How the TGA regulates software based medical devices

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Medical Devices Safety, Regulatory Compliance, Therapeutic Goods Regulation

Published

February 24, 2021

Last updated

February 24, 2021

Description

This guidance summarises the regulatory approach of the TGA for software based medical devices

Organization

Country / Region

Australia

License

Other (Non-Commercial)

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