The 5th Medical Devices Subcommittee Meeting

Agenda

1. Classifications of new medical devices and improved/generic medical devices, and their principles on review
2. Concept and challenges in risk/benefit evaluation of medical devices

List of Handouts

• Document 1　Classifications of new medical devices and improved/generic medical devices, and the differences of their review principles(Material provided by Dr. Makoto Hashizume, a member of the subcommittee)
• Document 2　Incident cases of medical devices(Material provided by Dr. Hideo Kusuoka, a member of the subcommitte)
• Document 3　Regulatory Science for medical devices(Material provided by Dr. Yoshihiro Muragaki, a member of the subcommittee)