glance: Old Rules vs. New Rules
- What This Means for Your Business
1. The Legal Foundation Behind IDAK
Medical device distribution licensing in Indonesia sits within the country’s Risk-Based Business Licensing (Online Single Submission, or OSS) system. The current framework is built on four layers of regulation:
- Law No. 6/2023 — the enactment of Government Regulation in Lieu of Law No. 2/2022 on Job Creation into law, the overarching legal basis for risk-based licensing reform.
- Government Regulation (PP) No. 28/2025 — on the Implementation of Risk-Based Business Licensing and Investment Facilities. This regulation replaces PP No. 5/2021, aligns licensing with the updated 2025 Indonesian Standard Business Classification (KBLI), and further integrates the licensing system while reinforcing legal certainty.
- Ministry of Health Regulation (Permenkes) No. 11/2025 — sets out business activity and product standards for risk-based licensing in the health subsector.
- Ministry of Investment/BKPM Regulation (Permeninves) No. 5/2025 — provides the technical guidelines and procedures for risk-based licensing and investment facilities through the OSS system.
These regulations simplify and speed up business licensing through OSS based on risk classification — low, medium, or high. Medical device distribution falls into the high-risk category, which carries specific licensing requirements beyond a basic business registration.
2. How Business Licensing (PB) Works for Distributors
Under the risk-based system, every business actor must hold a Business License (Perizinan Berusaha / PB) before starting and running operations. For high-risk business activities — which includes medical device distribution — the PB consists of two elements:
- NIB (Nomor Induk Berusaha / Business Identification Number); and
- Izin (the operating license itself).
On top of that, any business that needs additional legality to operate or commercialize its activities must also hold a PB UMKU (a supporting license for business operations). For medical device distributors specifically, this structure translates into:
- Izin = IDAK (Medical Device Distribution Permit)
- PB UMKU = CDB Certificate for medical devices (Good Distribution Practice certification)
3. Business Classification: Two Types of Distributors
Under the new rules, medical device distribution businesses are classified into two categories:
- Medical Device Distributor — the primary licensed entity.
- Branch of a Medical Device Distributor — an operational unit under an already-licensed distributor.
Core Requirements
- A Medical Device Distributor must be a legal business entity in the form of a limited liability company (PT) or a cooperative.
- A Branch Distributor must also be structured as a business unit of a licensed Medical Device Distributor, itself incorporated as a PT or cooperative.
- The business location may differ from the company’s registered office, provided this does not reduce the effectiveness of internal supervision.
- The company must have a physical (non-virtual) facility with adequate infrastructure to carry out distribution activities.
- At minimum, the facility must include: an administration area, a receiving area, a shipping area, a quarantine area, and a storage area.
Requirements for the Technical Responsible Person (PJT)
- Every distributor must appoint a full-time Penanggung Jawab Teknis (PJT) with at least a Diploma III (D-3) qualification in health sciences, engineering, or applied science.
- The PJT is responsible for ensuring that all medical device distribution activities meet the safety, efficacy, and quality requirements set out under the Good Distribution Practice (CDB) standard for medical devices.
- The cooperation between the PJT and the Distributor (or Branch Distributor) must be formalized through a notarized deed of agreement — not merely a legalized document, as was previously accepted.
4. Types of IDAK Applications
Companies can apply for IDAK under four different tracks, depending on their current licensing status:
| Application Type | Applies When |
|---|---|
| New Application |
|
| Extension | The applicant holds a valid IPAK (Medical Device Distributor License) or SDAK, which will be converted into an IDAK. |
| Amendment | Changes to business actor data, business activity data, or technical attachment data (business location, PJT, or product group). |
| Update | For companies whose IDAK is still within its validity period (not yet lifetime), allowing them to submit an update or extension request directly through OSS. |
IPAK = Medical Device Distributor License (older terminology). SDAK = Medical Device Distributor Certificate, issued on or before 2021 with a 5-year validity period.
5. What’s Inside the IDAK Certificate
The IDAK certificate is issued as a Risk-Based Business License and includes a separate technical attachment detailing the scope of what the company is licensed to do:
- Business location and contact details
- Name, educational background, and status of the appointed PJT
- The specific medical device product groups the company is authorized to distribute (Electromedical Radiation, Electromedical Non-Radiation, Non-Electromedical Sterile, Non-Electromedical Non-Sterile, and/or In Vitro Diagnostic devices)
- Applicable requirements, verification method, and validity period for each licensed scope
6. Transitional Provisions
For companies with applications already underway, the new regulation includes clear transitional rules under Chapter VI:
- Article 37 — Business licenses and PB UMKU applications in the health subsector that are still in process, not yet verified, or not yet effective by the time the OSS system is adjusted to PP No. 28/2025, will continue to be processed under the previous Ministry of Health Regulation No. 14/2021 (as last amended by Regulation No. 17/2024).
