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AusUDID: Everything Medical Device Manufacturers Need to Know | Practical RA
REGULATORY ALERT – AUSTRALIA AusUDID: Everything Medical Device Manufacturers Need to Know Before July 2026 AusUDID UDI compliance is now a legal requirement for Australian sponsors — with mandatory submission of UDI records for Class IIb and Class III medical devices required from 1 July 2026 ⏱ 1 July 2026: Mandatory AusUDID compliance deadline for Class IIb &…
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Choosing an Australian Sponsor for Your Medical Device: What to Look For
REGULATORY ALERT – AUSTRALIA Choosing an Australian Sponsor for Your Medical Device: What to Look For The partnership between a manufacturer and Sponsor is a critical piece of your Australian market access puzzle. This guide will help you perform your due diligence and identify a competant a trusted partner for long-term success. Once you’ve established…
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Australia Medical Device Registration: Do I Need an Australian Sponsor? | Practical RA
REGULATORY ALERT – AUSTRALIA Do I Need an Australian Sponsor for My Medical Device? If you’re an overseas medical device manufacturer looking to sell in Australia, you almost certainly need an Australian Sponsor. Here’s exactly when it’s required, what the Sponsor is responsible for, and what happens if you try to supply without one. Who…
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CE Marking Australia: How to Use EU MDR Certification for TGA Registration | Practical RA
REGULATORY ALERT – AUSTRALIA CE Marking in Australia: Using Your EU MDR Certification for TGA Market Access CE Marking can pave the way for market access all around the globe. Here’s why Australia should be at the top of your list of markets to expand into. If your medical device already holds CE Marking under…
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What Is Regulatory Affairs in Medical Devices: The Ultimate No Nonsense Guide
Introduction In the complex world of medical device development and commercialization, regulatory affairs plays a pivotal role in ensuring products are safe, effective, and compliant with global requirements. What is regulatory affairs in the medical device industry? At its core, regulatory affairs is the profession responsible for navigating the intricate web of regulations governing medical…
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FDA eSTAR: Navigating the New Era of Medical Device Submissions
Introduction To The FDA eSTAR Program The medical device industry is witnessing a significant transformation in regulatory affairs, particularly in how manufacturers submit their applications to the US Food and Drug Administration (FDA). The Electronic Submission Template And Resource (eSTAR) program represents the FDA’s commitment to modernizing the review process for medical devices, moving away…
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Leveraging Approvals and Market Access with CE-Marking
Leveraging EU MDR CE Marking for Global Medical Device Market Access A comprehensive guide to maximizing your regulatory strategy through EU MDR compliance Introduction Navigating the complex landscape of medical device regulatory affairs can be challenging for manufacturers seeking global market access. While many companies view regulatory compliance as merely a hurdle to overcome, strategic…
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Technical documentation under the EU MDR
The Evolving Landscape of European Medical Device Regulatory Affairs: Navigating EU MDR 2017/745 Requirements For professionals in regulatory affairs or innovative MedTech companies, understanding technical documentation under the European Medical Device Regulation (MDR 2017/745) represents a critical competency in today’s global healthcare market. The implementation of the EU MDR marked a significant shift from the…