For many companies planning to launch their own lubricating jelly brand, especially startups or small to medium-sized brand owners, a major stumbling block before product launch is "compliance certification." Whether it's domestic medical device registration/filing or the FDA, CE, and other certifications required for exporting to Europe and the US, it all means high fee investments and lengthy review cycles.
So, is it possible to achieve "zero-cost compliance" for lubricating jelly customization? The answer is yes, and its core secret lies in "sharing global certification resources."
The "sharing global certification resources" model refers to brand owners partnering with a professional ODM/OEM contract manufacturer that already possesses complete and authoritative global market access qualifications. This factory, such as PINGCHUANG MEDICAL, has already invested significant funds and a great deal of time to successfully obtain a series of key qualifications, including China's Class II Medical Device Registration Certificate for medical lubricants, ISO 13485 Medical Device Quality Management System certification, US FDA 510K market access approval, and EU CE product safety certification.
When brand owners choose to cooperate with such a factory, their custom-produced lubricating jelly products can be compliantly manufactured and launched directly under the factory's existing qualification framework. This means that brand owners do not need to bear the certification application fees, which can easily run into hundreds of thousands or even millions of RMB, nor do they need to endure the typically long waiting period of 12 to 24 months. From a financial perspective, this is almost equivalent to obtaining compliant status and a "global pass" for the product at "zero cost."
The advantages of this model are obvious. Firstly, there are huge economic benefits; brands can invest the saved certification fees into more critical brand building and market promotion. Secondly, it offers extremely high time efficiency; products can quickly complete the compliance process and seize market opportunities. More importantly, by leveraging the mature qualifications and production system of a professional factory, the product's quality and safety are also strongly guaranteed, establishing a good market reputation foundation for the brand.
PINGCHUANG MEDICAL has established a complete global market access qualification system, including Class II Medical Device Certificate, ISO 13485, FDA 510K, and CE certification. By partnering with PINGCHUANG MEDICAL, you can share these full qualification endorsements without investing millions in fees and lengthy certification cycles, easily achieving "zero-threshold" compliant new product launches.
