This guide is for export and market-development managers at foreign manufacturers of X-ray, CT, mammography, fluoroscopy, radiotherapy and nuclear medicine equipment who are choosing an Indonesian distribution partner, and for Indonesian trading companies deciding whether to enter this category. After reading it, you will know exactly which two licences define a lawful radiation medical device distributor in Indonesia, what the public data suggests about how many companies hold both, and how to verify a candidate before you negotiate terms.
In our experience assisting manufacturers of X-ray and CT systems with market entry, most distributor shortlists built by a commercial team before any regulatory screening contain at least one candidate whose Ministry of Health distribution licence does not cover the radiation electromedical category at all. In several cases we reviewed, none of the shortlisted candidates held a current import authorisation from the nuclear regulator on the day we checked. That gap is not visible from a company profile, a website, or a hospital reference list. It only shows up when the licence documents themselves are read against the categories they actually cover.
What Makes a Company an Eligible Radiation Medical Device Distributor in Indonesia
A lawful radiation medical device distributor in Indonesia must hold two separate authorisations issued by two separate regulators. The first is a distribution licence from the Ministry of Health, the Izin Distribusi Alat Kesehatan (IDAK), specifically covering the radiation electromedical device category, issued under Peraturan Menteri Kesehatan Nomor 14 Tahun 2021. The second is an import or transfer licence for ionising radiation sources issued by the Nuclear Energy Regulatory Agency (BAPETEN) under Undang-Undang Nomor 10 Tahun 1997 concerning Nuclear Energy and its implementing regulations. A company holding only one of the two cannot lawfully perform the full distributor function a manufacturer needs.
Two Regulatory Regimes, One Device
An X-ray unit, a CT scanner, or a linear accelerator is regulated twice over. It is classified as a medical device, and separately as a source of ionising radiation. Each classification triggers its own statute, its own licensing authority, and its own compliance obligations that a distributor must satisfy independently.
The Ministry of Health Distribution Licence (IDAK)
Distribution of medical devices in Indonesia requires an IDAK, governed today by Peraturan Menteri Kesehatan Nomor 14 Tahun 2021 concerning standards for business activities and products in risk-based business licensing in the health sector. This regulation replaced the earlier framework under Peraturan Menteri Kesehatan Nomor 1191/MENKES/PER/VIII/2010 on medical device distribution.
The detail manufacturers most often miss is that the IDAK is not a single blanket approval. Medical device distribution is broken into categories: radiation electromedical equipment, non-radiation electromedical equipment, in vitro diagnostics, and sterile and non-sterile non-electromedical products. Holding an IDAK proves nothing about which of those categories a company is actually licensed to distribute. The only question that matters is which categories are named on the certificate itself.
In Indonesian regulatory practice, this specific category is referred to as IDAK elektromedik radiasi, and it is the exact term to look for on a candidate’s certificate or to ask a candidate for directly. A generic IDAK listing, or one that names only non-radiation electromedical categories, does not satisfy this requirement, however similar the wording may look at a glance.
The BAPETEN Nuclear Licensing Regime
Utilisation of nuclear energy, including possession, import, and transfer of ionising radiation sources, requires authorisation under Article 17 paragraph (1) of Undang-Undang Nomor 10 Tahun 1997 concerning Nuclear Energy. That statute has since been amended by Undang-Undang Nomor 11 Tahun 2020, Peraturan Pemerintah Pengganti Undang-Undang Nomor 2 Tahun 2022, and Undang-Undang Nomor 6 Tahun 2023.
Licensing of ionising radiation sources sits under Peraturan Pemerintah Nomor 29 Tahun 2008, while radiation safety and security requirements are now governed by Peraturan Pemerintah Nomor 45 Tahun 2023, which superseded Peraturan Pemerintah Nomor 33 Tahun 2007. For a distributor, the licences that matter in practice are the import licence and the transfer licence, processed through BAPETEN’s Balis system and integrated with the national risk-based online single submission (OSS) platform. Import and export restrictions specific to consumer goods, ionising radiation sources, and nuclear materials are set out separately in Peraturan BAPETEN Nomor 3 Tahun 2024.
This authorisation is what BAPETEN itself refers to in Indonesian as the izin impor sumber radiasi pengion, the import licence for ionising radiation sources. It is worth using this exact term when corresponding with a candidate distributor or with BAPETEN directly, since it is the term that appears on the licence documents and in the Balis system itself.
A company that holds an IDAK but not a current BAPETEN import or transfer licence, or the reverse, is not a complete distribution solution for a radiation-emitting device. Both authorisations have to sit with the same legal entity for the arrangement to function.
