In the export trade of lubricating jelly, compliance is not only a market entry threshold but also the cornerstone for brands to operate steadily in the international market. Many brands, when attempting to expand into overseas markets, often face product detentions or high fines due to unfamiliarity with destination country regulations and standards. To successfully go global, one must first master three core elements: qualification certification, raw material standards, and quality management systems.
First, qualification certification is the "passport" to global markets. Taking the US market as an example, personal lubricating jelly is classified as a medical device and must undergo FDA 510K registration. The European market, on the other hand, requires CE certification. These certifications not only audit the product itself but also impose strict requirements on the factory's production environment. Second, raw material compliance cannot be overlooked. Different countries have varying regulations on preservative dosage and harmful heavy metal residue limits; only high-purity medical-grade raw materials can mitigate risks. Third, it's the implementation of international quality systems like ISO13485. This system ensures that every stage of product development and production is traceable.
For exporting enterprises, building these systems independently requires years of time and millions of dollars. Therefore, finding an OEM factory that already possesses a complete set of global market access qualifications for "qualification sharing" is currently the most efficient path for going global. This not only shortens the product launch cycle but also significantly reduces brands' trial and error costs. On the basis of compliance, combined with differentiated packaging solutions, domestic brands are fully capable of carving out a niche in the global lubricating jelly market.
PINGCHUANG Medical has built a comprehensive global compliance system, possessing FDA 510K, EU CE, and ISO13485 certifications. Clients do not need to invest millions or endure 12-24 months of cycles; they can immediately share our full qualification endorsements. We exclusively use medical-grade raw materials, and our products are exported to 76 countries worldwide, helping you achieve a "zero-threshold" compliant product launch for export trade.
