Asia The Medical Device Authority (MDA), the department of the Ministry of Health Malaysia responsible for medical device regulations, has published guidance dedicated to the registration of conformity assessment bodies (CABs). The document consists of two parts: general...
Russia The Roszdravnadzor, the medical device regulating authority of the Russian Federation, has published a guidance document dedicated to the methodical recommendations for the quality, effectiveness, and safety assessment of medical devices (in the part of medical...
FDA The Food and Drug Administration (FDA), the US regulating authority, has published a revised enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during COVID-19. Notes The present document actually constitutes a new...
Saudi Arabia The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published a guidance dedicated to the requirements for medical masks and particulate respirators – the medicinal products that become vitally important in the context of the COVID-19. The document also...
FDA The Food and Drug Administration (FDA) has published guidance dedicated to the procedures associated with the recognition and withdrawals of the FDA-recognized voluntary consensus standards medical device manufacturers may refer to in order to demonstrate conformity...
EU MDR/IVDR The Medicinal and Healthcare products Authority (MHRA) has published an updated version of the guidance describing the new medical device regulations related to Brexit. In particular, the amended document provides additional details regarding the way medical devices...
