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Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...

Updated Prescription Medicines Registration Process – TGA Australia

Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical...

Regulation & Re-classification of Software based Medical Devices - TGA Australia

Software-based Medical Devices are medical devices that incorporate or are software, including software as a medical device, or software...

Latest reforms to Post-Market Monitoring of Medical Devices- Australia’s TGA

A recent notice was published by Australia’s TGA details on the latest reforms to post-market monitoring of medical devices. The TGA...

Australian electronic Submission Basics Guide- Australia (TGA)

eCTD and NeeS are the standard electronic submission formats and allow the Common Technical Document (CTD) structure to be provided in an...

Reclassification of certain medical devices -Australia-TGA

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019(link is external) were made on 12 December 2019, which...

Submitting data in the eCTD format - Therapeutic Goods Administration - Australia

This information is for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format for...

Submitting data in the NeeS format - Therapeutic Goods Administration -Australia

This information is for sponsors and manufacturers wanting to submit data in the NeeS format for a: prescription medicine biological...