Category
Guidance Document
Organisation
Type
Standard
Version
1
Access
Open
Status
Active
Updated
May 2023
This document provides guidance for the mental health sector about when their digital tools, aids, apps and products, including internet-based services, may be regulated as medical devices by the Therapeutic Goods Administration (TGA).
It aims to support providers of digital mental health services or products understand their regulatory obligations and outlines key differences between regulation and oversight by the TGA for digital mental health tools and products.
Main sections:
· What is in scope of this document
· What is out of scope of this document
· What are Digital Mental Health Tools and Products
· When is digital technology a medical device?
· TGA regulation of digital mental health products
· Example Scenarios of Regulation
· Privacy and data protection
· Post-market monitoring and standard conditions of inclusion in the ARTG
· Post market reviews
· How to apply to the TGA for ARTG inclusion of your mental health product
It aims to support providers of digital mental health services or products understand their regulatory obligations and outlines key differences between regulation and oversight by the TGA for digital mental health tools and products.
Main sections:
· What is in scope of this document
· What is out of scope of this document
· What are Digital Mental Health Tools and Products
· When is digital technology a medical device?
· TGA regulation of digital mental health products
· Example Scenarios of Regulation
· Privacy and data protection
· Post-market monitoring and standard conditions of inclusion in the ARTG
· Post market reviews
· How to apply to the TGA for ARTG inclusion of your mental health product
Access Digital tools and medical devices v1.0
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