Medical Device Regulations for Non-Regulatory Professionals | 21 May 2025
Navigating medical device regulations doesn’t have to be intimidating — even if it’s not your core role. This interactive workshop is designed to give non-regulatory professionals a practical, working understanding of the regulatory environment that shapes everything from product development to marketing.
The workshop will cover the following areas:
The Big Picture
We will start with the basics—why regulations exist, how Australia’s TGA fits into the global picture, and what terms like “exempt,” “excluded,” “sponsor,” and “kind of medical device” actually mean.
Pre-Market Pathways
Understand how devices are classified based on risk, how classifications work differently for software as a medical device (SaMD), and how international evidence is used locally. Participants will explore the regulatory approval process — from concept to market — and receive hands-on experience with an activity that pits marketing and regulatory perspectives against each other.
Post-Market Realities
This session will explore what happens after a device is approved. We will break down post-market surveillance, adverse event reporting, off-label use, and the role of clinical-facing teams in feeding back real-world data. You will learn how decisions made after launch are just as critical to compliance.
Advertising & Promotion
What marketing messages and claims can or cannot be said? This session will unpack the advertising code of conduct and MTAA’s code of practice, with a focus on real examples. Participants will have a chance to test their judgment on sample ads.
Collaborating with Regulatory Teams
In the final session, we will give participants the tools to ask the right questions, flag potential issues early, and strengthen their partnership with regulatory teams.
Along the way, participants will take part in polls, case studies, and activities to help build an understanding of the relationship between regulatory affairs and your role, whether you work in product, sales, marketing, quality, or clinical teams.
Who Should Attend?
- Entry-level regulatory professionals
- MedTech professionals outside of regulatory departments:
- Business Development Managers
- Marketing Specialists
- Quality Professionals
- Clinical Specialists
- R&D (Research and Development) Teams
- Supply Chain and Logistics Professionals
- Legal and Compliance Officers
Note: This is a face-to-face event with no recordings available. Placements are strictly limited.
Registration
- Members $999 incl. GST per person
- Non-Members $1,287 incl. GST per person
Contact Information
Additional Information
Speaker Profiles
Understanding TGA Regulations and Why They Matter
Join Arjun Joshi from BSI to understand the fundamentals of Australia’s medical device regulations and the critical role they play in the industry.
Mastering Communication in Regulatory Affairs
Clear and effective communication with your regulatory team is key to successful medical device approvals and compliance. Alejandro will share insights on:
- Bridging the gap between technical teams and regulatory experts
- Streamlining processes for better compliance and faster approvals
- Turning feedback into action for continuous improvement
Post-Market Insights & Compliance—What You Need to Know
Join Colm O'Rourke, General Manager at MDSS AU Pty Ltd, as he explores the critical nuances of post-market regulations, including adverse events (AEs), off-label use, device changes, and the role of clinical-facing teams in gathering vital feedback.
Navigating Medical Device Advertising & Compliance
Join Kea Dent, an industry expert, as she provides essential insights into ensuring compliance, transparency, and ethical marketing in the MedTech space and delves into the intricacies of;
- The Advertising Code of Conduct
- The MTAA Code of Practice
- How to craft compliant claims
- Best practices for medical device advertising
Decoding the Pre-Market Landscape for Medical Devices
Join Seetal Erramilli from BSI as she unpacks the critical aspects of pre-market regulatory navigation, including:
- Risk & category-based classifications – Understanding key differences, including SaMD & other device types
- Comparing pathways across classes – A breakdown of regulatory routes and requirements
- Navigating approval processes – Flowcharts, frameworks, and essential steps
- Special Access Scheme – Insights into alternative pathways for unique cases
