The medical device industry is entering a period of opportunity!

In recent years, China has been continuously working to refine its legal and regulatory framework for medical devices, with a focus on the practical needs of the industry and public demand for medical devices, in order to promote the healthy and orderly development of the medical device sector.

As a result, the domestic medical-device industry has begun to enjoy significantly broader growth prospects. Data show that from 2014 to 2020, China’s medical-device market expanded by RMB 500 billion. In terms of growth rate, the market has maintained an average annual expansion of around 20%, outpacing the global market’s growth rate of approximately 5 percentage points.

Meanwhile, in addition to the continuous expansion of the market, a large number of domestically developed innovative medical devices are gradually emerging, and many clinical practices are being transformed by the introduction of new technologies and products. Furthermore, numerous medical-device companies are reporting strong financial performance.

Notably, amid the robust growth prospects for the medical-device industry, local governments are currently rolling out a series of favorable policies and documents to further promote the high-quality development of the sector. For instance, Guangdong Province recently issued the “Implementation Plan for Promoting the High-Quality Development of the Medical-Device Industry in Guangdong Province.”

The Plan explicitly states that, by 2025, the medical device manufacturing industry will strive to achieve an average annual compound growth rate of over 20% in operating revenue, with annual operating revenue for large-scale medical device manufacturers reaching RMB 250 billion; obtain approval for 50 national innovative medical device registration certificates; cultivate 35 companies listed on capital markets, including 2–3 demonstration enterprises with a market capitalization exceeding RMB 100 billion, 3–5 enterprises with annual operating revenue exceeding RMB 10 billion, and 5–8 enterprises with annual operating revenue exceeding RMB 5 billion.

Prior to this, the Zhejiang Provincial Drug Administration and the Provincial Department of Economy and Information Technology jointly issued the “Notice on Comprehensively Enhancing Medical Device Regulatory Capabilities and Promoting High-Quality Industrial Development” (hereinafter referred to as the “Notice”), with the aim of advancing the high-quality development of the medical device industry. According to the Notice, the development goals for Zhejiang’s medical device industry are as follows: by 2025, a number of leading enterprises with strong independent innovation capabilities will emerge; several medical device industrial parks with distinct agglomeration advantages will be established; a comprehensive, full-chain innovation system integrating industry, academia, research, and application, linking upstream, midstream, and downstream sectors, and fostering collaboration among large, medium, and small enterprises will be essentially in place; and the province’s medical device manufacturing output value will reach RMB 100 billion.

Analysis indicates that, viewed in aggregate across the various regional development plans for the medical-device industry, this sector will remain a priority for long-term development in all regions for the foreseeable future. However, it is important to note that, despite the rapid growth of the medical-device industry, numerous challenges still need to be addressed. Consequently, China’s domestic medical-device industry urgently needs to secure greater ownership of proprietary intellectual property and drive technological innovation in high-end medical devices. At the same time, domestic firms must focus more intently on cutting-edge frontiers, seeking breakthrough technologies at the very source of life sciences, so that continuous innovation can sustain the healthy development of the industry.

Currently, the industry generally believes that companies with independent R&D and innovative development capabilities—those able to continuously pioneer new technologies and meet emerging market needs—are poised to stand out. By achieving domestic substitution and gaining a foothold on the global stage, such firms will unlock greater room for growth.