Australia TGA updates GMP clearance Sponsor Information Dashboard (SID)
The TGA have updated their GMP clearance Sponsor Information Dashboard (SID) to provide an update on the GMP backlog reduction …
Australia TGA presents the UDI Launch Workshop (Sydney)
Are you a Sponsor or Manufacturer of a medical device on the ARTG? Are you aware of the Unique Device …
Access Generic Medicines Work-Sharing Initiative
The Therapeutic Goods Administration (TGA) Australia has released further information on the Generic Medicines Work-Sharing Initiative. It is an innovative …
Australia TGA Releases Guidance on Exemption for Certain Clinical Decision Support Software
The Therapeutic Goods Administration (TGA) Australia has released the first version of the guidance document on Exempt Clinical Decision Support …
Australia TGA Updates Regulation of Software Based Medical Device
The Therapeutic Goods Administration (TGA) Australia has released updates on the regulation of software based medical devices in August 2022. …
Australia TGA Releases Guidance on Exemption for Clinical Decision Support Software
The Therapeutic Goods Administration (TGA) Australia has released a guidance document on Exempt Clinical Decision Support Software (CDSS) for sponsors, …
Australia TGA Publishes Latest Clinical Evidence Guidelines for Medical Devices
The Therapeutic Goods Administration (TGA) Australia has released the latest guidelines on clinical evidence requirements for medical devices, including in …
Australia TGA Issues Factsheet on Software-Based Medical Devices in Digital Mental Health
The Therapeutic Goods Administration (TGA) Australia has released a factsheet on software based medical devices in digital mental health in …
Australia TGA Publishes Latest Guidance on Medical Device Patient Information Leaflets and Implant Cards
The Therapeutic Goods Administration (TGA) Australia has published the latest version of the guidance document on patient information materials (patient …
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