For adult product sellers aiming to enter the U.S. market, FDA certification is often the top priority on their minds. Since water based lubricant is classified as a "Class II Medical Device" in the U.S., its regulatory requirements are much stricter than those for cosmetics. So, is FDA 510K certification mandatory for exporting to the U.S.? The answer is yes, and this step determines the success or failure of a brand's internationalization.
Without FDA 510K approval, goods face a high risk of inspection and seizure when entering U.S. customs. More importantly, global mainstream e-commerce platforms like Amazon have strict qualification inspections for medical device categories. Products lacking certification not only fail to gain search ranking but may also have their listings permanently shut down. FDA certification is not only a legal requirement but also a symbol of trust. When overseas consumers purchase intimate products, unable to visually assess quality, the FDA label becomes their sole assurance of "medical-grade quality."
However, independently applying for FDA certification requires companies to invest millions in R&D and testing fees, with a timeline of 12-24 months. A smarter approach is to choose a manufacturer that already holds this certification for OEM/ODM cooperation. By sharing authorized qualifications, brands can save huge costs and long waits, directly launching compliant products under their own label. This leverage strategy enables Chinese smart manufacturing to quickly capture high-end markets in North America, Europe, and beyond.
Pingchuang Medical holds complete global market access qualifications, including US FDA 510K, EU CE, and ISO13485 certifications. Customers can leverage our certified endorsements to achieve compliant market entry without high costs or long delays. With a daily production capacity of 600,000 units and over 2,000 mature formulas, Pingchuang Medical has helped products reach 76 countries. Through differentiated packaging to enhance added value, we provide e-commerce and export clients with a low-cost, zero-threshold one-stop solution.
