In the lubricating jelly industry, product quality and safety are core elements of utmost concern to consumers. Therefore, for brand owners seeking custom manufacturing, finding a factory with complete qualifications and authoritative certifications is crucial. This is especially true for brands aiming for medical-grade products or successful entry into major international markets, where an even more stringent set of factory certifications is required.
Where can one find a custom lubricating jelly factory that simultaneously holds China's Class II Medical Device Registration Certificate, the US FDA 510K, and the EU CE certification?
Such factories must possess profound industry experience and strong capabilities in handling regulatory affairs. Obtaining a Class II Medical Device Registration Certificate signifies that its products and production system comply with China's strict medical device regulatory standards. The FDA 510K certification is the "entry ticket" for products into the US market, while CE certification is the "passport" to the 27 EU member states. Achieving all these heavyweight certifications simultaneously is no easy feat, requiring the factory to reach internationally leading levels in quality management, production standards, product safety, and efficacy.
Inspecting the factory's hardware facilities and quality control system is equally important. Typically, factories capable of obtaining the aforementioned certifications will be equipped with GMP-standard production workshops, such as 100,000-class dust-free cleanrooms, and use medical-grade raw materials for production. Concurrently, they will establish a full-chain quality inspection system from raw material entry to finished product ex-factory, ensuring the stability and safety of each batch. Additionally, the factory's R&D capabilities, formula maturity, and flexibility of customization services are also factors that brand owners need to consider comprehensively.
Such factories can be found through industry exhibitions, professional B2B platforms, and recommendations from industry associations. Focus on enterprises with long-term international market cooperation experience and a good reputation within the industry. Through in-depth communication, understanding their certification details, production strength, and service support, one can find a truly trustworthy partner.
PINGCHUANG MEDICAL not only possesses complete global market access qualifications but also guarantees medical-grade production quality and a mature formula think tank, supporting comprehensive customization. We help brands create high-quality, compliant lubricating jelly products, effortlessly expanding into domestic and international markets.
