Monthly Archives: February 2016

Medical devices are controlled and regulated by the Food, Drug, and Cosmetic Act (Code of Federal Regulations 21, 2010), which demands registration of any medical devices, which meets the definition of a medical device before starting selling it. It states that manufacturers are responsible for ensuring that e.g.: products are safe and labeled according to FDA’s labeling regulations, before any selling permission is given. Medical devices sector is a highly delimited part of economy; its regulatory procedures ensure patient safety, security and product quality. In fact it has significant implications for the overall industry’s performance. Each year, the number of…