The distribution of medical devices in Indonesia is a highly regulated and closely monitored activity by the government to ensure that every medical device circulating in the market meets safety, quality, and efficacy standards. This is crucial for protecting public health and ensuring that medical devices are used appropriately and responsibly.

For businesses, whether local or foreign entities wishing to enter the Indonesian market, a thorough understanding of the distribution process and its licensing requirements is essential to avoid legal or operational obstacles. Furthermore, non-compliance in the distribution process may result in serious legal consequences and disrupt business continuity.

In the context of regulations, the distribution of medical devices in Indonesia is governed by various prevailing and continuously updated regulations, including Minister of Health Regulation (Permenkes) No. 14 of 2021 concerning Standards for Business Activities and Products in Risk-Based Business Licensing in the Health Sector, which serves as the primary framework for OSS-RBA; and Minister of Health Regulation No. 62 of 2017 regarding the Licensing and Operation of Medical Device Distributors (IPAK/IDAK).

This article will provide an overview of the relevant authorities, licensing stages for medical device distribution, essential requirements, and special considerations for imported medical devices. It will also address common questions, such as whether product testing or expert personnel are required. This article serves as an introductory guide, with further detailed discussion in subsequent articles based on the classification of types of medical devices.

Read More: Understanding Good Manufacturing Practices (GMP) Indonesia

What is the Medical Device Distribution License (IPAK/IDAK)?

The Medical Device Distributor License (IPAK/IDAK) is an official license that must be obtained by every business entity wishing to conduct the distribution or supply of medical devices in Indonesia. This license is a form of government recognition that the company has the capacity, facilities, and quality standards required to distribute medical devices in accordance with applicable regulations.

IPAK/IDAK is not only for primary distributors but also covers businesses such as importers and suppliers, and in certain cases, retailers or medical device stores may also be required to obtain a similar license, depending on the product risk classification and the scale of the business.

Holding an IPAK/IDAK means that the company has met a series of administrative, technical, and human resource requirements, including the presence of certified medical device technical staff, appropriate storage facilities, product traceability systems, as well as commitment to reporting and distribution audits.

In Indonesia, the distribution of medical devices is overseen by the Ministry of Health of the Republic of Indonesia (Kemenkes RI). Kemenkes is the primary authority that sets the distribution standards and procedures and grants licenses through the following technical units:

1. Directorate General of Pharmaceutical and Medical Devices (Ditjen Farmalkes) – as the manager of general policies in the field of pharmaceuticals and medical devices.
2. Directorate of Medical Device Evaluation – responsible for evaluating the quality and safety of medical devices, particularly in the registration and licensing process.
3. Directorate of Medical Device Production and Distribution – plays a crucial role in supervising and issuing distribution licenses (IPAK/IDAK) and ensuring that the distribution chain is conducted in accordance with regulations.

Moreover, the application process and issuance of IPAK/IDAK are conducted electronically through the Online Single Submission – Risk Based Approach (OSS-RBA) platform, which is integrated with the Ministry of Health’s system.

General Requirements for Applying for IPAK/IDAK (Medical Device Distributor License)

To legally carry out the distribution or supply of medical devices in Indonesia, every business entity must apply for and obtain the IPAK/IDAK from the Ministry of Health of the Republic of Indonesia. This process is done through the OSS-RBA platform. The following are the general requirements that the company must fulfill when applying for IPAK/IDAK:

