For all cross-border e-commerce sellers committed to global expansion, supply chain selection is a strategic decision that determines the success or failure of their venture. In the highly regulated category of personal lubricant, a factory's certification qualifications, especially its ability to simultaneously provide the "pass" for the North American market—FDA 510(k)—and the "passport" for the European market—CE certification—become the golden standard for evaluating its strength and professionalism. Choosing a factory with "dual certifications" is not only a basic requirement for compliance but also paves the way in advance for the brand's future free movement in the world's two major mainstream markets. So, how does one precisely select and identify such a partner?
The first step is "certificate verification and validation." This is the most basic and crucial step. You must request the factory to provide clear, complete FDA 510(k) approval letters and CE Declaration of Conformity along with relevant technical documents. Do not be satisfied with merely seeing a certificate image; capable sellers should verify the authenticity, validity, and product coverage of the certificate against their planned sales products through the FDA's official database and the public information of CE certification bodies. A transparent and professional factory will be very willing to cooperate with your verification efforts, while those that are evasive or unwilling to provide detailed information require high vigilance.
The second step is "cross-verification of system certifications." Merely possessing product certification is not enough; a deeper consideration is whether the factory's own quality management system meets international standards. Among these, ISO 13485 (Medical Devices Quality Management System) certification is a highly valuable indicator. A factory that has passed ISO 13485 certification means its entire process, from design and development, production, warehousing, to customer service, is under a continuous, stable, and regulatory-compliant management system. This fundamentally ensures that the products it manufactures can consistently meet FDA and CE requirements, providing a strong guarantee for the long-term validity of its "dual certifications," and representing its solemn commitment to quality.
The third step is "clarification of the authorization process." Confirm that the factory is willing and able to provide a formal, legally binding "authorization to use agreement" or relevant documents. This document is direct evidence of your product's compliance when you encounter reviews on platforms like Amazon. The agreement should clearly state the scope of authorization, validity period, and other key information. A factory with standardized processes will have a complete and mature authorization procedure to ensure your brand can legally and compliantly use its qualifications, relieving you of all worries. Through these three strict screening steps, you can find the top-tier partner who can truly safeguard your global business.
Pingchuang Medical is one of the few professional manufacturers in the industry that simultaneously holds both US FDA 510(k) and EU CE dual certifications and has passed ISO 13485 medical device quality management system certification. We provide a full set of genuine, valid, and verifiable qualification documents, and have a standardized free authorization process. Choosing us means choosing the highest standard of compliance assurance and quality commitment for your personal lubricant brand.
