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...
RegDesk News/Info Manufacturers and distributors are two separate entities with the same goal in mind– they both want to sell medical devices. Manufacturers want to sell the products that they produce, but because they often have no reach, no network, or not enough resources to carry...
RegDesk News/Info Oftentimes, medical device manufacturers spend so much time attempting to comply with the complex regulations of their target markets that they fail to direct enough attention toward picking the right distributor for their product. Once a distributor is chosen,...
