Australia TGA Publishes Updates on Personalised Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published the latest document on personalised medical devices, including 3D-printed devices, in November …

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Australia TGA Publishes Guidance on Standards for Biologicals

he Therapeutic Goods Administration (TGA) Australia has published a new guidance on Therapeutic Goods Orders (TGO) 109 to provide a …

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Australia TGA Updates Guidelines on Clinical Evidence for Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published an updated guideline on clinical evidence requirements for medical devices, including in …

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Australia TGA Publishes Guidance on Standard for Human Cell or Tissue Products

The Therapeutic Goods Administration (TGA) Australia has published a guidance document for Therapeutic Goods Orders (TGO) 108 for manufacturers and sponsors of biologicals and human cell or …

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Australia TGA Releases Update on Reclassification of Certain Medical Devices 

The Therapeutic Goods Administration (TGA) Australia has announced an update on another medical device reform, which is the reclassification of certain medical devices, in November 2021.  …

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Australia TGA Publishes Guidance Document on Global Medical Device Nomenclature (GMDN) Terms

Therapeutic Goods Administration (TGA) Australia has published a guidance document on the Global Medical Device Nomenclature (GMDN) Terms, which discusses about the information to support sponsors and manufacturers, in …

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Australia TGA Publishes Guidance Document on Classification of Active Medical Devices

Therapeutic Goods Administration (TGA) Australia has published the first version of the guidance document on the classification of active medical devices (including software-based medical devices) in October 2021.  The guidance document will …

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Australia TGA Publishes Guidance Document on Reclassification of Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems

Therapeutic Goods Administration (TGA) Australia has published a guidance document on the reclassification of medical devices in direct contact with the heart, central circulatory system (CCS) and central nervous …

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Australia TGA Publishes Updated Guidance Document on Medical Device Patient Information Leaflets and Implant Cards

Therapeutic Goods Administration (TGA) Australia has published an updated guidance document on medical device patient information leaflets (PIL) and implants cards (including acceptance of Implementation Plans) in October 2021.   The …

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