Radioactive IVD Registration in Indonesia: Inside the IVD Radiation Regulatory Pathway

The mistake we run into most often is deceptively simple. A company files a radiolabeled IVD kit, a radioimmunoassay (RIA) reagent, say, exactly the way it would file an ordinary diagnostic, using nothing but a Kemenkes technical dossier. The Kemenkes review goes fine. The classification lands where expected. Then the shipment reaches the border, and it turns out the isotope inside the kit needed a clearance of its own, one that nobody had started.

In our experience, the fix isn’t really about paperwork at all. It’s about sequencing. A radioactive IVD kit is best understood as two products sharing a single label: the diagnostic itself, which Kemenkes reviews, and the radioactive substance inside it, which answers to a completely different regulator. Prepare both files from day one and the timeline holds together. Prepare them one after another, and the second one almost always catches you off guard.

That is really the whole logic behind the IVD radiation regulatory pathway in Indonesia. An ordinary IVD only ever has to satisfy Kemenkes, while a radioactive IVD has to satisfy Kemenkes and the national radiation regulator at the same time, well before a single unit can legally reach a hospital or laboratory shelf.

This guide walks through exactly that. It’s written for regulatory affairs managers, distributors, and importers about to place a radioactive IVD kit onto the Indonesian market, whether this is their first filing or their tenth, and it covers which two regulators are actually involved, where their requirements diverge from an ordinary IVD filing, and what needs to be lined up long before a shipment ever reaches customs.

If your product doesn’t contain a radioactive tracer, though, the pathway that matters more to you is the one covered in our companion article, Indonesia IVD Registration: How the Pathway Differs from a Medical Device, which walks through risk classification and the added clinical-evidence step for Class D infectious disease IVDs. That distinction lives entirely inside Kemenkes. The one covered here runs across two separate regulators, and it’s the subject of everything that follows.

The Core Difference: One Product, Two Approval Objects

IVD technology sold in Indonesia today is more varied than a simple lateral-flow strip. Some IVD kits carry an active pharmaceutical component, and a smaller but persistent category carries a radioactive tracer, most often an isotope such as iodine-125, used in radioimmunoassay (RIA) kits for hormone or tumor-marker testing.

In our experience preparing dossiers for this category, Kemenkes evaluators reviewing a radioactive IVD kit’s technical file routinely hold the file at the queue stage until the applicant can show an active or in-process authorization number from the national radiation regulator, even though Permenkes No. 62 Tahun 2017 does not itself list a nuclear clearance as a stated document requirement. The cross-check happens as reviewer practice, not as a printed checklist item, which is not the kind of detail a first-time applicant would anticipate from the regulation text alone.

A radioactive IVD kit is therefore evaluated as two separate approval objects held by two separate regulators. Kemenkes, through the Direktorat Jenderal Farmasi dan Alat Kesehatan (Ditjen Farmalkes), evaluates the kit as an in vitro diagnostic medical device under Peraturan Menteri Kesehatan (Permenkes) No. 62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga.

Separately, Indonesia’s national radiation regulator evaluates the radioactive content of the same kit as a controlled radioactive substance under Undang-Undang No. 10 Tahun 1997 tentang Ketenaganukliran and its implementing regulations. This is the second track behind nuclear regulatory compliance IVD applicants need to plan for, described in detail below.

The Standard IVD Registration Track Under Kemenkes

Every IVD product placed on the Indonesian market, radioactive or not, must first pass through Indonesia IVD registration under Permenkes No. 62 Tahun 2017. The applicant submits a technical dossier through the REGALKES electronic system managed by Ditjen Farmalkes, structured broadly along the ASEAN Common Submission Dossier Template used across ASEAN Medical Device Directive member states.

The dossier is evaluated against the product’s risk class, from Class A, the lowest risk, through Class D, the highest risk. The outcome is a Nomor Izin Edar (NIE), the distribution number that authorizes the kit to be marketed and sold in Indonesia.

This part of the process is identical whether or not the kit contains a radioactive tracer. Our 医疗器械和体外诊断试剂注册 service manages this Kemenkes track end to end. What is not identical is what has to sit alongside the Kemenkes dossier before the file can move forward, which is the second track described below.

The Second Track: Nuclear Regulatory Compliance for IVD

Nuclear regulatory compliance for IVD kits containing radioactive material sits with the national radiation regulator, not Kemenkes, and runs on a separate legal basis. Utilisation of a radioactive substance in Indonesia, including its import, requires a licence from the national radiation regulator under Article 17 paragraph (1) of Undang-Undang No. 10 Tahun 1997 tentang Ketenaganukliran.

Licensing procedure for the utilisation of ionising radiation sources and nuclear material follows Peraturan Pemerintah No. 29 Tahun 2008 tentang Perizinan Pemanfaatan Sumber Radiasi Pengion dan Bahan Nuklir. Radiation safety and radioactive source security requirements are set out in Peraturan Pemerintah No. 45 Tahun 2023 tentang Keselamatan Radiasi Pengion dan Keamanan Zat Radioaktif, which superseded the earlier Peraturan Pemerintah No. 33 Tahun 2007 on the same subject.

