Australia
The article highlights the key points related to the application of certain essential principles intended to ensure the safety and proper performance of healthcare products allowed to be marketed and used in Australia.
Australia
The new article provides an overview of the regulatory procedures associated with the changes to sponsorship in the context of medical devices intended to be marketed and used in Australia.
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the classification of active medical devices (including software-based ones). The document issued in...
Australia and Oceania
The Therapeutic Goods Administration(TGA), the Australian regulating authority in the sphere of medical devices, has published guidance describing specific aspects related to the Declaration of Conformity for certain low-risk medical devices. In particular, the scope...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulation, has published detailed guidance describing the documentation to be submitted by the applicant in the context of inclusion of a medical device to the...
