In the personal lubricant industry, which is closely related to human health, product compliance is the lifeline for brands to establish themselves in the market. Especially for brands aspiring to expand into international markets, obtaining authoritative certifications from target markets, such as US FDA certification and EU CE certification, is an indispensable "entry ticket."
However, these certification application processes are complex, time-consuming, and costly, often deterring many brands. PINGCHUANG MEDICAL, with its comprehensive global qualification system, provides a "fast track" for personal lubricant brands to achieve compliant market launch through qualification authorization.
FDA certification, particularly the 510(k) premarket notification for medical devices, is a mandatory requirement for products entering the US market. It signifies that the product has met the US Food and Drug Administration's standards for safety and effectiveness. The CE mark, on the other hand, is the "passport" for products entering the 27 EU member states and some other European countries, indicating that the product complies with relevant EU directives on health, safety, and environmental protection. Possessing both these mainstream international market access qualifications is a great affirmation of a manufacturing enterprise's quality management and product safety levels.
PINGCHUANG MEDICAL has been deeply involved in the personal lubricant field for many years. We have not only obtained the Class II Medical Device Registration Certificate for medical lubricants and ISO 13485 Medical Device Quality Management System certification domestically but have also successfully secured US FDA 510K and EU CE certifications in the international market. This means PINGCHUANG MEDICAL's products and production system have fully reached advanced international levels and are qualified for legal sales in major global markets.
For partner brands, PINGCHUANG MEDICAL's "qualification authorization" service brings enormous value. Brand owners do not need to invest huge sums of money (often in the millions) and lengthy periods (usually 12-24 months) to tackle these highly difficult certifications one by one. By cooperating with PINGCHUANG MEDICAL, their custom personal lubricant products can be produced and endorsed directly under PINGCHUANG MEDICAL's certification framework, thereby quickly obtaining compliant status and smoothly entering domestic and international markets. This not only greatly reduces the brand's startup costs and market risks but, more importantly, significantly shortens the product launch cycle, allowing brands to rapidly seize market opportunities.
