Post-Market Regulatory Affairs for Medical Devices Workshop - Melbourne 15 November 2023

9:00am Wednesday, 15 November 2023
5:00pm Wednesday, 15 November 2023
MedTech Workshop
Cliftons Melbourne Freshwater Place
Level 18/2 Southbank Blvd
Southbank, Victoria 3006

MTAA has organised a one-day workshop with TGA on Post-Market Regulatory Affairs for Medical Devices Workshop - Melbourne 15 November 2023. This interactive workshop will provide detailed coverage of the medical device regulations in Australia.

Essential Details

  • Date/Time: Wednesday, 15 November from 9:00 to 17:00 AEST
  • Location: Cliftons Melbourne Freshwater Place
  • 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

"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

Contact Information

Additional Information

Changes & cancellations

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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.