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

Fumiaki Ikeno, Koji Ikeda, Takahiro Uchida

研究成果: Article査読

1 被引用数 (Scopus)

抄録

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.

本文言語English
ページ(範囲)1-3
ページ数3
ジャーナルCardiovascular Intervention and Therapeutics
29
1
DOI
出版ステータスPublished - 2014 1

ASJC Scopus subject areas

  • 放射線学、核医学およびイメージング
  • 循環器および心血管医学

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