Australia and Oceania
In relation to difficulties associated with the Coronavirus or COVID-19, 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...
FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
FDA
The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of...
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...
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...
