The FDA certification registration is a major headache for many people engaged in cross-border e-commerce, especially for Chinese e-commerce businesses operating on Amazon and eBay. The complicated classification of product types and the numerous application forms have caused great inconvenience for everyone.

　　The Amazon platform has witnessed rapid growth in China over the past two years. An increasing number of domestic manufacturers and traders are eager to place their products for sale on the Amazon platform. The Amazon platform places great emphasis on product safety and compliance. For certain types of products, it requires sellers to provide relevant test reports and FDA certification registration numbers when listing the products on the platform.

　　The FDA certification in the United States is one of the executive agencies established under the Public Health Service (PHS) of the Department of Health and Human Services (DHHS). The product types it supervises include medical devices, food, drugs, cosmetics, radiation products, tobacco, etc. Here, we will focus on the common product categories on the Amazon platform: FDA certification registration of food, cosmetics, and medical devices.

The four products that typically require Amazon FDA certification are: 

1. Food Amazon FDA Certification Registration: 

According to the requirements of the modern US food safety act, the owners, operators, or responsible agents of domestic or foreign facilities that produce, process, package, or store human food or animal feed for consumption in the United States must register their facilities with the FDA. 

The types of products consumed by humans include alcoholic beverages, sugar-based confectionery, beverages, candies, cereal foods, cheese, coffee or tea, food colorings, seasonings, seafood, food additives, dairy products, broth or jam, nuts, etc. 

II. FDA Certification for Cosmetics on Amazon 

According to the cosmetics regulations of the US FDA, cosmetic registration is a voluntary requirement. Cosmetics enterprises can complete the cosmetic registration either before or after the products are launched in the US through the electronic system VCRP or by submitting paper documents. After the registration, the enterprise will obtain an enterprise registration number and a product formula number (CPIS). The materials that enterprises need to provide include enterprise information and product information. 

III. FDA Certification for Medical Devices on Amazon 

The US FDA classifies medical devices into three categories - Class I, Class II, and Class III - based on the level of risk. Class III has the highest risk. Most Class III products require a PMA application before they are marketed. The products need to undergo clinical trials. After obtaining the PMA number, the company needs to register and list the product, and obtain the registration number. Then, they can be put on the market. 

Class II products are considered medium-risk products. Most Class II products need to apply for the FDA 510K when entering the market. After obtaining the 510K number, enterprises need to register and list the products, and obtain the registration number. 

IV. Amazon FDA Certification for Laser Products 

Laser is known as the magical light. Laser products are classified into 4 categories based on their safety levels. As the level increases, the safety index of the laser products gradually decreases. Although laser products are practical, they are harmful to the human body. Level 1 laser products are considered safe products. 

Amazon FDA Certification Process: 

1. Preparation stage 

Production (sanitation) license, copy of the certificate of conformity; 

Company Profile (Establishment Date, Technical Strength, Main Products and Their Performance, Asset Status). 

2. Technical Preliminary Review Application Acceptance 

Submit the English versions of the DMF (Drug Master File) and SOP (Standard Operating Procedure) documents to the agent; 

3. Review of DMF documents 

The FDA carefully reviews and checks whether the information stated in the DMF documents is accurate. 

If the FDA does not identify any major errors and deems it to be in compliance, it will propose a pre-approval inspection plan. 

4. Amazon FDA Certification Inspection 

The FDA inspectors conducted an inspection of the factory, asking questions, and the factory was required to answer each question one by one.