In the U.S., electric toothbrushes are classified as medical device Class I products, and their market entry requires that they obtain a medical device FDA registration number and meet the certification requirements of the Federal Communications Commission (FCC). The U.S. Food and Drug Administration (FDA) is an international medical review authority, authorized by the federal government to enforce the administration and regulation of food and drugs. the FDA brings together doctors, lawyers, microbiologists, pharmacologists, chemists, statisticians, and other professionals to protect, promote, and enhance the health of the citizens.
FDA certification ensures the safety and efficacy of foods, drugs, cosmetics, and medical devices. Only materials, devices, and technologies approved by the FDA may be used in commercial clinical applications in the U.S. and nearly 100 other countries.
It is important to note that not all products must be FDA-certified. Product certification requirements vary by category, and for those products that must be FDA-certified, sellers can only sell them on platforms such as Amazon after completing the certification process. Any food, drug or other product that comes into contact with the human body must submit the corresponding certification file, otherwise it may risk being forced to be removed from the shelves. Amazon has recently banned a number of medical products that failed to provide FDA certification.
Specifically, in order to import a medical device into the U.S., it must meet the following FDA certification requirements:
The manufacturer must complete the FDA registration process and list the product.
Initial importers are also required to register with the FDA.
Depending on the classification of the medical device, a 510(k) Premarket Notification or Pre-Market Approval (PMA) may also be required. Prior to import clearance, registered initial importers are required to correlate their product with the manufacturer by providing the manufacturer's business registration number, business name and address, and product registration number.
Additionally, in the case of FDA approval for food products, the manufacturer is required to be registered with the FDA and the importer is required to have a Dunn & Bradstreet number. In short, FDA regulations ensure the safety and compliance of products before they are put on the market.
"Global e-commerce entrepreneurship, the first choice of the Green Circle", the Green Circle FDA guarantee program, do not do not come to the certificate to refund the full amount, the limit of 100.
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