Green Circle Speaks Cross Border] - Entering the United States! Mastering the importance of FDA certification and the key categories 💡.

The U.S. Food and Drug Administration (FDA) is a scientific regulatory agency responsible for ensuring the safety of food, cosmetics, drugs, medical devices, and radionuclides manufactured in or imported into the United States. 🛡️ As one of the first federal agencies whose primary function was to protect consumers, the FDA has been recognized internationally as one of the most authoritative food and drug regulatory agencies in the world. 🌍

So, why is FDA certification necessary? 🤔 The differences in the definitions of the above products between the U.S. and Taiwan have resulted in the U.S. having different classifications, jurisdictions, and regulatory requirements for these products. Therefore, companies must register or file accordingly before exporting to the U.S. in order to avoid the risk of being refused entry by the FDA or being added to the blacklist due to a lack of understanding of the regulations. 🛑

Products sold on Amazon that require FDA approval fall into the following categories:
1) Food: Includes food products and food contact products, which require FDA registration and food contact material testing respectively. 🍏

2) Medical devices: classified into one to three categories according to risk level, ranging from low-risk products such as eyeglasses to high-risk products requiring pre-market approval, such as lasers for surgery. 🩺

3) Pharmaceuticals: Includes human and veterinary drugs, especially OTC over-the-counter drugs and APIs. It is worth noting that some cosmetic products are also categorized as pharmaceuticals due to their specific functions. 💊

4) Laser radiating electronic products: Before exporting to the U.S., an Accession Number must be obtained and usually an IEC60825 test must be conducted to certify that the laser radiation is safe. 🔬

5) Cosmetics: According to the latest MoCRA, cosmetics exported to the U.S. must be registered with the FDA and replaced the previous Voluntary Cosmetic Registration Program (VCRP). 💅

In summary, for companies wishing to enter the U.S. market, complying with FDA regulations and conducting the necessary registrations and inspections is a critical step. This is not only a demonstration of corporate responsibility, but also an important strategy to ensure the smooth entry of products into the U.S. market and avoid legal risks. Enterprises should conduct timely operations according to the product category and FDA requirements to maintain the compliance and market competitiveness of their products. 📈

"Global e-commerce entrepreneurship, the first choice of the Green Circle", the Green Circle first choice of the FDA guarantee program, do not do not come to the certificate to refund the full amount, limited to 100.