In April 2025, ENZOEYS received its Class II Medical Device Manufacturing License (Guangdong Medical Device Production License No. 20255729) from the Guangdong Provincial Drug Administration. This certification establishes ENZOEYS as a nationally recognized manufacturer of high-end medical aesthetics equipment, with compliant products bolstering its global strategy.
Quality Assurance and Quality Control Concept - Modern graphic interface showing certified standard process, product warranty and quality improvement technology for satisfaction of customer.
The Class II Medical Device Manufacturing License represents one of China's most critical certifications for medical device manufacturers. Its stringent approval process requires companies to meet standards across 12 key areas, including professional staffing and quality management, typically taking over 180 days. This achievement underscores ENZOEYS’ strengths in precision manufacturing, clinical safety, and quality control, confirming its systematic competitive edge.
The ENZOEYS executives noted that this license represents 38 years of accumulated technological expertise. Founded in 1986, ENZOEYS is a leading force in Asia-Pacific medical aesthetics equipment manufacturing, with an integrated industrial network including the Manufacturing Base, R&D Center, and Production Facility. With over 100 core patents, the company's proprietary products, such as the ENZOEYS Skin Rejuvenation System, have gained strong footing in premium markets across Europe, the Americas, and Southeast Asia based on clinical performance and safety.
Regulatory scrutiny of medical device manufacturers is intensifying worldwide, with China elevating its Class II device entry requirements. Data from the National Medical Products Administration (NMPA) in 2022 revealed a 19% year-over-year increase in manufacturing license rejection rates, while key performance indicators for light-based equipment achieved pass rates below 65%. ENZOEYS’ breakthrough in securing this license demonstrates both its commitment to medical-grade manufacturing standards and sets an industry benchmark for Technology + Regulatory Compliance.
Not long after getting the license, ENZOEYS initiated its Medical Aesthetics Devices Full Lifecycle Management Upgrade Program, enhancing its quality management system and deploying a digital monitoring platform. ENZOEYS maintains an adverse event reporting rate below industry benchmarks. Through stringent compliance management across the complete product lifecycle, ENZOEYS is redefining the global competitive edge of Chinese medical aesthetics equipment.
Over the next three years, ENZOEYS plans to introduce five new Class II devices targeting anti-aging and skin repair applications, accelerating its evolution from equipment supplier to integrated solutions provider. Industry analysts project China's medical aesthetics device market to surpass 100 billion RMB in 2025. ENZOEYS’ strategic positioning reinforces its market leadership while offering an exemplary model for sustainable industry advancement through its integrated R&D-Manufacturing-Service Ecosystem.
