China's medical device industry is witnessing a fundamental shift in its growth logic, gradually moving from import substitution towards innovation and internationalization. Product development is also transitioning from a previous follow-the-leader approach to running abreast with, and even leading, global peers. Various sub-sectors within medical devices are flourishing, with major products or significant growth avenues emerging in cardiovascular, consumer healthcare, brain-computer interfaces, and surgical robotics. Furthermore, recent years have seen successful business development (BD) projects in areas like structural heart disease, peripheral interventions, neurointerventions, and early cancer screening. Some domestic device companies, after being acquired by overseas industry leaders, are expected to accelerate their global expansion. The primary views are as follows:

Innovation remains the perpetual theme in medical devices, with groundbreaking inventions driving changes in clinical diagnosis and treatment. Over the past two decades, numerous overseas companies have propelled industry transformation through innovative blockbuster products. Edwards Lifesciences' innovations in heart valves shifted valve disease treatment from surgery to interventional procedures. Intuitive Surgical's da Vinci surgical robot stands out, making minimally invasive surgery more convenient and precise. The competition between Dexcom and Abbott in the continuous glucose monitoring (CGM) sector has created a vast market approaching ten billion dollars. Shockwave Medical's product innovation with intravascular lithotripsy (IVL) provided a superior solution for treating vascular calcification.

Domestic medical device companies are evolving from following to running alongside global leaders, and from incremental improvements to breakthrough innovations, gradually shifting focus from import substitution to innovation and overseas expansion. The R&D capabilities of domestic firms have steadily strengthened, placing them on the same starting line as international leaders in many cutting-edge technological fields. United Imaging Healthcare's whole-body PET/CT and 5T MR systems are at globally leading levels. Mindray Medical launched the world's first critical care AI model. Domestic brain-computer interface companies are competing neck-and-neck with overseas leaders. The 5G remote technology in domestic endoscopic robots leads their foreign counterparts. Looking ahead, China's medical device industry will produce more "me-better" products, advancing from cost-performance advantages to performance advantages. It will also yield more first-in-class innovative products that lead industry transformation.

The landscape of medical device innovation is diverse and vibrant. In the cardiovascular sector, technologies like PFA, IVL, RDN, and TAVR are still in early stages of adoption. The global competitive landscape in consumer healthcare segments such as CGM, invisible orthodontics, and PIOL is favorable, with domestic companies matching the product strength of international leaders and accelerating their global push. The surgical robot market is dominated by Intuitive Surgical, while domestic companies are rapidly increasing their overseas sales volumes. Emerging fields like brain-computer interfaces and AI in healthcare represent vast, untapped potential.

Domestic policy support, encompassing comprehensive backing for high-quality development, priority reviews, and optimized reimbursement policies, is fostering a thriving environment for innovative medical devices. In January 2025, the General Office of the State Council issued guidelines to deepen reform of drug and medical device regulation and promote high-quality development of the pharmaceutical industry, followed by supportive policies from local governments. In December 2025, the National Medical Products Administration released a catalog for priority review of high-end medical devices, covering areas like cancer treatment, advanced imaging, brain-computer interfaces, surgical robots, and structural heart disease, accelerating the approval of innovative devices. The National Healthcare Security Administration has indicated that payment system reforms, such as DRG/DIP, will fully consider the application of new technologies, drugs, and devices.

The trend of global expansion and mergers and acquisitions is accelerating. The medical device industry frequently pursues independent overseas expansion, while BD and M&A activities are gradually increasing. Leveraging advantages such as a large population, extensive physician experience, clinical data, an engineering talent pool, and a robust supply chain, China's medical device innovation is progressively gaining global traction. Domestic companies employ various strategies for international expansion, often relying on their own strengths. Companies like Mindray Medical and Micro-Tech (Beijing) Co., Ltd., with their highly innovative products, have achieved high growth overseas, with international revenue accounting for approximately 50% of their total, establishing them as global leaders. The recent rapid surge in BD projects within the innovative drug sector, where numerous domestic drugs have achieved fast global market entry through BD deals, offers valuable lessons for the medical device field. Recent years have seen successful BD projects materialize in areas including structural heart disease, peripheral interventions, neurointerventions, and early cancer screening. The acquisition of some domestic device companies by overseas giants is anticipated to hasten their international outreach.

Potential risks include R&D or commercial progress falling short of expectations, intensifying market competition, patent disputes, geopolitical conflicts, exchange rate fluctuations, and changes in healthcare policies such as volume-based procurement leading to price reductions.