{"id":38322,"date":"2013-07-25T09:37:08","date_gmt":"2013-07-25T12:37:08","guid":{"rendered":""},"modified":"2022-02-24T13:57:48","modified_gmt":"2022-02-24T16:57:48","slug":"cir-07213-%e3%80%8c%e3%83%a1%e3%83%87%e3%82%a3%e3%82%ab%e3%83%ab%e5%88%86%e7%a7%91%e4%bc%9a%e3%80%8d%e3%83%a1%e3%83%b3%e3%83%90%ef%bc%8d%e5%8b%9f%e9%9b%86%e3%81%ae%e4%bb%b6","status":"publish","type":"post","link":"https:\/\/camaradojapao.org.br\/old-jp\/2013\/07\/25\/cir-07213-%e3%80%8c%e3%83%a1%e3%83%87%e3%82%a3%e3%82%ab%e3%83%ab%e5%88%86%e7%a7%91%e4%bc%9a%e3%80%8d%e3%83%a1%e3%83%b3%e3%83%90%ef%bc%8d%e5%8b%9f%e9%9b%86%e3%81%ae%e4%bb%b6\/","title":{"rendered":"CIR 072\/13: \u300c\u30e1\u30c7\u30a3\u30ab\u30eb\u5206\u79d1\u4f1a\u300d\u30e1\u30f3\u30d0\uff0d\u52df\u96c6\u306e\u4ef6"},"content":{"rendered":"

<\/p>\n

CIR-072\/13<\/span><\/p>\n

2013<\/span>\u5e74<\/span>7<\/span>\u6708<\/span>25<\/span>\u65e5<\/span><\/p>\n

\u4f1a\u54e1\u5404\u4f4d<\/span><\/p>\n

\u30e1\u30c7\u30a3\u30ab\u30eb\u5206\u79d1\u4f1a\uff08\u8cbf\u6613\u90e8\u4f1a\u6240\u5c5e\uff09<\/span><\/p>\n

\u65e5\u672c\u5149\u96fb\u3000\u6817\u7530\u79c0\u4e00<\/span><\/p>\n

\u5cf6\u6d25\u88fd\u4f5c\u6240\u3000\u52a0\u85e4\u5f70\u5f66<\/span><\/p>\n

\u30c6\u30eb\u30e2\u3000\u3000\u85e4\u7530\u8aa0<\/span><\/p>\n

 <\/span><\/p>\n

\u300c\u30e1\u30c7\u30a3\u30ab\u30eb\u5206\u79d1\u4f1a\u300d\u30e1\u30f3\u30d0\uff0d\u52df\u96c6\u306e\u4ef6<\/span><\/span><\/strong><\/span><\/strong><\/p>\n

