On August 26, the 15th China International Medical Device Regulatory Forum was held in Suzhou, Jiangsu Province, bringing together global leaders from regulatory agencies, international organizations, industry associations, academic institutions and leading enterprises to explore pathways for innovation and regulation in the medical device sectors. Guided by the National Medical Products Administration (NMPA), and supported by the Jiangsu Provincial People’s Government, the three-day conference is hosted by the Suzhou Municipal People’s Government.
The conference focuses on international medical device innovation trends, cutting-edge technological challenges, and key regulatory issues, while sharing updates on global regulatory changes, China’s evaluation and approval policies, technical rules, industrial development, and international cooperation in this sector. Through this effort, it aims to foster dialogue between regulators and industry experts to enhance innovation across the entire industry chain, strengthen full-lifecycle supervision, and promote high-quality development of the medical device sector. The conference consists of a plenary session and six sub-forums, the latter of which cover various topics including medical device innovation, clinical evaluation, medical device product R&D, post-market quality safety and compliance, cybersecurity and data security, and high-end medical equipment.
Xu Jinghe, Deputy Commissioner of the NMPA, stated that key areas of medical device innovation such as surgical robots, advanced medical imaging, AI-powered medical devices, and new biomaterials have been an emphasis within the NMPA for vigorously supporting high-end R&D and innovation. In 2025, 52 innovative products have been approved, bringing the total number to 367 so far. Moving forward, the NMPA will fully implement the State Council’s Guidelines on Deepening Drug and Medical Device Regulatory Reform to Promote High-Quality Development of The Pharmaceutical Industry. The administration will strengthen review support for innovative and clinically urgent products, optimize communication mechanisms, and facilitate the translation of cutting-edge technologies from lab to clinic. It will also deepen international regulatory coordination and mutual recognition, encourage global high-quality medical devices to be launched first in China, and establish the country as an internationally influential hub for medical device innovation and application—ultimately benefiting public health in China and worldwide.
This conference has established a high-level platform for China-global regulatory dialogue and created significant opportunity for deepened cooperation. Based on this platform, China will advance the modernization of its medical device regulatory system and drive high-quality growth in its pharmaceutical industry.
For foreign-funded medical device enterprise, the conference sends a strong positive policy signal, underscoring China’s commitment to not only welcoming foreign investment but also actively improving market access, enhancing regulatory transparency and predictability, and facilitating investment processes. These efforts collectively create a more favorable business environment in China, delivering expanded market opportunities, a more level competitive playing field, and clearer long-term growth prospects. SESEC will keep reporting as more information comes to light.
Chinese sources of the article：https://mp.weixin.qq.com/s/qTh8iHItwxlUtQS96jAVsA
https://www.ccfdie.org/cn/ggtz/webinfo/2025/06/1744578166414089.htm
https://www.suzhou.gov.cn/szsrmzf/szyw/202508/57103771b739473ab2dbeacc587c445f.shtml
