An Activity on R&D and Review Guidance of Medical Devices

R&D Guidance for "Navigation Aided Surgery" Workgroup

Note: This homepage is a tentative one to quickly provide information on our activity to establish R&D guidance of medical devices for navigation aided surgery. Original documents and terms are in Japanese. The translation here is unofficial.

"Navigation aided surgery" here refers to surgery that is performed under navigational aids by locatioal and other information and optionally by physical aids that is controlled by such information.

Surgical maniplulator, surgical robots, and surgical navigation systems are typical and currently growing examples of devices for nagivation aided surgery.

Published Guidance

METI [2008/06]
• R&D guidance for "Navigation Aided Surgery" - General guidance (974KB) * Translation English is to post shortly...
• R&D guidance for "Navigation Aided Surgery" - Particular guidance for Fracture Reduction Assistance System(236KB)
• R&D guidance for "Navigation Aided Surgery" - Particular guidance for Laser Scanning System for Brain Tumor Ablation (232KB)

MHLW [2010/01/18]
• Evalation Indices for Fracture Reduction Assistance System / Joint Surgery Assistance System (1.8MB)

FY2005-2009 Reports

Sorry, reports and these download pages are in Japanese only.

• R&D WG homepage [2006/09/13]
• Review WG homepage [2006/05/15]

Related links

Most of them are in Japanese.

• Socio-economic guidance committee of medical devices (List of METI committees)
• On R&D and Review Guidance of Medical Devices (METI press release)
  • Resumes of METI/MHLW Joint Committee
    (No. 1[2005/08/04], 2[2005/09/13], 3[2006/03/16], 4[2005/06/15])
• METIS "Important Themas" documents (JFMDA/METIS)
• FDA Presentations on Computerized and Robotic Surgical Systems (JSCAS) [2006/09/06]

Secretary Office,
R&D Guidance of Medical Devices,
National Institute of Advanced Industrial Science and Technology (AIST)