メキシコにおける医療機器の輸入制度 2012 年 2 月
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1. IE Copyright 2012 JETRO All rights reserved 102. 10 HS 9018 9019 9020 9021 9022 TT 9022 0 2014 4 1 0 11 1 Secretaria de Salud Secretaria de Salud Lieja 7 Col Juarez Delegacion Cuahtemoc 06600 Mexico DE TEL 52 55 5553 7184 2 COFEPRIS Comision Federal para la Proteccion contra Riesgos Sanitarios COFEPRIS Monterrey 33 Col Roma Delegacion Cuahtemoc 06700 M xico D F TEL 52 55 5080 5200 5216 6013 3
3. FDA FDA I FDA A FDA B FDA C D HC A HC B CAN CCO ISO 13485 03 C ISO 17021 D HC B E
4. QMS QMS For legalization of the foreign Consul in Japan Consul 82
5. 1 2 3 4 6 7 8 9 10 11 Copyright 2012 JETRO All rights reserved lt 12
6. 2011 12 31 2012 1 1 COFEPRIS COFEPRIS 90 COFEPRIS 1 8 6 1 30 179
7. 40 180 4 376 82 Registro Sanitario COFEPRIS 04 001 B COFEPRIS CIS 8 30
8. 3 3 179 180 wd gt 2010 10 26 3 FDA HC
9. GMP Perito Traductor Copyright 2012 JETRO All rights reserved 6
10. NOM NOM Certificate of Free Sale OCOD OO OO Lay 4 I
11. 2012 1 25 Ra 6 7 FDA S10 k PMA HC 0 3 Copyright 2012 JETRO All rights reserved D
12. Dispositivos Medicos 1 2 3 4 6
13. 96 E E 2 1 9 NOM4 1 1 23 1 2 3
14. 2 EE COFEPRIS 4 de Importaci6n 3 E Permiso Sanitario Copyright 2012 JETRO All rights reserved 1 B COFEPRIS 1 1 a b
15. 1 30 10 20 COFEPRIS
16. 2002 3 HS2007 2009 1 29 2007 9 27 23 7 30 2012 3 23 H TV HS 2 1 B 3 COFEPRIS Registro Sanitario 1 B
17. C Copyright 2012 JETRO All rights reserved COFEPRIS 3 COFEPRIS 3 5
18. gt 1 3 1 25 2011 1 28 2 2012 1 a b c d
19. H23 2012 2 1 Copyright 2012 JETRO All rights reserved 0UNBDOEYRR0RR2RRZINSE2EHSR3ERRC2828822RE88ESRR288 28Ei8SSRRR 2 2 kk 3 kk 4 kk 5 kkk NIS 7 8 i SS 0 SN kk 1 5 yu 10 Copyright 2012 JETRO All rights reserved 262
20. Copyright 2012 JETRO All rights reserved NOM 137 SSA1 2008 V E B E C D l E 1ii F G 8
21. 13 14 15 3 E E 1 gt O BS NOM 008 SCFI 2002 16 kk
22. CANIFARMA Camara Nacional de la Industria Farmaceutica CANIEARMA AV Cuauhtemoc 1481 Col Santa Cruz Atoyac 03310 M xico D F TEL 52 55 5688 9477 Copyright 2012 JETRO All rights reserved 12 I COFEPRIS IL COFEPRIS I IV V NOM 137 SSA1 2008 VI
23. 6 8 H E 10 SE 4 1 5 A E E E a E NOM 11 3 12
24. e f 4 a f Copyright 2012 JETRO All rights reserved 6 7 8 8
25. OE 7 2006 12 2012 11 2010 9 3 2010 10 26
26. 14 00 1 30 II 35 60 COFBPRIS III 2 VD COFEPRIS 7 7 A PWS NT NS EOED NER NN 30 77 5 FAN SE
27. D TEN AKANENE TEES WR IO EEL Copyright 2012 JETRO All rights reserved gt http wwwr cofepris gob mx AS Documents RegistroDispositivosMedicos Sclasif riesgosan ca t DM 251108 xls 5 5 Aviso de Funcionamiento D 1 1
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