What problem does it solve? Regulatory affairs and R&D professionals preparing medical device registration dossiers often struggle to determine which clinical evaluation pathway applies (exemption catalog, equivalent device comparison, or clinical trial) and how to structure a compliant Clinical Evaluation Report across China NMPA, EU MDR, and US FDA markets. ## Core Features & Use Cases - Pathway Decision Tree: Step-by-step determination across three routes—exemption catalog lookup, same-variety/equivalence comparison, and clinical trial—covering NMPA, MDR, and FDA requirements. - CER Writing Framework: Report structure based on MDCG 2020-13, including equivalence argumentation (technical, biological, clinical characteristics), literature search protocols (PICO, PRISMA-style), and clinical data appraisal checklists. - Official Reference Index: Curated links to NMPA/CMDE catalogs, MDCG guidance documents, and FDA 510(k)/De Novo/PMA resources, all flagged for manual version verification. - Use Case: A regulatory specialist registering a Class IIb device in the EU asks how to organize the CER; the skill loads the MDR chapter and returns the MDCG 2020-13 section skeleton, equivalence three-element checklist, literature search plan template, and SSCP/PMCF reminders. ## Quick Start Ask whether your medical device qualifies for clinical evaluation exemption in China, or request a CER chapter framework for your target market and device class.
