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

Abstract

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.

Is the total review time of new medical devices related to the size of the company?: Medical devices development and its related factors in Japan

“…The PMDA has operated based on the "Action Program to Accelerate Reviews of Medical Devices" in 2008 and "Mid-Term Plan of the Pharmaceuticals and Medical Devices Agency" in 2009 [12]. This result indicates that the PMDA's efforts have been successful and that the recent review periods in Japan are comparable to those of the United States [3]. However, this trend is only for the review time of new medical devices in Japan.…”

“…Several studies on review time for medical devices have been published [1,3,9]; however, little has been reported on streamlining in the development of medical devices, especially the factors contributing to review time. Our research has important value, as it is the first study aimed at finding the factors contributing to review time.…”

“…The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan have enacted many policy changes recently to promote patient access to innovative medical devices; thus, it is reported that the device lag is relatively improved. Ikeno et al pointed out that the MHLW and PDMA's review time for new innovative medical devices has been improving each year, with an average review time of 9.5 months [3]. The total time from the PMDA filing to introduction of the device to patients in Japan was found to be similar to that of the United States and four European countries: Germany, France, Italy, and the United Kingdom.…”

Development of ventricular assist device and heart transplantation in Japan: How people worked

“…During the last couple of decades, we have faced old‐style regulatory systems for medical devices and organ transplantation, which has inhibited the timely introduction of internationally accepted modalities 68 . To overcome the device lag particularly in case of implantable VADs, with Prof. Shun‐ei Kyo (UT), I worked to the Ministry of Health, Labor and Welfare (MHLW) representing 10 related academic organizations to speed up the device review system during 2008 to 2010.…”

Effective Use of Foreign Clinical Data in Approvals for Medical Devices in Japan

“…ducing and/or removing such delays [6]. As a result, the assessment time has been shortened from 16 to 9.5 months [7], and the assessment lag of around 0.5 years has been removed [8].…”