Innovation capability has grown from weak to strong, key technologies have advanced from low to high, and industrial development has expanded from small to large.
The medical device industry has achieved a breakthrough in domestic production.

Cardiac stents, PET‑CT scanners, high‑performance color Doppler ultrasound systems—these cutting‑edge medical devices encapsulate the latest technological advances in the healthcare field, providing robust support for public health. However, China’s medical device industry has long been hampered by a lack of core technologies in critical components and heavy reliance on imported equipment, a persistent challenge that continues to impede its development.

In 2014, while inspecting a medical device company in Shanghai, General Secretary Xi Jinping emphasized that medical equipment is an indispensable tool for the development of modern healthcare. He noted that some high-end medical devices remain unaffordable for grassroots institutions and ordinary patients, stressing the need to accelerate the localization of such technologies, reduce costs, and foster the continued growth of domestic brands. He also encouraged the medical device sector, affirming that it holds great potential for advancement.

Remarkably, thanks to the concerted efforts of all stakeholders, China’s medical device sector achieved a comprehensive breakthrough during the 12th Five-Year Plan period: innovative achievements emerged in rapid succession, with a series of significant, independently developed advances in high-end products such as MRI scanners, CT scanners, flat-panel detectors, and electrical stimulators. The capacity to supply advanced, high‑tech products improved markedly, and certain domestic offerings have secured a foothold in premium market segments. Meanwhile, the recognition of Chinese brands has risen substantially, giving rise to a broad development pattern characterized by “strengthening innovation capabilities from weak to strong, creating major products from scratch, advancing key technologies from low‑end to high‑end, and improving the application environment from unfavorable to favorable.”

Domestic production is experiencing an “explosive” surge.

The medical device industry spans multiple technological domains, including pharmaceuticals, mechanical engineering, and electronics. Its core technologies encompass medical-grade polymer materials, laboratory medicine, hematology, and life sciences, making it a multidisciplinary, capital-intensive high-tech sector. It is both a focal point of intense competition among global enterprises and a key indicator of a nation’s overall strength and its level of scientific and technological advancement. According to the “Several Opinions on Promoting the Development of the Health Services Industry” issued by the State Council, by 2020 the total scale of the health services industry is expected to exceed RMB 8 trillion, with medical devices accounting for approximately RMB 1 trillion.

More importantly, the unique characteristics of medical device applications mean that progress in this field is not merely an industrial issue but also a matter of public welfare, directly determining to what extent the challenges of difficult and expensive access to healthcare can be addressed.

Since CT scanners were introduced to China in the 1990s, large medical devices have been predominantly imported. Multinational corporations such as GE, Philips, and Siemens—collectively known in the industry as “GPS”—have long monopolized the Chinese medical‑device market. From top-tier medical institutions and Grade‑III hospitals to county‑level facilities, domestic brands have seen very limited adoption. Moreover, large and medium‑sized equipment, mid‑to‑high‑end medical devices, high‑value consumables, and advanced implantable and interventional products have all relied entirely on imports. Due to their prohibitive costs, many hospitals have opted for second‑hand equipment; in 1998, the total number of CT scanners installed nationwide was approximately 3,800, with second‑hand units accounting for about 48% of the fleet.

The persistently high share of imported medical devices has placed a heavy financial burden on patients and fueled an unwarranted rise in healthcare costs. At the root of this issue lies the lack of core technologies and brand competitiveness among domestically produced medical equipment. Against the dual backdrop of global economic competition and the ongoing deepening of China’s healthcare reform, domestic medical device manufacturers have launched a decisive battle to break through, with “domestic substitution” as their central objective.

After nearly two decades of concerted efforts—particularly since the launch of the 12th Five-Year Plan—and with the introduction of a series of favorable policies, a large number of medical device companies have risen to prominence, gaining footholds in China’s mid- to high-end markets. This has propelled the entire industry gradually up the value chain toward the mid- to high-end segment, enabling numerous product lines to achieve import substitution.

