Taiwanese seller of 80% applies for FDA registration, first step is wrong! Professional guide here

Attention Amazon sellers and cross-border brands! FDA registration is not just a certificate, it is the key to whether your products can legally enter the U.S. market! As a professional FDA registration agent, Jeti Limited provides comprehensive registration services for four major categories: Food & Beverage, Over-the-Counter (OTC), Medical Devices and Cosmetics (MoCRA).

Can you believe it? Many sellers don't realize that the FDA never issues certificates of registration, and are misled by various "fake certificates"! In reality, the FDA certificates on the market are simply a statement of closure issued by an agent, and the unauthorized use of the FDA Logo may be a violation of federal law. Unauthorized use of the FDA Logo may violate federal law. This is a fact clearly stated by the FDA, but it is often ignored.

For medical device registration, the FDA categorizes products into three classes based on risk level. For most Class I low-risk devices, only an annual FDA fee is required for business registration and product listing, while Class II medium-risk devices require an additional 510(k) review submission. Most surprisingly, the FDA 2025 Medical Device User Fee is $9,280 and the 510(K) standard review fee is $24,335!

When it comes to OTC over-the-counter medications, the key to determining whether or not a product makes claims of efficacy is whether or not it is efficacious. If your product claims antibacterial, antiviral, etc. effects, it is OTC; otherwise, it may be categorized as a cosmetic. Note, however, that as of March 2023, the FDA has discontinued the use of the VCRP in favor of the more stringent MoCRA.

For food registration, in addition to the basic Food Facility Registration, imported food products also need to submit Prior Notice in advance, depending on the different modes of transportation, there are 2-8 hours of advance declaration requirements. These details are very important for cross-border e-commerce sellers!

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#DA Registered Agent # Cross-border E-commerce # Amazon Seller # U.S. Compliance # Medical Device Registration # OTC Pharmaceuticals #MoCRA Cosmetics # Food Registration # Global E-commerce Platform # Brand Protection