In case of marketing class 2 devices in the USA, it is compulsory to proceed with the registration of the above mentioned products in the Global Unique Identification Database (GUDID) by September 24, 2016.
This obligation is already in force for class 3, implantable and life-saving devices and starting from September 2018 it will be applied to class 1 devices too.
Class 2 Medical Devices not provided with UDI code and not duly registered in GUDID database, starting from September 24, 2016, won’t be able to enter in the USA market.
For further information:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
