Cisema Will Present at RAPS Convergence 2026: Navigating Medtech & Pharma Regulations in China
Cisema is excited to announce our attendance at RAPS Convergence 2026, the leading global conference for regulatory affairs professionals in the medical device, pharmaceutical, biotechnology, and combination product industries.
During the conference, Hamish King (CEO) and Jacky Li (VP Hong Kong, Macau & GBA), will share their expertise in two sessions exploring China's evolving regulatory landscape. Their presentations will cover the latest developments in medical device and pharmaceutical regulations, market access, AI, and the growing role of real-world evidence (RWE).
Whether you're planning to enter the China market or adapting to changing compliance requirements, we invite you to connect with our team to discuss how Cisema can support your global regulatory strategy.
RAPS Convergence 2026: Event Details
- Dates: September 14–17, 2026
- Location: Charlotte Convention Center, 501 S College St, Charlotte, NC 28202, USA
- Schedule a Meeting
Cisema Presentations at RAPS Convergence 2026
China Medtech Session: Latest Updates & Hot Topics from Pre- to Postmarket
- Date & Time: Wednesday, September 16, 2026 | 1:00 PM – 2:00 PM EDT
- Speaker: Hamish King, CEO
Joining fellow regulatory and industry leaders, Hamish will discuss the latest developments shaping China's medtech regulatory framework, including evolving pre-market requirements, innovative regulatory pathways, the Green Channel, the GBA Connect Scheme, and post-market compliance.
Key topics include:
- The latest status of the new China Medical Device top level law
- Updates to pre-submission regulations for AI SaMD, robotics, and combination products
- New China GMP vs US and international equivalents
China's Evolving Drug Regulatory Landscape: Traditional Pathways, Regulatory Updates, and Emerging Roles of AI and Real-World Data
- Date & Time: Thursday, September 17, 2026 | 1:00 PM – 2:00 PM EDT
- Speakers: Hamish King, CEO & Jacky Li, VP Hong Kong, Macau & GBA
Hamish and Jacky will explore how regulatory reforms, AI, and real-world evidence are transforming pharmaceutical development and market access in China. The session will explore emerging initiatives such as the Hainan Boao Lecheng Pilot Zone and the Greater Bay Area (GBA), highlighting their growing role in regulatory strategy and product commercialization.