TGA medical device changes – guidance for health care professionals
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), Dan Miles, Occupational Therapy Australia (OTA), Samantha Hunter and Australian Hand Therapy Association (AHTA), Wendy Rowland, 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. A Q&A session will follow the presentation.
Preparation for the webinar
In order to get the most out of the session, it is recommended that all participants read through:
• The overview of the framework on the TGA's website; and
• Answers to frequently asked questions
If there are some examples that would be useful to raise at the session, please feel free to email them to firstname.lastname@example.org or raise them at the webinar.