Really don't use fake FDA certificates anymore! A must-read compliance guide for cross-border sellers in Taiwan

Really don't use fake FDA certificates anymore! A must-read compliance guide for cross-border sellers in Taiwan

Attention Taiwan Cross Border Exporters! Do you know how important US FDA registration is? Green Circle E-commerce specializes in providing four major categories of FDA registration agent services: Food & Beverage, Over-the-Counter (OTC), Medical Devices and Cosmetics (MoCRA), to ensure that your products legally enter the U.S. market.

You would never guess that many sellers are complacent with their "FDA certificates", but they don't realize that these certificates are not officially issued by the FDA! The FDA clearly states that it does not issue certificates of registration, and that the certificates in the marketplace are merely statements of closure issued by the agency. More importantly, the unauthorized use of the FDA Logo may violate federal law and have serious consequences!

For medical device registration, the FDA categorizes products into Class I (low risk), Class II (medium risk) and Class III (high risk) based on risk. Different categories have different application requirements and fee standards. For example, the FDA 2025 Medical Device User Fee is $9,280, while the 510(k) standard review fee is $24,335, and small businesses can apply for a reduced rate of $6,084.

For cosmetic registration, starting March 2023 FDA has stopped using VCRP and implemented MoCRA Act instead. The new act adds a number of requirements, including adverse event reporting, mandatory recall authority, and more. SPECIAL NOTE: Small businesses with annual sales of less than $1 million may be granted a partial exemption!

Want to know more? Join our Green Circle LINE and we'll be there for you:https://line.me/ti/p/g2Vc38nLnR

#DA Registered Agent # Cross-border E-commerce # Taiwan Seller # U.S. Market # Medical Equipment # OTC Pharmaceuticals #MoCRA Cosmetics # Food Registration # Compliance # Risk Prevention

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