Patient access to medical devices-what about Japan, the second largest medical device market?

Fumiaki Ikeno, Koji Ikeda, Takahiro Uchida

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


Patients' access to innovative medical devices in Japan still shows the gap between the other countries. The cause of this device gap is researched from the prior published data. We searched the review time of new innovative devices by the Pharmaceuticals and Medical Devices Agency (PMDA) and the submission time lag compared with the US and EU from the prior published data. The average review time was 9.5 months and the total time from PMDA to introduction of the device to patients in Japan is almost similar to the US and the four European countries. However, the time lag of the file submission between Japan and the US was 2.42 years, on average, between 2001 and 2009. The review time for new innovative medical devices by the PMDA has been improving year after year. On the contrary, the pre-submission delay still exists in Japan.

Original languageEnglish
Pages (from-to)1-3
Number of pages3
JournalCardiovascular Intervention and Therapeutics
Issue number1
Publication statusPublished - 2014 Jan
Externally publishedYes


  • Device lag
  • HBD
  • Medical device
  • Regulatory science
  • Reimbursement

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine


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