2023 Waitlist - Pre-Market Regulatory Affairs for Medical Devices Workshop

MTAA has organised for a series of two-day workshops on Pre-Market Regulatory Affairs for Medical Devices Workshop with TGA in 2023. These interactive workshops will provide detailed coverage of the medical device regulations in Australia.

We will be hosting these workshops in three different cities including Brisbane and Sydney. The final destination as well as exact dates of each workshop confirmed to those on the waitlist and RAF (Regulatory Affairs Forum) first. Note: These will all be face-to-face interactive workshops 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. 

Each workshop will run as two full-day sessions:

• Day One from 9:00 to 17:00 AEST
• Day Two from 9:00 to 17:00 AEST

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? 

Anyone interested in learning more about Regulatory and who would benefit from the opportunity to ask TGA questions directly should attend the training.