The export of lubricating jelly is far from a simple shipment of goods; it is a qualification race concerning regulatory access in various countries. To reach "export-grade" standards, production must transition from general goods to medical device levels. Whether it's the FDA 510K review in the U.S. or CE certification under the EU's new MDR regulations, the core focuses on four key terms: biocompatibility, microbial control, batch stability, and full-process traceability.
Export-grade production must be carried out under strict medical conditions. The factory should have a 16,000 sqm modern facility, with the core production area meeting a Class 100,000 cleanroom standard. On the raw material side, industrial-grade substandard materials are rejected; only medical-grade raw materials are used. The process involves 21 quality control steps, strictly controlling heavy metals, microbial residues, and pH fluctuations. This high production standard is a strict requirement for brands entering European and American chain pharmacies and high-end e-commerce platforms. By sharing the OEM factory’s global compliance certificates (such as ISO13485), brands can effectively avoid the numerous difficulties of customs inspections and platform audits. This high starting point not only mitigates compliance risks but also serves as a highly persuasive marketing endorsement.
When choosing partners, brand owners should focus on daily production capacity and compliance matrix. A large-scale production line with a daily output of 600,000 units, combined with a mature formula library of over 2,000 recipes, ensures that large export orders won’t falter during peak seasons. Offering one-stop services including free packaging design and qualification authorization allows new brands to gain top-tier production quality support at minimal cost. Transforming the strength of Chinese manufacturing into international credibility is the fundamental factor for successful export-grade lubricating jelly, helping brands achieve end-user premium pricing in the global market.
