Premarket Review Timeframes Improve for Japanese Medical Devices

The Pharmaceutical and Medical Devices Agency (PMDA) has reported steady reductions in review times for Class II and III pre-market approvals between fiscal years 2010 and 2014 and also in late 2015. A report was compiled and showed similar trends.

Emergo consultants in Tokyo credit these reductions to coordinated efforts by regulators and industry to accelerate the PMDA device review process.

The following review timeframes are to be reached by 2018: new devices will take 9-12 months for fast-track Yusenshisa applications; improved devices with clinical data will take 9 months; improved devices without clinical data will take 7 months; and generic devices will take 5 months. — Cynthia Jessup