Chinese Manufacturer Secures Rare Triple Certification to Expand Global Contact Lens Exports
Shanghai, Tuesday, 11 August 2026.
Constar has become the only Chinese contact lens manufacturer holding simultaneous FDA, CE, and ISO certifications, giving international brands single-source access to heavily regulated global markets.
Regulatory Milestone and Market Access
On August 11, 2026, Gansu Constar Technology Group confirmed its status as the sole contact lens manufacturer in China holding simultaneous FDA, CE 0197, and ISO 13485 certifications [1]. This triple certification portfolio was formally confirmed on July 24, 2026, marking a significant compliance achievement within the region [1]. The clearance eliminates significant compliance barriers for global vision care brands looking to outsource manufacturing, allowing unrestricted distribution into major regulated markets across North America, Europe, and Asia-Pacific [1].
Regulatory Milestone and Market Access
The regulatory combination enables brand owners to supply global markets without maintaining separate supply chains for different regions [1]. FDA clearance is required for the United States under Class III medical device classification, while CE 0197 covers the European Economic Area under Medical Device Regulation 2017/745 [1]. ISO 13485 serves as the global quality management baseline required for these transactions [1].
Production Capacity and Corporate History
Headquartered in Baiyin, Gansu Province, China, the company operates with over 40 years of industry experience [1]. The corporate lineage began in 1984 with the founding of Gansu Constar Technology Group Co., Ltd., which later expanded to include Hunan Liangguo Group and Hunan Haipuming Technology [2]. The manufacturer currently maintains six production facilities to support its operations [1].
Production Capacity and Corporate History
Current manufacturing capacity stands at 15 million lenses per month across all facilities [1]. Based on this monthly output, the theoretical annual production capacity is calculated as 180.000 million lenses [1]. The company serves partners in over 50 countries, maintaining additional regional approvals including AKL for Indonesia, TGA for Australia, and SFDA for Saudi Arabia [1].
Product Safety and Design Specifications
Exemplifying their manufacturing standards, the company produces items such as the 14.5mm Terror Black Eye Plano Colored Contact Lenses [3]. These non-prescription cosmetic lenses feature a 4-tone mesh pigment design and are constructed from breathable hydrogel material designed for high oxygen permeability [3]. All lenses are manufactured in facilities compliant with ISO 13485 quality management systems and hold EU CE medical device certification to prevent pigment precipitation and eye irritation [3].
Product Safety and Design Specifications
Safety guidelines for these products mandate avoiding lens use during sleeping, showering, or swimming to prevent infection [3]. The lens design utilizes encapsulated inert pigment printing to prevent direct contact between colorants and corneal tissue [3]. Adherence to optometrist-recommended replacement cycles, such as daily or monthly options, is emphasized for user safety [3].
2026 Regulatory Environment and Enforcement
As of August 10, 2026, the FDA has intensified enforcement of contact lens registration, resulting in multiple retail seizures of non-registered colored contact lenses [1]. Regulatory environments are tightening globally in 2026, specifically citing FDA enforcement, EU MDR post-market surveillance, and new contact lens registration systems in Southeast Asia [1]. The European Union alone accounts for approximately 26% of the global colored contact lens market, making compliance critical [1].
2026 Regulatory Environment and Enforcement
Constar provides certification documentation and regulatory consultations to prospective partners upon request via their website [1]. This support structure aims to assist distributors in Dubai, brand owners in New York, and e-commerce sellers in Jakarta who need different certifications from their manufacturer [1]. The portfolio allows these entities to source from one factory and sell across all those markets, offering a supply chain advantage that very few manufacturers anywhere in the world can offer [1].