US FDA registration

Enter the U.S. market through FDA-registered products to avoid the risk of "withholding"

  • Food
  • Drug
  • Cosmetic
  • Medical Instruments
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Why do FDA registration?

FDA (Food and Drug Administration) is the abbreviation of the U.S. Food and Drug Administration. Its responsibility is to ensure the safety of food, cosmetics, medical devices, and laser radiation products produced or imported in the United States. The following is a list (enumeration) of product categories regulated by the FDA:

Food: dietary supplements, bottled water, food additives, infant formula, pet food, etc.;

Cosmetics: cosmetic color additives, skin moisturizers and cleansers, nail polishes, perfumes, etc.;

Medical devices: prescription drugs, over-the-counter drugs, human vaccines, dental equipment, surgical implants, prosthetics, etc.;

Laser radiation products: microwave ovens, X-ray equipment, sun lamps, etc.;

Veterinary products: livestock feed, pet food, veterinary drugs, etc.;

Tobacco products: cigarettes, cigarette tobacco, roll-your-own cigarettes, smokeless tobacco, etc.

What does FDA certification mean?

1. The U.S. Customs has the right to "automatically detain" products without FDA registration! When the products arrive at the U.S. port, they will conduct random inspections one by one. Only if the samples are qualified, the batch of products can be released. It is necessary for the enterprise to complete the FDA registration or testing;

2. Approved by some small countries, because small countries do not have their own regulatory requirements, they will rely on the regulations of large countries to regulate exporters;

3. In the same industry products, improve product competitiveness.

Interpretation of US FDA certification

What is FDA certification

This may be a question asked by people who have never been in contact with FDA certification. So what is FDA certification? Many customers will tell me to do FDA certification. In fact, FDA certification is just a conceptual term, which is accurate in the actual operation process. In terms of FDA registration and FDA testing, there is no FDA certification. Because the concept of "certification" is widely used in the export process, people usually refer to FDA registration and FDA testing as FDA certification, but it must be clear FDA certification is just a commonly used statement. We do not object to such a statement, but we must be able to clarify the relationship between FDA certification, FDA registration, and FDA testing.

What is FDA registration, which companies and products are mainly aimed at

FDA registration is the process by which the US Food and Drug Administration (FDA) registers company and product information for products entering the US market. Its purpose mainly includes anti-terrorism and restricting market access of products that do not meet the requirements. (including all edible products and animal feed), medical device companies and products, laser radiation companies and products, pharmaceutical companies and products, cosmetics, and tobacco products. These types of companies and products need to be registered with the FDA Yes, of course you can also say it is FDA certified.

What is FDA testing, which companies and products are mainly aimed at

FDA testing is for some products that FDA needs to test to prove whether they can meet the specified requirements. FDA will formulate corresponding FDA testing regulations according to the use and actual use and contact conditions of different products, which will be completed by third-party laboratories with relevant testing capabilities. For testing, generally third-party laboratories do not need FDA authorization, but they need to have relevant testing capabilities and qualifications (generally called CNAS accreditation in China). FDA testing usually involves: food contact materials (that is, food in production, processing, storage, consumption, etc. Materials that can come into contact with food in a series of processes must be tested by FDA to prove that they will not contaminate food), followed by cosmetics (cosmetics need to pass FDA testing to prove that the use of it will not cause direct or potential harm to the human body. ), and in the registration process, FDA tests are required for some products whose performance parameters are uncertain. For example, laser products usually need to be tested for laser radiation levels, and sunglasses should be tested for lens drop and breakage.

FDA certification process

Based on the above, you can check whether the products and companies mentioned above are compatible with you, so as to further judge whether you need to do FDA registration or FDA testing, or both FDA registration and FDA testing. Of course, you need to do this. It can be said to be FDA certified.

The following is a general introduction to the operation process of FDA registration and FDA testing:

FDA registration is mainly the process of submitting data for review, and finally a registration number is generally obtained. Of course, in order to meet the FDA certification, third-party companies will generally issue a formal certificate based on the registration number. This certificate is not officially provided by the FDA. , and has no legal effect. Its function is to visually display the FDA registration number and the corresponding enterprise information through a picture, which is convenient for enterprises to use and display.

FDA testing is mainly to provide samples to the laboratory for testing. After the testing is completed, an FDA testing report will be obtained. According to the product testing data and the data required by the FDA to judge whether the product meets the FDA requirements, what you will get is only a testing report, not certification. Certificate.

How to apply for FDA certification?

FDA certification requires different costs and cycles for different types of enterprises and products. For specific handling and operation procedures, you can contact our company for targeted handling introduction.

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