Event
Regulatory Affairs for Medical Devices Workshop
- 25 Aug 2022
- 09:00AM
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- Level 13, 60 Margaret Street , Cliftons Sydney Margaret Street , Sydney, New South Wales 2000 , Australia
About the Event
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.
MedTech Workshop
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
- 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
For more information, contact MTAA.