Medical Device Regulatory Workshops Sydney
The MTAA Medical Device Regulatory Workshops 2026 are a series of TGA-led sessions designed to provide comprehensive insights into the evolving regulatory landscape for medical devices in Australia. These workshops aim to equip MedTech Professionals with the latest updates, compliance strategies, and best practices to navigate regulatory requirements effectively. Attendees will gain valuable knowledge on pre-market, post-market, software as a medical device and clinical evidence.
Learning outcomes
- Adverse events - definitions, sponsor and manufacturer responsibilities, TGA report review process
- Recalls - flow, types, decision-making about outcomes
- Reviews, safety, reclassification, managing feedback on reforms
- Q&A with TGA
Learning outcomes
- Overview of SaMD regulation
- Classification rules
- Software carve-out
- Clinical Decision Support System (CDSS)
- Evidence, artifacts, AI, cybersecurity
- Q&A with TGA
Learning outcomes
- Pre-clinical requirements
- Post-clinical requirements
- Q&A with TGA
Learning outcomes
- Basics of Australian Medical Device Regulations and TGA structure and personnel
- Leveraging comparable overseas regulator approvals for TGA applications
- TGA applications, variation applications, and application audits – best practice guidelines for a good submission
- TGA CA applications - best practice guidelines for a good submission
- Case studies
- Q&A with TGA
Who Should Attend?
- MedTech Regulatory Professionals
- Academia / Students focused on the medical device industry
- Small business owners with regulatory responsibilities
- Startups/entrepreneurs
Note: These are face-to-face workshops only, there are no recordings available. Placements are strictly limited.
Registration
The series offers a choice of 4 workshops, priced for members and non-members. Discounts are available for those attending the entire week. Four-Day Workshop Registration
- Members $3,564 incl. GST per person (includes all workshops)
- Non-Members $4,633 incl. GST per person (includes all workshops)
Day Registrations
- Members $990 incl. GST per person per workshop
- Non-Members $1,287 incl. GST per person per workshop
