医療機械器具（診療施設用・手術用・処置用機械器具（PDF：1030KB）
Contents
1.2. 5 2 0 0 200 400 600 800 100 0
3. bE Py 4 2
4. 8
5. 1 1 1 000 20 30
6. 1 4 700 2006 D 15 8
7. 2 2007 1 544 2008 1 772 14 8 72 4 26 9 2008 102 193 8 3 1
8. 2 2003 3 2004 2001 METIS 2004 E 2009 2
9. 2 I J 3
10. 2 1 a EE 5 1 00 200 400 600 800 1000
11. QOL QOL EBM Evidence based medicine
12. 50 0 40 0 30 0 20 0 10 0 00 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 J72 J74 Ar 2 10 1999 2004
13. 1 3
14. 2 GHTF GHTE Global Harmonization Task Force 1993 EU 3 IEC IEC International Electrotechnical Commission
15. 1 1 1 1 000 7 1
16. 2 2 FDA 1990 E the Safe Medical Device Act
17. ri 1 1 5 8 12 9 6 9 7 2 2 GDP 2006 15 3 11 1
18. CCC 10
19. 1 2 2 2007 9 2 2008 2007 160 0 A 120 ii ES ea 2 1 1 1 0 0 go am 8 co 1 1 1 1 Ra i 4 0 200 400 600 800 2007 United Nations UNComtrade SITC Rev 3 EU 27 EU
20. QOL 3 15 4
21. 2 1 1 1 1 J7 2 J7 4 72 720 J7210 723 724 i bie J74 J7400 H et J7400A J7400B J741
22. 2 ISO JIS 2009 9 1 2 1 1 1999 2000
23. 5 1 2004 3 30 KGMP 2006 3 1 700 350 KGMP KFDA 60 70 KGMP 7 EU MDD 8 JIRA
24. 4 TISO JIS 3
25. gt 9 i 1 2008 12 31 8 ul 1 3 1
26. 10 2 1999 2008 2 1 1 3 2008 389 2016
27. 4 4 1 1940 1950 1960 1970 1970 1980 1980 1990 QOL IVR Interventional Radiology ESWL DDS 2000 et iA gl No 119 2004 2001
28. ba V 2004 7 1 2007 NHS US Department of Health and Human Service 10 300 FE 6 1963 2004 5 30 200 1 033 0 10 300
29. 3 4 5 Del
30. 1980 1980 3 1992
31. 5 3 0 0 200 400 600 800 100 0 0 0 6 1 1999 1 2 Ys 1 2008 IPC k 12 31 IPDL
32. 2 4 2 CO NL
33. 6 JETRO HOME gt HOME gt gt J FILE gt gt Q amp A gt gt http www jetro go jp world n_america us qa 01 04A 041137 3 MDD
34. 2000 QOL Evidence Based Medical 2 1 J74 7J74
35. 20 gt 2009 11 2010 03 gt 20 1 2 1 15 2 3 3 1 4 1 20 2 A ee gt 2009 gt 14 11 2010 03 1 3
36. 3 Hm Pi Rr I kd
37. 4 4 2 1 IN 2 3 2 1
38. 2001 5 2 Us 1 1943 1948 1960 145 mt 2 1961
39. 27 53 8 421 5 270 A 9 3 6 000 4000 2 000 0 2 000 2004 2005 2006 2007 Korea Medical Device Industry Association 3
40. E ISO h 2
41. gt 3 2007 1 1 2008 12 31 gt 4 1960
42. RS 3 1 2006 2011 1 2 4 2 20 10 6 000 7
43. 18 2 20 2 20 3 JIRA 3 1
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46. 2 5 1 1
47. 1 J72x J74x 1999 2008 2009 2016 2
48. 2007 3 Hy uu EE 2007 2008 9 9 9 9 9 2 1 1 2002 7 115
49. 939 1 278 28 621 2 0 20 40 60 80 100 1 1 5 5 1 1 10 10 4 H i nd Re ICU
50. gt 5 B EF YH gt 6 gt 7 H 1999 1 1 gt zz
51. 2006 2008 PCT 18 F J72 J74 HH 4 4 ol 30 Ll 2007 gt J72 J74 1 H H 2008 H
52. TC62 4 JIS JIS JIS TO601 1 JIS IEC60601 1 Medical electrical equipment Partl General requirements for safety Amendment1 Amendmen 2 5 ISO ISO ISO13485 ISO TC Technical committee TC159 TC1S9 SC Subcommittee SC4 ISO13407
53. 2 IIb Ta 1 4 SFDA203 2006 5 10 GB9706 1 1995 IEC60601 1 110
54. J74 1999 2004 2005 400 2 1 1 600 a gt CD 8 8 8 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 4 J72 J74 3 J72 10 J74 2000 2004 200 231 2005 100 140
55. 1 gt J742 J743 hs J744 uf J746 Re 19 4 1 17 1 1 1999 1 1 2008 12 31 10 4 1
56. PMDA PMDA PMDA ml
57. 5 18 33 1276 33 1289 23 9300 2 9300 8 88 9 04 3 4 NN Hy 13 2 2 822 1
58. Business Technology Transfer Program f NE XK Cs Del Hy Global Harmonization Task Force lt 2004 4 3 F 1 974 HH TL 2 HH 11 64 1 Zap
59. 1 QOL 3 6 2 1
