{"id":7447,"date":"2026-08-18T09:38:26","date_gmt":"2026-08-18T02:38:26","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-08-18T09:38:28","modified_gmt":"2026-08-18T02:38:28","slug":"radiation-medical-device-distributor-indonesia","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/id\/radiation-medical-device-distributor-indonesia\/","title":{"rendered":"Radiation Medical Device Distributor Indonesia: Why the Eligible Pool Is Smaller Than You Think"},"content":{"rendered":"

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<\/strong>, what the public data suggests about how many companies hold both, and how to verify a candidate before you negotiate terms.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

\"Radiation<\/figure>\n\n\n\n

What Makes a Company an Eligible Radiation Medical Device Distributor in Indonesia<\/h2>\n\n\n\n

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.<\/a> 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<\/a> 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.<\/p>\n\n\n\n

Two Regulatory Regimes, One Device<\/h2>\n\n\n\n

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.<\/p>\n\n\n\n

The Ministry of Health Distribution Licence (IDAK)<\/h3>\n\n\n\n

Distribution of medical devices in Indonesia requires an IDAK, governed today by Peraturan Menteri Kesehatan Nomor 14 Tahun 2021<\/a> 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 <\/a>on medical device distribution.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

In Indonesian regulatory practice, this specific category is referred to as IDAK elektromedik radiasi<\/em>, 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.<\/p>\n\n\n\n

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Understanding IDAK and CDAKB: The Two Pillars of Medical Device Distribution in Indonesia<\/a><\/blockquote>