With global economic growth, population growth, an increasing aging population, and cognitive changes driven by various fertility and health issues, the global market size of the medical device industry is also expanding. As people become increasingly aware of healthcare, it is crucial to implement regulations that prioritize patient safety. Since its establishment in 1906, the U.S. FDA has been a key influencer of the industry. Other governments have also introduced various regulatory acts to adapt to new market changes.

Despite being a late comer, China’s medical device market is developing rapidly. Advancements in science and technology continually drive innovations and enhancements in medical devices, such as digitalization, artificial intelligence, remote monitoring, and 3D printing. Amidst these advancements, companies grapple with the challenges of ensuring product quality and safety, as well as adapting to evolving regulatory policies.

The Central Committee of the Party and the State Council demonstrate strong commitment to fostering the robust and swift development of the medical device industry, actively promoting innovation in this field. A series of supportive policies have been enacted and executed. In the course of these efforts, technological obstacles in high-end medical devices are being systematically overcome, leading to a steady rise in the domestic market share of domestically produced advanced medical equipment.

Due to the intensifying competition in the domestic market, Chinese medical device companies are now turning their focus towards the international market. This marks the beginning of a new era in the medical device market.