BAPETEN Import Licence Amendment: Why Adding a New Radiation Device Model Can Stall Your Shipments

This guide is for supply chain, import, and regulatory staff at Indonesian distributors already holding a BAPETEN import licence who are adding a device model to an existing portfolio. It is also relevant to manufacturers whose Indonesia launch date depends on a distributor’s ability to complete radiation device import Indonesia procedures on time.

In practice, distributors adding a model to an existing BAPETEN import licence run into a constraint that appears nowhere in BAPETEN’s published guidance. Industry association GAKESLAB Indonesia told BAPETEN directly that, since February 2023, an application for import approval could not be lodged in parallel with an application to amend the underlying import licence. Members reported that importation of radiation products was held up while they waited for the amended licence to be issued first. BAPETEN’s Directorate of Licensing for Radiation Facilities and Radioactive Substances responded that the Balis system was under development. This exchange is recorded in BAPETEN’s own published report of a meeting held on 10 March 2023. It is not stated in Peraturan BAPETEN Nomor 3 Tahun 2024, nor in any Balis user guidance. A distributor planning a launch date on the assumption that licence amendment and shipment approval run side by side is planning against a process that, at that point, did not exist.

What Is a BAPETEN Import Licence?

Utilisation of nuclear energy in Indonesia requires a licence under Article 17 paragraph (1) of Undang-Undang Nomor 10 Tahun 1997 tentang Ketenaganukliran. For importers of ionising radiation sources, that licence is administered under Peraturan Pemerintah Nomor 29 Tahun 2008 tentang Perizinan Pemanfaatan Sumber Radiasi Pengion dan Bahan Nuklir, and issued through BAPETEN’s Balis system.

A BAPETEN import licence does not grant general permission to import radiation equipment. It enumerates the specific ionising radiation sources the holder is authorised to bring into Indonesia. Adding a device model outside that list requires the licence itself to be formally amended before any shipment of that model can proceed.

Quick Answer: Can You Import a New Radiation Device Model Before the Licence Amendment Is Approved?

No. A BAPETEN import licence lists the specific ionising radiation sources a distributor is authorised to import. A model that is not yet listed cannot be covered by an import approval, because the entitlement the approval depends on does not exist yet. The licence amendment must be approved first.

BALIS BAPETEN and the OSS RBA System

Import licences and their amendments are filed through Balis, BAPETEN’s online licensing platform, integrated with Indonesia’s risk-based Online Single Submission system, OSS RBA. Under Peraturan Pemerintah Nomor 5 Tahun 2021 on risk-based business licensing, nuclear energy sector licences follow the nomenclature and requirements set out in that regulation’s Ketenaganukliran annexes.

によると BAPETEN’s own Balis FAQ, an applicant adding a new ionising radiation source to an existing licence issued through Balis 2.5 must file a licence amendment, known as permohonan perubahan izin, rather than a fresh application, provided a licence for the same activity was already issued through that system. This is the same application that, per the GAKESLAB report below, could not run in parallel with the import approval.

The BAPETEN Import Licence vs. Persetujuan Impor BAPETEN (Import Approval)

The licence and the import approval are two different instruments doing two different jobs. Confusing them is the most common reason a distributor misjudges how long it takes to bring in a new model.

The Reported Scheduling Constraint on Izin Impor Sumber Radiasi Pengion Perubahan

At a meeting on 10 March 2023, GAKESLAB Indonesia’s chairman told BAPETEN that a mechanism change from February 2023 had affected members’ ability to bring in radiation products. Import approval applications could not be lodged alongside licence amendment applications, so shipments waited for the amended licence to issue first.

BAPETEN’s response, recorded in the same published report, was that the Balis system was under development and that the agency would coordinate with other agencies on the difficulties raised. This is the association’s account of its members’ experience, reported by the regulator, not a stated provision in any regulation.

Because the response pointed to a system still being developed, the position may have shifted since March 2023. Distributors should confirm the current mechanism with BAPETEN’s Directorate of Licensing for Radiation Facilities and Radioactive Substances before committing to a delivery date for any source not yet on their licence.

Why This Falls on Working Capital

If licence amendment must complete before an import approval can be lodged, the two processing steps run one after the other instead of side by side. That converts what looks like an administrative step into a period in which the new model cannot enter Indonesia at all.

• Orders taken against an assumed delivery date can become undeliverable.
• Contractual installation dates expose the distributor to a regulatory process it does not control.
• A tender requiring delivery within a fixed period may be unwinnable if the licence does not yet cover the specified source.
• A manufacturer’s regional launch plan may be built around a milestone its Indonesian distributor cannot reach.

How This Connects to Medical Device Registration Indonesia (Radiation)

A BAPETEN import licence runs alongside, not instead of, the Ministry of Health’s medical device registration Indonesia radiation pathway. Distributing a radiation-emitting medical device such as an X-ray unit also requires an active IDAK with an Electromedical Radiation scope, a CDAKB certificate, and product-level AKL registration through Regalkes.

A device model added to a BAPETEN import licence still needs its own izin edar alat kesehatan radiasi before it can be sold. Our Radiation Medical Device Registration service coordinates the BAPETEN licence track with the Kemenkes IDAK, CDAKB, and AKL requirements so the two do not fall out of sequence.

This sequencing risk is not unique to radiation devices. Foreign bidders in government procurement frequently misjudge how registration timing interacts with tender deadlines, a pattern examined in our article on IHSS procurement and registration timing.

Practical Steps for Adding a Device Model to an Existing Licence

These steps reflect how the constraint described above plays out operationally. They point toward confirmation and coordinated filing, not toward self-filing an amendment without qualified support.

1. Confirm the current mechanism with BAPETEN before setting any delivery date for a source not yet enumerated on the licence.
2. Treat licence amendment as a lead-time item in the product introduction plan, positioned ahead of the first shipment rather than alongside it.
3. Where portfolio expansion is foreseeable, consolidate several models into one amendment application rather than filing sequentially.
4. In distribution agreements, define the delivery obligation by reference to a shipment window that begins on issuance of the amended licence, not a fixed calendar date.
5. Check licence enumeration against tender specifications before submitting a bid, not after award.

Because the licence sits with the local entity acting as import licence holder, coordinating an amendment often means coordinating with that holder directly. Our ライセンスホルダーサービス manages this on behalf of foreign manufacturers who do not have their own licensed entity in Indonesia.

Limitations of This Guide

The scheduling constraint described here is as reported by an industry association at a 2023 meeting, and BAPETEN indicated at the time that the relevant system was under development. This guide does not state the current mechanism, current processing durations, or fees, which should be confirmed directly with BAPETEN or with a qualified advisor before any commercial commitment is made.

結論

Whether an import approval can be lodged alongside a licence amendment is a scheduling detail, not a headline regulatory requirement, but it decides when a distributor can actually ship. Confirming the current position before committing to a delivery date costs a conversation with BAPETEN. Not confirming it costs undeliverable orders.

Product Registration Indonesia’s Radiation Medical Device Registration service coordinates BAPETEN import licence amendments with the Kemenkes IDAK, CDAKB, and AKL requirements for each device model, so a new model’s regulatory track and its commercial timeline stay aligned. Book a consultation with our Radiation Medical Device Registration team before you commit to a delivery date for a model not yet on your licence.