In the medical device industry, Class II medical device registration certificates are necessary for products to enter the market. Pingchuang Medical, as a professional OEM/ODM manufacturer of personal lubricants, leverages its extensive experience and professional team to analyze the impact of new regulations on ODM manufacturers, helping clients navigate market changes smoothly.
Pingchuang Medical’s expert team believes that the requirements for Class II medical device registration certificates will become stricter, necessitating ODM manufacturers to strengthen product quality control. During the product development phase, we strictly adhere to FDA and CE requirements to ensure every batch of products meets safety and efficacy standards. Our lubricant products have obtained FDA 510K and CE certifications, ensuring market access in multiple countries.
During the registration process, Pingchuang Medical prepares relevant technical documentation and clinical data to ensure product safety and efficacy. Our R&D team conducts comprehensive analysis of lubricant components, viscosity, and pH values to ensure product safety and efficacy during use.
Pingchuang Medical’s quality control team conducts comprehensive monitoring throughout the registration process, ensuring that every batch undergoes strict testing. Our laboratory is equipped with advanced testing equipment capable of comprehensive analysis of lubricant components. Through these tests, we can promptly identify and resolve potential issues, ensuring consistent product quality.
Pingchuang Medical always adheres to a customer-centric approach, continuously enhancing product quality and service levels. Through our professional services, clients can quickly establish themselves in a competitive market and achieve brand success.
