RegDesk Regulatory Roundup

Sep 2, 2020

Australian Regulatory Guidelines for Medical Devices

The Therapeutic Goods Administration (TGA) provided a set of detailed guidance documents to assist medical device manufacturers in achieving and sustaining compliance with regulatory requirements to be allowed for marketing in Australia – the Australian...

TGA Timeframes for Regulation of Medical Devices

Feb 27, 2020

Uncategorized

TGA Timeframes for Regulation of Medical Devices

The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulations, issued detailed and exhaustive research dedicated to the timeframes of procedures related to the medical device registration process describing the typical...

TGA Guidance on Considerations for Medical Devices

Feb 13, 2020

Australia and Oceania

TGA Guidance on Considerations for Medical Devices

The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health responsible for medical devices circulation, issues new guidance dedicated to the evidence requirements. The new guidance published by the TGA is intended to provide entities...