FDA is the abbreviation of US Food and Drug Administration. As a federal government agency directly under the jurisdiction of the US Department of Health and Human Services, its main function is to supervise and manage foods, dietary supplements, medicines (including veterinary drugs), medical devices, cosmetics, radiation electronic products, vaccines, biomedical preparations and blood preparations produced and imported in the United States. All products subject to FDA supervision must be registered with the FDA before entering the United States and obtain a valid registration number, so that the goods can be cleared smoothly when entering the country. Otherwise, you will face the risk that the goods will be detained by FDA or refused entry. Click to learn about FDA regulations for free.

The following are the registration requirements for products with the largest export volume in China:

1. Food and drink &; Dietary supplement FDA requires all enterprises engaged in food production, processing, packaging and storage to register with FDA before exporting food to the United States, and appoint an agent with an address in the United States to communicate with FDA on its behalf. In addition, before the goods arrive at American ports, the stakeholders of the goods also need to submit advance notice to FDA.

2. Medical Devices FDA requires all enterprises engaged in the production, preparation, dissemination, synthesis, assembly, processing or import and export of medical devices to register with FDA before exporting to the United States. Get a valid registration number. At the time of registration, you also need to appoint an effective American agent to communicate and contact with FDA on its behalf. In addition, FDA classifies medical device products into the following three categories:

Grade I-general monitoring-low risk (such as glasses, band-AIDS, etc. )-Most of them can be exempted from 5 10(k).

Class II-general monitoring and special monitoring-declaration before listing 5 10(k)-510 (k) is exempted for a few.

Category III-General Monitoring and Pre-marketing Approval (PMA)- All types of high-risk products (such as surgical lasers, PSA experiments, etc. Before exporting to the United States, it needs to be listed in the FDA, and a valid MDL number can be successfully cleared.

3. All pharmaceutical factories whose production is expected to be used for disease diagnosis, treatment, symptom relief, treatment or disease prevention, have pharmacological activities or other direct effects, or can affect the function and structure of the body, must register with the FDA, list the products, and obtain a valid NDC number. Non-US companies must also designate an American agent to contact the FDA and an authorized contact person to communicate with the FDA.

4. Radiation electronic products are in accordance with the requirements of American FD&; According to the requirements of Chapter 53 1 of Act C, any manufacturer, importer, wholesaler and distributor of electronic radiation products must submit a report to FDA. Product report or brief product report must be submitted to FDA before listing. The annual report shall be submitted to the US Food and Drug Administration on September 1 day every year, and the report shall cover the period of 12 months from the end date of the last report (June 30th). In addition, non-US companies must appoint an American agent to contact the FDA.

5. Cosmetics FDA currently implements the principle of voluntary registration of cosmetics, namely "VCRP" plan. The scheme consists of two parts, one is the registration of cosmetics production enterprises, and the other is the declaration of product ingredients. Enterprises can choose whether to register enterprises (limited to cosmetics production enterprises or packaging enterprises) or declare products. Enterprises can choose to register with the FDA before or after the products are sold in the United States, because their cosmetics can be cleared without FDA registration number. It should be noted that although the FDA implements the principle of voluntary registration of cosmetics, all cosmetics that need to be sold on e-commerce platforms such as Amazon and Alibaba need to be registered with the FDA and obtain the corresponding registration certificate before the platform is allowed to be put on the shelves. Although there is no need for FDA to review or approve cosmetics before they go on the market, FDA has strict requirements on the labeling and packaging of cosmetics. If the label or packaging of the product does not meet the requirements of the FDA, the FDA still has the right to detain the product, refuse entry or force it to be removed from the shelves when or after the products that have been put on sale in the US market. For all products under the supervision of FDA, in addition to completing the relevant registration, the unified requirement of FDA is that the product label must meet the requirements. According to the data of US Customs, 22% of the products supervised by FDA were detained because of unqualified labels. Therefore, before exporting to the United States, in addition to ensuring that enterprises must complete the relevant registration, it is also necessary to ensure that product labels meet the requirements of the FDA. Otherwise, even if the registration is completed, the product may face the risk of being detained by the FDA or refused entry.