Classification and pathway
Assess intended purpose, technology and risk. Distinguish general devices from IVD requirements and check exemptions before planning ARTG inclusion.
AU · TGA
Australia TGA market access
Coordinate device classification, an Australian sponsor, conformity evidence and ARTG inclusion, with support beyond the initial application.
How SUNGO supports your project
Sponsor and ARTG inclusion
Coordinate an Australian sponsor and reconcile manufacturer, device kind and sponsor details for the applicable ARTG application.
Evidence and declaration
Review available quality-system and overseas evidence, Manufacturer Evidence requirements and the Australian Declaration of Conformity. An EU declaration does not replace the Australian declaration.
Maintenance and UDI readiness
Support ongoing maintenance, change assessment and regulatory enquiries. Prepare applicable UDI data and AusUDID work against the requirements and dates for the device.
An overseas authorisation is not automatic permission to supply in Australia. Unless an exemption or another applicable provision applies, ARTG inclusion is required before supply; evidence and review requirements are device-specific.
AFTER THE INITIAL DISCUSSION
Build a product-specific document plan
You do not need every document for the first enquiry. We identify gaps after understanding your product and target market.
Intended purpose, models and classification rationale
Quality-system certificates and overseas authorisations, including their scope
Labelling, instructions and conformity evidence
Proposed sponsor and post-market responsibilities
Specific requirements are subject to product assessment and the competent authority’s current regulations.
TGA · Supply a medical device ↗ · TGA · Documentation for ARTG inclusion ↗
TGA application process
- 01
Confirm classification and application documents
- 02
Submit the application
- 03
Complete fee payment
- 04
Respond to review enquiries
- 05
Complete inclusion upon approval
Specific requirements are subject to product assessment and the competent authority’s current regulations.
INITIAL CONSULTATION
Start with two things
Send your product name and instructions for use, and tell Serena which market you are considering.
- Product name
- Instructions for use