60. 2 J746 2005 2006 2008 6 2 J720 746 40 12 30 9 6 10 3 0 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 9 J720 J720 4 J746 J746 2006 PCT 2007 7
61. 9 1 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 198 251 238 291 446 565 402 391 419 389 130 147 139 15 192 231 180 190 181 187 68 104 99 136 254 334 222 201 238 202 2009 2010 2011 2012 2013 2014 2015 2016 447 470 493 515 538 561 584 607 NO OO 202 22 E28 256 273 291 309 326 344 362 379 2009
62. x hy 4 tt rt a hy 2 2 1 250 _ 200 150 100 50 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 J72 J74 4 J72 1999 10 E 3 0 00 Je J74 2001 2003 2006 13 2003 2 143 43 2004 2007 100 2 3 1 160 140 120 100 80 60 40 20 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 4 J72
63. IDE Investigation Device Exemption Ks MRA RX ma FH DE SFDA State Food and Drag Administration E 8 E 2007 7 J
64. 2 FEF 2 7 064 1 4 1 200 000 1 000 000 800 000 600 000 400 000 200 000 0 200 000 400 000 H 9 3 7 3 E H E 1 6 845 1 220 2007 5 024 1 200 000 1 000 000 800 000 600 000 400 0
65. 139 85 81 1 4 6 1 2 3 632 363 57 4 85 3 4 58 9 2 742 404 54 4 149 20 1 57 7 7 903 520 57 6 139 15 4 81 9 0 825 651 78 9 214 7 0 600 500 400 300 200 100 0 363 600 500 400 300 200 100 57 404 58 34 27
66. J746 J720 J721 J740 J723 724 1 5 J742 1 9 J746 2 J741 J743 J744 4 1960 1
67. 45 4 25 8 25 8 2 EU 8 500 10 000 X MRI Bucomed 250 8 2
68. Owner Owner Representative 5 6 EU 27
69. 1948 NHS 99 5
70. 2007 1 1 2008 12 31 2 2 2 3 4 5 7 6 gt 2 1999 1 1 2008 12 31
71. United Nations UN Comtrade 3 20 000 1 6 1
72. 3 8 8 2025 2008 10 1 22 1 5 1 205 40 5 2 5 NIH National Institute of Health 1 2007 4 GHTF 5 STTR Small
73. 3 2010 3 10 14 16 1 gt gt 2 1 1999 1 1 2008 12 31 1 2 1 2 1 2 1 2 1 2 RR H 2 J72 30
74. FDA FDA FDA Federal Food Drug and Cosmetic Act 3 Class I TII Class I Class II Class II eplacement heart valves 5
75. 600 500 400 300 200 100 9 1 4 0 13 600 500 400 300 200 100 0 112 532 3 30 14 0 27 12 6 15 1 2 0 3 5 2 oT Ne 1 2007 2008 3 3 3 5 3 2 3 4 3 2 1 2007 2008 J72 238 254 492 J74 1306 1 518 2 824 1 544 1 772 3 316 3 4 1 1600 1 400 1200 1000 600 400 200 0 2007 2008 4 J72
76. 2006 4 J720 J7210 J742 J743 J744 2008 2004 2008 7 5 i 2008 100 2004 2008 I 166 3 pg 7 NA 108 6 50 Te 485 6 Va 46 5 8 15 7 i 8 21 3 10 4 39 3 10 4 12 2
77. 5 1 000 41 3 17 3 29 122 1 6 845 1 220 19 2 7 064 6
78. 10 4 7 9 4 5 6 5 GDP 7 6 GDP 18 16 14 _ i 12 10 a 8 4 6 4 Tr ea 2 0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 World Health Organization WHO Statistical Information System Total expenditure on health as percentage of gross domestic product 2005 6 1 475 2050 91 9 129 65 1950 5 2 2005 7 3 2050 E 16 2
79. J74 3 1 1 JPO USPTO OHIM SIPO KIPO 4 1 i 2 3 2007 1 1 2008 12 31 4 AH NHI Assignee Assignee Imventor EU European Union 27
80. 1 20 DD 1970 1980 QOL Quality of life
81. ie 1 3 2 1999 2008 1 1
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83. 143 0 118 3 6 656 19 8 662 20 0 841 25 4 10 10 231 83 79 27 13 13 4 3 1 3 3 2007 2008 3 1 149
84. 607 56 2008 202 2016 379 88 9 4 700 600 500 400 300 200 1 1 0 1999 2001 2003 2005 2007 2009 2011 2013 2015 100 80 60 40 20 0 1999 2001 2003 2005 2007 2009 2011 2013 2015 2009
85. 2 1 I 2 A 5 j ED 2 2 3 3592 2910 2155 1 1 1
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