Feb 2, 2023
Australia and Oceania
The article provides an overview of the new classification rules for certain medical devices recently introduced in Australia. Table Of Contents: The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical...
Read More
Sep 21, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document describing changes to the regulatory framework for software-based medical devices. The document describes the...
Read More
Jul 26, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a user guide on the post-market review compliance dashboard. The document describes in detail how responsible parties can access, review and...
Read More
Jul 13, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published an official information notice dedicated to custom-made medical devices. The notice is intended to provide...
Read More
Jun 16, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper describing proposed changes to the regulation of personalized medical devices. As mentioned in our previous article...
Read More