How Many Distributors Actually Qualify? What the Public Data Shows
No government body publishes a single count of companies holding both authorisations at once. The table below sets out the closest publicly available indicators. Each figure has a different scope and a different limitation, so none should be read as a direct answer.
| Indicator | Angka | Source and caveat |
|---|---|---|
| Utilisation permits issued in the medical field | 8,107 | Stated by BAPETEN’s public communication coordinator at a regulatory socialisation event. Covers end users such as hospitals and clinics, not distributors. |
| Utilisation permits issued in the industrial field | 5,426 | Same source and event. |
| Attendance by importers of ionising radiation sources at a BAPETEN licensing dissemination session | 114 of 152 participants (38 were BAPETEN staff) | From a BAPETEN report on an online event held 27 December 2021. Event attendance, not a register count. Directional only. |
| Domestic producers holding an X-ray production permit | 2 | Stated by BAPETEN in a formal audience with the Ministry of Health. Both described as assembly-based operations, with further applications pending. |
| Permit stock in DKI Jakarta | 5,505 permits across 803 institutions (3,536 valid, 1,969 expired) | BAPETEN. The date of this figure could not be confirmed from the source and should be treated as unverified until checked. |
The comparison that matters is between the first row and the third. Several thousand medical facilities across Indonesia are licensed to operate radiation equipment. The population of companies that can lawfully place that equipment into their hands appears, on the only public indicator available, to be smaller by roughly two orders of magnitude.
Why No Official Count Exists
The number a manufacturer actually wants, companies holding both an IDAK covering radiation electromedical devices and a current BAPETEN import or transfer licence, is not published anywhere because no single authority maintains that intersection. The Ministry of Health keeps its own register against Permenkes 14/2021. BAPETEN keeps its own register against the nuclear energy statutes and Peraturan Pemerintah Nomor 45 Tahun 2023. Neither system was built to answer the other’s question.
In short: the eligible distributor population for radiation-emitting medical devices in Indonesia is defined by the overlap of two independently maintained regulatory registers, that overlap is not published by either the Ministry of Health or BAPETEN, and a manufacturer must verify each candidate’s licence documents individually rather than relying on a public list.
How to Verify a Prospective Radiation Medical Device Distributor in Indonesia
The following checklist establishes whether a candidate is genuinely eligible. It should be worked through before heads of terms are signed, and certainly before any exclusivity commitment is made.
- Request the IDAK certificate itself, not a verbal or written statement that one is held, and confirm the radiation electromedical category is explicitly listed on it.
- Request the BAPETEN import licence, and the transfer licence if the arrangement involves onward distribution, and check both the validity dates and the scope of radiation sources covered.
- Confirm both licences are held by the exact legal entity that will sign the distribution agreement, not by a related company, affiliate, or sister entity.
- Check that the licensed scope matches the specific device type. Radiography, computed tomography, and radiotherapy equipment are not interchangeable categories within a single licence.
- Ask which qualified radiation protection personnel the candidate relies on to meet BAPETEN’s safety requirements, and confirm that individual is still employed by the company.
- If a candidate lacks one of the two authorisations, treat the time needed to obtain it as part of the overall market-entry timeline, not as a side issue to resolve later.
Common Mistakes Manufacturers Make When Selecting an X-ray Distributor Indonesia Buyers Can Rely On
Many manufacturers apply the same distributor-selection process across every market they enter, screening for hospital relationships, service infrastructure, and financial standing first, and treating licensing as paperwork to confirm afterward. For non-radiation medical devices that order of operations is usually workable, because the eligible distributor population is large.
For an X-ray distributor Indonesia manufacturers can actually rely on, or any radiation-emitting equipment distributor, that sequence tends to produce a shortlist where commercial strengths look identical across candidates but licence scope does not. A distributor with excellent hospital coverage and no current BAPETEN import licence cannot import the device on the manufacturer’s behalf, regardless of how strong its commercial profile is.
This is also where the two licensing regimes intersect with medical device registration Indonesia radiation rules more broadly. A distributor’s IDAK and BAPETEN status do not replace the manufacturer’s own device registration obligations with the Ministry of Health. They are parallel requirements, and a distributor’s licence gaps can delay a registration timeline even when the registration dossier itself is complete.
Limitations of This Data
The figures presented in this article are the best publicly available indicators and are not a register count of eligible distributors. The import licensing attendance figure reflects participation in a voluntary online event, not a population total. The Jakarta permit figures are undated in the original source and should be treated as unverified until confirmed. No figure here should be quoted as an authoritative count of eligible distributors. Licence scope and category definitions should always be confirmed against the current text of the applicable instruments at the time of any transaction, and all regulatory statements in this article should be reviewed by qualified counsel before being relied upon.
Selecting a Distribution Partner Without Guesswork
Distributor selection for radiation-emitting medical devices is a regulatory question before it is a commercial one. The eligible population sits at the intersection of two licensing regimes that do not share a register, that intersection is not published, and the available indicators suggest it is a small fraction of the broader medical device distributor market in Indonesia.
If you are preparing to appoint a distributor for X-ray, CT, mammography, fluoroscopy, radiotherapy, or nuclear medicine equipment, our Pemilihan Distributor di Indonesia service verifies IDAK category coverage and BAPETEN licence status for each candidate before you enter negotiations. It works alongside our Registrasi Perangkat Medis Radiasi service, which handles the Ministry of Health and BAPETEN approvals your device itself will need once a partner is confirmed.
For related guidance on how licensing details affect an existing distribution relationship, see our article on why your IDAK does not transfer when you change your company address in Indonesia.
Book a consultation with our Distributor Selection team before you shortlist candidates. We will confirm which prospective partners genuinely hold both the IDAK category and the BAPETEN licence your device requires, so your shortlist reflects the real eligible pool rather than a commercial guess.
