Breaking Through the MDSAP Barrier! FCVB Obtains Canadian Medical Device Registration Certificate, as Chinese Ophthalmic Innovation Technology Opens the Door to the North American Market

Breaking Through the MDSAP Barrier! FCVB Obtains Canadian Medical Device Registration Certificate, as Chinese Ophthalmic Innovation Technology Opens the Door to the North American Market

Good News

On September 3, 2025, the Foldable Capsular Vitreous Body (FCVB for short) successfully passed the rigorous review of Santé Health Canada and was awarded the Medical Device Licence (Licence Number: LN/NH: 113902).

This achievement marks that Vesber has not only successfully overcome the mandatory market access barrier of "MDSAP system certification" for the Canadian market, but also, with the efficient progress within just one year (from the launch in mid-September 2024 to obtaining the certificate in early September 2025), become one of the few domestic enterprises to break through the barriers of the high-end North American ophthalmic device market. It adds a key weight to the global expansion of China's original ophthalmic technologies.

PART.01 Decoding the "Most Difficult Certification": Vesber Tackles MDSAP to Secure the "Hard Threshold" for the North American Market

Canada is one of the markets with the strictest medical device supervision in the world, and MDSAP (Medical Device Single Audit Program) system certification is the mandatory "passport" for entering its market. This system is jointly led by regulatory authorities from five countries (Canada, the United States, Australia, Japan, and Brazil), and its audit covers the entire life cycle of medical devices, including "design and development, manufacturing, quality control, clinical verification, and post-market monitoring". Its core features are "high standards, full-chain coverage, and cross-border mutual recognition" — it not only requires enterprises to establish a quality management system that meets the standards of the five countries, but also imposes "nearly harsh" requirements on the authenticity of clinical data and the integrity of risk control processes. Especially for implantable ophthalmic devices, additional submission of long-term safety tracking data and complex case application reports is required.

Since launching the registration process in September 2024, Vesber has quickly established a special task force consisting of R&D, quality, compliance, and clinical experts. On one hand, it fully optimized its quality management system in line with MDSAP standards, establishing a "full-process traceable" mechanism from the procurement of medical-grade silicone raw materials (complying with ISO 10993 biocompatibility standards) to the sterile packaging of finished products. On the other hand, it collaborated with top domestic and international clinical institutions such as Zhongshan Ophthalmic Center of Sun Yat-sen University and Duisburg Eye Center in Germany to supplement clinical application data that meets North American diagnosis and treatment standards. It focused on verifying the safety and effectiveness of FCVB in patients with severe ocular trauma and silicone oil-dependent eyes, covering patient groups of different ages and axial lengths, and forming a complete clinical evidence chain. In the end, Vesber broke the industry dilemma of "long cycle and high difficulty" in MDSAP certification, demonstrating the team's mature capabilities in international compliance.

PART.02 FCVB Meets International High-End Standards: From "Product Export" to "Technology Export", Leading the Industry Upgrade

FCVB is an internationally pioneering innovative technology for eye preservation, having obtained a number of international certifications, including ISO 13485 certification, EU CE certificate, Australian TGA certificate, and more than 20 patents in multiple countries. In China, FCVB obtained the registration certificate from the National Medical Products Administration (NMPA) through the innovative channel, and was listed as a model of the transformation and upgrading from "Made in China" to "Created in China" in the review of the 40th anniversary of China's reform and opening-up by the NMPA.

In addition, the "Consensus on the Treatment of Severe Ocular Trauma and Silicone Oil-Dependent Eyes Using Foldable Capsular Vitreous Body", led by Professor Yan Hua (Head of the Ocular Trauma Group, Ophthalmology Branch of the Chinese Medical Association) and Ferenc Kuhn (International President of Ocular Trauma), and compiled by 36 ophthalmic experts worldwide, was officially published in the international authoritative journal Journal of Evidence-Based Medicine in its English version.

Let the World Share China's New Ophthalmic Technology

As a national high-tech enterprise, Vesber has focused on the R&D of innovative ophthalmic devices since its establishment in 2007. In the future, taking the Canadian certification as a new starting point, Vesber will collaborate with global ophthalmic experts to carry out multiple phases of international surgical live broadcasts and clinical seminars through platforms such as the China-Europe (Germany) Innovation Center, promoting the globalized and standardized application of FCVB technology in North America and Europe. It will bring more original Chinese ophthalmic technologies to the world and contribute "Chinese solutions" to the global prevention and treatment of blinding eye diseases.