FCVB Obtains Thailand Certification, Empowered by Multiple International Accreditations, Unlocking New Territories in Overseas Markets!
Release time: Mar 31,2026
Another major breakthrough has been achieved for the domestically developed Foldable Capsular Vitreous Body (FCVB)! On March 20, FCVB was successfully granted Thailand Medical Device Registration Certification, officially approving its access to the Thai market. This marks a crucial step in the layout of this internationally pioneering ophthalmic innovative product in the Southeast Asian market, and further demonstrates the innovation strength and international competitiveness of China’s medical devices.
Core Breakthrough: FCVB Secures Thailand Certification, Expanding Footprint in Southeast Asian Market
As an internationally pioneering innovative technology for eye salvage, FCVB is independently developed by Vesber Biotechnology Co., Ltd., representing a high-end ophthalmic implant device entirely researched and manufactured in China. Its core advantage lies in its ability to accurately simulate the structure and function of the human vitreous body, breaking foreign technological monopolies. The National Medical Products Administration of China has recognized FCVB as a typical example of China’s medical device industry transforming from "Made in China" to "Created in China".
Designed to mimic the morphology of the human vitreous cavity, FCVB can be permanently implanted in the eye, effectively solving clinical dilemmas of traditional vitreous substitutes, such as inability to remain in the eye long-term and the need for repeated surgeries. It helps patients with severe ocular trauma and silicone oil-dependent eyes preserve their eyeballs, avoiding enucleation and ocular prosthesis implantation, thus greatly reducing the physical, psychological and financial burdens on patients.
Since its approval for the domestic market in 2017, FCVB has been clinically applied in more than 300 hospitals across 11 countries worldwide, serving over 6,000 patients, and its clinical value has been widely recognized by ophthalmologists both at home and abroad. The entry into the Thai market will provide a novel treatment option for local patients suffering from severe ocular trauma, retinal detachment and other ophthalmic diseases, helping to elevate the level of ophthalmic medical care in Thailand. Meanwhile, it lays a solid foundation for FCVB to further explore markets in Southeast Asia and globally, enabling domestic advanced ophthalmic innovative technologies to benefit more international patients.
Global Recognition: Backed by Multiple Certifications, Demonstrating the Strength of Domestic Medical Devices
The acquisition of Thailand Medical Device Registration Certification is not FCVB’s first international recognition. To date, FCVB has established a comprehensive international accreditation system. It has successively obtained ISO 13485 Quality Management System Certification, MDSAP (Medical Device Single Audit Program) Certification, as well as market access qualifications in numerous countries and regions including Canada, Saudi Arabia, Singapore and Australia (TGA Registration). It has also secured approval in Hong Kong, China and multiple international patents, fully proving that its product quality, safety and efficacy have reached international advanced standards.
As a pioneer in FCVB surgery since 2021, Sichuan Provincial People’s Hospital has performed this procedure for nearly 20 patients suffering from ocular trauma and silicone oil dependency to safeguard their ocular health with professional expertise. It represents the inheritance and upgrading of the hospital’s diagnostic and treatment technologies, as well as its commitment to delivering high-quality, precise medical services for patients with complex eye diseases.
Compared to conventional surgery, FCB implantation offers significant advantages. The procedure requires only a 4mm conjunctival incision, causes minimal tissue damage, and results in less postoperative pain and faster recovery.
