Brazil
Anvisa, the Brazilian national healthcare authority, has published a regulation dedicated to the software with the intended medical purpose. Purposes of the New Brazilian SaMD Regulation The document outlines the main regulatory issue to be solved by the legislative...
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...
Asia
The Food and Drug Administration (FDA) has published a safety communication dedicated to the use of the cold-therapy mode of water-circulating hot/cold therapy devices. The document is intended to remind the users of the aforementioned devices about the importance of...
Asia
The Medical Device Authority (MDA) of Malaysia has published a guidance document dedicated to the requirements for registration of conformity assessment bodies (CABs). In particular, the document describes the requirements the entity shall meet in order to be eligible...
FDA
The Food and Drug Administration (FDA) has announced new improvements to the electronic Medical Device Reporting (eMDR) system to simplify uploading data and storing information related to adverse events associated with medical devices. The amended rules would be also...
