The U.S. Food and Drug Administration (FDA) Modernization Act requires that all companies engaged in the manufacture, formulation, dissemination, synthesis, assembly, processing, or import or export of medical devices must be registered with the FDA and have their products listed. In addition, non-U.S. companies must submit to the FDA the name, address and telephone number of a U.S. agent who will liaise with the FDA.
A U.S. agent must also be designated, and the U.S. agent is responsible for emergency and routine communications. A U.S. agent is a person in the U.S. or with a place of business in the U.S. whom a foreign facility designates as its registered agent for the purpose of FDA registration.
The FDA's classification of medical devices is based on function, and the following household products are also classified as medical devices by the FDA: toothbrushes (manual and electric), eyeglasses, sanitary napkins, adult diapers, weight scales, facial massagers, and noise-canceling headphones.
To learn more about medical device certification, we recommend consulting with Registrar Corp, the Shenzhen representative office of FDAREGISTRAR, a U.S.-based company that was founded in 2003 and is dedicated to assisting companies around the world in complying with U.S. Food and Drug Administration (FDA) regulations. Headquartered in Virginia, USA, the company has 19 offices around the world and has assisted more than 30,000 companies in more than 160 countries. The team includes former FDA officials, scientists and industry veterans. Strong and trustworthy!