About the Event
MTAA has organised a two-day workshop with TGA on Pre-Market Regulatory Affairs for Medical Devices Workshop - Melbourne 16-17 November 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, 16 November from 9:00 to 17:00 AEDT
- Friday, 17 November from 9:00 to 17:00 AEDT
- Location Cliftons Melbourne Freshwater Place
- 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.
- Basics of Australian Medical Device Regulations and TGA structure and personnel
- QMS requirements – ISO 13485, MDSAP
- Intended use and classification of Medical Devices
- Market authorisation - EU & FDA
- 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
- Essential Principles, Risk Management, and Clinical Evidence Requirements
- Case studies
- Most recent regulation changes and impacts
- 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
Visit the website to find out more and to register!