Regulatory Affairs for Medical Devices Workshop

9:30am Thursday, 17 March 2022
1:00pm Friday, 18 March 2022
MedTech Workshop
Karstens Sydney
Level1/111 Harrington street The Rocks
Sydney 2000

MTAA has organised a two-day workshop on Regulatory Affairs for Medical Devices Workshop from 17-18 March 2021. This interactive workshop will provide detailed coverage of the medical device regulations in Australia.

The workshop will run as two half-day sessions:

  • Thursday, 17 March from 9:30 to 13:00 AEDT
  • Friday, 18 March from 9:30 to 13:00 AEDT
  • Location Karsten's Harrington Street, The Rocks, Sydney


  • Morning tea
  • Light networking lunch on Friday

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? 

  • $1,240 Inc. GST for members
  • $1,550 Inc. GST for non-members

Event Sold Out

If the event is sold out you may wish to join the waiting list by emailing Please supply your name, company name, email address and phone number, and we will contact you upon the next availabilty

Sold Out

Contact Information

Additional Information

Changes & cancellations

Cancellations for all face-to-face training and events will be accepted up to five business days prior to the training and are subject to a cancellation fee of $50. Attendees from the same organisation may be swapped prior to the training if MTAA is advised. No refunds are issued for cancellations after this time.

If a cancellation is made less than five days prior to an event, without prior notice or substitution, there will be no refund. Should MTAA cancel an event, a full refund will be made.

P: +612 9900 0600 or E:

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.