Gao Jian | TowardPi's Zhou Jian: China's High-End Medical Manufacturing Is Accelerating Global Expansion—Avoid Domestic-Style Price Wars Overseas

OCT is the high-end ophthalmic device with the fastest localization process in China, showing a situation of "both quantity and quality rising." According to the "2025 High-End Ophthalmic Device Report" by Arterial Intelligence, the number of domestically produced ophthalmic OCT devices approved by NMPA has surpassed that of imported ones; meanwhile, in core parameters such as scanning speed, imaging depth, imaging range, and imaging resolution, products from leading domestic companies have also exceeded imported products.

The overseas market is a considerable incremental market for domestically produced high-end ophthalmic equipment, and excellent performance is the confidence behind these products fully controlling pricing power in the international market. A domestically produced OCT with superior performance can be sold at twice the price of internationally renowned brands.

Taking TowardPi as an example, the company has achieved sales of two ophthalmic OCT products overseas, including the flagship model "Beiming" series and the entry-level model "Yaoguang" series. Among them, the "Beiming" series can achieve a scanning speed of 400,000 times/second, a scanning depth of 6mm, and an ultra-wide-angle range of 24mm×20mm for a single scan. In the past, the global OCT market was dominated by German, Japanese, and American brands, with mainstream products having a scanning speed of about 100,000 times/second, a scanning depth of around 3mm, and an imaging range of approximately 12mm×12mm.

Better performance parameters mean more accurate and faster measurement of retinal blood flow density, enabling more precise fundus diagnosis based on these images.

"Relying on performance advantages, we have prioritized developed countries and regions as our overseas target markets, with Europe and Japan being the main markets. About half of the equipment is sold to Europe, focusing on traditional powerhouses such as France, Italy, Germany, Spain, and Switzerland. This strategy differs from the traditional approach of Chinese medical device companies that rely on cost-performance advantages," said Zhou Jian, Vice President of TowardPi and head of the International Business Division.

It is understood that TowardPi's pricing system in overseas markets is similar to that in China: the entry-level model "Yaoguang" series is about 10% higher than the price of international flagship equipment, while the flagship model "Beiming" series far exceeds the price range of international brands, being twice or even more than the price of similar products.

Although the price is significantly higher than other international well-known brands, high-performance OCT products are still popular in various markets.

In the industry's established perception, customers in developed markets typically have a stronger willingness and ability to purchase high-end equipment. However, according to Zhou Jian, even in Latin America, the high-priced "Beiming" series remains popular. The core reason is that every country and region has leading medical institutions representing the highest local healthcare standards, and the demand for high-end equipment from such institutions is universal across global markets. In contrast, the "Yaoguang" series, which focuses on volume sales, has a higher market share in Europe. This is mainly because Europe has many ophthalmic clinics with sufficiently high basic standards, creating a situation where there is demand for top-tier models while also driving larger procurement volumes of basic models.

Moreover, just as the public enjoys sharing novelties on social media, in any type of market, when doctors experience the superior performance of high-end products and capture image quality unattainable by other devices, they also voluntarily share their experiences. This becomes a highly convincing channel for word-of-mouth promotion.

"Although many Chinese products are labeled as 'cheap' by the outside world, in specialized fields like high-end ophthalmic equipment, customers prioritize device performance over the attribute of origin. Especially in European and Japanese markets, professionals are more willing to pay for cutting-edge technology," said Zhou Jian.

First, establish the quality system foundation with ISO13485 certification.

Zhou Jian introduced that ISO13485 is not a direct market access certificate, but it is one of the important passes for medical device companies to enter the global market. As an internationally recognized standard for quality management systems in medical devices, the core technical documents and quality control processes required for subsequent market access applications in various countries are all generated based on this system. Completing ISO13485 certification in advance can significantly reduce the difficulty of subsequent registrations. "If a company’s primary goal is to expand overseas, it is recommended to choose an internationally recognized certification body, as the ISO13485 certificates issued by such bodies are highly recognized abroad. Some overseas distributors have frankly stated that the value of this certification alone can reach several million US dollars."

Subsequently, complete the CE MDR certification to efficiently cover 2/3 of the mainstream overseas markets.

As the current EU medical device access standard, although the MDR is more stringent compared to the previous MDD: it not only strengthens the traceability management throughout the product's entire lifecycle but also imposes higher requirements on origin traceability, clinical evidence, etc., and extends the certification cycle from less than a year in the past to about two years. The value of MDR certification goes far beyond the EU market.

Zhou Jian explained that many countries in Asia, Latin America, and Africa often require CE MDR certification as a prerequisite for the registration of medical devices. Holding this certification allows entry into a fast-track process for local registration, reducing the review period. When advancing local registration, parts of the technical documentation submitted for CE MDR can often be reused, further lowering application costs. "This entire process can basically cover about two-thirds of the main overseas markets, including core regions such as Europe, Southeast Asia, and South America."

In the "Central Axis" plan summarized by TowardPi, the United States and the FDA are arranged as "branches."In Zhou Jian's view, the remaining approximately one-third of the market is mainly concentrated in the United States. Although the market volume is large, the investment required for FDA certification is also extremely high. Companies can consider it as a secondary option and decide whether it is necessary to invest based on their own resources and market demand.

Finally, MDSAP certification can be used as an optional supplement, covering five countries: Australia, Canada, the United States, Brazil, and Japan.It should be noted that MDSAP is not a one-size-fits-all certification. Only Canada allows expedited access through MDSAP, while the other four countries still require separate registration applications. However, after obtaining MDSAP certification, the annual review processes in these four countries can be combined, reducing the cost of repeated inspections. This option is more suitable for companies with relatively sufficient funds and long-term plans to enter these countries.

In general, for enterprises going overseas, it is necessary to accurately position the target market and comprehensively plan the certification process based on their own cash flow, market priorities, etc., to avoid blind or inefficient investment.