Against the backdrop of ongoing upgrades in global medical device regulations in 2025, China’s revised Regulations for the Supervision and Administration of Medical Devices has officially taken effect. The State Council’s Opinions on Deepening Reform of Pharmaceutical and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry emphasizes “strengthening life cycle supervision” and “establishing a modern regulatory system aligned with industry progress.” The new regulations focus on “full-process control, scientific supervision, and social co-governance,” requiring companies to achieve risk management across the entire chain from R&D, production, distribution, to use.

In this context, companies are confronted with the triple challenges of “rising compliance costs, accelerated technological iteration, and multi-country regulatory coordination.” This conference focuses on the “risk identification – control – monitoring” loop, helping companies build proactive compliance capabilities and seize opportunities for high-quality development.

• Medical device manufacturers: heads of departments of manufacturing, technology, quality R&D, as well as project/company leaders.
• The enterprises engaged in medical device regulatory and quality consulting, research and services.
• Medical device quality regulatory agencies and others