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What is Establishment Registration for medical device exports?
Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. The regulations for establishment registration are provided in 21 CFR 807. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. Congress has also authorized FDA to implement a user fee for certain types of establishment registrations processed after September 30, 2007. Your registration is not considered complete until FDA has been notified that all requirements have been met. ESTABLISHMENT Any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution. OWNER/OPERATOR The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment. The owner/operator is responsible for registering the establishment. Registration of an establishment is not an approval of the establishment or its products by FDA. That is, it does not provide FDA clearance to market. Unless exempt, premarketing clearance or approval is required before a device can be placed into commercial distribution in the U.S. Misbranding by Reference to Establishment Registration Number: Title 21 of the Code of Federal Regulations, Section 807.39, states, 'Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.' Product labeling and Internet sites cannot reference your establishment registration number or make reference to your establishment being registered or approved by FDA. If your product labeling or Internet sites list your establishment registration number or makes reference to your establishment being registered and approved by the FDA, then these references must be removed.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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