What it is
What is TGA compliance?
TGA compliance means fulfilling the requirements of the Therapeutic Goods Act 1989 and its regulations. Medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.
- Device classification (risk-based, with GMDN coding)
- Conformity assessment procedures and evidence
- Technical documentation demonstrating safety and performance
- An Australian sponsor for overseas manufacturers
- ARTG inclusion and post-market obligations
Why it matters
Why TGA compliance is important
- Legal market access across Australia
- Validated safety and performance of your device
- Reduced legal and regulatory risk
- Credibility with Australian healthcare professionals
How we help
Our TGA services
- Device classification and regulatory strategy
- Conformity assessment preparation (including use of MDSAP / EU evidence)
- Technical documentation assistance
- Sponsor coordination and ARTG application support
- Post-market obligations and adverse event reporting setup
01
Compliance experts
Expertise in TGA regulations and global submission processes.
02
Regulatory alignment
Aligned with TGA and ISO 13485 requirements.
03
End-to-end support
From classification to complete post-market compliance.
04
Timely execution
Focused on speed, quality and accuracy for every device.
The regulatory journey
From regulatory strategy to TGA approval
- 01Framework identificationWe confirm the regulatory pathway that applies to your product and target market — MDSAP, MDR, FDA, TGA or MHRA.
- 02Regulatory strategyDevice classification, pathway selection and a realistic timeline to support launch planning.
- 03Technical documentationRisk management, clinical/performance evidence, labeling and QMS records built to each authority’s expectations.
- 04Submission and liaisonWe prepare and submit the application, manage questions from the authority or Notified Body, and track progress.
- 05Approval and market accessClearance, CE or UKCA marking, ARTG inclusion or registration, enabling your product to be placed on the market.
- 06Post-market complianceOngoing surveillance, vigilance, periodic updates and renewals to maintain compliance.
