Australia is not a market where a used unit can be sold on the strength of its condition alone. The device has to sit inside a regulatory inclusion, a local sponsor has to carry the obligations, and the unit has to match the device that was included. The condition report matters, but it comes after those three checks.

How the Australian System Works

Australia regulates therapeutic goods through the Therapeutic Goods Act 1989 and the TGA. Medical devices are classified by risk, assessed against the Essential Principles, and entered in the Australian Register of Therapeutic Goods before they can be supplied, unless a specific exemption applies.

The TGA is the regulator, and the ARTG is the register. The system is built around the device and the sponsor rather than around each unit: a manufacturer demonstrates conformity for a device, a sponsor takes responsibility for supplying it in Australia, and the register records the inclusion. A used unit does not get its own ARTG entry; it is supplied under the inclusion for the device, provided it matches the included configuration and the conditions of inclusion.

Comparable questions arise in the US under FDA rules, in Europe under the EU Medical Device Regulation 2017/745, in the UK under MHRA guidance and in Japan under PMDA requirements, while WHO guidance frames the shared principles. The Australian answer is still set by the TGA and the ARTG.

That structure is why the Australian question is not simply \”is the device approved\”. It is \”which device is included, who is the sponsor, and does this unit correspond to the included device\”. The answers sit in different documents, and a buyer should see all three before committing.

ARTG Inclusion and What It Attaches To

ARTG inclusion attaches to a device and a sponsor, not to a serial number. A used unit can be supplied under an existing inclusion if it matches the included device, its intended purpose and the conditions of inclusion; a materially different configuration cannot ride on that entry.

Australia uses a risk-based classification that runs from Class I through Class IIa, Class IIb and Class III, with active implantable medical devices treated separately. The class determines the conformity assessment route and the evidence the manufacturer must hold. The sponsor\’s inclusion is recorded against the device, and the manufacturer\’s evidence supports it.

For a used unit, the matching exercise is practical: manufacturer, model, configuration, software version, accessories and intended purpose. If the unit was rebuilt with a different subsystem or updated beyond the version covered by the manufacturer\’s evidence, the sponsor needs to establish whether it still matches the included device. That is a question for the sponsor and the manufacturer, not for the buyer\’s inspection report.

Sponsor Obligations

The sponsor is the Australian entity responsible for the device in Australia. It ensures the device is included in the ARTG, holds the manufacturer\’s evidence, monitors post-market performance, reports adverse events and manages recalls.

A sponsor is not a forwarding address. It must be able to answer the TGA, hold the conformity evidence, maintain distribution records and act when a safety issue emerges. For imported used equipment, the sponsor is also the party that can confirm whether the unit is within the inclusion and whether the supplier is entitled to place it on the Australian market.

If the manufacturer is outside Australia, the sponsor is the local anchor for the regulatory relationship. That makes the sponsor\’s identity a commercial question as well as a compliance one: a buyer should know who the sponsor is, what devices its inclusion covers and whether it has the technical file for the configuration being sold. The sponsor\’s identity and confirmation belong in the purchase file, not in a conversation after the unit has shipped.

Refurbishment and the Sponsor Question

Refurbishment can change the sponsor\’s position. If the work creates a different device or a significant change, the existing inclusion may no longer describe the unit, and the entity responsible for the change may need to take on manufacturer obligations.

The boundary is the same one that appears in other markets: servicing and maintenance keep a device within its existing conformity; a new subsystem, a changed performance specification or a new intended purpose can take it outside. In Australia, the practical consequence is that the sponsor must be able to show the device still matches the ARTG inclusion, or a new inclusion or variation is required.

For a seller, this means the refurbishment file is part of the regulatory file, not a separate quality document. For a buyer, it means the question \”who refurbished it\” is followed immediately by \”does the sponsor know, and does the inclusion still cover it\”.

Labelling and Instructions

Labelling for the Australian market must identify the manufacturer and the Australian sponsor and must include the information required for the device and its class. Instructions must be in English and must match the configuration supplied.

A used unit that arrives with a European or US label may need an Australian sponsor label or overlay before supply. The overlay has to be controlled: it must not obscure required information, and it must be applied in a way that survives storage and transport. Keep the original label photograph, the overlay artwork and the applied result in the unit file.

Instructions for use are part of the same requirement. A manual that describes a different software version, or that is incomplete, is a labelling defect even if the device itself is in good condition. The buyer should confirm the language, the version and the completeness of the instructions before the unit ships.

Import Permits and Biosecurity

Most medical devices included in the ARTG can be imported without a device-specific permit, but some classes and circumstances require TGA permission, and all imports are subject to biosecurity requirements. Used equipment adds packaging, soil and contamination questions that new equipment usually does not.

The TGA\’s import requirements depend on the device and the reason for import. A unit imported for supply is treated differently from one imported for personal use, repair, clinical trial or exhibition. The importer should confirm the route before shipping, because an import that arrives under the wrong pathway can be held or exported at the importer\’s cost. The logistics sequence before that point is set out in the guide to exporting medical equipment from Hong Kong.

Biosecurity is a separate control. Wood packaging, soil on wheels or frames, and biological residues can trigger inspection or treatment. A decontamination record and a clean packaging declaration are practical documents, not paperwork for its own sake. They also support the condition claim when the unit arrives.

Nominate the importer of record before the shipment is booked. The importer is the party that will be asked for the TGA permission, the ARTG details and the biosecurity declaration, and it may not be the same entity as the buyer or the sponsor. Where a customs broker is used, brief the broker on the device classification and the applicable pathway, because a medical device entry lodged as general cargo is difficult to correct after arrival. Keep the entry documents with the unit file so the next shipment starts from a known baseline.

Evidence for an Australian Buyer

An Australian buyer should receive evidence that links the unit, the device inclusion and the sponsor. The table below is the working set; each missing item should be recorded and assessed rather than replaced by an assurance.

Records and checks: the Australian entry file

Where Grey Areas Remain

Several questions do not have a single answer that applies to every used unit. They depend on the device, the sponsor\’s inclusion, the work performed and the way the unit is supplied.

A private sale between individuals is not the same as supplying devices in trade, and the obligations that attach to a business supply may not attach in the same way to a one-off private transfer. A unit imported for personal use may follow a different route from one imported for resale. A device that is included for one intended purpose may not be included for another. And an exemption that applies to a particular import reason does not automatically cover a later sale.

The practical response is to write down the facts and ask the sponsor or the TGA before shipping. A written answer, dated and tied to the unit, is worth more than a general statement that used equipment is allowed.

If you are preparing an Australian entry file and want the ARTG, sponsor and condition evidence reviewed together, send the model and what you already hold to the HHG team. More guides on records, refurbishment and cross-border entry are in the Knowledge section.