For cross-border sellers aiming for global markets, supply chain selection is the first strategic step. In the personal lubricant field, an ideal factory's core value lies not only in its production capabilities but also in the completeness of its compliance certifications. A factory that can simultaneously provide both US FDA 510(k) and EU CE dual certifications is undoubtedly a hallmark of a top-tier partner.
When screening, sellers should focus on the following points. Firstly, verify the authenticity and validity of the certifications. Request clear scanned copies of certificates from the factory and verify them through official channels. Secondly, understand the subject and scope of the certification to ensure it covers the type of products you plan to sell. Thirdly, confirm whether the factory is willing and able to provide formal "authorization for use" documents, which serve as your legal basis for platform reviews. Finally, and very importantly, examine the factory's own quality management system, for example, whether it has passed ISO13485 (medical device quality management system) certification, which indirectly confirms the value of its certifications and its ability to maintain them long-term.
Pingchuang Medical is one of the few professional factories in the industry that simultaneously holds both FDA 510(k) and CE dual certifications and has passed ISO13485 system certification. We provide genuine, valid, and authorized full qualifications, making us your most reliable and worry-free choice for global market expansion.