 <\/span><\/p>\n

\u3053\u306e\u5ea6\u3001\u30d6\u30e9\u30b8\u30eb\u65e5\u672c\u5546\u5de5\u4f1a\u8b70\u6240\u8cbf\u6613\u90e8\u4f1a\uff08\u4f0a\u5439\u6d0b\u4e8c\u90e8\u4f1a\u9577\uff09\u306e\u4e2d\u306b\u300c\u30e1\u30c7\u30a3\u30ab\u30eb\u5206\u79d1\u4f1a\u300d\u3092\u8a2d\u7f6e\u3059\u308b\u3053\u3068\u3068\u306a\u308a\u307e\u3057\u305f\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4e00\u793e\u3067\u306f<\/span>ANVISA<\/span>\uff08\u6ce8<\/span>1<\/span>\uff09\u306a\u3069\u30d6\u30e9\u30b8\u30eb\u653f\u5e9c\u3068\u306e\u554f\u984c\u89e3\u6c7a\u306b\u5411\u3051\u305f\u8a71\u3057\u5408\u3044\u306a\u3069\u96e3\u3057\u3044\u90e8\u5206\u3082\u3042\u308a\u307e\u3059\u304c\u3001\u3053\u308c\u3092\u7d44\u7e54\u3068\u3057\u3066\u3084\u3063\u3066\u3044\u3053\u3046\u3068\u3044\u3046\u3053\u3068\u304c\u4e3b\u65e8\u3067\u3059\u3002\u30d6\u30e9\u30b8\u30eb\u306b\u306f<\/span>ABIMED<\/span>\uff08\u6ce8<\/span>2<\/span>\uff09\u306a\u3069\u306e\u5354\u4f1a\u3082\u3042\u308a\u3001\u305d\u308c\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u3082\u4f75\u884c\u3057\u3066\u884c\u3048\u3070\u3088\u3044\u3068\u601d\u3044\u307e\u3059\u304c\u3001\u3053\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u5206\u79d1\u4f1a\u306f\u3001\u30ab\u30de\u30e9\u306e\u7d44\u7e54\u3068\u3057\u3066\u65e5\u672c\u653f\u5e9c\uff08\u5927\u4f7f\u9928\u30fb\u7dcf\u9818\u4e8b\u9928\u53ca\u3073\u539a\u52b4\u7701\u7b49\uff09\u3068\u5171\u306b\u554f\u984c\u89e3\u6c7a\u306b\u5411\u3051\u305f\u6d3b\u52d5\u3092\u884c\u3063\u3066\u3044\u3053\u3046\u3068\u3044\u3046\u3082\u306e\u3067\u3059\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u6628\u5e74\u30e1\u30ad\u30b7\u30b3\u3067\u65e5\u672c\u306e\u85ac\u4e8b\u5236\u5ea6\u306e\u540c\u7b49\u6027\u8a8d\u5b9a\u304c\u5b9f\u73fe\u3057\u305f\u3053\u3068\u3001\u307e\u305f\u5b89\u500d\u653f\u6a29\u306e\u653f\u7b56\u304c\u8ffd\u3044\u98a8\u306b\u306a\u3063\u3066\u3044\u308b\u3053\u3068\u3067\u3001\u65e5\u672c\u30b5\u30a4\u30c9\u3067\u306f\u539a\u52b4\u7701\u306b\u533b\u7642\u56fd\u969b\u5c55\u958b\u6226\u7565\u5ba4\u304c\u8a2d\u7f6e\u3055\u308c\u3001\u6d77\u5916\u3067\u306e\u3053\u3046\u3044\u3063\u305f\u6d3b\u52d5\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u4f53\u5236\u304c\u3068\u3089\u308c\u3066\u304a\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u65e5\u672c\u533b\u7642\u6a5f\u5668\u7523\u696d\u9023\u5408\u4f1a\u3082\u5f8c\u62bc\u3057\u3092\u3057\u3066\u304f\u308c\u307e\u3059\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u7c73\u56fd\u306e<\/span>FDA<\/span>\uff08\u6ce8<\/span>3<\/span>\uff09\u306f\u65e2\u306b<\/span>ANVISA<\/span>\u3068\u8272\u3005\u306a\u8a71\u3092\u3057\u3066\u3044\u308b\u3068\u3044\u3046\u60c5\u5831\u3082\u3042\u308a\u307e\u3059\u3002\u65e5\u672c\u3082\u65e5\u672c\u653f\u5e9c\u306e\u3054\u5354\u529b\u3092\u3044\u305f\u3060\u304d\u306a\u304c\u3089\u3001\u3053\u308c\u306b\u9045\u308c\u306a\u3044\u3088\u3046\u306b\u3057\u3066\u3044\u304b\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u601d\u3044\u307e\u3059\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5c31\u304d\u307e\u3057\u3066\u306f\u3001\u4e0b\u8a18\u306e\u8981\u9818\u3067\u30e1\u30f3\u30d0\u30fc\u306e\u52df\u96c6\u3092\u884c\u3044\u305f\u3044\u3068\u601d\u3044\u307e\u3059\u3002<\/span><\/strong><\/strong><\/p>\n

