Cisema Will Present at MEDICA 2026: AI, Data & Device Regulation in China
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Cisema will present at MEDICA 2026, the world's leading event for medical technology, digital health, diagnostics, and connected care.
Representing Cisema will be Hamish King, CEO, and Shouzheng Tan, Vice President Southeast Asia. Hamish and Shouzheng will deliver a presentation examining the most significant regulatory developments shaping China's healthcare technology sector since MEDICA 2025. Covering medical devices, IVDs, AI-enabled technologies, health data, quality management systems, and market access, the session will highlight the changes companies need to understand when developing and commercializing healthcare technologies in China.
Companies developing or commercializing healthcare technologies in China and the broader Asia-Pacific region are invited to meet Hamish and Shouzheng to discuss their regulatory priorities and plans for the market.
Cisema Presentation at MEDICA 2026
AI, Data and Devices: China’s Biggest Regulatory Changes Since MEDICA 2025
- Date: Monday, November 16, 2026
- Duration: 30 minutes, including Q&A
- Speaker: Hamish King, CEO
China's regulatory landscape for medical devices, IVDs, AI-enabled products, and digital health continues to evolve at pace. With the revised Medical Device GMP taking effect on November 1, 2026, manufacturers face new requirements as they review quality systems and compliance strategies.
China’s wider focus on intelligent healthcare, connected care and stronger primary healthcare is also creating new considerations for AI medical devices, remote monitoring, point-of-care diagnostics, wearables and home-care technologies. At the same time, closer attention is being given to health data, cybersecurity, interoperability, and the transfer of personal information across borders.
This session will bring these developments together, explaining what they mean for companies developing, registering, and commercializing healthcare technologies in China.
Key topics will include:
- Revised China Medical Device GMP and the transition requirements for quality management systems
- New expectations for AI medical devices, SaMD and connected healthcare technologies
- Health data governance, cybersecurity, privacy and interoperability requirements
- Cross-border data requirements affecting cloud diagnostics, AI training and remote services
- Regulatory developments for diagnostics, remote monitoring and online device distribution
- Implications for product development, compliance and China market access
About MEDICA 2026
MEDICA brings together healthcare professionals, technology developers, manufacturers and industry leaders from around the world. Its 2026 program will place particular focus on AI in diagnostics and imaging, smart hospitals, point-of-care testing, telemedicine and remote monitoring, areas closely connected to the regulatory changes now taking place in China.
Event Details
- Dates: November 16–19, 2026
- Location: Messe Düsseldorf, Messeplatz, 40474 Düsseldorf, Germany
Further Information
Explore how Cisema supports medical devices, IVD and digital health companies with regulatory approval, quality compliance and market entry:
- China Medical Device Regulatory Services
- Malaysia Medical Device Registration Services
- Indonesia Medical Device Registration Services
- Singapore Medical Device Registration Services
- Vietnam Medical Device Registration Services
- Thailand Medical Device Registration Services
- Philippines Medical Device Registration Services
Learn more about China’s revised GMP for medical devices: