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
Australia

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

Inclusions

  • 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 pd@mtaa.org.au. 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: pd@mtaa.org.au

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.