COVID-19 The European Commission (EC) responsible for medical devices regulatory framework has published an official notice informing about its proposal to roll out the new In Vitro Diagnostic Medical Devices Regulation to ensure uninterrupted availability of vitally important...
COVID-19 The Saudi Food & Drug Authority (SFDA), the regulating authority in the sphere of medical devices in Saudi Arabia, has published a guidance document dedicated to the requirements for unique device identification (UDI) for medical devices. The present document...
COVID-19 The Ministry of Healthcare of Peru has adopted a special regulation dedicated to the in vitro diagnostic (IVD) tests intended to be used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the «novel coronavirus». For this...
COVID-19 The Food and Drug Administration (FDA) has issued a special warning describing the risk for patients associated with the protective barrier enclosures without negative pressure used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus...
COVID-19 The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, has issued a final version of the guidance dedicated to the multiple function device products. Regulatory Background The regulatory framework to be applied for a...
COVID-19 The Food and Drug Administration (FDA) has published a new template for emergency at-home and over-the-counter diagnostic COVID-19 tests and medical devices for use in non-lab settings, such as homes, offices, or schools. FDA: Regulatory Background In order to...
