From February 1, 2016 it is possible to apply for the account to register class 2 devices in the FDA Global Unique Device Identification Database (GUDID).
Starting from September 24, 2016, in fact, only class 2 GUDID-registered Medical Devices will be able to be marketed in the territory.
To register, it is necessary to stamp the UDI code on the device (if applicable), the label and packaging and to have a quality system in compliance with the U.S. cGMP referred to the new regulation.
To support Companies, the FDA issued a check list that can be found at the link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm427424.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery .
For further information: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416113.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
