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ブラジルの医療機器市場と規制

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2. 4 ANVISA wo N Copyright C 2012 JETRO All rights reserve
3. BM 2001 ANVISA 185
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5. ag ne 2 1 1997 237 http www mma gov br port conama legiabre cfm codlegi 237 2002 47 400 http www al sp gov br repositorio legislacao decreto 2002 decreto 20n 47 400 20de 2004 12 2002 htm 2007 51 686
6. Copyright C 2012 JETRO All rights reserved 9 1 1 1 1 1 1 a Brazilian Health Device 2010 47 9 100 17 5 700 36 6 700 6 3 300 2003 2010 2009 E
7. 2 TECNOPUC http www pucrs br agt tecnopuc Copyright C 2012 JETRO All rights reserved 49 1 4 E A 1
8. SUS 1 SUS SUS 75 SUS SUS 10 5 8 1 9 000 1 1 000
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10. 25 000 19 076 20 000 16 959 14 692 10 000 5 000 0 1960 1970 1980 1991 2000 2010 74 73 72 71 70 69 2000 2001 2002 2003 2004 2005 2006 2007 2008 IBGE Kenbridge Consultant 7 World Population Prospects The 2010 Revision Copyright C 2012 JETRO All rights reserved 29 D E C SUS8
11. AG 6 987 188 716 438 398 725 1 177 369 1 1 365 507 907 957 138 282 067 14 339 338 I EL 2010 2010 2010 A 131 294 879 267 970 187 513 6 045 570 46 131 564 9 098 465 1 247 059 478 878 3 882 468 37 388 991 28 604 421 33 915 894 364 961 4 513 718 353 500 4 237 300 11 461 201 529 42 334 335 5 935 624 222 402 269 1 464 782 47 979 172 1 308 422 25 937 220 Copyright C 2012 JETRO All rights reserved 156 360 22 041 952 184 HAMIL RAW E JL 2010 2010 2010 4 003 149 130 124 539
12. 2012 3 Copyright C 2012 JETRO All rights reserved 3 F s gnc SS eee 8 1 D 8 2 9 3 kk 9 1 Hi e sS isu an Wa G A u Na GRRE MTC Re AER OR 10 1 1 E E E a E ON E 10 IR MA e E ai a a ieee Gee 10 1 1 2 i 29 1 1 3 34 1 1 4 IERE RBOB NIR sect cacdessecvesetssencdcdsscsatesdcenssectscnedevsseteteadeceestase 35
13. 245 2009 119 2008 70 6 19 21 8 20 99 7 6 100 499 Copyright C 2012 JETRO All rights reserved 46 2008 38 2007 4 226 2008 Programa de Apoio 4 Competitividade dos Arranjos Produtivos Locais de Minas Gerais http www fiemg org br Default aspx tabid 11909 3 2006 ICU
14. ANVISA 2009 ANVISA 67 ANVISA
15. g D ie 3 ANVISA 1 2 ANVISA GMP ANVISA GNP GMP 1 GMP
16. E Copyright C 2012 JETRO All rights reserved 52 MB
17. 71 10 91 35 9 40 17 88 10 60 5 89 I 11 89 2011 2 9 12 381 2011 SUS SUS
18. ANS ANS ANS PRL ES OER BREE Hi EE Ca SAS EP 1 14 A C CBHPM
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21. TH anh 3 FE SAD Littl Z u Z gt gt 3 Copyright C 2012 JETRO All rights reserved 41 4
22. ANVISA ANVISA 2001 25 2 a 2001 25 1 2 ANVISA 3
23. fist b 7 L 15 814 48 100 17 660 22 100 19 660 16 100 713 68 3 63 2011 2 9 12 381 2011 2010 1 26 19 914 2010 2008 12 30 11 897 2009 547 40 3 46 616 17 3 49 up 2009 2010 2011 5 967 83 100 0 6 657 81 100 0 7 443 64 100 0 595 19 9 7 667 03 10 0 771 49 10 4 2011 2 9 12 381 2011 2010 1 26 12 214 2010 2008 12 30 14 2000 29 11 897
24. CE 2 ANVISA 1988 13 2002 1 11 10 406 224 1973 12 31 6 015 129 6 1980 1 31 84 451 3 1973 1 11 5 869 156 157 HHO 24 ul T 2
25. 1998 9 656 http www planalto gov br ccivil_03 leis L9656 htm 1990 8 078 http www planalto gov br ccivil_03 leis L8078 htm 2 9 2 SUS SUS ANS SUS ANS ANS 2 9 3
26. Kenbridge Consultant Copyright C 2012 JETRO All rights reserved NBR IEC 60601 2 50 2003 NBR IEC 60601 2 51 2003 peepee NBR IEC 60601 3 1 0 5MHz 5MHz NBR IEC 1689 1998 NBR ISO 7785 1 1999 NBR ISO 7785 2 1999 NBR ISO 9919 1997 NBR ISO 11195 2000 NBR ISO 9680 1997 NBR ISO 6875 1998 NBR ISO 8835 2 2010 INMETRO 127 OC
27. ANVISA Copyright C 2012 JETRO All rights reserved 124 T aie E tA DZ ti 2 3 4 ANVISA
28. 5 E 70 10 SUS 1 3 a
29. Copyright C 2012 JETRO All rights reserved 8 2 v ANVISA ANVISA 2 5 m Cadastro Y GMP m Registro GMP 2 8
30. a Dabi tk Kavo SEADE 2001 3 BA 15 SEADE Funda o Sistem Estadual de An lise de Dados Copyright C 2012 JETRO Al
31. mT Copyright C 2012 JETRO All rights reserved 30 E 2 9 ee 5 000 4 500 4 000 3 500 3 000 2 500 2003 2004 2005 2006 2007 2008 2009 2010 2011 ANS Kenbridge Consultant B 9
32. FTPASRE16 69 2 000 5 FIPASE E NMM x Ur 16 FIPASE Funda
