Regulatory Affairs for Medical Devices Workshop - Melbourne 27-28 October 2022

MTAA has organised a two-day workshop on Regulatory Affairs for Medical Devices Workshop Melbourne from 27-28 October 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, 27 October from 9:00 to 17:00 AEDT
• Friday, 28 October from 9:00 to 17:00 AEDT
• Location Cliftons Melbourne Collins St 

Inclusions

• Morning tea on both days 
• Lunch on both days 
• Afternoon tea on both days 

Note: This is a face-to-face interactive workshop only with no recordings available. Placements are strictly limited to 35 attendees and the class size will not be extended to ensure the best learning experience.

This Workshop will be the last one held in 2022.  We are in talks with the TGA for future events in other Australian cities however, these are not confirmed and will not occur until next year at the earliest. Once we have any new workshops locked in, they will be posted to the MTAA website under Events and promoted in our e-newsletter and social media.

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