Regulatory Affairs for Medical Devices Workshop - Sydney

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

• 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