Japan’s Fast-break Scheme: Streamlining Conditional Early Approval System for Innovative Medical Devices – Part 2
The previous blog on the Fast-break Scheme (Part 1) discussed Japan’s conditional early approval system for innovative medical devices, covering four (04) essential steps, the rationale and requirements for the application review process, the eligibility criteria, the application submission process, the MHLW and PMDA’s Regulatory guidelines, the review process, eligibility without pre-development consultation, and the key considerations for describing eligibility summaries.