Navigating SaMD Registration, Exempt Software, and Excluded Software under Australian TGA Regulations
December 11, 2024
45 Minutes
Join the Webinar at your Convenient Time
For AMR & EU Regions
10:00 AM EST | 04:00 PM CET
For RoW Region
11:30 AM IST
What Is It All About?
Australia’s regulatory framework for Software as a Medical Device (SaMD) is becoming increasingly complex, with evolving standards aimed at ensuring the safety and quality of digital health technologies. For medical device manufacturers, compliance with these TGA (Therapeutic Goods Administration) regulations is essential to avoid compliance issues and penalties. Are you fully informed on Australia’s SaMD regulations, exemptions, and the various criteria that classify software under the TGA framework?
To guide you through these complexities, we’re presenting an exclusive webinar, “Navigating SaMD Registration, Exempt Software, and Excluded Software under Australian TGA Regulations.” This session, will provide a comprehensive overview of TGA’s regulatory landscape for SaMD, covering crucial areas such as risk classification, submission pathways, criteria for exempt and excluded software, and post-market obligations.
The webinar will be hosted by Kristen Laudicina, and our in-house Regulatory expert - Bharath Rajendran will elaborate on:
- 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
Given the keynotes and with due consideration for your hectic schedule, we anticipate seeing you in the webinar. Register now! Stay informed. Stay compliant.
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
For AMR & EU Regions
10:00 AM EST | 04:00 PM CET
For RoW Region
11:30 AM IST