North America
USA & Canada-
Manufacturers that are involved in the production and distribution of medical devices in the USA are required to register annually with the FDA. The Center for Devices and Radiological Health (CDRH) is the FDA center responsible for overseeing the medical device program.
-
If you are planning on marketing your medical device in Canada, you will need to secure a license issued by Health Canada – either a Medical Device License (MDL) or a Medical Device Establishment License (MDEL), depending on your device.