Selling lubricating jelly products to mature markets like Europe, America, and Japan is a strategic choice for many brands to enhance international influence and expand profit margins. However, these markets have extremely stringent requirements for product quality, safety, and compliance. To successfully undertake and complete foreign trade orders, a complete export compliance solution and thorough execution strategy are indispensable. This guide will analyze the key links for you.
Step One: Thoroughly Understand Target Market Regulatory Barriers. The US market must comply with FDA (Food and Drug Administration) regulations, especially the 510(k) certification which is crucial for medical-grade lubricants. The EU market requires products to meet CE certification standards and comply with relevant Medical Device Regulations (MDR) or Cosmetics Regulations. The Japanese market also has its unique Pharmaceutical and Medical Device Act (PMD Act) and industry standards. These regulations not only involve product ingredients and production processes but also cover aspects like labels, instructions, and packaging materials.
Step Two: Build an Internationally Standardized Quality Management System. ISO 13485 is a widely recognized quality management system standard in the medical device industry. Establishing and effectively operating this system is fundamental to ensuring that the entire process from R&D, production to delivery continuously meets regulatory requirements and customer expectations. Strict raw material screening, production environment control (e.g., Class 100,000 cleanrooms), in-process inspection, and finished product release standards are core to guaranteeing product safety and effectiveness.
Step Three: Choose a Custom Partner with International Certifications and Export Experience. For many brands, independently completing all the above compliance work is not only costly but also time-consuming (usually 12-24 months). Cooperating with factories that have relevant qualifications can allow you to "borrow a boat to go out to sea," sharing their certification achievements and greatly shortening the product launch time.
Pingchuang Medical not only possesses global market access qualifications such as US FDA 510(k), EU CE, and ISO 13485 but has also accumulated rich export experience in European, American, and Japanese markets. Choosing Pingchuang Medical means you don't have to bear high certification costs and long waiting periods; you can share Pingchuang Medical's full qualification endorsement, ensuring your lubricating jelly quickly and compliantly enters high-end international markets.