33. 1 2004 124 4 i 2 1 2009 13 5 1 3 2009 13 5 2 4 FA 2009 13 5 7 i i 5 2 2009 13 5 9 10 I 6 2009 13 5 4 e II W 3 7 2009 13 5 5 e IOA 8 2009 13 5 3 2011 a INMETRO OR 27 2011 b INMETRO 3 OCP
34. 2 5 1 ANVISA 2 ANVISA ANVISA 3 8 INMETRO 6 4 ANVISA IV I HO 2 b 2011 2
35. 9001 30 00 18 0 1 65 7 6 18 90 18 9018 1 9018 11 00 14 2 1 65 7 6 18 9018 12 9018 12 10 0 2 1 65 7 6 18 9018 12 90 14 2 1 65 7 6 18 Copyright C 2012 JETRO All rights reserved 147 COFINS PIS Imp ICMS SP Imp 9018 13 00 0 2 1 65 7 6 18 9018 14 9018 14 10 PET 9 2 169 0 18 9018 14 90 14 2 1 65 7 6 18 9018 19 9018 19 10 0 2 1 65 7 6 18 9018 19 20
36. MRI XX CT 2010 5 ANVISA GMP 1 2 3 v
37. Copyright C 2012 JETRO All rights reserved 51 3 INCOR INCOR
38. http www anvisa gov br legis portarias 117_81 htm 1984 o 1984 DIMED 6 IUD http www anvisa gov br legis portarias 06_84 htm 1986 o 1986 8 http www anvisa gov br legis portarias 03_86 htm o 619864F A T4945 BEV FEC ERR ih O FP YO FERC BETO Bil http www anvisa gov br legis portarias 04_86 htm 1988 o 1988 3 http www anvisa gov br legis portarias 03_88 htm o 1988 DIMED 8
39. Copyright C 2012 JETRO All rights reserved 160 3 2 2 cae fr Be cal Or E n a x GMP 2 3 2 3 3 E ANVISA
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41. b DAIL Copyright C 2012 JETRO All rights reserved 138
42. http portal ANVISA gov br wps wcm connect 991239804745928e9aelde3fbc4c6735 manual_EquipMe d_ANVISA_abr_10 pdf MOD AJPERES Copyright C 2012 JETRO All rights reserved 136 2 XX 3 4
43. NBR IEC 60601 1 1 2004 EMC NBR IEC 60601 1 2 2006 Re AVEZE SU AX BURRS IC IT OE NBR IEC 60601 1 3 2001 NBR IEC 60601 1 4 2004 NBR IEC 60601 2 2 2001 NBR IEC 60601 2 3 1997 NBR IEC 60601 2 4 2005 NBR IEC 60601 2 5 1997 NBR IEC 60601 2 6 1997 X NBR IEC 60601 2 7 2001 NBR IEC 60601 2 10 2002 NBR IEC 60601 2 12 2004 NBR IEC 60601 2 13 2004 MAITRE NBR IEC 60601 2 16 2003 DEER N UBER A ae NBR IEC 60601 2 18 2002 NBR IEC 60601 2 19 2000 NBR IEC 60601 2 20 1998 NBR IEC 60601 2 21 2000 NBR IEC 60601 2 22 1997 NBR IEC 60601 2 24 1999 NBR IEC 60601 2 25 2001 KIH NBR IEC 60601 2 26 1997 NBR IEC 60601 2 27 1997 X NBR IEC 60601 2 28 2001
44. 1 GMP Copyright C 2012 JETRO All rights reserved 116 Ee PR ae on eR 7 0 J gt h 1 GMP CAFE LF BPFC GMP 1994 1 bee cae 2000 59 INMETRO 2 P p CHAD 2001 185 185 2006 2007 32 I 3 Cadastro Registro 4 ANVISA 2009 24 2001 185 2009 13 2011
45. Copyright C 2012 JETRO All rights reserved 141 A AVL 11B 2 000 12C 5 000
46. X MRI CT X 2011 12 Philips M Siemens Siemens 10 5 000 X CT MRI 2010 E 23 2011 2 Hy M GE Healthcare 2010 6 22 10 5 000
47. 1 6 26 1 ABIMO ABDI 3 2008 11 99 70 BM 9 2 ABIMO Associa o Brasileira de Industria de Artigos e Equipamentos M dicos Odonto16dicos Hospitalares e de Laborat rios 3 ABDI Agencia Brasileira de Desenvolvimento Industrial Copyright C 2012 JETRO All rights reserved 11 3 3 ABIMO R 120 000 R 120 000 R 1 200 000 R 1 200 000 R 15 000 000 R 15 000 000 R 50 000 000 R 50 000 000 R ABIMO c
48. ABIMO 22 46 2 World Health Statistics 2011 1 6 2 1 1963 800
49. Hospitalar Jornada Paulista de Radiologia JPR 27 26 2012 Hospitalar 5 22 25 MEDICA fd 13 MEDICA 2012 11 14 17 FCB 27 2012 JPR 5 3 6 a Copyright C 2012 JETRO All rights reserved 161 3 3 3 3 1 1 2 SUS SUS 3 3
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54. Copyright C 2012 JETRO All rights reserved 53 4 2006 2011 5 5 2008 2 VIP 2011 1 000 1 6 3
55. GMP Copyright C 2012 JETRO All rights reserved 115 ANVISA GMP 2 E 2 2 ANVISA ANVISA gm ANVISA
56. Philips gt z 45 ANAHP 3 5 Copyright C 2012 JETRO All rights reserved 166 4 a
57. ANVISA 2 3 2 ee ee sn CN N Rae eee s s Ania EO 2 7 2 ANVISA 1996 196
58. Copyright C 2012 JETRO All rights reserved 144 COFINS PIS Imp ICMS SP Imp 3006 10 10 WY VAR VFN BEAK 2 0 1 65 7 6 18 3006 10 20 AT Vv ASAT BER Z 2 0 1 65 7 6 18 3006 10 90 12 0 1 65 7 6 18 3006 20 00 10 0 1 65 7 6 18 3006 30 3006 30 1 3006 30 11 2 0 0 0 18 Serer 2 0 0 0 18 3006 30 13 2 0 0 0 18 3006 30 15 2 0 0 0 18 300
59. 2001 ANVISA 185 III B 8 2001 ANVISA 56 j 34 2010 ANVISA
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62. ANVISA ANVISA 2 3 2 2 5 2 5 1 a GNP GMP 2000 6 27 Af 59 ANVISA GMP 8 1 2 3 ANVISA
