Masterclass China

• Update your regulatory knowledge
• Pre-Market Registration (PMR): Minimalise your efforts and costs
• Acceptance of European registration tests
• Clinical pathways: From feasibility study report to a clinical trial
• Perfect your cooperation with your NMPA legal agent
• Chinese IFU and label

Who should attend

• Regulatory, clinical and quality affairs
• Strategy & corporate development
• Product management
• Distribution and sales

China for advanced: Get your deep dive in latest regulatory changes, optimisation of PMR and Chinese post-market surveillance system.

The two webcasts will provide detailed updates about recent regulatory changes in China - including the new medical device law which came into force in 2021 and continues to generate substantial new subsidiary regulation. Last, but not in least, our local experts will address the PMS and related change management with many examples.

Questions and discussions are explicitly welcome. Take advantage of the interactive opportunity to talk directly to local experts during the Q&A sessions.

• Up-to-date knowledge of the registration authorities in China. Optimisation of pre-market registration (PMR) with minimal effort and cost. Understanding the acceptance of European regulatory testing in China. Insights into clinical pathways from feasibility study report to clinical trial. Improved cooperation with the NMPA legal representative. Information on the Chinese Instructions for Use (IFU) and label requirements.