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

9:00am Thursday, 25 August 2022
5:00pm Friday, 26 August 2022
MedTech Workshop
Cliftons Sydney Margaret Street
Level 13, 60 Margaret Street
Sydney, New South Wales 2000
Australia

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

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

 

Contact Information

Additional Information

Changes & cancellations

Click here to view the MTAA Events and Facilitated Training Terms and Conditions.

Tax invoice

You will be emailed a paid tax invoice once payment is complete. A copy of all your transactions are also available in your Transaction History tab on your My MTAA Account and can be viewed here anytime.