63. 5 1 2 GMP ANVISA g INMETRO INQS INMETRO INMETRO OCPs 2 3 4 Copyright C 2012 JETRO All rights reserved 170 5 2 5 2 1 Importacao Rua Traipu 125 I Hospitalar Horiba
64. 4 ANVISA 2011 7 2011 34 2011 25 Copyright C 2012 JETRO All rights reserved 157 25 2012 Be ee ee A So ot RT TH E 2012
65. Copyright C 2012 JETRO All rights reserved 121 1 2004 O O 124 4 2 2001 s O 1 185 A 3 2001 185 e 38 5 f 2001 4 1 e 185 B ae I 2001 5 1 185 B 2001 6 185 C 7 er I K 2001
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69. Copyright C 2012 JETRO All rights reserved 1990 8 080 54 1 7 a 1996 4 1 000 E 2000 E 1996 1997 1999 2000 27 22 29 89 29 80 28 90 27 94 28 28 27 75 25 46 27 32 27 12 26 04 25 66 25 56 24 74 37 01 30 97 30 49 26 77 26 36 27 31 26 22 TIFA 33 99 31 70 31 70 31 57 30 87 29 78 28 73 25 66 31 96 31 54 34 60 33 62 30 04 28 83 oT 33 94 29 54 29 25 28 44 27 23 27 84 27 80 36 95 32 15 34 34 28 22 27 50 29 85 27 10 26 58 28 77 28 98 28 55 27 28 29 55 29 39 25 74 24 96 24 48 24 00 22 40 23 67 23 56 32 55 27 58 27 10 26 42 24 04 25 58 26 17 24 74 25 10 24 99 24 17 21 50 24 03 24 26 2
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72. ABIMO 486 101 42 45 149 94 55 486 ABIMO 76 8 SOR ELT 1 Copyright C 2012 JETRO All rights reserved 42 Ax ZERI LAST Brazilian Health Device b ABIMO
73. E L FRE 3 5 INMETRO 2 HH K 4 INCQS 1 OCPs INMETRO EE gt wo Sj E INMETRO
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78. 2008 2009 2010 11 302 220 11 468 115 12 960 834 412 525 826 409 681 315 489 622 682 401 223 606 398 213 200 476 661 848 Kenbridge Consultant 6 ABIMED Associa o Brasileira da Industria de Alta Tecnologia de Equipamentos Produtos e Suprimentos M dico Hospitalares Copyright C 2012 JETRO All rights reserved 15 50 000 48 000 46 000 44 000 42 000 40 000 38 000 36 000 48 962 b q ul 40 968 2008 2009 2010 Z Kenbridge Consultant 2010 16 GE MRI Toshiba CT Philips Ja
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86. Copyright C 2012 JETRO All rights reserved 40 EM OMA OE ARRIR SUS c 2011 2014 9 589 PAC2 2
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114. http www al sp gov br repositorio legislacao decreto 2007 decreto 20n 51 686 20de 2022 03 2007 htm b X CT 2011 112 2011 z z http www cnen gov br seguranca normas pdf Nrm301 pdf Copyright C 2012 JETRO All rights reserved 167 112 2011 http www cnen gov br seguranca normas mostra norma asp op 602 1998 9 765 https www planalto gov br ccivil_03 Leis L9765 htm
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155. LASCOD TECNOLOGIA EM 2039 GDK DENSELL SAUDE Ltda LEONE MANFREDI Omni Inc Operon Lodan Com rcio e 55 11 Biotop 20 Sao Paulo SP 1986 Representa es Ltda 4611 3055 Biopharma Cuddon Tofflon Jeiotech LANCO DIXTAL MULT MED Rua Doroty de SAMTRONIC EQUIPAMENTOS 55 15 21 Oliveira 86 Jardim 1989 BARRAFB HOSPITLARES 3227 4442 do Sol Sorocaba SP FANEM LTDA HOSPIMETAL PHILIPS Digimed Rua Carlos Alberto KTK Santos 37 Marconi Neomed do Brasil Condominio Porto 55 71 Peas 22 2001 Medicare Ltda Miragem Galpao 29 3369 3173 Zeiss Buraquinho Lauro Olidef CZ de Freitas BA Sismatec Avenida PHILIPS Expedicion rio H lio DIXTAL Gamacamp Produtos 55 19 23 Alves Camargo 138 N A RESPIRONIX Hospitalares Ltda 3251 1587 Jardim IV LANCO Centena
156. 2011 1 19 2011 10 ee 1 2 f 8 O HS NCM 5 4 ABIMED X
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193. Omega Medical Imag 55 11 Industria e Com rcio Pacaembu Sao 1954 ing 3665 1090 p H Ambriex S A Paulo SP Ferraris Respiratory Stanford research BIOCAM Rua Doutor Alves do FANEM EQUIPAMENTO 55 19 Banho 890 Jardim do 1999 STRYKER MEDICO 3272 8000 Trevo Campinas SP Pro life HOSPITALAR LTDA Bley Med R Bom Jesus 969 Crist foli 55 41 20 Equipamentos Juvev HeartSine Technologies 3353 1314 M dicos Ltda Curitiba Parana Microem Brasmedica Av Assis Brasil 6 186 55 51 Com rcio Cj 304 Bairro 3023 8856 1998 N A Importacao e Sarandi Porto 55 51 Exportacao Ltda Alegre RS 3062 8849 55 61 3037 8106 55 61 I BSB MEDICAL QI 33 Bloco A Sala XX 9989 8984 ASSIST TECNICA E 103 105 Centro X
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199. bvsms saude gov br bvs saudelegis gm 2009 prt1660_22 07_2009 html e 2011 o 2011 2 cadastro registro http www emergogroup com files brazil normative instruction in no 2 3lmay2 IU 011 en pdf Copyright C 2012 JETRO All rights reserved 106 2 1 2 1997 1 5 79 094 3 4 anal aes 1994 12 12 2 043 FRU 1998 4 686 e PR E TAY e
