Clinical Strategy China (NMPA): From MDR Approval to Market Access

Achieving EU MDR approval is a major milestone, but it doesn't guarantee a smooth route into the Chinese market.

Join Nick Guo, General Manager of Cisema Beijing, and Zimo Chu, Project Manager for China Clinical Trials, for a comprehensive two-day webinar hosted in partnership with FORUM Institut für Management GmbH. Together, they will demystify how to leverage your existing MDR data for NMPA approval and pinpoint exactly where additional evidence or local trials will be needed to secure market access in China.

Drawing from real-world experience, Nick and Zimo will explain how the NMPA assesses clinical evidence developed for EU MDR, how to catch critical evidence gaps before they turn into costly regulatory delays, and how to pick the optimal clinical evaluation pathway. You will also gain actionable insights into planning and running fully compliant clinical studies on the ground in China.

Webinar Overview: From MDR Approval to Market Access

Across two sessions, the webinar will examine how clinical evidence generated for EU MDR can be assessed and applied within China's NMPA framework.

Day One: Strategy

Focuses on auditing your existing MDR clinical data and mapping out your target NMPA clinical pathway. Participants will explore when a Clinical Evaluation Exemption may apply, when a Clinical Evaluation Report (CER) is sufficient, and when additional clinical investigations are required. The session also covers the role of predicate devices, overseas clinical data, real-world evidence, and Feasibility Study Reports in supporting registration.

Date & Time: September 23, 2026 | 09:00–11:30 CEST

Day Two: Execution

Transitions from strategic planning to real-world execution, covering the practical requirements for conducting clinical investigations in China, from study design and site selection to data management and post-market follow-up.

Key areas of discussion will include:

• Assessing existing MDR clinical evidence and identifying potential gaps
• Selecting the appropriate NMPA clinical evaluation pathway
• Planning clinical studies, sites and investigator requirements in China
• Managing Chinese GCP, PIPL and post-market clinical requirements
• Avoiding common issues that can lead to NMPA questions, delays or rejection

Date & Time: September 24, 2026 | 09:00–11:30 CEST

By the end of this webinar, medical device professionals will have a clear, practical blueprint for translating MDR approvals into an effective, compliant clinical strategy for China.

Further Information

To learn more about Cisema’s support for medical device manufacturers entering China, including clinical strategy, study planning, NMPA registration and lifecycle compliance, explore Cisema’s China Clinical Trial and Medical Device Registration Services.