Volume 34, Issue 9 pp. 699-702

Japanese Guidance for Ventricular Assist Devices/Total Artificial Hearts

Takashi Yamane

Corresponding Author

Takashi Yamane

National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan;

Pharmaceuticals and Medical Devices Agency, Tokyo, Japan;

Dr. Takashi Yamane, National Intitute of Advanced Industrial Science and Technology (AIST), Namiki1-2-1, Tsukuba, Ibaraki, 305-8564, Japan. E-mail: [email protected]Search for more papers by this author
Shunei Kyo

Shunei Kyo

University of Tokyo Hospital, Tokyo, Japan;

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Hikaru Matsuda

Hikaru Matsuda

Hyogo University of Health Sciences, Kobe, Japan;

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Yusuke Abe

Yusuke Abe

Graduate School of Medicine, University of Tokyo, Tokyo, Japan;

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Kou Imachi

Kou Imachi

Graduate School of Medicine, University of Tokyo, Tokyo, Japan;

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Toru Masuzawa

Toru Masuzawa

Graduate School of Engineering, Ibaraki University, Hitachi, Japan;

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Takeshi Nakatani

Takeshi Nakatani

National Cardiovascular Center, Suita, Osaka, Japan;

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Kazuhiro Sase

Kazuhiro Sase

Medical School, Juntendo University, Tokyo, Japan;

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Koichi Tabayashi

Koichi Tabayashi

Graduate School of Medicine, Tohoku University, Sendai, Japan;

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Setsuo Takatani

Setsuo Takatani

Tokyo Medical and Dental University, Tokyo, Japan;

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Eisuke Tatsumi

Eisuke Tatsumi

National Cardiovascular Center, Suita, Osaka, Japan;

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Mitsuo Umezu

Mitsuo Umezu

Department of Advanced Medical Engineering, Waseda University, Tokyo, Japan; and

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Toshie Tsuchiya

Toshie Tsuchiya

National Institute of Health Sciences, Tokyo, Japan

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First published: 26 September 2010
Citations: 15

Presented in part at the 17th Congress of the International Society for Rotary Blood Pumps held October 1–3, 2009 in Singapore.

Abstract

To facilitate research and development (R&D) and to expedite the review processes of medical devices, the Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) founded a joint committee to establish guidance for newly emerging technology. From 2005 to 2007, two working groups held discussions on ventricular assist devices and total artificial hearts, including out-of-hospital programs, based on previous guidance documents and standards. Based on this discussion, the METI published the R&D Guidelines for innovative artificial hearts in 2007, and in 2008 the MHLW published a Notification by Director regarding the evaluation criteria for emerging technology.

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