\u7279\u306b\u5316\u5b66\u54c1\u95a2\u9023\u306e\u4f01\u696d\u3082\u95a2\u5fc3\u304c\u304a\u3042\u308a\u3068\u5bdf\u3057\u307e\u3059\u3002\u69d8\u3005\u306a\u696d\u7a2e\u3068\u6a2a\u65ad\u7684\u306b\u60c5\u5831\u4ea4\u63db\u30fb\u5354\u529b\u3057\u3042\u3046\u4e8b\u3092\u76ee\u7684\u3068\u3057\u3066\u304a\u308a\u307e\u3059\u306e\u3067\u7686\u69d8\u596e\u3063\u3066\u3054\u53c2\u52a0\u4e0b\u3055\u3044\u3002<\/span><\/p>\n

\u4e00\u7dd2\u306b\u554f\u984c\u89e3\u6c7a\u306b\u5411\u3051\u3066\u6d3b\u52d5\u3057\u3066\u3044\u304d\u307e\u3057\u3087\u3046\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\uff08<\/span>\u6ce8<\/span>1<\/span>\uff09<\/span>\u56fd\u5bb6\u885b\u751f\u76e3\u7763\u5e81 <\/span>Agência Nacional de Vigilância Sanitária <\/span> \u533b\u7642\u6a5f\u5668\u306e\u88fd\u54c1\u767b\u9332\u30fb\u8a31\u8a8d\u53ef\u3001\u4fdd\u5065\u5206\u91ce\u306e\u4f01\u696d\u6d3b\u52d5\u8a31\u8a8d\u53ef\u3001<\/span>GMP<\/span>\u8a8d\u8a3c\u306e\u767a\u884c\u306a\u3069\u30d6\u30e9\u30b8\u30eb\u56fd\u5185\u306b\u304a\u3051\u308b\u4fdd\u5065\u5206\u91ce\u306e\u88fd\u54c1\u8ca9\u58f2\u306b\u95a2\u3059\u308b\u696d\u52d9\u3092\u4e00\u62ec\u7ba1\u7406\u30fb\u76e3\u7763\u3057\u3066\u3044\u308b\u6a5f\u95a2\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\uff08<\/span>\u6ce8<\/span>2<\/span>\uff09<\/span>\u30d6\u30e9\u30b8\u30eb\u533b\u7642\u6a5f\u5668\u30cf\u30a4\u30c6\u30af\u7523\u696d\u5354\u4f1a <\/span>Associação Brasileira da Industria de Alta Tecnologia de Equipamentos, Produtos e Suprimentos Medico-Hospitalares<\/span><\/p>\n

 <\/span><\/p>\n

\uff08\u6ce8<\/span>3<\/span>\uff09\u30a2\u30e1\u30ea\u30ab\u98df\u54c1\u533b\u85ac\u54c1\u5c40 <\/span>Food and Drug Administration<\/span><\/p>\n

