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

- NMPA Regulatory Framework for Medical Device Clinical Evaluation - Clinical Evaluation Pathways: CER, Clinical Trials and RWD - Study Design and Conduct in China - Data Management, PIPL Compliance and PMCF - NMPA Submission Pitfalls, IP Protection and TimelinesThis seminar equips medical device professionals with a clear regulatory and operational roadmap for clinical evaluation and clinical investigations under Chinas NMPA framework. Building on existing MDR approvals, it provides a structured approach to pathway selection, evidence gap analysis, study planning and compliant execution in the Chinese market.LernzieleThis seminar equips medical device professionals with a clear regulatory and operational roadmap for clinical evaluation and clinical investigations under Chinas NMPA framework. - Day 1 focuses on the strategic and regulatory dimension: participants learn how to navigate the NMPAs clinical evaluation pathways, assess which existing MDR data are transferable and determine whether additional clinical evidence is required.- Day 2 addresses operational implementation: participants gain practical knowledge on site selection, GCP compliance, data management and how to avoid common pitfalls that lead to delays or rejections.ZielgruppenProfessionals and senior leaders in the medical device industry with solid experience in clinical evaluation and clinical investigations under the EU MDR who are strategically preparing market access in China.