Your Specialist Route Into The
Australian Market
We guide overseas medical-device manufacturers through TGA registration, Australian Sponsorship and reimbursement — and remain your point of contact long after approval.
Or call +61 413 578 665
- 01 Market entry strategy
- 02 TGA registration
- 03 Australian Sponsor appointment
- 04 Market access
- 05 Ongoing quality & regulatory support
Pathway mapped to the device before a single form is opened.
We hold your ARTG entries with no interest in your distribution.
Every assessment milestone tracked and reported back to you.
QMS, variations and post-market obligations kept current.
Manufacturers Entering The Australian Market
We work with overseas manufacturers entering the Australian market, and with local companies managing their ongoing quality and regulatory obligations — audit readiness is only one part of it.
First-time entrants
Overseas manufacturers bringing a device into Australia for the first time, mapping the pathway from scratch.
Companies needing a sponsor
Manufacturers who need a non-commercial Australian sponsor rather than handing control to a distributor.
Reimbursement
Manufacturers navigating Prostheses List inclusion.
Local teams under load
Australian device companies needing QMS maintenance, audit readiness and register upkeep.
A Small Market With An Unforgiving Process
TGA logic is not FDA or EU MDR logic
The TGA does not mirror overseas classification rules. A wrong class or an incomplete dossier costs months, not days.
The wrong sponsor is a standing risk
The sponsor holds your ARTG entry and carries legal obligations for you. An importer with commercial interests ties your access to their business.
Approval without funding is not access
For implantables, the Prostheses List sets private hospital reimbursement — with its own evidence, coding and pricing logic.
Inclusion is not the finish line
QMS maintenance, post-market surveillance, adverse-event reporting and audits run for the life of the product.
Approval without funding is not market access.
We run ARTG inclusion and reimbursement as one sequence — including Prostheses List listing for implantables — so your device reaches the market with funding secured.
One Partner, The Whole Pathway
Most sponsors assemble Australia from parts: a consultant for the dossier, an importer as sponsor, someone else for funding. We run the route as one project and stay on it after inclusion.
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Step 01
Market entry strategy
We confirm classification, evidence gaps and the fastest compliant route before money is spent.
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Step 02
TGA registration
We prepare and lodge the application — Class I to III — and answer requests for information.
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Step 03
Sponsor appointment
We act as your non-commercial Australian sponsor, so distribution decisions stay yours.
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Step 04
Reimbursement
We build and lodge the funding case, including Prostheses List applications for implantables.
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Ongoing
Quality & upkeep
ISO 13485 maintenance, audit attendance, post-market obligations and ARTG and UDI upkeep.
Two Decades Inside One Regulatory System
RQSolutions has worked in Australian medical-device regulation since 2002 and is listed as a TGA-recognised sponsor entity. Where a client needs approvals in other markets, we coordinate them through partner consultancies — one point of contact, wider reach.
Registration, Start To Inclusion
Eight service lines, ordered the way projects usually run. Clients start anywhere on this list; most end up using several.
Regulatory
Device registration and TGA applications across every risk class — Class I to III — including classification advice and responses to requests for information.
Sponsorship
We act as your non-commercial Australian sponsor and PLAC representative — one legal entity holding your ARTG entries, with no interest in your distribution.
Quality management
QMS setup, implementation and maintenance to ISO 13485, with internal and external audit support — including preparation for and attendance at certification audits.
Health economics & reimbursement
Government reimbursement strategy and optimisation, with particular depth in implantable devices accessing private hospital funding through the Prostheses List.
Document management
Retrieval, organisation and lifecycle management of regulatory documentation, so the current version is the one on file when an assessor or auditor asks.
Global assistance
Product approvals in additional markets, coordinated through an established network of partner consultancies and managed from one point of contact in Australia. See our partners →
Certificate legalisation
Legalisation of TGA certificates through the Department of Foreign Affairs and Trade (DFAT) and destination-country embassies, for markets that require authenticated documentation.
UDI compliance
UDI applicability assessment, AusUDID data preparation and labelling review, aligned to your device's TGA compliance timeframe. Read our UDI guide →
What Sponsors Say About Working With Us
Our company used George as a consultant to perform registration of our medical devices in Australia. George's deliverables were always on time, and I would highly recommend George to any medical device company that requires device registration and/or Sponsor services in Australia.
Our company used George as a consultant to perform registration of our medical devices in Australia. George's deliverables were always on time, and I would highly recommend George to any medical device company that requires device registration and/or Sponsor services in Australia.
TGA & Industry Updates
Entering The Australian Medical Device Market: A Practical Guide
Entering the Australian medical device market requires more than submitting an application to the Therapeutic Goods Administration (TGA). Instead, the appropriate pathway depends on your device, its intended…
Read more →
What The Latest TGA UDI Guidance Means For Medical Device Manufacturers
Australia's Unique Device Identification (UDI) framework has moved from preparation to implementation. As a result, it brings new compliance responsibilities for medical device manufacturers and sponsors supplying devices…
Read more →
A Guide To Appointing Your Australian Sponsor
What your Australian Sponsor is responsible for — and the questions to ask before appointing one. For an overseas medical device manufacturer planning to enter the Australian market,…
Read more →Let's Get Your Device To The Australian Market.
Tell us the device class and intended claims — we will map the pathway and the timeline. Free scoping call, no obligation.
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