U.S. FDA certification mainly includes what items and products

FDA is the U.S. Food and Drug Administration (Food and Drug Administration) for short. For the U.S. Department of Health and Human Services under the jurisdiction of the federal government agencies, its main function is responsible for the U.S. domestic production and imported food, dietary supplements, drugs (including veterinary drugs), medical devices, cosmetics, and radiation electronic products, vaccines, biomedical preparations, blood preparations, supervision and management. All products regulated by the FDA must be registered with the FDA before entering the U.S. and obtain a valid registration number before the goods can be successfully cleared at the time of entry. Otherwise, there is a risk that the goods will be detained or denied entry by the FDA. Click for free to learn about FDA's regulatory requirements

The following are the registration requirements for the largest categories of products exported from China:

1. Foods, beverages & dietary supplementsThe FDA requires that all companies engaged in the production, processing, packaging, and storage of food products must be registered with the FDA prior to exporting food products to the U.S., and designate a U.S. agent to communicate with the FDA on their behalf. FDA. In addition, stakeholders of the shipment are required to submit a Prior Notice to the FDA before the shipment arrives at a U.S. port.

2. The FDA requires all companies that manufacture, formulate, distribute, synthesize, assemble, process, or import/export medical devices to register with the FDA before exporting to the United States. Obtain a valid registration number. At the time of registration it is also necessary to designate a valid U.S. agent to communicate and liaise with the FDA on its behalf. In addition, the FDA classifies medical device products into the following three categories:

Class I - General Surveillance - Low Risk (e.g., eyeglasses, band-aids, etc.) - Most are exempt from 510(k)

Class II - General Surveillance and Special Surveillance - Premarket Notification 510(k) - few exempt from 510(k)

Category III - General Surveillance and Premarket Approval (PMA) - -High risk (e.g., surgical lasers, PSA experiments, etc.) All types of products need to be listed with the FDA before exporting to the U.S. to obtain a valid MDL number for smooth customs clearance.

3. DrugsAll drug plants that produce drugs intended for use in the diagnosis, treatment, symptomatic relief, management, or prevention of disease that have pharmacological activity or other direct effects, or that can affect the function and structure of the body, are required to be registered with the FDA (drug establishment registration) and to be listed (drug listing) to obtain a valid MDL number for customs clearance. listing), to obtain a valid NDC number. Non-U.S. companies must also designate a U.S. agent to liaise with the FDA and an authorized contact person to communicate with the FDA.

4. Radiation electronic products under the U.S. FD& C Act, Chapter 531 requirements, any electronic radiation products manufacturers, importers, wholesalers and distributors are required to submit reports to the FDA. Product reports or abbreviated product reports must be submitted to the U.S. FDA before marketing. Annual reports are due to the FDA on September 1 of each year and are required to cover a 12-month period from the last report end date (June 30th). In addition, non-U.S. companies must designate a U.S. agent to liaise with the FDA.

5. Cosmetics FDA currently implements the principle of voluntary registration for cosmetics, the "VCRP" program. The program consists of two parts, one is the registration of cosmetic manufacturers, the other part is the declaration of product ingredients. Companies can choose whether or not to register (limited to cosmetic manufacturers or packagers) or declare their products. Companies can choose to register with the FDA before or after their products are marketed in the U.S., as cosmetics do not require an FDA registration number for customs clearance. It should be noted that, although the FDA implements the principle of voluntary registration for cosmetics, all cosmetics that need to be sold on e-commerce platforms such as Amazon, Alibaba, etc. need to be registered with the FDA and obtain the appropriate certificate of registration before being allowed to be listed on the platform. Although cosmetics do not need to be marketed before the FDA's pre-market review or approval, but the FDA for cosmetic labeling, packaging and other strict requirements, if the product labeling or packaging does not meet the FDA's requirements, then in the U.S. market or after the product or the FDA has the right to detain the product, refused to enter the country or mandatory requirements have been on the shelves of the product off the shelves. For all products regulated by the FDA, in addition to completing the relevant registration, the FDA unified requirements are product labeling must meet the requirements. According to U.S. Customs data, 22% of FDA-regulated products are detained because of unqualified labeling. Therefore, before exporting to the United States, in addition to ensuring that enterprises to complete the relevant registration, but also need to ensure that the product labeling is in line with FDA requirements. Otherwise, even after completing the registration, the product may face the risk of being detained by the FDA, or refused entry.