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214. 6 70 8 71 3 71 6 71 8 72 1 72 3 68 4 68 7 68 7 69 0 69 6 69 9 70 2 70 5 70 8 Alv 67 5 67 8 67 8 68 1 68 7 69 0 69 3 69 6 69 8 68 2 68 5 68 5 68 8 69 3 69 6 69 9 70 2 70 4 69 9 70 2 70 2 70 4 70 9 712 71 4 71 7 71 9 IBGE Projec6es demogr ficas preliminares 2000 2008 m 74 4 747 75 3 75 6 75 9 76 2 764 1 jem mal a zo a nal rao mal ns wo 72 4 72 2 72 5 72 8 73 1 73 5 73 8 74 1 74 4 71 8 72 2 72 5 72 8 73 2 73 5 73 8 74 1 74 4 71 8 72 9 73 2 73 5 73 8 74 1 74 4 74 7 75 0 72 6 70 4 70 8 71 1 71 5 71 8 72 1 72 5 72 8 ING 70 0 73 2 73 5 73 8 74 1 74 4 74 7 75 0 75 3 72 8 72 5 72 8 73 2 73 5 73 8 74 1 74 4 74 7 72 2 71 6 72 0 72 3 72 6 73 0 73 3 73 6 73 9 70 9 69 2 69 2 69 7 70 5 70 9 71 3 71 7 72 1 68 8 69 7 69 7 70 1 70 9 71 3 71 7 72 1 72 5 69 3 72 7 72 7 73 0 73 7 74 1 74 4 74 7 75 1 72 4 72 3 72 3 72 7 73 4 73 7 74 1 74 4 74 8 69 0 70 3 70 3 70 7 71 5 71 8 72 2 72 6 73 0
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225. 00 2008 2009 2010 G Z Kenbridge Consultant Copyright C 2012 JETRO All rights reserved 17 Mm MRI MRIOR AM FI 2008 2009 2010 3 099 732 3 557 990 2 486 668 118 144 094 94 745 121 137 231 260 EISA A 115 044 362 491 187 131 A 134 744 592 Z Kenbridge Consultant MRI MRI 15 000 13 728 814 10 000 9 475 5 000 2008 2009 2010 Kenbridge Consultant Copyright C 2012 JETRO All rights reserved 18 E PET PET PET 2008 ERX 1 000 2008 2009 2010 530 4 183 975 i A 48 2 971 993 11 137 902 22 415 787 CNEA A 2 971 463 A 11 133 719 422 414 812
226. 022 21 20 0 0 1 65 7 6 18 9022 21 90 0 0 1 65 7 6 18 9022 29 E E 0 0 1 65 7 6 18 9022 29 90 14 0 1 65 7 6 18 9022 30 00 x Z ARE 0 0 1 65 7 6 18 9022 90 9022 90 1 9022 90 11 14 5 1 65 7 6 18 9022 90 12 14 5 1 65 7 6 18 9022 90 19 14 5 1 65 7 6 18 9022 90 80 14 5 1 65 7 6 18 9022 90 90 14 5 1 65 7 6 18 94 02 Copyright C 2012 JETRO All rights reserved 155 COFINS PIS Imp ICMS SP Imp 9402 10 00
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228. 1 51 1 62 1 20 8 7 5 12 8 22 9 38 5 55 7 66 5 22 1 m 4 7 7 9 13 1 27 5 36 6 48 2 16 2 6 8 10 1 15 5 30 8 41 0 53 0 17 4 8 9 12 2 17 9 34 1 45 4 57 8 18 6 SVS CGDANT VIGITEL Copyright C 2012 JETRO All rights reserved 87 2008 23 9 21 2 26 6 29 7 27 6 31 8 27 0 25 3 28 7 19 6 17 5 21 7 26 5 24 8 28 6 23 3 21 8 24 8 19 2 17 7 20 7 24 8 23 4 26 3 22 3 21 2 23 3 19 7 17 7 21 7 21 7 19 9 23 6 20 8 19 4 22 1 15 2 18 5 16 8 19 5 17 8 21 2 17 4 16 2 18 6 T SVS CGDANT VIGITEL Copyright C 2012 JETRO All rights reserved 2008 H a ike 25 35 t l 65 PA 34 44 G Bl 13 9 14 1 15 2 19 8 16 2 7 0 16 9 23 9 18 0 17 9 23 1 20 0 9 7 19 2 33 9 21 9 20 7 26 4 23 7 12 4 21 6 9 4 17 0 17 6 19 2 17 8 5 7 17 0 14 4 20 6 20 7 22 3 22 0 8 0 18 6 19 4 24 2 23 7 25 4 26 1 10 4 20 02 9 9 11 9 14 9 14 8 10 5 6 9 13 8 15 0 15 5 17 4 17 4 13 5 9 5 15 5 20 1 19 1 19 8 20 0 16 5 12 0 17 2 9 5 13 7 12 8 12 8 8 4 4 3 12
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230. 11 2 3 i i 1 e 4A o 2 8 http www anvisa gov br servicos form protocolo peticao_v11 doc ANVISA NOMA OS 4 http portal anvisa gov br wps portal anvisa home ce Produtos para Sa de orienta es Cadastro de Produtos 5 ANVISA
231. 12 5 2 2010 FL 316 709 958 765 969 032 A 449 259 074 55 836 250 883 758 278 A827 922 028 47 256 112 726 193 308 A678 937 196 25 220 705 681 398 469 A656 177 764 103 576 045 550 485 548 A 446 909 503 84 457 550 59 270 705 25 186 845 633 056 620 3 667 075 340 A3 034 018 720 Brazilian Health Device Kenbridge Consultant 2010 1 3 gt F4
232. 19 20 9019 20 10 14 2 1 65 7 6 18 9019 20 20 14 2 1 65 7 6 18 9019 20 30 14 8 1 65 7 6 18 9019 20 40 14 8 1 65 7 6 18 9019 20 90 14 8 1 65 7 6 18 Copyright C 2012 JETRO All rights reserved 151 COFINS PIS Imp ICMS SP Imp Saas 9021 10 9021 10 10 14 0 1 65 7 6 18 9021 10 20 4 0 1 65 7 6 18 9021 10 9 9021 10 91 0 0 1 65 7 6 18 9021 10 99