The strategic objectives for the 12th Five-Year Plan, as defined by the key science and technology program for medical devices, have been largely achieved. The “three major categories” of new primary‑level equipment—X‑ray machines, ultrasound systems, and biochemical analyzers—have undergone comprehensive technological upgrades, while high‑end products such as MRI scanners, color Doppler ultrasound systems, CT scanners, and PET‑CT scanners have successfully been localized. On average, the acquisition cost of domestically produced medical devices is more than 30% lower than that of imported brands, providing crucial support for upgrading the equipment and services of medical institutions and offering robust assurance for the smooth advancement of China’s healthcare reform.

The medical device industry has continued to grow rapidly, at a pace far outstripping the average GDP growth rate. In 2001, China’s medical device market was valued at RMB 17 billion; by 2015, it had surpassed RMB 300 billion, more than a fifteenfold increase over 15 years, with an annual compound growth rate of 23%.

A favorable policy climate ushers in a spring of development.

China’s medical device industry is experiencing a period of robust growth, driven in no small part by favorable government policies. Guided by the principle of “combining innovation-driven development with demand‑pull,” policymakers have first mapped out a national roadmap for domestic production.

During the 12th Five-Year Plan period, the Ministry of Science and Technology formulated the “Special Plan for the Development of the Medical Device Industry (2011–2015),” which, centered on three key priorities—“basic‑level upgrading, high‑end breakthroughs, and cutting‑edge innovation”—allocated 1.2 billion yuan in national funding to support product research and development. According to Wu Yuanbin, Director-General of the Department of Social Development at the Ministry of Science and Technology, this initiative has significantly strengthened the medical device sector’s endogenous drive for independent innovation and its overall innovative vitality, with “innovation‑driven development” achieving pioneering breakthroughs.

“The projects supported by the state have a very clear focus: obtaining medical device registration certificates. Encouragingly, virtually all the projects funded by national grants have achieved this goal,” said Zhang Zhaofeng, Director of the Biotechnology and Pharmaceutical Division of the Department of Social Development at the Ministry of Science and Technology. A medical device registration certificate serves as the industry’s “pass” for market access; only products that obtain this certification can be marketed, and it also signifies that the product has been accepted by the market. The enterprises receiving these funds have demonstrated exceptionally high R&D efficiency, and the central government’s financial support has played a pivotal guiding role, spurring substantial investment from private capital.

The “Made in China 2025” strategy has been unveiled, designating high-performance medical devices as a key priority for driving breakthroughs in development.

To address the issue of heavy reliance on imported high-end medical devices, it is also necessary to dismantle the barriers stemming from a lack of trust in and recognition of domestically produced medical devices, as well as the reluctance to purchase or adopt them.

“Even when performance is comparable, the price gap is significant, and users prefer to pay a premium for imported high-end brands rather than opt for domestic ones, largely out of concern about potential risks.” In response to this lukewarm reception faced by domestic manufacturers, in 2015 the National Health and Family Planning Commission launched the first round of selection for outstanding domestically produced medical devices, publishing a list of 95 such products. The selected devices—such as desktop color Doppler ultrasound systems, digital X-ray machines, and fully automated biochemical analyzers—are market‑competitive, meet the needs of primary‑care settings, and have achieved notable market shares, thereby paving the way for public hospitals to take the lead in promoting the use of domestically made equipment.

Making innovative medical devices affordable for grassroots facilities and accessible to the public has made the primary‑care level a key focus of domestic‑product adoption. “The grassroots level does not equate to the low‑end market; on the contrary, the more basic the setting, the higher the demands for digitalization, intelligence, and networking in medical equipment,” explained Zhang Zhaofeng. With the demonstration and widespread deployment of innovative medical devices, over 100,000 such products—valued at RMB 380 million—have been installed in primary‑care institutions to date. These devices have reached 96 million patients, directly benefiting 11.61 million individuals, while generating RMB 20.1 billion in output value. This has significantly advanced the adoption and penetration of domestically produced medical devices and fostered the development of a robust domestic market for such products.

While support is being provided, regulatory oversight is also being strengthened, creating a synergistic effect that fosters industry development. For these companies, stringent controls are far from a straitjacket; once their products successfully pass all regulatory hurdles and enter the market, the likelihood of their quality being called into question diminishes significantly, and many firms stand to benefit.

Following regulatory measures, the industry’s longstanding issues of being small-scale, fragmented, and disorganized have been substantially addressed, ushering in a new phase of consolidation and upgrading and setting it on a path of sustainable, healthy development.

