directory :

1. Overview of compliance certification

2. The meaning of FDA compulsory certification

3. FDA compulsory certification classification and scope

4. FDA mandatory certification application process

5. Detailed Explanation of FDA Compulsory Certification Fees

1. Overview of compliance certification :

Hot products such as electric toothbrushes, massagers, and facial cleansers still need to apply for FDA registration. FDA registration not only involves food, drugs, cosmetics , but also medical devices. Therefore, all sellers should pay attention to the fact that the coverage of medical devices is very wide, ranging from medical gloves to cardiac pacemakers, all of which are under the supervision of FDA.

According to the classification of FDA medical devices, electric toothbrushes, facial cleansers, beauty instruments, massagers and even fitness equipment (whether charged or not) generally belong to Class I medical devices, and only need to complete FDA registration.

2. The meaning of FDA compulsory certification :

Dear big sellers, please pay attention. It is understood that the Food and Drug Administration (Food and Drug Administration) is referred to as FDA. FDA is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). . As a scientific management agency, FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical equipment and radiation products produced or imported in the United States . It was one of the first federal agencies whose primary function was to protect consumers.

FDA compulsory certification classification and scope :

The classification of FDA certification usually includes the following 6 categories:

1. Food FDA registration

It is mandatory to export to the United States or to be listed on the Amazon platform, so this needs to be paid special attention to, but usually only some conventional foods can be made, such as instant noodles, tea, snacks, drinks, and meals. The cost can be settled by a few K, and the validity period is valid in even-numbered years. For example, the registration in September 2020 is valid until the end of 2022 (note that products such as meat and seafood cannot only be registered with the food FDA, even if you can apply for it and export customs clearance There will also be spot checks, because this kind of control is strictly under the jurisdiction of the Ministry of Agriculture, and you need to consult the freight forwarding customs for details)

2. FDA registration of laser products

At present, the laser FDA needs to be specific to each product. The laser FDA registration period is relatively short, and it is a mandatory certification. All laser radiation products exported to the United States or Amazon in the United States need to be registered with the laser FDA. The validity period is renewed every year, and the next year will be reviewed annually .

3Cosmetic FDA registration

Cosmetic FDA registration for export is voluntary or required by customers; if it is a must for Amazon cosmetics, the cost is several thousand RMB depending on the number of products, and then the cosmetic FDA is valid for a long time according to the current FDA regulations. After completion With the corresponding FDA registration number, you can check all the filing information on the US FDA official website.

At present, the most cross-border sellers do are 3 types of cosmetics and 6 types of food . Remind some big sellers of products such as electric massage chairs, electric massage sticks, foot massagers, neck massagers, waist massagers, and head massagers. Products that mainly rely on motor (motor) vibration, such as appliances, foot baths, massage pillows, facial massagers, and foot massagers, require Class I certification for Class 4 medical devices .