233. 2 5 970 24 684 6 908 29 507 5 311 18 856 5 340 17 000 1 732 11 017 4 251 126 377 36 441 65 781 24 155 74 573 16 068 38 393 20 112 33 659 7 028 16 172 9 959 23 278 4 130 10 467 8 681 23 368 8 210 11 967 3 191 14 590 4 471 7 542 2 577 7 009 3 715 2 828 966 5 156 2 578 1 810 768 YAP Zx 4 EM 122 442 32 474 79 496 10 472 71 644 14 655 48 923 8 066 59 188 17 524 37 500 4 164 33 874 7 711 22 867 3 296 295 520 88 324 154 586 52 610 184 171 42 161 96 644 45 366 91 011 24 213 51 623 15 175 59 329 12 729 33 349 13 251 61 131 19 937 27 225 18 969 34 907 8 027 15 424 11 456 20 113 5 299 9 653 5 161 138 058 2 484 6 231 4 343 38 120 14 312 16 927 6 881 20 870 5 593 9 609 5 668 7 728 3 033 3 566 1 129 4 445 1 446 2 168 831 A MI 68 195 18 709 32 449 17 037 39 775 7 358 17 482 14 935 Jui 18 895 4 418 10 241 4 236 11 308 1 889 5 638 3 781 ail 13 226 4 465 6 622 2 139 6 933 1 451 3 697 1 785
234. 2 712 1 088 202 2 781 1 681 1 057 43 431 181 167 83 742 487 251 4 8 255 2 030 5 678 547 18 430 8 572 9 584 274 3 432 700 2 473 259 11 126 5 327 5 720 79 18 913 5 168 11 890 1 855 41 140 19 890 20 324 926 3 903 1 019 2 480 404 14 476 4 642 9 395 439 5 990 2 063 3 304 623 8 063 4 894 2 798 371 1 554 519 750 285 1 974 886 997 91 4 144 1 614 2 185 345 4 937 3 616 1 262 59 x 769 394 272 103 760 453 304 3 a 5 715 1 684 3583 448 9 148 4 593 4 318 237 1 164 209 873 82 2 543 687 1 786 70 1 711 563 1 058 90 1 511 1 160 332 19 813 211 569 33 585 449 131 5 1 356 643 596 117 2 020 1 338 558 124 505 122 338 45 537 279 251 7 2 834 1 045 154 240 3 438 1 908 1 475 55 1 127 169 753 205 1 341 445 894 2 3 401 939 1545 917 2 927 1 827 760 340 3 401 939 1 545 917 2 927 1 827 760 340 IBGE _Estatisticas da Sa de Assist ncia M dico Sanitaria 2009 Copyright C 2012 JETRO All rights reserved 1 7 3
235. 23 90 2 27 61 83 4 50 29 29 15 14 aws ssee ses 4z4g szee omal 605 soo 1209 527 62 276 189 177 41 52 84 219 21 128 63 29 10 8 11 595 59 308 228 293 44 101 148 291 20 202 69 106 9 58 39 938 113 436 389 300 84 79 137 426 37 238 151 83 24 24 35 638 61 328 249 226 53 80 93 335 i7 204 114 64 12 27 25 797 69 315 413 182 51 49 82 284 25 149 120 59 15 20 24 1 385 131 651 603 332 72 91 169 574 49 312 213 84 16 21 47 FRAT AM 273 46 112 115 138 36 34 68 161 25 80 56 71 18 22 31 325 30 200 95 162 29 73 67 Copyright C 2012 JETRO All rights reserved 71 165 17 110 38 53 9 27 17 3 408 274 2 119 1 015 904 202 341 361 1 407 41 1 094 272 213 26 130 57 5 238 518 2 064 2 656 1 677 400 287 990 854 54 480 320 106 17 26 63 1 086 91 453 542 276 60 42 174 317 21 194 102 35 8 8 19 4 101 327 2 193 1 581 662 150 169 343
236. 3 5 91 5 11 4 11 3 38 2 75 2 17 1 68 1 15 1 40 100 00 2 07 8 61 11 28 10 77 10 47 10 21 9 51 7 87 6 45 5 52 4 61 3 64 2 76 2 04 1 55 1 13 0 74 0 78 100 00 1 44 6 21 8 18 7 93 8 16 8 80 9 08 8 23 7 33 7 04 6 57 5 60 4 48 3 39 2 54 2 01 1 44 1 57 100 00 1 72 7 04 8 86 8 84 9 12 9 42 9 50 8 67 7 69 6 92 5 86 4 66 3 60 2 68 2 00 1 47 0 95 1 01 100 00 1 30 5 76 8 13 8 32 8 62 8 85 8 67 7 70 7 20 7 23 6 75 5 67 4 61 3 54 2 67 2 04 1 43 1 49 100 00 IBGE Censos demogr ficos contagem populacional e proje es e estimativas demogr ficas Copyright C 2012 JETRO All rights reserved 57 1 7 2 110 4 340 A SORIA 328 387 601843 174 110 719 628 122 818 261 894 4 561 13 618 9 312 11 556 5 712 10 223 7 785 10 203 598 16 086 1 238 1 262 18 664 18 596 2 728 33 853 2 179 3 956
237. 4619 9 812 56 544 SVS Sistema de Informa es Copyright C 2012 JETRO All rights reserved 76 2007 2007 FE 1m 1 4 5 9 10 70 75 me 14 74 79 6 17 1 04 0 60 0 67 2 18 3 14 3 23 2 99 3 18 3 81 4 35 4 91 5 83 6 53 7 85 8 45 9 61 25 44 100 00 10 20 1 99 1 08 1 08 2 91 4 11 4 09 3 80 3 68 4 01 4 70 5 21 5 87 6 30 7 21 8 24 8 17 17 35 100 00 3 15 0 52 0 32 0 42 1 49 2 14 2 26 2 38 2 87 3 86 5 06 6 25 7 01 7 62 8 81 10 231 11 37 24 24 100 00 5 02 1 02 0 55 0 70 2 19 3 25 3 31 3 33 3 66 4 52 5 31 6 16 6 76 7 65 8 82 9 41 9 38 18 95 100 00 2 78 0 47 0 31 0 48 1 58 2 14 2 08 2 20 2 68 3 62 4 64 5 81 6 88 8 01 9 40 11 01 11 90 24 01 100 00 2007 FE 1 1 4 5 9 10 15 35 40 55 60 65 70 H e 14 19 397 44 59 64 69 74 4 26 0 71 0 45 0 59 2 48 3 67 3 58 3 40 3 70 4 51 5 46 6 47 7 16 7 71 8 74 9 46 9 71 17 95 100 00 4 41 0 81 0 44 0
