Post-Market Regulatory Affairs for Medical Devices Workshop - Sydney 18 May 2023

9:00am Thursday, 18 May 2023
5:00pm Thursday, 18 May 2023
MedTech Workshop
Cliftons Sydney Margaret Street
Level 13, 60 Margaret Street
Sydney, New South Wales 2000

MTAA has organised a one-day workshop with TGA on Post-Market Regulatory Affairs for Medical Devices Workshop - Sydney 18 May 2023. This interactive workshop will provide detailed coverage of the medical device regulations in Australia.

Essential Details

  • Date/Time: Thursday, 18 May from 9:00 to 17:00 AEST
  • Location: Cliftons Sydney Margaret Street
  • Inclusion: Morning tea, lunch and afternoon tea


Session 1 | Introductions and ice breaker

9:00am - 9:30am (30-minute session)

Hosted by Dr Jasjit Baveja 

Session 2 | TGA Overview: TGA Structure with Focus on Surveillance 

9:30am - 10:00am (30-minute session)

Speaker: To be announced

Session 3 | Adverse events: definitions, sponsor and manufacturer responsibilities, TGA report review process 

10:00am - 10:45 (45-minute session)

Speaker: To be announced

Morning Tea Break

10:45am - 11:15am (30-minute break)

Session 4 | Activity 1 – Adverse events: examples and what would you do 

11:15am - 12:00pm (45-minute session)

Speaker: To be announced

Session 5 | Recalls activity: flow, types, decision-making about outcomes  

12:00pm - 12:45pm (45-minute session)

Speaker: To be announced

Lunch Break

12:45pm - 1:45pm (60-minutes)

Speaker: To be announced

Session 6 | Activity 2 – Recalls activity: different types and how you would process them 

1:45pm - 2:30pm (45-minute session)

Speaker: To be announced

Session 7 | Post-market reviews discussion

2:30pm - 3:00pm (30-minute session)

Post-market reviews discussion: introduction into recent reforms, and focus on post-market reforms (what, why and timelines e.g. reclassification, mandatory adverse event reporting, UDI PICs/PILs and rationale for reforms) 

Speaker: To be announced

Afternoon Tea Break

3:00pm - 3:30pm (30-minute break)

Session 7 | Activity 3 - Post Market Reviews: safety example, reclassification example, and how we deal with feedback on reforms

3:30pm - 4:00pm (30-minute session)

Session 8 | Clinical Evidence requirements  

4:00pm - 4:30pm (30-minute session)

Wrap up, Q&A, networking and feedback 

4:30pm - 5:00pm (30-minute)


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.

Learning outcomes

  1. This is a new program - MTAA is working with TGA to finalise the content
  2. Q&A with TGA

Who should attend? 

Regulatory professionals should attend the training. 

How much does it cost? 

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

Contact Information

Additional Information

Changes & cancellations

Click here to view the MTAA Events and Facilitated Training Terms and Conditions.

Tax invoice

You will be emailed a paid tax invoice once payment is complete. A copy of all your transactions are also available in your Transaction History tab on your My MTAA Account and can be viewed here anytime.