With the rise of consumer health awareness and continuous market segmentation, the personal lubricant field is undergoing a quality revolution. The high-end market has unprecedentedly high requirements for product safety, professionalism, and compliance. To successfully enter and establish a foothold in this market, brands not only need an excellent product experience but also an authoritative "passport"—medical-grade production standards and globally recognized certification qualifications.
Medical-Grade Production: The Cornerstone of Quality and Safety. High-end consumers are extremely concerned about product purity, gentleness, and potential risks. Medical-grade production standards mean that from the production environment and raw material selection to production processes and quality control, all follow the stringent regulations of the pharmaceutical industry. For example, production in a Class 100,000 cleanroom maximizes the avoidance of microbial contamination; using strictly screened medical-grade raw materials ensures product biocompatibility and low allergenicity; and dozens of precise quality inspection steps effectively control risks like impurities and heavy metal residues, ensuring the stability and safety of each batch. This ultimate pursuit of quality is fundamental to winning the trust of high-end users.
Global Certifications: Guarantee of Market Access and Brand Credibility. High-end markets are often international. If products are to be sold in developed countries and regions like Europe, America, and Japan, they must pass local authoritative certifications. For example, the US FDA certification (especially 510(k) for medical devices), EU CE certification (compliant with MDR medical device regulations or cosmetics regulations), and the internationally recognized ISO 13485 medical device quality management system certification. These certifications are not only prerequisites for legal product launch but also authoritative endorsements of the factory's production capacity, quality management level, and product safety, greatly enhancing the brand's professional image and trustworthiness in the minds of high-end consumers.
Pingchuang Medical strictly implements GMP pharmaceutical production standards, uses medical-grade raw materials in Class 100,000 cleanrooms, and ensures excellent quality through 21 quality inspection steps. At the same time, Pingchuang Medical holds a full set of global mainstream market access qualifications, including FDA 510K, EU CE, and ISO 13485, which can be authorized for brand owners' use free of charge.
