TGA registration process
Five stages, each with a clear purpose
- 01
Product assessment
- 02
Registration strategy
- 03
Documentation preparation
- 04
Submit the application
- 05
ARTG and ongoing maintenance
Core services
Which TGA pathway fits your product?
Tell us your product's intended use, existing authorizations and launch plans,
Start with classification and documentation needs.
- Registration strategy
- Local Sponsor
- Chinese-language communication
AustraliaTGA registration and market access
Explore our Australian services
CanadaRegistration and market channels
Explore our Canadian services
Selected cases
Multiplex viral antigen test
IVD Class 3
For combined respiratory virus antigen testing. The certificate lists different combinations and settings including self-testing and point-of-care use.
View case and certificate
Gastrointestinal endoscopic haemostatic clip
MD Class IIb
A long-term indwelling clip device for closure and haemostasis during gastrointestinal endoscopy. Refer to the certificate for locations and indications.
View case and certificate
Dental ceramic
MD Class IIa
Ceramic blanks for custom dental restorations such as crowns, bridges, veneers, inlays and onlays.
View case and certificate