Introduction to Regulatory Affairs - Sydney 1 May 2024

MTAA has organised a one-day workshop with TGA on an Introduction to Regulatory Affairs - Sydney on 1 May 2024. This interactive workshop will provide a broad overview of pre-and-post market medical device regulations in Australia with more information on upcoming in-depth modules in the future.

Essential Details

• Date/Time: Wednesday, 1 May from 9:00 to 17:00 AEST
• Location: Cliftons Sydney Margaret Street
• Inclusion: Morning tea, lunch and afternoon tea

Note: This is a face-to-face interactive workshop only with no recordings available. Placements are strictly limited to 50 attendees and the class size will not be extended to ensure the best learning experience.

Learning outcomes

1. Life cycle regulation of medical devices and TGA structures
2. Approach to risk-based regulation: intended purpose, risk classification, essential principles and importance of QMS
3. Approach to risk: overview adverse event reporting and recall actions
4. Australia’s place in the world of medical device regulation, with reference to IMDRF, similarities to EUMDR, global networks (safety and emerging tech), and comparable overseas regulators.
5. Routes to the ARTG: Comparable overseas regulators and conformity assessment
6. Post-market review
7. TGA’s approach to refinement of regulations and consultation – keeping regulations fit for purpose
8. Overview of TGA resources and entry points
9. Q&A with TGA

Who should attend? 

Targeted to those new to the Regulatory profession, this workshop will also benefit those who work alongside Regulatory Affairs and want an overview to better understand this area.

How much does it cost? 

• $990 Inc. GST for members
• $1,287 Inc. GST for non-members

"I recently attended the MTAA-organized TGA workshop for the Pre-Market and Post-Market Regulatory Affairs for Medical Devices and it was exceptional! The TGA staff exhibited a remarkable willingness to address questions from the industry, making the workshop an invaluable platform for interaction. It is truly gratifying to be part of a country where the regulatory body is so hands-on, actively listening to industry concerns and providing much-needed support to the industry. TGA's commitment to offering clarification on the ever-evolving regulations and their interpretations is highly commendable. Grateful for the excellent workshop organised by the MTAA and their team members!" - Ram Kannan