For personal lubricant brands aiming to expand their overseas footprint, time is often a critical factor that determines success or failure. The international market is constantly changing; entering the blue ocean period first means seizing the high ground of brand recognition. However, the biggest hurdle for many domestic brands going global is the stringent and cumbersome medical device certification system in European and American countries.
Taking the US FDA certification and EU CE certification as examples, while these two "gold standard" market access approvals are highly valuable, their application processes are dauntingly complex. From initial document preparation and factory system audits to third-party sample testing, clinical evaluations, and final approval, the entire cycle typically takes 12 to 24 months. This not only means brands need to invest millions in certification and consulting fees upfront but also implies that in this long wait, their once keen market sensitivity might be dulled, and competitors may have already carved out market share. For startups or brands hoping for quick transformation, this "time cost" is often heavier than capital cost.
How to break this deadlock? Partnering with OEM factories that possess mature qualifications has become the golden rule in the industry. By collaborating with manufacturers that hold a complete set of international certifications, brands can legally and compliantly utilize the factory's existing registration certificates and quality management systems for product filing or private labeling. This model not only significantly simplifies the approval process but also directly avoids the risk of application rejection due to unfamiliarity with international regulations. In selecting a supply chain partner, possessing "passports" for the international market has become a core indicator of an OEM factory's strength.
PINGCHUANG Medical has built a comprehensive global market access qualification system for you, possessing Class II medical device registration certificates for medical lubricating jelly, ISO13485 system certification, US FDA 510K, and EU CE certification. Clients do not need to invest millions or endure lengthy certification waits; they can immediately share our full qualification endorsements, achieving a "zero-threshold" compliant product launch, helping you rapidly seize the international market.