1. Business Legality
   IPAK/IDAK can only be applied for by a legally established business entity that meets the following legal requirements:
   • The Company’s Deed of Establishment and the Latest Deed of Amendment (if applicable), showing business activities in the field of medical devices.
   • Business Identification Number (NIB) issued through OSS-RBA with KBLI 46591 – the Indonesian Standard Business Classification for Wholesale Trade of Laboratory, Pharmaceutical, and Medical Devices.
   • The Company’s Taxpayer Identification Number (NPWP), as a registered and active taxpayer.These legal documents serve as the foundation to demonstrate that the company is formally prepared to operate in the medical device distribution sector.
2. Technical Operational Documents
   The company must also demonstrate operational readiness to distribute medical devices through the following technical documents:
   • Building Layout and Storage Facility – demonstrating the storage area and supporting facilities in compliance with security and sanitation standards. Office and warehouse facilities must have ownership data and clear lease agreements (not virtual offices), where a minimum lease agreement of 2 years is required according to PMK No. 14 of 2021. For Electromedical Products, additional workshop facilities and technicians are required to meet the standards. The workshop facilities can be integrated with the warehouse or be in a separate location as needed.
   • Standard Operating Procedures (SOPs) that include:
     • Distribution and storage procedures for medical devices
     • Packaging and transportation
     • Handling of damaged, expired, or recalled products
     • Reporting and documentation of distribution activities
   • Quality Management System Documents – including quality policies, internal audits, and corrective actions to ensure the validity of the distribution chain.These documents demonstrate that the company operates not only administratively but also possesses an accountable internal quality control system.
3. Pharmaceutical Technical Staff / Responsible Technical Person (PJT)
   One key element in the IPAK/IDAK licensing process is the presence of Pharmaceutical Technical Staff, also known as the Responsible Technical Person (PJT). The requirements include:
   • A minimum educational background of a D3 or S1 in pharmacy, electromedical engineering, medical laboratory technology, or public health.
   • Registered in the Ministry of Health’s Information System (SIKL) and can be proven by an official appointment letter from the company.
   • Competency in handling medical device products, including documentation, reporting, and technical audits.The presence of a PJT is a mandatory requirement because the PJT is professionally responsible for the safety and operational eligibility of the medical device distribution process. In the case of IDAK, PJTs are not required to hold CDAKB certification. However, if the distributor seeks CDAKB certification, the PJT must undergo CDAKB training as scheduled by the Ministry of Health. CDAKB certification is intended for distributors importing products from abroad and registering medical device permits.Apart from PJTs, if the products include electromedical devices, a technician with at least a high school diploma in mechanical/electrical engineering is required. For radiation electromedical products, a medical radiology technician qualification is also necessary.
4. Document Requirements
   To meet the IPAK/IDAK licensing requirements, additional documentation is needed, such as:
   • Product brochures for each type of product
   • Warehouse equipment requirements, including:
     • Fire extinguishers (APAR)
     • Air conditioning (AC)
     • Thermohygrometer
     • Pallets
     • Racks
     • Collection points
     • Evacuation routes

Read More: Tanda Daftar Gudang

Is Product Testing Required for Medical Devices?

To ensure the safety, quality, and efficacy of medical devices to be distributed in Indonesia, the government, through the Ministry of Health, mandates several technical procedures, including product testing and the involvement of qualified personnel. Both aspects are crucial in the licensing and operational distribution process.

When Is Medical Device Product Testing Required?

Not all medical devices are required to undergo laboratory or technical testing. However, this requirement highly depends on the product’s risk classification, which is divided into four classes based on Minister of Health Regulation No. 62 of 2017 concerning the Licensing of Medical Devices and Household Health Supplies, as well as its relevant regulations. The following is a summary of the classification and its testing implications:

1. Class A – Class I (Low Risk): Medical devices such as bandages, gloves, and medical tapes. These products typically only require administrative evaluation and quality documentation without in-depth laboratory testing.
2. Class B – Class II.A (Low to Medium Risk): For example, syringes, digital blood pressure monitors, or electronic stethoscopes. These may require basic technical testing to prove product safety and functional effectiveness.
3. Class C – Class II.B (Medium to High Risk): Includes infusion pumps, pacemakers, and surgical support devices. These require more complex technical testing and sometimes limited clinical trials.
4. Class D – IV.D (High Risk): Examples include ventilators, defibrillators, or heart implants. These must undergo testing at accredited laboratories, either domestically or internationally, and may require clinical trials to support their medical claims.

Note:
The Ministry of Health may request testing results from accredited laboratories or independent organizations recognized internationally for imported medical devices.

Read More: Tanda Daftar Gudang

Conclusion

The distribution of medical devices in Indonesia is a complex and highly regulated process to ensure that every product circulating in the market is safe, of high quality, and beneficial. Compliance with regulations is not only a legal obligation but also a determining factor for operational success and business sustainability in the health sector.

Obtaining a Medical Device Distributor License (IPAK/IDAK) is the first step that must be completed by every business entity, whether local or foreign. This license can only be obtained if the company meets the legal, technical, quality management, and competent technical personnel requirements.

Additionally, it is important to understand that product testing is not always required for every type of product, but it is mandatory for medical devices with medium to high risk (Classes B, C, and D). This testing may include technical testing, limited clinical trials, or quality certification from accredited laboratories, either domestically or internationally.

With the risk-based licensing system integrated through the OSS-RBA platform, the medical device distribution process is now more transparent, efficient, and can be monitored in real-time. However, this transparency also demands that business operators possess a comprehensive understanding of regulatory requirements and high operational preparedness.

Ultimately, for companies wishing to enter the Indonesian medical device market legally and sustainably, understanding all aspects of licensing, testing, and technical personnel is key. Compliance with regulations not only opens doors to the market but also serves as an ethical foundation for supporting a safer national health system for the entire population.

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ET Consultant is a Business Consultant and Legal Consultant Expert that provides support for local and multinational clients to start and manage their business operations in Indonesia. ET Consultant specializes in Business Incorporation, Licensing & Legal, Accounting & Taxes, Immigration, and Advisory Services.

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