Anyone planning to distribute medical devices in Indonesia will quickly run into two acronyms: IDAK and CDAKB. They are often mentioned together, but they are not the same thing. One is a business license, the other is a quality management standard. Understanding the difference, and how they work together is the first step before diving into the technical details of each one.
What Is IDAK?
IDAK stands for Izin Distribusi Alat Kesehatan, or Medical Device Distribution License. It is the official permit a business entity must hold before it is legally allowed to procure, store, distribute, or supply medical devices in Indonesia, whether at wholesale or retail scale.
IDAK is issued through Indonesia’s risk-based licensing system, OSS-RBA (Online Single Submission – Risk-Based Approach), under business classification code KBLI 46691, which covers large scale trade in pharmaceutical, laboratory, and medical devices. The license itself is approved with technical clearance from the Ministry of Health (Kemenkes), through the Directorate General of Pharmaceutical and Medical Devices (Ditjen Farmalkes).
IDAK is actually a newer term for what used to be called IPAK (Izin Penyalur Alat Kesehatan), regulated under Minister of Health Regulation (Permenkes) No. 1191/Menkes/Per/VIII/2010 on Medical Device Distribution. When Indonesia moved to the integrated OSS-RBA licensing framework, this was folded into Permenkes No. 14 of 2021 on Standards for Business Activities and Products in Risk-Based Business Licensing in the Health Sector, which now serves as the primary legal basis for issuing IDAK today.
To obtain IDAK, a company generally needs to show:
- A legally established business entity (PT or cooperative) with a valid deed of establishment reflecting activity in the medical device sector.
- A Business Identification Number (NIB) under KBLI 46691.
- Physical premises (office and warehouse)that meet distribution standards (virtual offices are not accepted for this purpose). Importantly, the license is tied to this specific registered address, so relocating the office or warehouse later means the company must update or reprocess its IDAK accordingly, rather than simply carrying the existing license over to the new location.
- A Penanggung Jawab Teknis (PJT), or Responsible Technical Person, with a relevant educational background such as pharmacy, electromedical engineering, medical laboratory technology, or public health, registered in the Ministry of Health’s information system.
- Compliance with CDAKB, the good distribution practice standard discussed below.
Without IDAK, a company cannot legally import, store, or distribute medical devices in Indonesia, doing so is treated as unauthorized distribution and can trigger administrative sanctions or legal consequences under Indonesia’s Health Law.
What Is CDAKB?
CDAKB stands for Cara Distribusi Alat Kesehatan yang Baik, or Good Distribution Practice for Medical Devices. Where IDAK is the license to operate, CDAKB is the operational and quality standard that a distributor must actually follow once it is operating.
The legal foundation for CDAKB is Minister of Health Regulation (Permenkes) No. 4 of 2014 on Good Distribution Practice for Medical Devices. According to the Ministry of Health’s own published module on this regulation, Article 2 Paragraph 1 of Permenkes No. 4/2014 states that every medical device distributor, and every branch of a distributor, must implement CDAKB when carrying out distribution activities. The Ministry notes that CDAKB is modeled on the international standard for Good Distribution Practice (GDP), adapted to Indonesia’s regulatory context.
CDAKB sets out requirements covering, among others:
- Quality management systems, documented, structured, and consistently applied.
- Personnel management, including competency and training records for staff handling medical devices.
- Facilities and infrastructure, proper storage conditions to prevent damage or contamination.
- Procurement, storage, and transportation, ensuring the integrity of devices throughout the supply chain.
- Traceability, the ability to track a product’s movement, which supports authenticity and helps prevent counterfeit or substandard devices from reaching end users.
- Control over outsourced activities, where third parties are involved in parts of the distribution process.
CDAKB applies across the main categories of regulated medical devices: radiation based electromedical devices, non-radiation electromedical devices, sterile non-electromedical devices, non-sterile non-electromedical devices, and in-vitro diagnostic devices.
How IDAK and CDAKB Work Together
It helps to think of it this way: IDAK is the permission to be a distributor; CDAKB is the proof that the distributor knows how to do it properly. In practice, a company applying for IDAK is expected to demonstrate that it meets CDAKB requirements as part of the licensing process, since Kemenkes ties the operational standard to the license itself. A company cannot simply hold a legal permit while ignoring how it actually stores or transports devices, the two are meant to function as a single system of accountability, from paperwork down to the warehouse floor.
This linkage also reflects the broader intent behind Indonesia’s medical device regulations: making sure that every device reaching a hospital, clinic, or patient has passed through a chain of custody that is licensed, monitored, and quality-controlled from the point of import or manufacture to the point of use.
Why This Matters for Businesses Entering the Indonesian Market
For foreign manufacturers and local distributors alike, IDAK and CDAKB are not optional formalities, they are prerequisites for legally operating in Indonesia’s medical device sector, and they are closely tied to obtaining a product’s marketing authorization (Izin Edar) as well. Companies that overlook either requirement risk delays, rejected applications, or regulatory action once operations are underway.
Because both frameworks involve detailed technical, administrative, and human resource requirements, businesses often work with experienced regulatory consultants to navigate the application process through OSS-RBA and ensure their operations align with CDAKB from day one.
Need Help Securing IDAK and CDAKB Compliance?
Navigating IDAK licensing and CDAKB certification can be time-consuming without the right local expertise, from preparing the correct SOPs to appointing a qualified Penanggung Jawab Teknis and passing Kemenkes assessment. Product Registration Indonesia helps foreign manufacturers and local distributors manage the entire process, from OSS-RBA licensing to CDAKB readiness and medical device marketing authorization (Izin Edar), so your products can enter and stay in the Indonesian market without regulatory setbacks.
Sources
- Directorate General of Pharmaceutical and Medical Devices, Ministry of Health of the Republic of Indonesia (Ditjen Farmalkes Kemenkes RI), Module on Good Distribution Practice of Medical Device, farmalkes.kemkes.go.id
- Minister of Health Regulation (Permenkes) No. 4 of 2014 on Good Distribution Practice for Medical Devices (Cara Distribusi Alat Kesehatan yang Baik)
- Minister of Health Regulation (Permenkes) No. 1191/Menkes/Per/VIII/2010 on Medical Device Distribution
- Minister of Health Regulation (Permenkes) No. 14 of 2021 on Standards for Business Activities and Products in Risk-Based Business Licensing in the Health Sector