238. 49 5 012 4 932 4 808 2 1 176 1 281 1 547 1 706 1 720 1 656 1 775 1 865 1 930 1 944 546 583 648 668 692 865 910 1 025 1 126 1 224 947 1 016 1 042 1 141 1 151 1 273 1 562 1 706 1 804 2 053 248 258 271 297 380 402 251 282 350 418 210 226 242 279 310 337 460 523 604 651 660 706 749 787 902 997 42 43 55 62 67 112 117 126 141 142 Copyright C 2012 JETRO All rights reserved 63 1986 1987 1988 89 1990 1992 1999 2002 2005 200 394 449 520 588 591 725 932 764 624 720 162 151 157 172 171 210 351 345 337 380 425 458 482 496 487 599 632 882 982 1 010 93 103 100 101 106 147 191 242 426 444 795 813 857 928 996 1 831 1 870 2 147 2 281 2 742 101 107 108 100 96 138 217 221 270 288 1 195 207 363 452 536 608 721 9 546 9 977 10 182 10 499 10 791 13 106 16 265 18 911 22 834 28 234_ 596 701 704 802 855 1 011 1 669 1 846 2 152 2 621 733 772 806
239. 5 2 017 305 2 824 1 615 977 232 1 753 834 904 15 798 357 430 11 awm 286397 euay 51 154 23372 123502 2363 82305 17344 18 338 5 417 11 214 1 707 8 589 2 247 5 245 1 097 6 750 2 246 4 006 498 3 092 992 1 742 358 13 863 1 998 11 137 728 6 705 749 5 480 476 6 395 694 5 459 242 3 531 315 3 015 201 31 916 11 046 18 547 2 323 15 620 4 110 10 015 1 495 14 021 3 090 9 682 1 249 7 754 1 386 5 559 809 ean 19 133 6 433 8 986 3 714 9 644 2 534 4 297 2 813 Copyright C 2012 JETRO All rights reserved 59 9 382 2 864 3 872 1 646 5 172 1 236 1 812 2 124 20 455 5 490 14 243 722 9 290 1 919 6 852 519 7 773 1 711 5 864 198 3 871 596 3 119 156 42 409 8 644 30 986 2 779 28 861 3 686 18 079 2 096 20 166 3 730 15 066 1 370 12 095 1 802 9 202 1 091 12 416 4 469 6 484 1 463 6 400 1 899 3 279 1 222 6 397 1 612 3 549 1 236 3 588 805 1 726 1 057 9 815 1 663 7 228 924 5 831 739 4 374 718 5 648 828 3 974 846 3 644 404 2 574 666 68 052 16 711 43 329 9 012 37 56
240. 50 0 87 1 08 1 38 1 61 2 08 2 97 3 93 4 85 5 88 6 85 8 36 10 16 12 08 31 73 100 00 SVS Sistema de Informa es sobre Mortalidade SIM Copyright C 2012 JETRO All rights reserved 77 2 2000 2007 AD 1 000 2000 2001 2002 2003 2004 2005 2006 2007 5 2 71 52 72 52 71 gal72 52 178 51 173 51 74 51 le6 8 46 57 43 55 42 154 42 54 44 56 42 54 40 5 2 40 148 5 0 67 49 6 7 48 6 6 47 66 4 7 66 46 65 45 les 45 16 0 5 5 77 54 78 53 80 5 3 80 52 177 51 78a 50 77 5 0 6 9 5 3 66 52 le65 s51le4l lgs1ilesl solesl sole3l 49 1e 2 49 57 5 6 77 55 78 54 7 6 5 3 175 52 75 51 73 50 70 49 65 59 68 gsglegl sslesl l5s7 le7 s7 67 sele7 5sele7 5ssle0 l lm o e ee Sa zfs 7o zo s 6 7 ase ee oer es
241. 6 125 1 960 3 333 832 3 357 731 1 925 701 vy FZ u gt YIN 12 290 5 487 5 053 1 750 6 115 2 187 2 653 1 275 4 216 1 285 2 275 656 2 314 577 1 225 512 27 582 8 318 15 691 3 573 15 605 3 635 9 265 2 705 13 117 2 537 8 857 1 723 7 808 1 345 5 296 1 167 24 087 7 207 9 002 7 878 13 890 3 202 5 081 5 607 PIST 24 087 7 207 9 002 7 878 13 890 3 202 5 081 5 607 Copyright C 2012 JETRO All rights reserved 60 4 0 4 0 56 166 amp 180 4 0 Je 4 0 F a a 4747 433 200 184 49 1 032 799 192 41 206 75 108 23 487 359 103 25 273 111 111 51 722 418 285 19 161 45 73 43 420 175 244 1 TIFA 1 219 517 577 125 2 212 1 171 957 84 772 220 447 105 1 409 614 740 55 435 120 164 151 642 379 101 162 167 67 92 8 330 292 35 3 1 679 610 889 180 3 870 1 597 2 132 141 597 102 389 106 1 606 279 1 288 39 327 100 205 22 524 271 210 43 189 43 139 7 342 185 139 18
242. 6 30 16 2 0 0 0 18 3006 30 17 2 0 0 0 18 sane cae 2 0 0 0 18 3006 30 19 12 0 0 0 18 3006 30 2 3006 30 21 2 0 0 0 18 3006 30 29 12 0 0 0 18 3006 40 3006 40 1 3006 40 11 12 0 1 65 7 6 18 Copyright C 2012 JETRO All rights reserved 145 COFINS PIS Imp ICM
243. 6 920 1 595 5 825 23 952 17 195 6 757 1987 32 450 20 174 12 276 7 062 1 703 5 359 25 388 18 471 6 917 1988 338 632 21 472 12 160 7 123 1 823 5 800 26 509 19 649 6 860 1989 34 831 22 706 12 125 7 127 1 889 5 238 27 704 20 817 6 887 1990 35 701 23 858 11 843 7 280 2 034 5 246 28 421 21 824 6 597 1992 41 008 26 729 14 279 7 430 2 114 5 316 33 578 24 615 8 963 1999 48 815 32 606 16 209 7 806 2 613 5 193 41 009 29 993 11 016 2002 53 825 37 674 16 151 7 397 2 588 4 809 46 428 35 086 11 342 2005 62 483 43 987 18 496 7 155 2 727 4 428 55 328 41 260 14 068 2009 74 776 50 253 24 523 6 875 2 839 4 036 67 901 47 414 20 487 IBGE Diretoria de Pesquisas Departamento de Popula o e Indicadores Sociais Pesquisa de Assist ncia M dico Sanitaria 2009 Copyright C 2012 JETRO All rights reserved 65 1976 2009 6 1976 443 888 119 062 324 826 1977 455 712 121 209 334 503 1978 475 452 124 575 350 877 1979 488 323 118 463 369 860 1980 509 168 122 741 386 427 1981 522 769 124 866 397 908 1982 530 501 127 580 402 921 1983 534 055 127 521 406 534 1984 538
