Australia TGA market access
Your TGA market access partner in Australia.
Ocevia supports overseas medical device and IVD manufacturers with regulatory strategy, ARTG inclusion, Australian sponsor services, and ongoing compliance.
- ARTG
- Inclusion support
- Sponsor
- Australian representation
- Compliance
- Post-market obligations
Built for overseas manufacturers
A clear route into the Australian medical device market.
Entering Australia requires more than a submission. Manufacturers need the right pathway, appropriate evidence, a local sponsor model, and a plan for ongoing TGA responsibilities.
Ocevia brings these moving parts into one disciplined market access process for technical, quality, regulatory, and commercial teams.
Where we help
Focused pages for each stage of your Australian pathway.
Regulatory services
Strategy, ARTG inclusion, technical documentation, clinical evidence, labelling, QMS, and post-market compliance.
02Australian sponsor services
Independent sponsor representation, ARTG entry management, TGA correspondence, records, and lifecycle obligations.
03Market access process
A practical sequence from initial assessment and evidence readiness through to submission and post-market support.
Independent sponsor model
Keep regulatory control separate from sales channels.
Overseas manufacturers often rely on local distributors for commercial launch. Ocevia can support an independent sponsor model so regulatory communication, ARTG records, and post-market duties remain professionally managed.
View sponsor pageClient focus
Support for manufacturers entering or expanding in Australia.
Resources
Helpful topics for Australian market entry.
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