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...
COVID-19
The World Health Organization (WHO), the international organization focused on public health protection, issued a notice providing medical device manufacturers and industry representatives additional information that addresses COVID-19-related issues. The document...
Canada
The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance describing the way the Interim Order on medical devices, recently issued by the authority, should be applied. The initial document implements a set of additional...
Canada
The Health Canada, the Canadian regulating authority in the sphere of medical devices, issued an interim order and guidance document concerning the importation and marketing of medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulation, issued guidance highlighting the performance requirements applicable to ventilators used in Australia during the outbreak of the Coronavirus Disease 2019...
COVID-19
The Food and Drug Administration (FDA or the Agency) issued guidance dedicated to extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices in the context of the Coronavirus Disease 2019 (COVID-2019) caused by the “novel coronavirus” – the virus...