Long-lasting pain relief that replaces imports, yielding tangible results.

Favorable policies and a conducive environment have given rise to a series of pioneering innovations: China’s first domestically developed medical heavy-ion accelerator has successfully delivered its first beam, meeting all design specifications, thereby ending the country’s reliance on foreign‑made technology and equipment for heavy‑ion radiotherapy and marking the localization of one of the world’s largest medical devices. A breakthrough in the complete set of technologies for amorphous‑silicon flat‑panel X‑ray detectors signifies that China has established a fully integrated industrial chain in the digital X‑ray imaging sector, achieving key advances from assembly to core technologies and cutting installation costs for X‑ray systems by half. The 64‑slice CT scanner has been successfully launched, delivering submillimeter‑level resolution and elevating domestically produced CT scanners to the high‑end segment. Moreover, an independently developed brain pacemaker has entered the market, placing China at the international forefront of active implantable neuroregulatory devices.

As technological breakthroughs continue, leading enterprises are expanding rapidly and proactively positioning themselves to compete in the global market, while a wave of innovative startups is burgeoning. Meanwhile, medical device industry clusters are emerging at an accelerated pace—

Neusoft Medical, the first company to develop a domestically produced CT scanner, has since expanded its footprint in the high‑end medical‑device sector, offering an extensive portfolio of eight major product lines—ranging from CT and MRI to PET/CT—and providing comprehensive solutions across three key areas: radiological imaging, routine diagnostics, and radiotherapy and nuclear medicine. Shenzhen Mindray’s electrocardiographs and patient monitors have been adopted by 110,000 medical institutions nationwide, including more than 95% of China’s top-tier Grade‑III hospitals. Meanwhile, Xinhua Medical’s oxygen concentrators, nebulizers, sphygmomanometers, stethoscopes, and ultra‑low‑flow oxygen valves now hold the largest market share in China, with its oxygen concentrators even ranking first globally in sales. As for MicroPort Medical, it has built the capability to compete with leading international firms such as Medtronic and Boston Scientific; its coronary stent products have largely achieved domestic production, with a localization rate exceeding 80%. “China now boasts world‑class expertise in manufacturing cardiac interventional devices, and its standards are on par with those of other developed countries,” remarked a senior executive from a foreign company in this field.

According to an analysis by a responsible official from the Ministry of Science and Technology and relevant experts, the rapid development of domestically produced medical devices is the result of multiple factors acting in concert—

After years of technological accumulation, China’s research and development investment has entered a phase where its efforts are yielding tangible results, making it possible to master key core technologies—this constitutes the “R&D dividend” that underpins technological advancement. With a large population and widespread clinical application, the vast amounts of data generated from instrument and equipment use provide robust market support for product refinement and commercialization. The level of medical device technology is closely tied to the overall industrial capacity; after decades of development, “Made in China” now boasts strong manufacturing capabilities and solid process‑technology foundations. Over the past few years, there has been an unprecedented surge in overseas talent returning to start businesses in China, coupled with a substantial domestic talent pool, creating a powerful human‑resource base. Although this is a capital‑intensive sector, with clearly defined market demand and appropriate policy guidance, investor enthusiasm remains high, ensuring ample funding to fuel enterprise growth.

With a series of safeguards in place, coupled with enterprises rolling up their sleeves and working hard, the first battle in the fight to turn things around has been won.

If the 12th Five-Year Plan focused on import substitution, then the key words for the 13th Five-Year Plan are “cutting-edge, critical, independent, and leading”—aiming to spearhead international frontier technologies, accelerate the development of disruptive innovations, achieve breakthroughs in 10–20 cutting-edge core technologies, establish a patent pool of more than 300 patents, and drive the advancement of next-generation diagnostic and therapeutic devices. The plan also seeks to fully localize mainstream high-end products, enhance their competitiveness, develop 40–50 original new products, and foster the growth of emerging technologies such as minimally invasive therapies, AI‑based diagnostics, and smart healthcare. Furthermore, it will prioritize the cultivation of 8–10 large enterprise groups with international competitiveness and 80–100 sizable, innovation‑driven high‑tech firms. Domestic medical groups will be encouraged to pursue overseas technology integration and strategically position themselves in the global forefront of future medical device fields. (Reporter: Han Ji)