Australia
The article highlights the aspects related to the inclusion of new products in the Australian Register of Therapeutic Goods (ARTG), a country’s register of healthcare products allowed for marketing and use in the country.
Australia
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable overseas regulators/assessment bodies for medical devices (including in vitro diagnostic ones) for abridgement of TGA conformity assessments and as information required for applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).
Asia
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...
Medical Devices
This article highlights he differences between intended use and indications of use, along with their significance. Table of Contents In the highly regulated world of medical devices, precision in terminology makes a significant impact. It is important for preparing...
Asia
This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...
Australia and Oceania
The new article provides a brief overview of the regulatory approach towards software-based products intended to be marketed and used in Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
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