Hamish King, CEO, and Victoria Caldy, Business Development & Marketing Director at Cisema, present a comprehensive overview of major regulatory developments affecting medical devices in China during 2024 and what manufacturers should prepare for in 2025.

This on-demand session explores approval trends, the new draft medical device law, fast-track pathways such as the Greater Bay Area (GBA) program, and key compliance updates impacting foreign manufacturers.

What You’ll Learn

• Key medical device approval and registration trends in China from 2018–2023
• The proposed China Medical Device Draft Law and what it means for foreign manufacturers
• How the Greater Bay Area (GBA) fast-track pathway can accelerate China market entry
• Updates to good supply practice requirements for distributors
• New classification rules for radio-frequency beauty devices
• Updates to usability engineering documentation requirements
• Changes to GB electrical safety standards and product-specific sub-standards
• New guidance on real-world evidence, clinical evaluation pathways, and IVD classification
• Post-market compliance requirements and NMPA inspection trends

Watch the Webinar On Demand

Webinar Details

• Title: 2024 Round-Up of China Medical Device Regulations‍
• Speakers: Hamish King (CEO, Cisema) and Victoria Caldy (Business Development & Marketing Director, Cisema)‍
• Date: December 12, 2024‍
• Duration: ~30 minutes‍
• Language: English‍