244. 7 244 499 22 483 67 189 33 325 64 012 15 528 43 457 14 862 16 859 2 290 26 467 2 573 4 971 IBGE Diretoria de Pesquisas Coordena o de Popula o e Indicadores Sociais Pesquisa de Assist ncia M dico Sanitaria 2009 110 4 340 A fe eae 40 40 40 40 6 035 3 659 1 706 670 3 178 1 774 944 460 2 929 1 769 859 301 1 522 858 457 207 3 093 1 274 1 280 539 1 532 495 618 419 2 268 685 1 105 478 1 220 281 549 390 12 542 4 618 7 275 649 7 132 2 261 4 476 395 9 563 2 715 6 341 507 5 880 1 479 4 082 319 2 737 1 236 916 585 1 111 256 495 260 1 713 967 643 103 718 268 368 82 22 201 6 442 11 596 4 163 12 440 2 964 6 035 3 441 11 323 1 887 6 564 2 872 6 902 1 015 3 309 2 578 2 770 1 498 1 100 172 1 225 774 357 94 1 912 1 110 730 72 834 589 204 41 6 227 3 90
245. 71 12 420 389 0 4 163 852 0 6 1 2 12 256 537 6 1 484 088 22 199 752 1 367 611 35 152 911 1 136 020 30 252 734 2 671 169 7 214 785 Copyright C 2012 JETRO All rights reserved 185
246. 721 127 537 411 184 1985 532 283 137 543 394 740 1986 521 346 114 548 397 798 1987 519 698 115 842 403 856 1988 527 196 120 776 406 420 1989 522 895 119 530 403 365 1990 533 558 124 815 408 743 1992 544 357 135 080 409 277 1999 484 945 143 074 341 871 2002 471 171 146 319 324 852 2005 443 210 148 966 294 244 2009 431 996 152 892 279 104 IBGE Diretoria de Pesquisas Coordenacao de Populacao e Indicadores Sociais Pequisa de Assist ncia M dico Sanitaria 1976 2009 Copyright C 2012 JETRO All rights reserved 66 720 354 4 18 332 366 351 15 79 a 212 64 3 10 51 148 142 6 35 380 288 11 47 230 92 84 8 8 165 91 3 21 67 74 68 6 6 1 010 786 60 117 609 224 216 8 70 500 299 13 49 237 201 196 5 65 444 388 235 22 181 56 51 5 17 112 56 7 13 36 56 51 5 17 2 742 2 057 71 54 1 932 685 631 54 247 380 100 8 19 73 280 266 14 70 288 217 25 22 170 71 68 3 5 137 74 4 11 59 63 61 2 5 721 486 10 27 449 235 219 16 90 144 61 3 58 83 80 3 29 28204 19348 138 ae 18824 8886 s229 657 a m 2 621
247. 9 12 6 17 3 15 5 15 3 11 1 6 4 14 4 15 7 20 9 18 1 17 9 13 8 8 6 15 9 6 6 8 1 10 6 12 7 10 8 7 1 10 1 8 8 10 1 12 5 14 5 12 7 8 8 11 0 11 1 12 1 14 3 16 3 14 6 10 5 11 9 SVS CGDANT VIGITEL Copyright C 2012 JETRO All rights reserved 89 2008 Scns ts l 25 34 ik n gt 34 RZ ZE 55 64 ik Sn 65 ix P 15 3 22 8 20 8 17 1 7 4 1 5 19 1 18 8 26 5 23 7 20 2 10 2 2 8 20 7 22 2 30 2 26 7 23 3 12 9 4 1 22 3 18 5 22 2 21 3 14 8 9 2 3 6 18 9 21 7 24 9 23 5 16 6 11 0 4 9 20 1 25 0 27 6 25 7 18 4 12 8 6 2 21 3 16 4 19 8 15 2 12 3 6 0 1 4 16 4 21 5 23 0 17 5 15 0 8 6 2 7 18 1 26 6 26 8 19 8 17 8 11 2 3 9 19 8 13 9 16 1 15 0 13 0 8 1 2 0 14 5 18 8 19 8 17 7 15 7 11 0 3 3 16 0 23 8 23 5 20 3 18 5 14 0 4 7 17 5 16 7 12 9 10 2 7 9 3 7 11 7 22 9 15 9 12 6 10 1 5 5 u 18 3 29 0 18 9
248. I IV 2000 97 2011 14 2011 27 2011 Ps ha 3 2010 850 2008 5 2008 e 238 2008 450 2008 39 2006 2006 185 3385 2010 3 2006 Copyright C 2012 JETRO All rights reserved 108 2 2 B ANVISA 1 ANVISA
249. Ps TUV Rheinland do Brasil Ltda Suzete Schipa Suzuki Fone 11 3638 5700 Avenida Paulista n 302 2 3 e 4 andar Bela Vista Sao Paulo CEP 01310 000 BRTUV Avalia es da Qualidade S A Thais Futo Fone 11 4689 9400 Alameda Madeira 222 3 Andar Cj 31Alphaville Barueri CEP 06454 010 Det Norske Veritas Certificadora Ltda Mauricio Venturini Fone 11 3305 3305 Av Alfredo Egydio de Souza Aranha 100 3 Andar Bloco D Jardim Santo Ant nio S o Paulo CEP 04726 170 BVQI do Brasil Sociedade Certificadora Ltda Luiz Carlos Daniel Dantas Fone 11 2655 9001 Avenida do Caf 277 5 Andar Vila Guarani Sao Paulo CEP 04311 200 UL do Brasil Certifica es S C P ricles da Silva Arilho Fone 11 3049 8300 pericles arilho br ul com Rua Fid ncio Ramos 195 2 andar Vila Ol mpia S o Paulo CEP 04551 010 NCC Associa o NCC Certifca es do Brasil S rgio Toshio Yochiy Fone 19 3731 6990 www ncc org br Rua da Conceicao n 233 salas 2 505 2 510 a 2 515 Centro Campinas CEP 13010 050 SGS ICS Certificadora Ltda Sergio Figueiredo Fone 11 5501 4295 sergio figueiredo sgs com Avenida das Na es Unidas 11633 4 A CJ 41B Brooklin S o Paulo CEP 04578 000 ICBR Instituto de Certifica es Brasileiro S A Ismar An
