FDA certification of medical devices refers to the evaluation and certification of the quality and safety of medical devices by the US Food and Drug Administration (FDA). The export of medical devices to the United States must be registered by FDA. Otherwise, the goods will be detained and customs clearance will not be smooth.

Second, the FDA classification of medical devices

FDA classifies medical devices mainly according to their functions. The following household products also belong to FDA-classified medical devices: toothbrushes (manual and electric), glasses, sanitary napkins, adult diapers, weighing scale, facial massagers, noise-reducing headphones, etc.

Third, the regulatory requirements of the US FDA.

(1) The modernization act of the US Food and Drug Administration (FDA) requires that all enterprises engaged in the production, preparation, dissemination, synthesis, assembly, processing or import and export of medical devices must register with the FDA and list their products. In addition, non-US companies must submit to the FDA the name, address and telephone number of the American agent who contacts the FDA.

(2) At the same time, an American agent must be appointed to be responsible for emergency and daily communication. American agent refers to a registered agent who has a business place in the United States or in the United States and is designated by a foreign factory for FDA registration. ?

For more information about FDA certification, please contact our official website of RegistrarCorp