解説特集：医療機器の法規制と保険
薬事承認申請から保険収載まで：新医療機器FFRCTの場合
2020 年 58 巻 2-3 号 p. 99-105
詳細
2020 年 58 巻 2-3 号 p. 99-105
Barriers to entry into the medical device market in Japan are generally recognized as high. One of the reasons is that the regulatory process is difficult to understand. This article clarifies the process from regulatory application to reimbursement listing by organizing FFRCT information published in multiple administrative documents. FFRCT was approved as a brand-new medical device in 2016 and was listed as a new technology fee in 2018. Among the findings obtained in the regulatory process, those which are general and do not contain business secret are also described. It is expected that entry into the medical device market will be made easier by taking an overview of the regulatory process.
