Introduction:
In addition to considering factors such as product packaging, transportation,** and marketing, merchants must also obtain approval from the U.S. Food and Drug Administration (FDA) to avoid the risk of "delisting" when selling food, masks, cosmetics and other products on Amazon in the United States. This article will detail the role and responsibilities of the FDA, as well as the FDA registration process and related considerations that merchants need to consider when selling products on Amazon.
1. Get to know the FDA:
1.1 What is FDA?
The FDA is the highest law enforcement agency authorized by the U.S. Congress to specialize in food and drug administration. Its full name is the Food and Drug Administration.
1.2 The main tasks of the FDA:Ensure the safety of food, cosmetics, medical devices, laser radiation products, tobacco, etc., produced or imported in the United States.
1.3 FDA's scope of management:FDA regulates a wide range of products, including food, cosmetics, medical devices, laser radiation products, veterinary products, tobacco products, and more.
II. FDA Registration Process and Categories:
2.1 What is FDA registration?FDA registration is the process of registering companies and businesses to obtain a registration number.
2.2 Several categories of FDA registrations:
Food FDA Registration.
FDA registration of medical devices.
Cosmetics registration.
FDA test report for food contact materials.
2.3 Validity period of FDA registration:
Food FDA: Renews every even-numbered years.
FDA for medical devices: valid for one year, renewed in October every year.
Cosmetic FDA: Permanently valid.
Laser radiation FDA: valid for one year, renewed in July every year.
FDA: valid for one year, renewed in October every year.
3. FDA registration process:
3.1 Food FDA Registration Steps:
Step 1: Confirm whether the product falls within the scope of FDA food control.
Step 2: Select a US** person
Step 3: Prepare the English information of the enterprise and the English information of the product.
3.2 FDA registration steps for medical devices:
It consists of two parts: business registration and product listing.
It is most cost-effective for companies to register with the FDA in October-December of each year.
After successful registration, you will get the registration number of the enterprise and the product registration number.
3.3 Steps for Cosmetics Registration:
There are two types: factory registration and product registration.
The prerequisite for product registration is factory registration.
After successful registration, you will get a business registration number and a product ingredient record number.
3.4 FDA test report of food contact materials:
Conduct FDA standard testing and obtain test reports.
Check that the report meets the relevant FDA requirements.
Finally, the FDA Certificate of Conformity was obtained.
4. Frequently Asked Questions:
4.1 Which agency issued the FDA certificate?
FDA registration does not have a certificate, but intermediaries** will provide proof to help manufacturers obtain FDA registration numbers.
4.2 Does FDA need to designate an accredited laboratory for testing?
FDA does not designate accredited laboratories, but GMP quality accreditation is provided to service-oriented testing laboratories.
4.3 Do I have to have a U.S. person to register with the FDA?
Yes, businesses must designate a U.S.** person to be responsible for process services when registering with the FDA.
4.4 Do I need to send samples for FDA registration?
In most cases, FDA registration does not require sending samples and is a declaration of good faith.
4.5 What is 510k certification?
510K certification is based on the FDA's classification of the risk level of medical devices, and companies need to submit relevant information to obtain approval.
V. Conclusions
With a comprehensive understanding of the FDA registration process and related categories, merchants can effectively avoid the risk of "delisting" on platforms such as Amazon due to not being approved by the FDA, and improve the compliance and credibility of their products in the US market. When selling food, masks, cosmetics and more, ensuring that the products meet FDA standards is a key part.