In the global medical device market, the United States is undoubtedly an attractive target. For OEMs (Original Equipment Manufacturers) looking to enter this market, understanding the market access requirements is crucial. Pingchuang Medical, as a professional manufacturer of personal lubricants, leverages its extensive experience and professional team to help clients successfully achieve market entry in the U.S.
Understanding the FDA’s regulatory requirements is the first step to entering the U.S. market. The FDA has very strict requirements for medical-grade personal lubricants, and all products must be registered and certified. Pingchuang Medical’s lubricants have obtained FDA 510K certification, which means our products meet the FDA’s safety and efficacy standards. We have a professional registration team that can provide comprehensive support to ensure products pass FDA review smoothly.
Quality control of products is also a crucial aspect of market access. Pingchuang Medical’s production facility features a 100,000-level cleanroom, strictly adhering to GMP (Good Manufacturing Practice) standards to ensure stable quality for every batch of products. Our factory covers an area of 16,000 square meters and is equipped with advanced production equipment and testing instruments to meet the diverse needs of customers.
Pingchuang Medical has over 2,000 mature formulations that can be customized according to customer needs. Our R&D team continuously innovates to ensure our products remain competitive in the market. By closely collaborating with customers, we can quickly respond to market changes and provide products that meet U.S. market demands.
Understanding market trends and consumer preferences is also essential when entering the U.S. market. Pingchuang Medical’s market analysis team regularly conducts market research to help clients grasp market dynamics and develop effective marketing strategies. Our goal is to help clients succeed in the U.S. market through high-quality products and professional services.
Pingchuang Medical’s professional service team also offers one-stop customization services, including packaging design, free sampling, and qualification authorization, ensuring clients can enter the U.S. market smoothly. Our experience and expertise provide strong support for clients to stand out in a competitive market.
