MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), UK’s authority responsible for the regulation of medical devices, issued guidance on field safety notices (FSNs). The document is intended to assist medical device manufacturers in preparing the...
North America
The Center for Devices and Radiological Health (CDRH), a division of the U.S. Food and Drug Administration (FDA) responsible for pre-marketing assessment and evaluation of medical devices and general supervision on manufacturing and performance of medical devices,...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), a special advisory body of the European Commission (EC) issued a detailed guidance on software classification according to the new medical device regulations: 2017/745 (MDR) and 2017/746 (IVDR). Medical Software Regulated...
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,...
