Redefining "Made in China": how Chinese high-end ophthalmic devices are winning global markets

For a long time, the "Made in China" label has been globally synonymous with distinct "cost-effectiveness": offering more comprehensive features at a lower price. This perception is particularly prominent across multiple sectors, including medical devices and consumer electronics.

Historically, in China's medical device exports, low-value consumables such as syringes, infusion sets, and medical gloves have carved out a substantial market share by leveraging this high cost-performance ratio. According to statistics from the China Chamber of Commerce for Import & Export of Medicines & Health Products, China's medical device exports maintained steady growth in the first half of 2025. In terms of product mix, this included both traditionally dominant medical consumables and a growing number of higher-technology diagnostic and therapeutic equipment.

Underpinning these data are two major trends in China's high-end medical equipment sector: first, the accelerated process of domestic substitution, where companies are actively expanding into overseas markets after having secured significant market share domestically; second, enhanced in-house R&D capabilities for core components, driving substantial breakthroughs in key parameters and performance, thereby strengthening their competitiveness in the global market.

Focusing on the ophthalmology sector, in recent years several Chinese high-end diagnostic devices have achieved comprehensive breakthroughs in key technologies, with core performance parameters surpassing those of comparable imported products. These devices have gained rapid market acceptance internationally upon launch.

While the immediate goal of going global is to bring products to the worldwide market, it extends far beyond simply "selling goods." In the process of international expansion, companies often face multiple challenges, including brand recognition, certification barriers, and channel trust. How should Chinese innovative enterprises break through these critical constraints?

OCT represents the high-end ophthalmic device with the most rapid domestic adoption in China, demonstrating simultaneous advancement in both volume and quality. According to VCBeat's 2025 High-End Ophthalmic Equipment Report, the number of domestically produced ophthalmic OCT devices approved by the NMPA has surpassed that of imported products. Concurrently, in key performance parameters such as scanning speed, imaging depth, imaging range, and resolution, products from leading Chinese manufacturers have already exceeded those of international competitors.

International expansion represents a substantial incremental market for China's high-end ophthalmic equipment, while superior performance provides the foundation for these products to command premium pricing overseas. A high-performance domestic OCT system can achieve a price point up to twice that of internationally renowned brands.

Assessment of Chinese Product Competitiveness in Key Ophthalmic Segments (Darker shading indicates superior performance of Chinese products on technical metrics). Image Source: VCBeat "2025 High-End Ophthalmic Equipment Report"

Taking TowardPi Medical as an example, the company has successfully commercialized two ophthalmic OCT products overseas: the flagship "BMizar (北溟)" series and the entry-level "Yalkaid (瑶光)" series. The "Beiming" series achieves a scan rate of 400,000 A-scans per second, a scan depth of 6mm, and an ultra-widefield single-capture area of 24mm×20mm. Historically, the global OCT market has been dominated by German, Japanese, and American brands, with mainstream products typically offering scan rates around 100,000 A-scans per second, scan depths of approximately 3mm, and imaging areas around 12mm×12mm.

Superior performance parameters enable more precise and rapid measurement of retinal blood flow density, facilitating more accurate fundus diagnosis based on these enhanced images.

"Leveraging this performance advantage, we have prioritized developed countries and regions for our overseas target markets, with Europe and Japan as our primary focus. Approximately half of our devices are sold in Europe, particularly in key markets like France, Italy, Germany, Spain, and Switzerland. This represents a departure from the traditional Chinese medtech strategy of competing primarily on cost-effectiveness," stated Zhou Jian, Vice President of TowardPi Medical and Head of International Business.

It is understood that TowardPi Medical maintains a similar pricing structure internationally as in China: the entry-level Yalkaid series is priced approximately 10% higher than flagship devices from international brands, while the flagship BMizar series significantly exceeds the price range of international competitors, commanding twice or more the price of comparable products.

Despite the notably higher price point compared to other renowned international brands, these high-performance OCT systems continue to see strong demand across diverse markets.

While conventional industry wisdom suggests that clients in developed markets typically exhibit stronger purchasing power and willingness for premium equipment, Zhou Jian noted that even in Latin America, the high-priced BMizar series remains highly popular. The core reason is that every country and region has leading medical institutions representing the highest local standard of care, and the demand for cutting-edge equipment configuration among these top-tier institutions is a universal trend across global markets. Conversely, the volume-oriented Yalkaid series holds a larger market share in Europe, primarily because the region's numerous ophthalmology clinics, which already maintain high baseline standards, generate substantial procurement volume for base models alongside their demand for top-tier systems.

Furthermore, just as the public enjoys sharing new discoveries on social media, doctors across all market types actively share their user experience when they witness the superior performance of high-end equipment and capture image quality unattainable with other devices. This has become a highly persuasive form of word-of-mouth marketing.

"While external perceptions often label Chinese products as 'cheap,' in specialized fields like high-end ophthalmic equipment, clients prioritize performance over country of origin. Particularly in European and Japanese markets, professionals demonstrate a clear willingness to pay for leading technology," Zhou Jian stated.