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252. TD 37 OO 39 1 3 ii 42 1 4 50 51 1 52 1 6 1 52 1 6 2 53 1 6 3 54 1 7 BERR OGL K Eu WARE T S TBER aaa 55 1 7 1 i 55 112 hie AEO R aiaa a a a a e aeai eataa 58 1 7 3 ee 63 1 73 1 7 5 KERR e i 76 1 OR 81 1 7 7 i 85 Copyright C 2012 JETRO All rights reserved 4 2 klik 94 2 1 i 94 2 1 19 BETS
253. asilia DF 3426 0202 Exporta o e Investimentos CNEN Rua General Severiano 90 Rio 55 21 4 Comiss o Nacional de Energia de Janeiro RJ 2173 2000 2001 Nuclear 55 61 3445 5 Conselho Federal de Medicina SGAS 915 Lote 72 Bras lia DF 5900 MDIC Minist rio do Desenvolvimento Esplanada dos Minist rios 55 61 6 Industria e Comercio Exterior Bloco J Bras lia DF 2027 7000 BNDES Avenida Rep blica do Chile 55 21 7 Banco Nacional de Desenvolvimento 100 Rio de Janeiro RJ 2172 7447 Econ6mico e Social ABIMED Associa o Brasileira da Industria de Avenida Irai 79 Cjs 92 93 55 11 8 Alta Tecnologia de Equipamentos Moema Sao Paulo SP 5092 2568 Produtos e Suprimentos Medico Hospitalares ABIMO Associa o Brasileira de Industria de 1 Avenida Paulista 1313 Sala 55 11 9 Artigos e Equipamentos M dicos 806 Edificio Fiesp Sao 3285 0155 Odontolddicos Hospitalares e de Paulo SP Laborat rios AMB Rua S o Carlos do Pinhal 324 55 11 10 Associacao M dica Brasileira Bela Vista Sao Paulo SP 3178 6800 ANAHP Rua Cincinato Bra
254. d 139 2 8 2 2 9 2 9 1 SUS SUS mM SUS SUS 1988
255. d 150 COFINS PIS Imp ICMS SP Imp 9018 90 31 0 8 1 65 7 6 18 9018 90 39 14 8 1 65 7 6 18 9018 90 40 AT hie 8 0 1 65 7 6 18 9018 90 50 DTF RE 14 8 1 65 7 6 18 9018 90 9 9018 90 91 14 8 1 65 7 6 18 9018 90 92 MJER 16 8 1 65 7 6 18 0 8 1 65 7 6 18 9018 90 93 esa 9018 90 94 0 8 1 65 7 6 18 9018 90 95 0 0 1 65 7 6 18 9018 90 96 AED Automatic External Defibrillator 0 8 1 65 76 18 9018 90 99 16 8 1 65 7 6 18 90 19 9019 10 00 14 8 1 65 7 6 18 90
256. e E AHS act TW BLA Copyright C 2012 JETRO All rights reserved 2010 6 2011 5 METIS 1 42
257. echnik J R EHLKE amp Cia 55 41 16 1661 Juveve 1971 Eppendorf LTDA 3352 2144 AGB Curitiba PR Instrumentation Laboratory SUPELCO SIGMA ALDRICH JJR Instrumental 55 11 SKC Pall Gelman 17 Sao Paulo SP 1993 Ltda 2059 5600 Fisher Scientific Inter national Inc Whatman Copyright C 2012 JETRO All rights reserved 173 Jupiter Distribuidora Edwards Lifesciences Avenida Yara n 345 de Produtos e 55 11 Medline 18 Vila Yara NA Equipamentos 3656 5800 Pharmaplast Osasco SP Hospitalares Ltda Hartmann BIOTECH LOHCUS 55 11 TERUMO COMERCIO E 19 Sao Paulo 3670 2020 1990
258. erved 118 E II 2009 ANVISA 24 2011 2 TE 2 _ 2004 1 3 124 4 2009 2 TE 4 A A 24 4 3 2009 24 4 2 I I 4 2000 97 r YE 5 2 5 2011 2 3 i 6 20
259. ga 37 f 55 11 11 Associacao Nacional de Hospitais 4 Andar Paraiso Sao 3253 7444 Privados _ Paulo SP Copyright C 2012 JETRO All rights reserved 177 SHS Quadra 6 Bloco A Sala 55 61 12 Federacao Nacional dos Medicos 211 Bras lia DF 3042 3700 Rua Par 197 Pituba 55 71 13 Sociedade Brasileira de Cancerologia Salvador Bahia 3240 4868 Av Marechal Camara 160 55 21 14 Sociedade Brasileira de Cardiologia Sala 330 Centro Rio de 3478 2700 Janeiro RJ Rua Funchal 129 conjunto 21A 55 11 15 Sociedade Brasileira de Cirurgia Plastica Vila Olimpia Sao Paulo SP 3044 0000 Av Brigadeiro Luis Ant6nio 55 11 16 Sociedade Brasileira de Reumatologia 2 466 sala 93 Sao Paulo SP 3289 7165 Rua Bambina 153 Botafogo 55 21 17 Sociedade Brasileira de Urologia Rio de Janeiro RJ 22 46 4092 SPR Avenida Paulista 491 Cj 55
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261. leis 19677 htm o 1998 9 695 1990 8 072 1977 6 437 2 5 10 https www planalto gov br ccivil_03 leis 19695 htm 1999 o 1999 9 782 ANVISA https www planalto gov br ccivil_03 leis 19782 htm Copyright C 2012 JETRO All rights reserved 95 2001 o 2001 10 205 199 4 https www planalto gov br ccivil_03 leis leis_2001 110205 htm 2009 o 2009 11 972 1999 9 782 GMP 2 https www planalto gov br ccivil_03 _ato2007 2010 2009 lei 111972 htm Copyright C 2012 JETRO All rights reserved 96 E Decretos 1974 o 1947 74 170
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