New US FDA regulations have a significant impact on ocean freight customs clearance.
In this article, Weefreight will share some essential documents you must prepare in advance, hoping they will be helpful.
Common Documents
Commercial Invoice: Clearly indicate in English the product name, quantity, unit price, total value, intended use, country of origin, and other information. Avoid simply stating “sample” or “gift”; clearly state the commercial purpose.
Packing List: Consistent with the invoice information, detail the dimensions, weight, and contents of each package.
Authorization: If the recipient is not a US company, provide an importer authorization letter and tax ID number.
Specific Product Documents
Food: Complete company registration on the FDA website in advance and obtain a PIN. Provide a Nutrition Facts table in English that complies with FDA labeling standards, as well as a health certificate issued by Chinese Customs.
Medical devices: Depending on the device category, provide FDA 510(k) clearance or premarket notification, along with an English technical manual. Class II and higher devices require additional approval. Also, provide the FDA medical device registration number, including the manufacturer’s registration number and product listing number. In addition, for ophthalmic medical devices, a drop ball test report is required.
Cosmetics: Provide product compliance certification, such as a heavy metals test report.
Other Documents
Certificate of Origin: Some products, such as agricultural products and textiles, require a certificate of origin.
Test Reports: Depending on the product type, test reports such as ingredient analysis and additive safety certification may be required.
In addition, effective July 9, 2025, the FDA will rescind the “low value exemption” for small imported packages valued at $800 or less. All FDA-regulated products must submit a complete declaration using Entry Type 86, including the 10-digit tariff number, product ingredients, and instructions for use. For food and feed products, Prior Notice reporting obligations remain.
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