As part of Japan’s Five Year Action Plan, Japan has set goals for specific in-house improvements to ease the process of obtaining clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) and reduce lengthy review times. The PMDA hopes to more than double their review staff by 2013 and is establishing three distinct review divisions for “brand new” devices, improved versions of “existing” devices and “me-too” devices.

What does this mean for review times? At present, review of brand-new devices takes approximately 21 months; with the increase in staff, and improved efficiency of the process, that number is planned to drop to 14 months by 2013. Similarly, the goal is to shorten the review time for “improved” devices from 16 (or 11 if no clinical data) to 10 months, and “me-too” products from 8 to 4 months.

We will pass along more information on this as it becomes available.