The 3rd Medical Devices Subcommittee Meeting

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Agenda

1. How to handle improved / partially changed medical devices
2. Safety measures of medical devices
3. Ways to proceed discussions in the Medical Devices Subcommittee
4. Others

List of Handouts

• Document 1-1 How to handle improved or generic medical devices(Review process of improved / generic medical devices)
• Document 1-2 Previous actions of regulatory authorities on generic medical products and improved medical products
• Document 2 Safety measures of medical devices
• Document 3 Ways to proceed to discussions in the Medical Devices Subcommittee
• Ref.1 Overview of review process of medical devices
• Ref.2 Targeted outcomes of the Subcommittees
• Ref.3 Partial amendment of Pharmaceutical Affairs Law