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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
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…
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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…