Companies including foreign and domestic establishments that are engaged in manufacturing and marketing medical devices including export only devices are required to register yearly with US FDA. Registered establishments are required to list the devices along the activities made on the devices too.
The following are the businesses that are required to register and list the devices.
Manufacture: Establishments that makes by chemical, physical, biological, or other procedures, any article that meets the definition of “device”.
Contract Manufacture: Establishments that manufacture the device as per other establishment specifications.
Specification Developer: Companies that develop specifications for a device that is distributed under the establishment’s own name but performs no manufacturing.
Contract Sterilizer: Provides a sterilization service for another establishment’s devices.
Repackage- Establishments that package the finished devices into different containers excluding shipping containers.
Relabel- Establishments that change the content of the labeling that they have received from the original manufacturer for distribution under the establishment’s own name.
Foreign Export: Establishments that export the devices from a foreign country including the devices manufactured in the United States.
Re-manufacture: A person or establishment who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.
Export only device: Companies who manufactures the devices that are sold only in foreign countries and manufactured in the United States.
Complaint file establishment: Establishments that manage only complaints.
Initial Importer: Any company who furthers the marketing of a device from a foreign manufacturer to the person who makes final sale of the device to the consumer but does not perform any other action on the device.
Establishments that are registered with US FDA must renew their registration every year between October 1st and December 31st every year by paying FDA’s MDUFA fees.
Liberty Management Group, as a leading FDA consultant, helps with MDUFA payment, FURLS account creation, medical device establishment registration, device listings and renewals.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us
www.fdahelp.us