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Exciting News: Chinese Innovative Ophthalmic Device Makes Further Inroads Overseas! FCVB Secures Saudi Arabia Medical Device Registration Certification
Release time: Dec 29,2025
On December 28, 2025, the Foldable Capsular Vitreous Body (FCVB) successfully obtained the Medical Device Marketing Authorization (MDMA) registration certification from the Saudi Food and Drug Authority (SFDA). This milestone marks the official entry of FCVB—an internationally pioneering innovative ophthalmic device—into the core medical market of the Middle East. It will bring a brand-new eye-preserving treatment solution and rehabilitation hope to patients with severe ocular trauma, silicone oil-dependent eyes, and complex retinal detachment in Saudi Arabia and across the Middle East.
PART.01 Landmark Certification: FCVB Officially Approved for Saudi Arabia's High-End Medical Market
FCVB's successful acquisition of the SFDA MDMA certification has drawn industry attention for its efficient approval process. The product submitted a complete set of registration documents in September and smoothly passed SFDA's rigorous review to obtain certification in December—achieving expedited clearance within three months without any major document supplements. This efficiency is extremely rare among cases of high-end Chinese ophthalmic devices entering the Saudi market.
This remarkable achievement is attributed to Vesber's mature quality management system, the high-quality registration materials meticulously prepared by its professional team, and, most importantly, the outstanding core innovation value of FCVB itself. The certification officially opens the door for this internationally pioneering eye-preserving device to enter the core medical market of the Middle East, offering new hope for local patients suffering from severe ophthalmic conditions such as severe ocular trauma, silicone oil-dependent eyes, and complex retinal detachment.
Saudi Arabia is renowned for its stringent access thresholds for medical devices. SFDA certification strictly adheres to the international ISO 13485 quality management system standards, setting extremely high review requirements for the clinical safety, long-term effectiveness, technological innovation of medical devices, and the standardization of enterprise quality management systems. In the industry, the average certification cycle for overseas medical devices applying for SFDA approval is significantly longer than three months, with major document supplements being a common occurrence.
Vesber's expedited clearance not only fully confirms that FCVB fully meets Saudi Arabia's high regulatory standards but also intuitively demonstrates the company's professional capabilities in international registration and application, as well as the maturity and reliability of its quality management system.
PART.02 FCVB Meets International High-End Standards: From "Product Export" to "Technology Transfer," Leading Industry Upgrade
With its unique technological advantages and solid clinical efficacy, FCVB has served over 6,000 patients worldwide, successfully saving them from the pain of enucleation and significantly improving their quality of life. Thanks to its outstanding innovation value, FCVB obtained registration approval in China through the National Medical Products Administration's (NMPA) special approval channel for innovative medical devices. It has been included in the Ministry of Science and Technology's Innovative Medical Devices Catalog and recognized as a key achievement in the 40th anniversary review of China's medical industry development since the reform and opening-up.
As a classic example of the transformation and upgrading from "Made in China" to "Created in China," FCVB fully showcases the strong strength of China's medical innovation.
Furthermore, as an internationally pioneering innovative technology for eye preservation, FCVB has obtained multiple international certifications, including ISO 13485 certification, MDSAP certification, EU CE Mark, Australian TGA certification, Canadian registration, and more than 20 patents globally. It has successfully entered the clinical markets of over 11 countries, including the United Kingdom, Turkey, Russia, and Australia, benefiting patients worldwide.
Two days later, laser photocoagulation was performed on the retinal hole in the right eye. Postoperative examination showed the retinal hole was located on the buckle ridge with good adhesion. The patient and her family were satisfied with the postoperative outcome and expressed their gratitude to Director Li's team!
12/24
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