Nov 10, 2016


  • Japanese Pre-market Approval (PMA) review timeframes have been gradually improving in recent years.
  • A joint effort between Japanese regulators and industry is likely driving this decrease in review times.
  • Faster review timeframes should drive more interest from foreign medical device firms in Japanese market registration, according to Emergo consultants.

Japan’s medical device market regulator has improved its review timeframes for premarket reviews of some devices over the past several years, indicating that efforts to reduce market access delays may be paying off.

The Pharmaceutical and Medical Devices Agency (PMDA) reported steady reductions in review times for Class II and III pre-market approvals (PMA) between fiscal years 2010 and 2014, according to the agency’s most recent annual report. Emergo consultants in Tokyo also attribute these reductions to coordinated efforts by regulators and industry to accelerate the PMDA device review process.

The Collaboration Plan to Accelerate Review of Medical Devices, originally announced in early 2014, set the following review timeframes to be reached by 2018:

  • New devices: 12 months/9 months for fast-track Yusenshisa applications
  • Improved devices with clinical data: Nine months
  • Improved devices without clinical data: Seven months
  • Generic devices: Five months

The PMDA’s most recent annual report states that total review times for improved medical devices that did not require clinical data declined from 14.5 months in 2010 to just six months in 2014; for improved devices that do require clinical data, review times increased from 15.5 months in 2010 to 17.3 months in 2012, but then fell to 9.9 months in 2014.

A report compiled in late 2015 by medical device industry trade groups including the Japan Federation of Medical Devices Associations and the Medical Technology Association of Japan showed similar trends.  

“These figures strongly suggest that the PMDA’s Collaboration Plan has begun taking effect,” says Michiharu Miyahara, President and CEO of Emergo Japan. “Assurances of timelier PMA reviews should drive more interest especially from foreign device manufacturers in the Japanese market.”

More information on Japan’s medical device regulatory system can be found in our whitepaper, PMDA registration webinar and regulatory process chart.


  • Stewart Eisenhart