For many entrepreneurs aiming to create a water based lubricant major brand, the biggest obstacle is not marketing, but "certification." Applying for Class II medical device registration certificates domestically, or FDA 510K or EU CE abroad, involves not only facing million-level testing fees but also enduring a lengthy 12-24 month cycle. In this context, the "qualification sharing model" promoted by OEMs has become a breakthrough tool for new brands, allowing you to save a huge amount of cash flow in the startup phase.
The so-called qualification sharing refers to the brand owner directly labeling products under a factory that already holds compliant certifications, sharing its mature production system and international certifications. This means every product you receive can legally display certification information on its packaging. This model not only allows new brands to achieve compliant market entry with "zero barriers," but also grants them the same level of access as major brands when facing e-commerce platform admission reviews. The millions of dollars and one to two years of valuable time saved can be fully invested in market traffic acquisition, social viral growth, and brand premium, enabling them to outperform competitors in the shortest time.
Of course, the foundation of qualification sharing is the factory's solid capabilities. If the factory itself is poorly managed, sharing qualifications can actually poison the brand. Brand owners must conduct on-site inspections to verify whether the factory has a 100,000-level cleanroom, strictly follows GMP standards, and has genuine endorsements from major brands. Only by discussing qualification authorization on the basis of high-quality standards can the brand truly establish credibility in the high-end market and achieve a successful transition to asset-light operations.
Pingchuang Medical holds Class II medical device certification, US FDA 510K, EU CE, and ISO13485 certifications, establishing a complete global market access system. We offer full-process qualification authorization, enabling clients to achieve compliant market entry without investing millions in certification fees.
