Japan’s Medical Device Pre-Market Review Timelines Improving

Between 2010-2014, Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has been decreasing review times for Class II and Class III pre-market devices. The current Collaboration Plan to Accelerate Review of Medical Devices will implement the following faster timelines by 2018:

  1. New devices: 9-12 months for “fast-track” Yusenshisa device applications
  2. Generic devices: 5 months
  3. Improved devices: 9 months with clinical data, 7 months without clinical data

Future PMDA annual reports will indicate that the Collaboration Plan implementations have caused positive changes in the medical device review timelines.