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Home / Experience  /  4.1. How to Register Medical Device Distribution Permit (IDAK)
4.1. How to Register Medical Device Distribution Permit (IDAK)
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April 8, 2026
Experience Features Finance Funds

Basic Information

1. Medical Devices are instruments, apparatus, machines and/or implants that do not contain drugs that are used to prevent, diagnose, cure and alleviate diseases, treat sick people, restore health in humans, and/or form structures and improve body functions.

2. Medical Device Distribution Permit (IDAK) is a permit granted by the Indonesian Ministry of Health to distributor or importer companies to distribute medical devices in Indonesia.

3. Medical Device Distribution Permit (IDAK) is a form of supervision of the distribution of medical devices to ensure the quality, safety, and benefits of products circulating in Indonesia.

4. Categories of Medical Devices in the Medical Device Distribution Permit (IDAK) are divided into:

  • Radiation Electromedical;
  • Non-Radiation Electromedical;
  • Non-Sterile Electromedical;
  • Non-Sterile Non-Electromedical;
  • In Vitro Diagnostic Products (DIV);

5. The Validity Period of the Medical Device Distribution Permit (IDAK) is 5 Years.

6. Types of IDAK changes include:

  • Changes to Technical Person in Charge;
  • Changes to Company Leaders;
  • Changes to Address without changing Location;
  • Addition of Product Categories;

Flow Process and Processing Time

1. Processing Time: ±45 Working Days;

*) The completion time above, starts after all required data is complete;

2. Flow Process:

  • Step 1: Collecting Required Document;
  • Step 2: Drafting Document and Applying Medical Device Distribution Permit (IDAK);
  • Step 3: Receive and pay Payment Order (SPB) (2 Working Days);
  • Step 4: Document verification by Ministry of Health (20-40 Working Days);
  • Step 5: Submission of additional data based on Ministry of Health feedback (if any);
  • Step 6: Issuance of Medical Device Distribution Permit (IDAK) (5 Working Days);
  • Step 7: Receiving Medical Device Distribution Permit (IDAK);

Document Required

1. Company Document

Company Legal Document

  • Deed of Establishment + Approval from the Ministry of Law and Human Rights
  • Business Identification Number (NIB)
  • Company Tax ID (NPWP)
  • Appropriate KBLI (Indonesian Standard Industrial Classification for medical device distribution)

📍 Domicile & Operational Documents

  • Domicile Certificate / Business Address
  • Warehouse / Office Layout
  • Proof of ownership or lease agreement

👤 Technical Person in Charge (PJT)

  • ID Card (KTP)
  • Educational Certificate (preferably in a relevant or healthcare field)
  • Professional License (STR), if applicable
  • Statement Letter of appointment as PJT

🏭 Quality System & Operations

  • SOP for distribution (receiving, storage, delivery)
  • SOP for complaint handling & product recall
  • Company organizational structure
  • List of warehouse equipment (AC, thermometer, etc.)

📦 Warehouse & Storage

  • Warehouse photos
  • Temperature monitoring system (if required)

2. Product Document

These documents are related to the medical devices you intend to distribute:

📄 Product Legal Documents

  • Marketing Authorization (AKL/AKD)
  • Certificate of Free Sale (CFS)
  • Letter of Authorization (LoA) from the principal/manufacturer

📑 Technical Documents

  • Product specifications
  • Brochure / catalog
  • Product labeling & packaging
  • IFU (Instructions for Use)

🔬 Testing & Safety (if required)

  • Test reports / laboratory results
  • Risk analysis
  • Clinical evaluation (for certain devices)
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