Australia and Oceania
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...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical devices, announced the reduction of annual charges for medical devices listed on the prostheses list. Prostheses Medical Devices: Regulatory Background According...
Australia and Oceania
In relation to difficulties associated with the coronavirus, The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, issued a notice dedicated to the delay in the implementation of certain regulatory changes in...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, put out a statement to finalize the process of feedback and received comments from industry representatives regarding public consultations on the scope of...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical devices regulation, issued guidelines describing how medical device manufacturers shall apply for inclusion of the COVID-19 test in the national register of medicinal products...
Australia and Oceania
Australia’s authority responsible for medical devices regulation, the Therapeutic Goods Administration (TGA), issued detailed guidelines on the regulatory approach to be applied to the test intended to identify the Coronavirus Disease 2019 (COVID-19). COVID-19 Test...