- Article 38 — Business licenses and PB UMKU already issued before the risk-based OSS system took effect under PP No. 28/2025 remain valid and will have their validity period updated in accordance with prevailing regulations.
If your IDAK application was already submitted before the OSS system transition, it won’t be discarded or restarted — it continues under the previous rules until it’s processed. But once issued, its validity period will be adjusted to align with the new regulation.
7. Key Changes at a Glance: Old Rules vs. New Rules
| Area | Previous Rule | New Rule (PP 28/2025) | Notes |
|---|---|---|---|
| Validity period | IDAK valid for 5 years, renewable | IDAK valid for as long as the business remains active | PP 28/2025, Article 5(10) |
| Eligible business actors | Non-individual legal entity in the form of PT or Cooperative | Legal entity in the form of PT or Cooperative (the “non-individual” restriction is removed) | Opens the door for individually-owned PTs (PT Perorangan) to register for a license |
| Facility requirements | Physical building and facilities matching product requirements, with an office address, warehouse, and/or non-virtual workshop | Business location must include, at minimum: receiving area, shipping area, administration area, quarantine area, storage area, and a workshop area (adjusted to the product group distributed) | Removes the ambiguous term “warehouse,” replaced with “business location,” with clearly defined required areas |
| PJT education requirement | Tiered by product group: up to 3 product groups required minimum D-III; 4–5 product groups required minimum S1 | Simplified to a flat minimum of D-III in Health Sciences, Engineering, or Applied Science | Simplifies the PJT education requirement |
| Cooperation agreement with distributor | Cooperation agreement legalized by a notary | Cooperation agreement in the form of a notarized deed, containing at minimum the rights and obligations of both parties, the cooperation period, and termination clauses | Strengthens legal validity and mandates specific clauses |
| Services provided by distributor | Product sales, product delivery, product information, after-sales service, complaint/adverse event handling | Unchanged | Will be incorporated into the PB UMKU CDB Certificate requirements |
| Correction of application deficiencies | Not previously regulated | Corrections may be made a maximum of 2 times, with a maximum of 10 working days per correction | Ministry of Investment/BKPM Regulation No. 5/2025, Article 203(4) |
| Reporting obligations | Previously addressed under conformity assessment and supervision provisions |
Reports must be submitted through the national health information system:
|
8. What This Means for Your Business
The shift from a fixed 5-year license to a license that stays valid as long as the business remains operational is a welcome relief for compliance teams — but it also raises the stakes on getting the initial application and every subsequent amendment right, since renewal is no longer an automatic checkpoint to catch outdated data. At the same time, the new facility requirements, simplified PJT education standard, and stricter cooperation-agreement clauses mean companies preparing a new IDAK application, extension, or update should review their internal documentation carefully before submitting through OSS.
For distributors — especially foreign or newly established companies entering the Indonesian market — navigating these overlapping regulations (Law No. 6/2023, PP No. 28/2025, Permenkes No. 11/2025, and Permeninves No. 5/2025) alongside the transitional provisions can be time-consuming without the right guidance.
Frequently Asked Questions
What is IDAK?
IDAK (Izin Distribusi Alat Kesehatan) is Indonesia’s official Medical Device Distribution Permit, issued as part of the country’s risk-based business licensing (OSS) system for companies distributing medical devices in Indonesia.
Is IDAK still valid for only 5 years?
No. Under PP No. 28/2025, IDAK is now valid for as long as the business remains active, replacing the previous fixed 5-year validity period with mandatory renewal.
Can an individually-owned PT (PT Perorangan) apply for IDAK?
Yes. The new regulation removes the previous “non-individual” restriction on eligible business actors, opening the door for PT Perorangan to register for the license, provided it is still incorporated as a PT or cooperative.
What qualifications does a Technical Responsible Person (PJT) need?
Under the new rules, a PJT must hold at least a Diploma III (D-3) in health sciences, engineering, or applied science, and must work full-time for the distributor. This simplifies the previous tiered requirement based on product group.
What’s the difference between IDAK and CDB Certification?
IDAK is the core operating license (Izin) for medical device distribution, while the CDB Certificate is the PB UMKU — a supporting license required to operate at the operational/commercial stage, confirming the distributor meets Good Distribution Practice standards.
