The regulatory process from product design to market entry on a global scale is a challenging endeavor for medical technology companies. Particularly for small and medium sized medtech businesses it is a challenge to get an overview of the diverging device market authorization paths that differ considerably from the European Union (EU) approval.
This course gives participants an overview how to plan and implement international Medical Device Registration from a European regulatory perspective with a focus on high risk devices including device drug combination medical devices, software medical devices and in-vitro diagnostics. The participants will be given insight on the regulatory and quality system strategy, product registration and local agent requirements in major device markets in the Americas, the Asia Pacific and China.
Delegates will acquire competences in international medical device registration pathways, timelines and costs and learn from hands-on industry practice. The course will cover both initial market access as well as life cycle requirements and quality system implications.