Companies that are involved in the production and distribution of medical devices that are intended for marketing in the U.S. are required to register their facility on-line with the FDA. There is a fee for registering applicable facilities, which changes annually. Facility registrations and device listing must be carried out between 1 October and 31 December to be valid for the following year.
With effect from FDA fiscal year starting January 2013, registration and listing has been applied to a wider group of facilities involved in device manufacture and processing, with contract manufacturers making 'finished devices' (as defined by FDA in 21 CFR 820.3(l)) and contract sterilizers now being required to register and list. In addition non-US manufacturers exporting device to the US must include in their product listings information on all entities involved with the importation of the devices into the US, including brokers and agents, but not carriers. All registration information must be verified annually and updated if changes have occurred.
Non-US registered companies (including contract manufacturers and contract sterilizers) must also provide the FDA with contact information for their US Agent prior to exporting to the US.
GEMAR is ready to assist you with registration and listing, and can answer any questions that you may have - contact us for further information.