Against the backdrop of the global medical device industry rapidly advancing toward “precision, intelligence, and globalization,” regulatory policies worldwide have undergone significant adjustments during 2024-2025, imposing higher demands on technological innovation and market access. China’s revised Regulations for the Supervision and Administration of Medical Devices and the State Council’s Opinions on Deepening Reform of Pharmaceutical and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry emphasize strengthening lifecycle supervision and supporting the global expansion of innovative products. Simultaneously, international policies, such as the EU’s new MDR regulations and the US FDA’s guidelines on AI medical devices, continue to evolve. Companies now face the triple challenges of “multi-market compliance coordination, evolving technical standards, and data security risks.” In this context, there is an urgent need to establish a global compliance system that spans the entire chain—from R&D and registration to production and distribution—ensuring deep alignment between technological innovation and regulatory requirements.

• Discuss the key regulations and response strategies in the medical device industry
• Seek ways to accelerate the medical device products launch
• Jointly promote the innovation and development of medical device products
• Combine with the concurrent exhibitions to provide a platform for medical device regulatory practitioners to communicate and interact with each other

• Medical device manufacturers: heads of the departments of registration, quality, compliance, medical, and R&D, as well as project/company leaders
• Domestic and international providers engaged in medical device regulatory consulting, testing, certification, inspection, clinical trials, etc.
• Medical device regulatory agencies and research organizations