Navigating SaMD Registration, Exempt Software, and Excluded Software under Australian TGA Regulations
The webinar was successfully concluded on
December 11, 2024
Topics Covered:
In a nutshell, during the webinar, our presenter – Bharath Rajendran discussed the following topics:
- Introduction to SaMD (Software as a Medical Device)
- TGA's Regulatory Framework for SaMD
- Understanding Exempt Software - Criteria for software exemptions under TGA regulations.
- Excluded Software – Explaining what qualifies as excluded software and examples.
- Overview of Submission Process, Audit, and Review for SaMD
- Risk Classification of SaMD: Understanding TGA’s risk classification system for SaMD and its implications.
- Managing Post-Market Obligations for SaMD
- Common Pitfalls in SaMD Registration
- Future Trends with AI in SaMD Regulation
- Q&A and Key Takeaways
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Kristen Laudicina is the Vice President of Strategic Account for Freyr’s Medical Devices Center of Excellence (CoE). She currently oversees the North and South American Regions and supports Freyr’s Medical Device CoE team. Kristen has 14+ years of experience within Life Sciences, from Preclinical through Commercial Manufacturing, and understands the client’s needs from both a Sponsor and Service Provider perspective.
With Backed by over 10 years of experience in regulatory affairs and recognized expertise in TGA regulations. Bharath Rajendran has crafted strategies that accelerate approvals, reducing time-to-market by up to 30%. He has successfully led submissions for over 100 devices, including complex and high-risk categories, facilitating swift market access and compliance in Australia. Bharath’s work spans from start-ups to global corporations, where he plays a vital role in shaping regulatory strategies. His expertise includes guiding clients through pre-market submissions, audits, and post-market obligations, ensuring that manufacturers are fully prepared for regulatory inspections. Bharath’s influence extends to developing best practices for regulatory compliance, streamlining operations in Australia’s dynamic medical device sector.
Host
Kristen Laudicina
Vice President of Strategic account, Medical Devices
Presenter
Bharath Rajendran
Manager, Medical Device Regulatory Affairs Centre of Excellence- Australia