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Who must register as an establishment for medical device exports?
Manufacturers An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device intended for commercial distribution (marketing) is required to register. This includes manufacturers, contract manufacturers and contract sterilizers that place the device into commercial distribution, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (that is, manufacturers of components or accessories that are intended to be sold or leased directly to the end user.) Initial Distributor An initial distributor (or importer) takes first title to the devices imported into the U.S. and further distributes the devices. Initial distributors/importers are required to register. However, they are NOT required to list the devices that they import. Foreign establishments (manufacturers and exporters) Foreign establishments that manufacture, prepare, propagate, compound, or process a device that is imported, or offered for import, into the U.S. are required to register their establishments. This includes contract manufacturers and contract sterilizers. Foreign establishments must also list the devices that they export to the U.S. Definitions of establishment activities are provided below. Prior to registering your establishment, please review the definitions and determine what type of activities your establishment is performing. Please note that most establishments are also required to list their devices. Please note that the following groups are not required to register: Wholesale distributors of devices who do not manufacturer, repackage, process or relabel a device. A 'wholesale distributor' is defined as any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user. Refurbishers and domestic distributors
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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