Observing the leading brands in the water based lubricant industry, you'll find a striking commonality in their supply chain choices: they only cooperate with factories that have FDA certification. Even if part of their business is sold domestically, they still adhere to very high international standards. This is not only to meet export demands but also a well-considered brand premium strategy and risk management logic, reflecting the top brands' pursuit of a "quality ceiling."
FDA certification means the factory meets top global standards in production environment, raw material control, and validation systems. The FDA review process imposes nearly stringent requirements on product biocompatibility, ensuring no toxicity or irritation during mucosal contact. For major brands, this authoritative endorsement is a powerful tool for building brand credibility. In consumers' eyes, products with FDA backing represent "medical-grade safety," effectively distinguishing them from low-cost, inferior products and supporting higher retail prices. This competitive advantage, like a dimensionality reduction strike, is key for brands to quickly break through in a crowded market.
In addition, supply chain stability is the lifeline of major brands. Factories with international certifications such as FDA and ISO13485 typically have more advanced automation equipment and stricter quality control processes, ensuring batch consistency in large-scale production. This effectively prevents PR crises caused by quality fluctuations. By closely partnering with such strong manufacturers, major brands can focus more on marketing innovation and market expansion without worrying about compliance risks on the production side. Choosing an FDA-certified factory is essentially choosing the world's highest level of quality assurance system.
As a company certified by the US FDA 510K and EU CE, Pingchuang Medical has a 16,000-square-meter modern facility and a 100,000-class cleanroom. We strictly follow GMP standards and maintain long-term OEM partnerships with well-known domestic and international brands such as Songji Medical and Beilele. By leveraging Pingchuang Medical's full qualification endorsement, clients can achieve compliant market entry without high certification costs. Our daily production capacity of 600,000 units supports brands in establishing high-end market competitiveness in 76 countries worldwide.
