part PART I Negotiating a Common Understanding -- chapter 1 The Global Market for Healthcare Technology -- part PART II Argentina and Brazil -- chapter 2 Argentina -- chapter 3 Brazil -- part PART III Australia -- chapter 4 The Therapeutic Goods Act of Australia -- chapter 5 General Therapeutic Device Labeling in Australia -- chapter 6 The Therapeutic Goods Amendment of 2002 -- part PART IV Canada and Mexico -- chapter 7 The Food and Drugs Act of Canada -- chapter 8 General Medical Device Labeling in Canada -- chapter 9 Radiation-Emitting Device Labeling in Canada -- chapter 10 Mexico -- part PART V China, Korea, and Thailand -- chapter 11 Peoples Republic of China -- chapter 12 Republic of Korea -- chapter 13 Thailand -- part PART VI European Union -- chapter 14 The European Medical Device Directives -- chapter 15 The Medical Device Directive (MDD) -- chapter 16 The Active Implantable Medical Device Directive (AIMDD) -- chapter 17 The In Vitro Diagnostic Device Directive (IVDD) -- part PART VII Japan -- chapter 18 The Pharmaceutical Affairs Law of Japan -- chapter 19 General Medical Device Labeling in Japan -- part PART VIII United States -- chapter 20 The Federal Food, Drug, and Cosmetic Act -- chapter 21 General Device Labeling in the United States -- chapter 22 In Vitro Diagnostic Product Labeling -- chapter 23 Radiation-Emitting Device Labeling -- chapter 24 Bringing Devices to Market in the United States -- chapter 25 Good Manufacturing Practice in Labeling -- chapter 26 Special Labeling Requirements for Specific Devices in the United States -- part PART IX Development of Device Labels -- chapter 27 Reducing Labeling Problems -- chapter 28 Designing Good Labeling.