Regulatory Affairs for Medical Devices Workshop
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
- 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?
- $1,240 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 firstname.lastname@example.org. Please supply your name, company name, email address and phone number, and we will contact you upon the next availabilty
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: email@example.com
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.