One, the U.S. FDA medical device certification
Medical device FDA certification refers to the U.S. Food and Drug Administration (FDA) on the quality of medical device products and safety assessment and certification. Medical devices exported to the United States is mandatory to have FDA registration. Otherwise, the goods will be detained and cannot be successfully cleared.
The FDA classification of medical devices
The FDA classification of medical devices is mainly based on functionality, and the following household products belong to the FDA classification of medical devices: toothbrushes (manual and electric), eyeglasses, sanitary napkins.
The FDA's classification of medical devices is mainly 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, scales, facial massagers, and noise-cancelling headphones.
Three, the U.S. FDA regulations
(1) The U.S. Food and Drug Administration (FDA) Modernization Act requires that all companies engaged in the production, formulation, dissemination, synthesis, assembly, processing, or import and export of medical devices must be registered with the FDA and product listing. 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.
(2) A U.S. agent must also be designated, who is responsible for emergency and routine communications. A U.S. agent is a person in the U.S. or with a business location in the U.S. whom a foreign plant has designated as a registered agent for the purpose of FDA registration.
To learn more about FDA certification, you can contact us at RegistrarCorp's website
.