Australia TGA Publishes Document on Refinements to the Personalised Medical Device Framework

Therapeutic Goods Administration (TGA) Australia has published a document regarding the refinements to the personalised medical device framework in August 2021.  After a public …

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Australia TGA Publishes Finalised Guidance Document on Regulatory Changes for Software Based Medical Devices

Therapeutic Goods Administration (TGA) Australia has published the finalised guidance document on regulatory changes for software-based medical devices in August 2021.  The guidance provides a …

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Australia TGA Publishes Updated Document on Prescription Medicines Registration Process

Therapeutic Goods Administration (TGA) Australia published an updated document on the registration process for prescription medicine applications on the 12th of August …

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Australia TGA Publishes New Guidance on the Management of GMP Compliance Signals

The guidance dated version 1.0 May 2021, outlines the Good Manufacturing Practice (GMP) compliance requirements for manufacturing biologicals and medicines …

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Australia TGA Updates Regulatory Position for Data Collection Components Used by Software As a Medical Device

Rapid innovation in technology has driven significant changes to software function and adoption, giving rise to a larger number of devices …

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Australia TGA Issues 3 Guidances on Transitional Arrangements and Obligations on Reclassification of Medical Devices in April 2021 

Reclassification of Active Medical Devices for Therapy with a Diagnostic Function. Version 1.0, April 2021: https://www.tga.gov.au/resource/reclassification-active-medical-devices-therapy-diagnostic-function   This guidance aims to assist sponsors …

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Australia TGA Updates Comparable Devices in the Clinical Evidence Guidelines For Medical Devices

TGA has issued version 2.0 of Clinical evidence guidelines: Medical devices in March 2021 to update the section on Comparable …

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Australia TGA Releases New Standard for Medicines with Data Matrix Codes or Serialisation

A new standard clarifying requirements for serialisation and data matrix codes on medicines supplied in Australia commences on 1 January …

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Australia TGA Changes ARTG Inclusion Process for Class 1 IVD Medical Devices

On 4 December 2020, the TGA inclusion process for Class 1 in vitro diagnostic (IVD) medical devices in the Australian …

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