Varying entries in the ARTG: medical devices and IVDs

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

In Vitro Diagnostic Medical Devices (IVDs)

Published

August 6, 2024

Last updated

August 6, 2024

Description

This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.

Organization

Country / Region

Australia

License

Other (Non-Commercial)

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