Sep 17, 2020
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...
Read More
Sep 16, 2020
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...
Read More
Aug 25, 2020
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...
Read More
Aug 18, 2020
FDA
The Food and Drug Administration (FDA or the Agency) has answered the most important questions related to importing, registration and listing of medical devices during the pandemic associated with the outbreak of the Coronavirus Disease 2019 (COVID-19). Importing...
Read More
Aug 3, 2020
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...
Read More