Regulatory Affairs for Medical Devices Workshop - Sydney 25-26 August 2022

MTAA has organised a two-day workshop on Regulatory Affairs for Medical Devices Workshop Sydney from 25-26 August 2022. This interactive workshop will provide detailed coverage of the medical device regulations in Australia.

The workshop will run as two full-day sessions:

• Thursday, 25 August from 9:00 to 17:00 AEST
• Friday, 26 August from 9:00 to 17:00 AEST
• Location Cliftons Sydney, 60 Margaret Street, Sydney Australia

Inclusions

• Morning tea on both days 
• Lunch on both days 
• Afternoon tea on both days 

Learning outcomes

1. Basics of Australian Medical Device Regulations and TGA structure and personnel
2. QMS requirements – ISO 13485,  MDSAP
3. Intended use and classification of Medical Devices
4. Market authorisation - EU & FDA
5. Leveraging comparable overseas regulator approvals for TGA applications
6. TGA applications, variation applications, and application audits – Best practice guidelines for a good submission
7. TGA CA applications - Best practice guidelines for a good submission
8. Essential Principles, Risk Management, and Clinical Evidence Requirements
9. Case studies
10. Most recent regulation changes and impacts
11. Q&A with TGA

Presenters

• Jasjit Baveja, Associate Director, Policy, Ph.D. at MTAA
• Simon Singer, TGA
• Zorik Avakian, TGA
• Benno Schmidhauser, TGA
• Jane Shum, TGA
• Andrew Bathgate, TGA

Who should attend? 

Regulatory professionals should attend the training. 

How much does it cost? 

• $1,980 Inc. GST for members
• $2,574 Inc. GST for non-members