Regulatory Blog

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

As part of its updated guidelines on testimonials and endorsements in advertising, the Therapeutic Goods Administration (TGA) updated its...

When applying for inclusion in the Australian Register of Therapeutic Goods (ARTG), different classes of medical device require different...

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

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

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

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

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

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

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