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Regulatory Science/The Science Board/Standard Development

The 4th Medical Devices Subcommittee Meeting

Press Release

Date and Time: June 12, 2013  from 10am to 12pm

Agenda / List of Handouts

Agenda
  1. Vision of development of combination products
  2. Various issues surrounding review and safety measures of medical devices
  3. Others
List of Handouts
  • Document 1 Discussion on "combination products" which are combination of medical devices and pharmaceuticals (including bio-products.)(Material provided by Dr. Yuichi Tei, a member of the subcommittee)
  • Document 2 Consideration and issues on benefit-risk evaluation of medical devices(Material provided by Dr. Hiroshi Kasanuki)
  • Ref.1 Points to be checked to invite external experts
  • Ref.2 Method of future discussion of the Medical Devices Subcommittee(The same material as the handout #1 distributed at the 3rd Medical Devices Subcommittee Meeting)