For Importing Fda Regulated Products In

Global Regulatory Requirements for Medical Devices

medical devices. Medical devices are regulated under the Federal Food Drug & Cosmetic Act (FD&C Act) Part 800-1299. Manufacturers importing medical devices into the USA must designate a United States agent, register the establishment, list the device, manufacture according to the quality system requirements and file a Premarket Notification 510 ...

  Devices, Medical, Requirements, Regulatory, Global, Importing, Regulated, Global regulatory requirements for medical devices