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

Medical Technology Association of Australia



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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

  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

For more information, contact MTAA.