Medical Device Regulatory Workshops Sydney

This practical session covers sponsors’ ongoing obligations, including adverse event reporting, conditions of inclusion, annual reporting, and the TGA’s signal management processes. Participants will also work through post‑market review scenarios, respond to information requests, and engage in workshop activities and a Q&A with the TGA.

Speakers: 

• Katie Burns (Director, Devices Post Market Review Section)
• Dan Yang (Assistant Director, Devices Post-Market Monitoring Section)

Learning outcomes

1. Adverse events - definitions, sponsor and manufacturer responsibilities, TGA report review process  
2. Recalls - flow, types, decision-making about outcomes   
3. Reviews, safety, reclassification, managing feedback on reforms 
4. Q&A with TGA 

This hands‑on session provides a practical overview of the regulatory framework for software as a medical device (SaMD), including the software carve‑out and clinical decision support systems (CDSS). Topics will include software classification rules, Essential Principles, evidence and documentation requirements, cybersecurity, advertising, post‑market obligations, and AI considerations. The session will include applied examples and conclude with a Q&A with the TGA.

Speakers:

• Olivia Reeves (Director, Medical Device Software)

• Gabrielle Harradine (Assistant Director, Medical Device Software)

Learning outcomes

1. Overview of SaMD regulation 
2. Classification rules 
3. Software carve-out 
4. Clinical Decision Support System (CDSS) 
5. Evidence, artifacts, AI, cybersecurity 
6. Q&A with TGA 

This practical workshop covers clinical evaluation requirements, including indirect evidence and substantial equivalence, clinical investigation design, real‑world evidence (RWE), and post‑market responsibilities. Participants will work through interactive activities and conclude with a Q&A with the TGA.

Speakers:

• Christine Gee (Medical Officer, Devices Clinical Evaluation Section)
• Anna Calik (Devices Clinical Evaluation Section)

Learning outcomes

1. Pre-clinical requirements 
2. Post-clinical requirements 
3. Q&A with TGA 

This session provides a practical introduction to the TGA and the Australian regulatory framework, covering therapeutic goods and medical devices, risk classifications, Essential Principles, regulatory guidance, fees and charges, with time for Q&A.

Speakers:

• Jane Shum (A/g Director Medical Device Authorisation Executive Section)
• Tao Tan
• Morteza Yousefi (Applications Manager - Conformity Assessment)
• Mohik Metha

Learning outcomes 

1. Basics of Australian Medical Device Regulations and TGA structure and personnel 
2. Leveraging comparable overseas regulator approvals for TGA applications 
3. TGA applications, variation applications, and application audits – best practice guidelines for a good submission 
4. TGA CA applications - best practice guidelines for a good submission 
5. Case studies 
6. Q&A with TGA