Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a guidance document dedicated to software for use with COVID-19 rapid antigen self-tests. Apart from other aspects, the document describes...
Uncategorized
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements to be applied in the case of software intended to be used with rapid...
Europe
The UK Medicines & Healthcare products Regulatory Agency (MHRA), the country’s regulating authority in the sphere of medicinal products and medical devices, has published a guidance document dedicated to the equipment for temperature screening intended to be used...
Canada
Health Canada, the Canadian regulating authority in the sphere of medical devices, has published guidelines dedicated to medical device shortages and actions to be taken by parties involved in this regard. In particular, the document describes measures to be taken in...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published guidelines on special framework for importation and sale of medical device devices intended to be used in the context of the Coronavirus Disease 2019 (COVID-19) caused by...
