RegDesk News/Info
Sometimes, managing medical device submissions can feel like dating in high school- lots of rejection. In an industry where regulatory compliance comes with the highest stakes, it’s surprising that failure to comply with submission requirements is so...
RegDesk News/Info
RIMS is a growing category of regulatory software solutions designed to help RA teams achieve faster submissions with fewer rejections. However, despite their novel nature, most platforms are already behind the times, technologically speaking. This article discusses...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the investigation of safety- and performance-related issues associated with medical devices. Apart from other aspects, the document...
Europe
Last Wednesday, as part of our monthly #WebinarWednesday series, RegDesk hosted an immensely informative presentation about recent changes to medical device regulations in the Eurasian Union. This month’s featured speaker, Eurasian regulatory expert Alexey...
Europe
MHRA Guidance on Medicines and Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, published updated guidance on distinguishing medicines and medical devices in controversial...
RegDesk News/Info
Changes to Class I Medical Device Requirements in Brazil Agência Nacional de Vigilância Sanitária (ANVISA) is the regulatory body responsible for the regulation and approval of pharmaceuticals and medical devices in Brazil. On March 3, 2019, ANVISA published a...
