ARTG entry management
Prepare and manage ARTG inclusion activities and maintain sponsor records for ongoing supply.
Australian sponsor services
Independent TGA sponsor support for overseas manufacturers.
Ocevia helps overseas medical device and IVD manufacturers manage the Australian sponsor model, ARTG inclusion, TGA communications, and ongoing post-market obligations.
Discuss sponsor support
Why sponsor matters
The sponsor is more than an application contact.
An Australian sponsor is the local entity responsible for TGA communication, ARTG records, and key post-market compliance activities connected to products supplied in Australia.
An independent sponsor model can help manufacturers keep regulatory control separate from commercial distribution and reduce long-term transfer risk.
Sponsor responsibilities
What Ocevia can support.
TGA liaison
Act as the Australian point of contact for TGA communication, application questions, and compliance requests.
Manufacturer evidence
Review manufacturer evidence, technical documentation, labelling, quality evidence, and submission readiness.
Post-market duties
Support adverse event reporting, recalls, complaints, changes, audit requests, and lifecycle compliance.
Timelines and cost factors
Timing depends on device class, evidence readiness, and TGA review requirements.
- Device classification and intended purpose
- Existing approvals and comparable overseas evidence
- Completeness of manufacturer evidence and technical files
- Whether the application is selected for TGA audit
- Scope of ongoing sponsor and post-market support required
FAQ
Common sponsor questions.
Does an overseas manufacturer need an Australian sponsor?
Generally, overseas manufacturers need an Australian-based sponsor to include and supply medical devices in Australia, unless a specific exemption applies.
Can a distributor act as the sponsor?
A distributor may be able to act as sponsor, but many manufacturers prefer an independent sponsor to keep regulatory control separate from sales relationships.
What happens after ARTG inclusion?
Sponsor responsibilities continue after inclusion, including maintaining evidence, responding to TGA requests, managing changes, and supporting post-market reporting.
Can we change our Australian sponsor later?
Sponsor transfer is possible, but it requires planning so ARTG entries, manufacturer evidence, agreements, and ongoing supply obligations remain controlled.
Sponsor review