The primary hurdle for Chinese products entering global markets is obtaining the necessary market access certifications from target countries. With over 190 countries and regions requiring separate medical device registration, pursuing approvals on a country-by-country basis is highly inefficient and consumes significant corporate resources. For companies new to international expansion, developing an effective certification strategy is crucial for determining the pace of their global entry.

Given the pivotal role of the U.S. FDA in the global medical device landscape, many manufacturers treat its approval as their first strategic step overseas. Yet, are there more diversified pathways available?

Taking TowardPi Medical as an example: after securing CE certification in July 2024 and commencing overseas shipments in September, the company had already installed its equipment in nearly 30 countries by September 2025. Zhou Jian noted that the company projects its overseas installations will reach 200 units by the end of 2025, effectively replicating its domestic market development scale internationally on an annual basis. "By 2026 to 2027, TowardPi Medical's overseas sales volume for the same product categories are expected to surpass those in China. At that point, the company will have transformed into a high-end medical device manufacturer predominantly driven by its international business," he stated.

In managing certification strategy, Zhou Jian has developed a "central axis" approach that prioritizes cost-effectiveness while ensuring comprehensive market coverage.

The "central axis" approach for global certification route planning. Image provided by the interviewee

The foundation begins with establishing a quality system through ISO 13485 certification.

Zhou Jian explained that while ISO 13485 is not a direct market access credential, it serves as a critical passport for medical device companies entering global markets. As an internationally recognized quality management system standard for medical devices, it generates the core technical documentation and quality control processes required for subsequent country-specific approvals. Obtaining ISO 13485 certification in advance significantly reduces later registration complexities. "For companies focused on global expansion, we recommend selecting internationally accredited certification bodies, as their ISO 13485 certificates carry substantially higher recognition overseas. Some international distributors have confirmed that this certification alone can create millions of dollars in value," he noted.

The next step involves obtaining CE MDR certification to efficiently cover approximately two-thirds of key international markets.

As the current medical device access standard in the European Union, MDR imposes stricter requirements compared to the previous MDD: it not only strengthens traceability management throughout the product lifecycle but also raises standards for origin tracing and clinical evidence. The certification process has extended from under one year to approximately two years. However, the value of MDR certification extends far beyond the EU market.

Zhou Jian explained that many countries in Asia, Latin America, and even Africa often treat CE MDR certification as a prerequisite for their own medical device registration. Holding this certification can grant access to expedited local review channels, significantly shortening approval cycles. When pursuing local registrations, companies can frequently reuse portions of the technical documentation submitted for CE MDR, further reducing application costs. "Following this pathway essentially enables coverage of about two-thirds of major overseas markets, including core regions such as Europe, Southeast Asia, and South America," he stated.

In TowardPi Medical's "central axis" strategy, the United States and its FDA certification are positioned as an optional "branch line." Zhou Jian views the remaining one-third of the market as primarily concentrated in the U.S.—while substantial in size, the resource commitment for FDA approval is proportionally high. Companies can therefore treat it as a selective pathway, determining whether the investment is necessary based on their own resources and market demands.

Finally, MDSAP certification serves as a supplementary option. It covers five countries: Australia, Canada, the United States, Brazil, and Japan. It is important to note that MDSAP is not a universal pass—only Canada accepts it for expedited market access. The other four countries still require separate registration submissions; however, holding MDSAP allows for consolidated annual audits in those nations, reducing redundant inspection costs. This option is better suited for companies with relatively strong funding that plan long-term engagement in these specific markets.

In summary, for companies expanding globally, it is essential to precisely define target markets and strategically align certification processes with their cash flow and market priorities—avoiding both impulsive and inefficient investments.

For medical device companies with relatively focused product lines and in the early stages of global expansion, the distributor model offers distinct advantages: it significantly reduces market entry costs while minimizing financial risks in the collection process. Consequently, selecting the right distributors becomes critical to successful international expansion.

In July 2024, the very day after TowardPi Medical obtained CE certification, its Italian distributor Alfa Instruments promptly facilitated the first order from a client—eliminating any gap between regulatory approval and commercial sales.

This seamless transition was no coincidence. As early as 2023, TowardPi had already initiated other key steps in its global strategy, synchronizing distributor onboarding, sales team training, and product certification applications—laying a solid foundation for its rapid market penetration overseas.

In 2023, even before its completion, TowardPi's Shanghai Global Demonstration Center welcomed its first cohort of international distributors for site visits, contract signings, and training certification. Since then, the company has maintained continuous progress in training and contracting distributors across its target markets.

When seeking qualified distributors, traditional channels such as mutual visits and industry exhibitions remain the most critical pathways.

