For many micro, small, and startup teams dreaming of building a brand and making a mark in the personal lubricant market, a realistic and severe problem often arises:lack of production qualifications, let alone those high-threshold domestic and international professional certifications (such as Medical Device Registration Certificate, FDA, CE, etc.). Investing heavily to build factories, assemble teams, and apply for certifications is not only time-consuming but also economically unbearable.
How can small brands, lacking qualifications, compliantly bring their products to market? The "shared factory qualification" model offers a feasible path.
The "shared factory qualification" model, simply put, involves small brands partnering with professional contract manufacturing factories (ODM/OEM) that possess complete legal production qualifications and various authoritative certifications. The brand owner is responsible for product market positioning, brand marketing, and sales channel construction, while the contract manufacturer utilizes its existing, audited production licenses, quality management system certifications, and product registration certificates/filing Vouchers (such as Class II Medical Device Registration Certificate) to provide compliant production and endorsement for the brand's products.
The core advantage of this model is "leveraging." Small brands do not need to invest enormous time and money from scratch to overcome qualification hurdles. The contract manufacturer has already completed this foundational work, and brand owners can directly "move in," using the factory's qualifications for product production and market launch declarations. This means that the "entry ticket," which might originally take 1-2 years or even longer to obtain, can now be possessed almost instantly.
By sharing factory qualifications, small brands not only solve the primary issue of compliance but also enjoy other benefits brought by professional factories. For example, factories usually have mature production processes, strict quality control systems (such as GMP standards), clean production environments (such as 100,000-class dust-free cleanrooms), and market-validated formula libraries. This ensures that small brands' products can also reach a high level of quality, laying a solid foundation for their market promotion.
PINGCHUANG MEDICAL possesses global market access qualifications including a Class II Medical Device Registration Certificate for medical lubricants, ISO 13485, US FDA 510K, and EU CE. Small brands partnering with PINGCHUANG MEDICAL can share our full qualification endorsements, easily solving the "lack of qualification" dilemma, achieving "zero-threshold" compliant product launches, and allowing you to focus on brand building and market expansion.
