,Freyr Australia's Comprehensive Medical Device Services
- Expert Liaison with the Therapeutic Goods Administration (TGA)
- Pre-submission meetings and strategic consultations with TGA
- Australian sponsor services for compliance
- Medical device classification and grouping
- Conformity Assessment Body (CAB) liaison and approvals
- ARTG listing support for Class I, IIa, IIb, III, AIMD devices, and Classes 2, 3, and 4 IVDs
- MDSAP Certification for Seamless Market Entry
- QMS establishment, audits, and training
- Post-approval changes management and license renewals
Simplify your ARTG listing and TGA approval process.
Why Partner with Freyr?
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Regulatory Intelligence (RI)-Driven Solutions for Faster Approvals
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Single Partner for End-to-End Regulatory Needs
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99% Right-First-Time Submissions — Save Time and Costs
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Trusted and Preferred Australian Sponsor Services
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Local Experts with a Deep Understanding of Australian Market Dynamics
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Category-Specific Specialists
Speak with our TGA Experts and start your journey to compliance Now!
Frequently Asked Questions
The Therapeutic Goods Administration (TGA) is Australia’s Regulatory body for therapeutic goods. Registration ensures that your medical devices meet Regulatory requirements and are safe for market entry.
The steps typically involve device classification, conformity assessments, sponsor engagements, and TGA submissions. Freyr can seamlessly handle each step.
Depending on the device class, the process can take several weeks to months. Freyr’s expertise ensures timely and accurate submissions to speed up approvals.
Yes, we provide post-approval support, including license renewals, audit preparations, and change management.
Our deep Regulatory expertise, local presence, and high success rate with Right-First-Time submissions set us apart.