TGA releases: Reform of Medical Device Regulation (TGA historical documents)
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TGA releases: Reform of Medical Device Regulation (TGA historical documents)

TGA REFORMS – HISTORICAL DOCUMENT (blog originally published 21 May 2013): The TGA has released an exposure draft of a Regulation Impact Statement (RIS) on proposed changes to premarket assessment requirements for medical devices. The RIS is in response to the earlier consultation document on device reforms, released in January. The RIS provides details on…

Medical Device Reforms – Navigating the Impact of EU Reforms on the Reclassification of select Medical Devices in Australia
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Medical Device Reforms – Navigating the Impact of EU Reforms on the Reclassification of select Medical Devices in Australia

Recognising the impact of the European Union (EU) reforms from the overhaul of medical device directives (MDD) and in vitro device directives (IVD) to regulations (MDR/IVDR), Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) have proactively engaged in public consultations to align Australian medical device regulations with the new EU framework.  Consultations commenced in…

Regulation of Medical Apps – iPhones & other Smart Devices

Regulation of Medical Apps – iPhones & other Smart Devices

The number of medical Apps on both the Apple and Android platforms is increasing and mobile technology is increasingly being embraced by healthcare professionals, especially since the pandemic. With the increase in medical software programs and medical technology, such as robotics and diagnostic software, it’s important the manufacturers are aware of the regulatory requirements (Regulation…