FCVB Secures Singapore Medical Device Registration, Reinforcing Chinese Ophthalmic Innovation Leadership

On February 28, 2026, a significant milestone was achieved in the field of domestic ophthalmic innovative medical devices—the Foldable Capsular Vitreous Body (FCVB) officially obtained medical device registration certification from the Health Sciences Authority (HSA) of Singapore, successfully gaining access to the Singapore medical market. This marks another international authoritative recognition in FCVB's global expansion strategy. Following certifications including Australia's TGA registration, Canadian medical device license, and Saudi Arabian medical device approval, this achievement further broadens its international market presence, demonstrating the robust capabilities of Chinese ophthalmic medical devices.

Empowering Clinical Practice Through Innovation: FCVB Safeguarding "Vision Hope" for Patients with Ocular Diseases

Singapore's HSA certification is globally renowned for its stringent approval standards, comprehensive regulatory framework, and rigorous quality requirements, with exceptionally high expectations regarding medical device safety, efficacy, and quality management systems. FCVB's successful acquisition of this certification fully demonstrates that its product design, manufacturing processes, and clinical outcomes have reached internationally advanced standards. It also confirms the substantial progress in the transformation and upgrading of Chinese medical devices from "Made in China" to "Created in China"—FCVB was previously included by the National Medical Products Administration as a significant achievement in the review of medical industry development during the 40th anniversary of Reform and Opening-up, establishing itself as a benchmark of domestic medical innovation.

As a pioneering globe-saving innovative technology developed independently by Vesber Biotechnology Company, FCVB represents a high-end ophthalmic implant device created entirely through Chinese research and development. Its core advantage lies in precisely simulating the structure and function of the human vitreous body. Through specially designed components including the balloon, drainage tube, drainage valve, and fixation loop, it effectively addresses industry challenges such as the inability of vitreous substitutes to remain in the eye long-term, failure to provide sustained retinal tamponade, or the need for repeated surgeries. This provides patients suffering from severe ocular trauma and silicone oil-dependent eyes with a novel treatment option that preserves the globe and avoids prosthetic implantation, significantly enhancing patients' quality of life and treatment experience.

Significant Certification Achieved: Singapore HSA Approval Demonstrating International Competitiveness

This attainment of Singapore HSA certification represents another international qualification for FCVB, which is no stranger to global market recognition. To date, this product embodying Chinese ophthalmic innovation has accumulated multiple domestic and international authoritative registrations across regions including Asia and the Americas. These include China Medical Device Registration, Canadian Medical Device License, as well as EU CE Certificate, Australian TGA Certificate, and other international qualifications. FCVB has successfully entered clinical markets in more than 11 countries including the United Kingdom, Turkey, and Russia, serving patients worldwide and consistently gaining international recognition through proven performance.