Pre-Market Regulatory Affairs for Medical Devices Workshop - Sydney 24-25 August 2023

MTAA has organised a two-day workshop with TGA on Pre-Market Regulatory Affairs for Medical Devices Workshop - Sydney 24-25 August 2023. This interactive workshop will provide detailed coverage of the medical device regulations in Australia.

The workshop will run as two full-day sessions:

• Thursday, 24 August from 9:00 to 17:00 AEST
• Friday, 25 August from 9:00 to 17:00 AEST
• Location Cliftons Sydney Margaret Street

Inclusions

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

Note: This is a face-to-face interactive workshop only with no recordings available. Placements are strictly limited to 35 attendees and the class size will not be extended to ensure the best learning experience.

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

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

"The courses I've taken in the past haven't been as interesting or as comprehensive as this workshop on medical device regulatory affairs. The MTAA has established a direct line of communication between us and experienced and properly trained TGA personnel so that they can answer any questions that may arise. TGA access has made a real difference in understanding the ever-changing medical device regulatory environment. I was happy to suggest my colleagues to take this course in the future. Many thanks to MTAA and TGA for organising this workshop." - Freddy Torres, Pharmacovigilance Associate, Merz Australia Pty. Ltd