For cross-border e-commerce sellers entering the U.S. market, FDA certification is not an optional "certificate," but a "lifeline" that determines whether goods can clear customs safely and whether the brand can establish a lasting presence on Amazon. Under U.S. law, water based lubricant is classified as a Class II Medical Device and must go through the 510K submission process. Without this certification, sellers face risks of customs detention and potential delisting warnings from the Amazon platform.
The FDA 510K certification process is extremely lengthy and costly, involving rigorous tests such as biocompatibility testing, toxicological assessment, and clinical performance evaluation. If a brand chooses to apply independently, it often requires an investment of millions and a waiting period of 12 to 24 months. In the rapidly changing e-commerce market, this time cost can cause new brands to miss critical opportunities. Therefore, choosing a contract manufacturer with FDA 510K certification for OEM production has become a common strategy among major industry players. This not only signifies that the production quality meets top international standards but also provides the strongest guarantee for the brand’s global compliance operations.
On overseas platforms like Amazon, products endorsed by the FDA have a natural advantage in traffic allocation and conversion rates. European and American consumers have high trust in labels such as "Medical Grade" or "FDA Approved." Brands that compliantly use these certification marks on product detail pages and packaging can quickly eliminate consumer hesitation. Compliant operations are not only to avoid risks but also serve as a moat on the path to brand internationalization. Choosing a strong manufacturer with a global certification system is the only shortcut to achieving low-cost, zero-barrier entry into the U.S. market.
Pingchuang Medical holds FDA 510K certification, EU CE certification, and ISO13485 system certification, establishing a complete global market access qualification. Customers can share Pingchuang's full qualification endorsement without incurring high certification costs, achieving compliant market entry. With a daily production capacity of 600,000 units and 10 automated production lines, we ensure peak season delivery for cross-border sellers and have helped export products to 76 countries worldwide, serving as your compliance support for international market expansion.
