About the Event

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

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.

Click here for more information.

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