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TGA Medical Device Changes – Guidance for Health Care Professionals

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  • Overview

A new regulatory framework for custom-made medical devices and 3D printing commenced on 25 February 2021. What does this mean for allied health care professionals?


Join this presentation and hear about the regulatory changes from Rebecca Bateson of the Therapeutic Goods Administration. Rebecca will be providing:

  • The background around the regulatory environment for medical devices
  • An overview of the changes
  • Specific examples demonstrating the impact of the new framework
  • Information about the deadlines and transition periods for impacted devices
  • Next steps for impacted stakeholders


Executive staff members from Australian Physiotherapy Association (APA), Occupational Therapy Australia (OTA) and Australian Hand Therapy Association (AHTA) will also be part of the webinar and will help to facilitate the session with the TGA to help two-way communication for the changes.



Rebecca Bateson
Assistant Director, Devices Emerging Technology and Diagnostics
Therapeutic Goods Administration



Wendy Rowland 
Chief Executive Officer 
Australian Hand Therapy Association


Carol Jewell
Acting National Manager – Professional Practice and Development
Occupational Therapy Australia


Date of Live Event



CPD Hours

1.0 Hours


Please note: The content of this Lecture on Demand (LOD) was captured via a recording of a live lecture at the APA premises. Due to the nature of the event and the recording method, this LOD may not have captured some of the questions/comments from live audience. Your purchase of this module indicates your acceptance of this.


Image: Tom Claes, Unsplash.com