In short: a radioactive IVD kit cannot lawfully enter Indonesia on a Kemenkes izin edar alone. The importer, or its appointed licence holder, must also secure authorization from the national radiation regulator covering the radioactive substance itself, processed through its own online licensing system, now integrated with Indonesia’s risk-based Online Single Submission (OSS) platform under the national radiation regulator’s Regulation No. 3 Tahun 2021 tentang Standar Kegiatan Usaha dan Standar Produk pada Penyelenggaraan Perizinan Berusaha Berbasis Risiko Sektor Ketenaganukliran.

Import Follows the Nuclear Regulator’s Requirements

Import of the radioactive component follows the national radiation regulator’s process requirements at every stage, not a generic customs timeline set by the importer. Shipment description, packaging, on-site radiation protection equipment, and the storage facility for the radioactive material all have to be documented to the national radiation regulator’s satisfaction before a consignment is authorized to enter the country.

This step is separate from, and in addition to, the customs clearance that applies to a non-radioactive IVD shipment. It cannot be initiated using the same paperwork the importer uses for an ordinary reagent shipment.

The Two Tracks Are Not Interchangeable

Holding a Kemenkes izin edar does not authorize import of the radioactive tracer, and holding an import licence from the national radiation regulator does not authorize commercial distribution of the finished IVD kit. Both authorizations must be held, current, and matched to the same product and the same legal entity for a shipment to be lawful.

Standard IVD vs Radioactive IVD: A Side-by-Side Comparison

The table below sets out where the two pathways run in parallel and where a radioactive IVD kit picks up an additional requirement.

Where the Two Pathways Intersect During Registration

A short sequence clarifies which pathway a given product follows and where the two regulators’ requirements meet.

1. Does the IVD kit contain any radioactive isotope or tracer? If no, it follows the standard Kemenkes-only pathway under Permenkes No. 62 Tahun 2017.
2. If yes, has the applicant identified the isotope type and activity level? This detail determines the specific regulator category the kit falls under.
3. Has an authorization from the national radiation regulator for the radioactive substance been secured, or at least initiated, in parallel with the Kemenkes dossier? In our experience, files without a matching reference from the national radiation regulator are commonly held at the Kemenkes review stage, even when the technical file itself is complete.
4. Is the importer of record the same legal entity named on both the Kemenkes izin edar and the national radiation regulator’s licence? A mismatch between the two documents is one of the more frequent causes of a blocked shipment we encounter.

In short: a radioactive IVD kit needs a Kemenkes izin edar under Permenkes No. 62 Tahun 2017 and a matching authorization from the national radiation regulator under UU No. 10 Tahun 1997, held by the same legal entity, before it can be lawfully imported and distributed in Indonesia.

Common Missteps We See With Radioactive IVD Registration

• Treating clearance from the national radiation regulator as a formality to arrange after the Kemenkes izin edar is issued, rather than running it in parallel from the start.
• Assuming the importer of record already used for non-radioactive products automatically qualifies to import radioactive material.
• Underestimating the facility documentation the national radiation regulator expects for radioactive storage, which is a different standard from general warehouse compliance under Permenkes-based good distribution practice.
• Treating “the kit contains a radioactive component” as sufficient detail, when isotope type and activity level are what actually determine which of the national radiation regulator’s requirements apply.

Because the exact classification and required reference from the national radiation regulator vary by isotope, activity level, and intended use, this determination is generally worth running past a regulatory partner before a submission timeline is locked in, rather than resolving it in isolation from the Kemenkes filing.

Radiation Medical Device Registration Services in Indonesia: How We Support Radioactive IVD Filings

Product Registration Indonesia’s Radiation Medical Device Registration Services in Indonesia cover both the standard IVD track and the added nuclear regulatory compliance IVD applicants encounter when a kit contains a radioactive tracer. We coordinate the Kemenkes technical dossier and the national radiation regulator’s authorization as a single project timeline, rather than as two disconnected filings run by separate teams.

For manufacturers whose portfolio also includes radiation-emitting instrumentation used alongside these kits, such as gamma counters, our 辐射医疗器械注册 service handles the equipment side of the same shipment.

For a broader look at how the national radiation regulator and Kemenkes approvals are sequenced for radiation-related medical products, see our related article on radiation-emitting medical device registration in Indonesia. For the classification-driven differences that apply to non-radioactive IVDs, including the Class D infectious disease efficacy step, see Indonesia IVD Registration: How the Pathway Differs from a Medical Device.

Book a consultation with our 医疗器械和体外诊断试剂注册 team to map the Kemenkes and the national radiation regulator requirements for your specific radioactive IVD kit before you commit to an import or launch date.