Selling food, cosmetics, drugs, and other products on Amazon US not only requires consideration of product packaging, transportation, pricing, and marketing, but also requires approval from the US Food and Drug Administration (FDA). Products registered with the FDA can enter the US market for sale to avoid the risk of delisting.
Compliance and quality assurance are key to successful exports, and obtaining FDA certification is the "passport" to enter the US market. So what is FDA certification? What types of products need to be registered with the FDA?
The FDA is a regulatory agency of the US federal government responsible for ensuring the safety, efficacy, and compliance of food, drugs, medical devices, and other related products. This article will introduce the importance of FDA certification, the classification of certification, the certification process, and the materials required for applying for certification. By obtaining FDA certification, companies can convey confidence in product quality and safety to consumers and further expand their market.
The Importance of FDA Certification
FDA certification is one of the key factors for many companies to achieve success in the US market. Obtaining FDA certification means that the product meets the strict standards and requirements of the FDA, with high quality, safety, and compliance. For consumers, FDA certification is an important guarantee of product quality and safety, helping them make informed purchasing decisions. For businesses, obtaining FDA certification can enhance brand reputation, increase consumer trust, and help products stand out in a fiercely competitive market.
FDA testing
2. Classification of FDA certification
FDA certification covers multiple product categories, mainly including food, pharmaceuticals, medical devices, biologics, and radiation products. The FDA has developed corresponding certification standards and procedures for different product categories. Food certification includes registration of food production enterprises, approval of food additives, and compliance of food labels. Drug certification covers clinical trials and approvals of new drugs, equivalence certification of generic drugs, as well as the production and sale of drugs. Medical device certification includes classification of medical devices, 510 (k) pre-market notification, and PMA (pre-approval) application. Biological product certification involves the approval and registration of vaccines, blood products, and gene therapy products. Radiation product certification covers safety certification for medical equipment, medical radiopharmaceuticals, and electronic products.
3. Which products require FDA certification?
3.1 FDA testing and certification of food packaging materials
3.2 FDA testing and certification of glass ceramic products
3.3 FDA testing and certification of food grade plastic products
3.4 Food: including processed food, packaged food, frozen food, etc
3.5 Medical Devices: Masks and Protective Equipment, etc
3.6 Medications: Prescription and over-the-counter drugs, etc
3.7 Food additives, dietary supplements, etc
3.8 Beverages
3.9 Food related materials
3.10 FDA testing and certification of coating products
3.11 Plumbing Hardware Products FDA Testing and Certification
3.12 FDA testing and certification of rubber resin products
3.13 Sealing Material FDA Testing and Certification
3.14 FDA testing and certification of chemical additives
3.15 Laser Radiation Products
3.16 Cosmetics: Color additives, skin moisturizers, and cleansers, etc
3.17 Veterinary products: veterinary drugs, pet food, etc
3.18 Tobacco products
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Medical FDA registration
Post time: Aug-14-2024
