Medical Device and IVD Regulatory Affairs
Practical, Independent Support.
Practical RA provides regulatory affairs services for medical devices and in vitro diagnostic medical devices (IVDs), supporting manufacturers with compliant market access and ongoing regulatory obligations across the EU, US, Australia and key international markets.
We are dedicated to empowering small businesses with practical knowledge to navigate global regulatory requirements.
Regulatory Support for Medical Devices and IVDs
EU MDR / IVDR Support
Practical assistance for EU regulatory compliance and transition activities.
US FDA Support
Hands-on services to deliver 510(k) clearance, plan pre-submissions or identify suitable Product Codes and predicates
Regulatory Strategy
Support across classification, technical documentation, and regulatory pathways in global markets.
Australian Sponsor (TGA)
Australian Sponsor services for overseas manufacturers supplying medical devices and IVDs in Australia.
Our client focus
We work with organisations that value clear regulatory advice, defined responsibilities, and practical solutions. Our approach is structured, risk-based, and aligned to regulatory expectations.
- Overseas medical device and IVD manufacturers
- Start-ups and established manufacturers
- Organisations entering new markets or managing regulatory change
Why Practical RA?
Quality Learning Materials
We have created and collated the highest-quality materials available online, to complete your learning portfolio.
Freely shared knowledge
Our tailor-made resources and tools were designed and used by regualtory affairs professionals. Now we have made them available to everyone.
Meet SAGE.
EU Submission Builder for Small Businesses
Designed by seasoned professionals for self-starters. SAGE guides you through every step to create an approval-ready EU MDR 2017/745 submission, entirely in house.
No subscriptions. No consultants needed.
Achieve Regulatory Independence with SAGE.
Latest Regulatory Insights
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Choosing an Australian Sponsor for Your Medical Device: What to Look For
Choosing an Australian Sponsor for Your Medical Device: What to Look For Once you’ve established that you need an Australian Sponsor, and most overseas manufacturers do, the next question is who to choose. The Sponsor you appoint will hold legal regulatory responsibility for your device in Australia, appear on your product labelling, and be your […]
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Do I Need an Australian Sponsor for My Medical Device? | Practical RA
Do I Need an Australian Sponsor for My Medical Device? If you’re an overseas manufacturer looking to sell your medical device or IVD in Australia, the short answer is almost certainly yes: you need an Australian Sponsor. But what exactly does that mean, what are they responsible for, and what happens if you don’t have […]
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CE Marking to TGA: How to Use Your EU MDR Certification to Enter the Australian Market
If your medical device already holds CE Marking under EU MDR 2017/745, you may be closer to selling in Australia than you think. The TGA recognises EU MDR certification as valid manufacturer evidence for ARTG inclusion, meaning you can often bypass a full TGA conformity assessment entirely. Here’s what you need to know. Why Australia […]
European Office: Practical RA
67 Rue Saint-Jacques, 75005 Paris, France
Australian Office: Practical RA Pty Ltd
Level 4, 80 Market Street, South Melbourne VIC 3205, Australia