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...
EU MDR/IVDR
The Ministry of Healthcare of Peru has published new guidance dedicated to the validation of medical devices intended to be used in the context of the outbreak COVID-19. Regulatory Background According to the document, medical devices (including ones intended for in...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG) has published a template of the post-market clinical follow-up (PMCF) plan to be used by medical device manufacturers to place their devices on the EU market. Due to the legal nature of the document, the provisions stated...
