Product Classification Determination and Registration Route Planning
Class I Filing / Class II Provincial Registration / Class III NMPA Registration
Analysis of Clinical Evaluation Pathway Strategy
Exemption from clinical trial / Equivalence comparison / Clinical trial, helping select the optimal pathway and control schedule and costs.
Overseas Market Access Planning
US FDA (510(k)/Establishment Registration and Listing), EU MDR (Technical Documentation & Clinical Service), market access for Southeast Asia, Japan, Australia, the Middle East and other regions.
Develop Full Lifecycle Registration Strategy
Including timeline planning, milestone setting and risk contingency plans.
