Regulatory Affairs for Medical Devices Workshop

MTAA has organised a two-day workshop on Regulatory Affairs for Medical Devices Workshop from 25-26 August 2022. Hosted in Sydney, this interactive workshop will provide detailed coverage of the medical device regulations in Australia.

Learning Outcomes

• 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

Event Details

Date: Thursday 25 August 2022 to Friday 26 August 2022
Time: 9:00 - 17:00 AEST 
Venue: Cliftons Sydney Margaret Street, Level 13, 60 Margaret Street, NSW 2113

Food/Drinks: Morning tea, afternoon tea and lunch provided on both days

Price: $1,980 Inc. GST for members, $2,574 Inc. GST for non-members

Limited Placements

Placements are limited to 35 people only.

Tel: +61 2 9900 0600

Email: events@mtaa.org.au

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