Related Experiment Video
Updated: Jun 8, 2026
08:49
Use of Two Intracorporeal Ventricular Assist Devices As a Total Artificial Heart
Published on: May 11, 2018
Japanese guidance for ventricular assist devices/total artificial hearts
Takashi Yamane1, Shunei Kyo, Hikaru Matsuda
1National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan. yamane.t@aist.go.jp
Artificial Organs
|October 2, 2010
Summary
Japanese ministries established guidance for emerging medical technologies like artificial hearts. This expedited research, development, and review processes for innovative devices, fostering technological advancement.
Area of Science:
- Medical Device Development
- Biomedical Engineering
- Regulatory Science
Background:
- The need for streamlined processes for novel medical technologies was identified.
- Existing guidance documents and standards formed the basis for new recommendations.
Purpose of the Study:
- To establish joint guidance for newly emerging medical technologies.
- To expedite the review processes for innovative medical devices in Japan.
- To develop specific R&D guidelines and evaluation criteria for artificial hearts and related technologies.
Main Methods:
- Formation of a joint committee by the Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI).
- Establishment of two working groups to discuss ventricular assist devices and total artificial hearts (2005-2007).
- Review and utilization of previous guidance documents and standards.
Main Results:
- METI published the R&D Guidelines for innovative artificial hearts in 2007.
- MHLW published a Notification by Director on evaluation criteria for emerging technology in 2008.
- Development of a framework to support R&D and expedite reviews for advanced medical devices.
Conclusions:
- The collaborative effort successfully produced actionable guidelines for emerging medical technologies.
- The established criteria facilitate the evaluation and approval of innovative devices like artificial hearts.
- These initiatives aim to accelerate the availability of life-saving medical technologies.
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