"In 2023, we invited the Alfa Intes Group, parent company of Alfa Instruments, to visit our Beijing R&D headquarters. With over six decades of expertise in ophthalmic medical technology, Alfa Intes brings deep industry heritage. As its commercial subsidiary, Alfa Instruments possesses installation and maintenance experience for nearly 1,000 high-end OCT systems, making them the ideal partner for our distribution in Italy," Zhou Jian explained. During the visit, Alfa Intes gained hands-on experience with in-production equipment and learned about our R&D capabilities and future roadmap, developing a comprehensive understanding of TowardPi Medical and its products. "Although the original plan was to announce the partnership after TowardPi secured CE certification, Alfa Intes grew highly confident following their visit, anticipating that the collaboration would exceed expectations. Consequently, they officially announced the partnership in December 2023—well ahead of schedule—to initiate market cultivation at the earliest opportunity."

In Zhou Jian's view, Chinese medical device companies now operate with sufficiently standardized R&D and production systems, making proactive invitations to key target distributors for on-site visits an effective trust-building measure. Additionally, industry exhibitions remain vital for connecting with quality distributors—particularly those specialized, niche-focused events. For companies new to global expansion, while 80% of exhibition time may be spent engaging end-users, the critical 20% dedicated to interacting with potential distributors directly impacts subsequent market development.

TowardPi's international team at an overseas exhibition booth. Photo provided by the interviewee

The partnership between equipment manufacturers and distributors is a two-way selection process. Maintaining clear selection criteria is equally important as extensively engaging with potential partners.

Zhou Jian emphasized that professional expertise unequivocally outweighs scale. Even distributors with prior collaborations with international giants like Philips or Siemens may not qualify if they lack deep ophthalmology-specific experience. "Naturally, strategic alignment between the distributor and the product brand is equally crucial. Just as luxury car brands wouldn't choose electric bicycle retailers for distribution, high-end ophthalmic devices require partners with corresponding resources and vision to effectively demonstrate product value to the industry."

Endorsement from quality distributors serves as a significant reference for other leading distribution companies when considering partnerships, substantially accelerating global market penetration.

It was revealed that TowardPi Medical's contract with EBC Europe, a top French distributor, was largely influenced by the experience and recommendation of the Alfa Intes Group. Similarly, after Oculus's Latin American distributor became a sales partner for TowardPi, internal sharing within Oculus led to the subsequent inclusion of its Spanish and Brazilian branches, as well as other Oculus-affiliated distributors, into TowardPi's distribution network.

Notably, TowardPi Medical has gained recognition from optical giant Nikon, with its products now being introduced to the Japanese market through Nikon's distribution channels.

In early 2025, TowardPi partnered with Nikon Solutions, Nikon's equipment import-export subsidiary, which now holds exclusive responsibility for the promotion, sales, and after-sales service of all TowardPi OCT products throughout Japan. In April 2025, at the 129th Annual Meeting of the Japanese Ophthalmological Society, TowardPi's OCT products made their debut at the Nikon booth following the completion of Japan PMDA certification.

"Japanese corporations exercise extreme rigor in partnership selection, conducting thorough evaluations and repeated verifications across all aspects. The process from initial contact, due diligence, to final signing is meticulous. Ultimately, TowardPi became the third major ophthalmic medical device brand introduced to Japan by Nikon Solutions," stated Zhou Jian.

In ophthalmology, Nikon had previously acquired two companies—UK-based Optos and Japan's Chuo Sangio Co.—covering both ophthalmic diagnostic device R&D and equipment sales. To date, Nikon has deployed diagnostic equipment including ultra-widefield fundus cameras and fully automated non-mydriatic fundus cameras through Optos. Its subsidiary Nikon Solutions handles the distribution of ophthalmic devices from Optos and Germany's Oculus in Japan, with a product range extending beyond fundus cameras to include optical biometers, corneal topographers, and non-contact tonometers. Following the collaboration with TowardPi Medical, Nikon has added high-performance OCT to its portfolio—both proprietary and distributed—further consolidating its comprehensive high-end ophthalmic equipment lineup.

To date, TowardPi Medical's international distributor network spans over 70 countries and regions. Through its clear distributor network strategy, the company has not only accelerated its global footprint expansion but also established a solid foundation for professional sales and service in its target markets.

As reflected in statistics from regulatory authorities and industry associations, the product mix of Chinese medical device exports is rapidly evolving, showing a clear shift from traditional low-value consumables toward high-end diagnostic and therapeutic equipment.

Zhou Jian shares a similar perspective: Chinese companies are currently at a stage comparable to that of Japanese firms in the 1970s and 1980s, gradually transitioning from cost-effectiveness to high-precision and advanced technology. "As more Chinese brands of this caliber enter the international market, clients will recognize this as an inevitable trend rather than an isolated occurrence."

From another angle, establishing a premium image for "Made in China" requires concerted efforts from a broader coalition of enterprises.

While intense domestic competition has historically driven rapid innovation and iteration across sectors, it has also led to "internal involution" and even price wars. The international market presents a timely opportunity for Chinese companies to move beyond this pattern. "In overseas markets, Chinese firms should unite, uphold both technological and pricing standards, avoid cutthroat competition, and collectively build the image of Chinese high-tech products." This is not only Zhou Jian's aspiration for the industry's future but also a crucial step for China's high-end medical devices to overcome biases and secure their place in the global market.