 <\/span><\/p>\n

\uff0d\u3000\u8a18\u3000\uff0d<\/span><\/strong><\/strong><\/p>\n

 <\/span><\/p>\n

 <\/span><\/p>\n

\u6d3b\u52d5\u65b9\u91dd\uff1a<\/span><\/strong>\u533b\u7642\u95a2\u9023\u4f01\u696d\u306f\u30d3\u30b8\u30cd\u30b9\u3092\u901a\u3058\u30d6\u30e9\u30b8\u30eb\u56fd\u6c11\u306e\u5065\u5eb7\u306b\u8ca2\u732e\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u308b\u304c\u3001\u305d\u306e\u30d3\u30b8\u30cd\u30b9\u3092\u5c55\u958b\u3059\u308b\u4e0a\u3067\u56f0\u3063\u3066\u3044\u308b\u70b9\u3092\u53d6\u308a\u4e0a\u3052\u3001\u30ab\u30de\u30e9\u306e\u7d44\u7e54\u3068\u3057\u3066\u554f\u984c\u89e3\u6c7a\u306b\u5411\u3051\u305f\u6d3b\u52d5\u3092\u884c\u3046\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5177\u4f53\u7684\u306b\u306f\u3001\u4e00\u4f8b\u3068\u3057\u3066\u3001<\/span>ANVISA<\/span>\u306e\u88fd\u54c1\u767b\u9332\u306e\u5be9\u67fb\u304c\u7570\u5e38\u306b\u9045\u304f\uff11\u5e74\u4ee5\u4e0a\u304b\u304b\u3063\u3066\u3044\u308b\u3068\u304b\u3001<\/span>ANVISA<\/span>\u306b\u3088\u308b\u30d6\u30e9\u30b8\u30eb\u56fd\u5916\u306e\u5de5\u5834\u306e<\/span>GMP(Good Manufacturing Practice <\/span>\u533b\u85ac\u54c1\u7b49\u306e\u88fd\u9020\u54c1\u8cea\u7ba1\u7406\u57fa\u6e96<\/span>)<\/span>\u67fb\u5bdf\u304c<\/span>2<\/span>\u5e74\u4ee5\u4e0a\u5f85\u305f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u306a\u3069\u306e\u554f\u984c\u304c\u3042\u308a\u3001\u3053\u308c\u306b\u3064\u3044\u3066\u65e5\u672c\u3067\u85ac\u4e8b\u627f\u8a8d\u304c\u3042\u308c\u3070\u30d6\u30e9\u30b8\u30eb\u3067\u306e\u5be9\u67fb\u3092\u7c21\u7d20\u5316\u3059\u308b\u3068\u304b\u65e5\u672c\u898f\u5236\u5f53\u5c40\u306e\u5de5\u5834\u67fb\u5bdf\u7d50\u679c\u3092\u8a8d\u8a3c\u3059\u308b\u306a\u3069\u3001\u65e5\u672c\u306e\u85ac\u4e8b\u767b\u9332\u30fb\u5236\u5ea6\u306b\u3064\u3044\u3066\u540c\u7b49\u6027\u3092\u8a8d\u5b9a\u3057\u3066\u3082\u3089\u3046\u3053\u3068\u3092\u63d0\u6848\u3057\u3066\u3044\u3053\u3046\u3068\u3044\u3046\u3082\u306e\u3067\u3059\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u3082\u3061\u308d\u3093\u3001\u30e1\u30f3\u30d0\u30fc\u9593\u306e\u60c5\u5831\u5171\u6709\u3001\u89aa\u7766\u3082\u56f3\u3063\u3066\u3044\u304d\u305f\u3044\u3068\u601d\u3044\u307e\u3059\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5bfe\u8c61\u4f01\u696d\uff1a<\/span><\/strong>\u533b\u7642\u95a2\u9023\u306e\u30d3\u30b8\u30cd\u30b9\u3092\u3057\u3066\u3044\u308b\u4f01\u696d\uff08\u533b\u7642\u6a5f\u5668\u3001\u533b\u85ac\u54c1\u3092\u554f\u308f\u305a\uff09<\/span><\/p>\n

<\/span> <\/span>\u8cbf\u6613\u90e8\u4f1a\u4ee5\u5916\u306e\u90e8\u4f1a\u306e\u4f01\u696d\u3082\u3082\u3061\u308d\u3093\u53ef\u3067\u3059\uff08\u305d\u306e\u5834\u5408\u5206\u79d1\u4f1a\u52a0\u5165\u3068\u540c\u6642\u306b\u8cbf\u6613\u90e8\u4f1a\u3078\u3082\u81ea\u52d5\u7684\u306b\u30b5\u30d6\u90e8\u4f1a\u54e1\u767b\u9332\u3055\u305b\u3066\u9802\u304d\u307e\u3059\uff09\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u30e1\u30f3\u30d0\u30fc\u5e0c\u671b\u306e\u4f01\u696d\u306f\u3001\u4f01\u696d\u540d\u3001\u4ee3\u8868\u8005\u3001\u30e1\u30f3\u30d0\u30fc\u306e\u65b9\u306e\u6c0f\u540d\u30fb\u30e1\u30fc\u30eb\u30a2\u30c9\u30ec\u30b9\u3001\u73fe\u5728\u30d3\u30b8\u30cd\u30b9\u3092\u5c55\u958b\u3059\u308b\u4e0a\u3067\u56f0\u3063\u3066\u3044\u308b\u70b9\u3092\u3054\u8a18\u5165\u306e\u4e0a\u3001\u30ab\u30de\u30e9\u4e8b\u52d9\u5c40<\/span><\/strong> <\/span><\/strong>secretaria@camaradojapao.org.br<\/span><\/a> <\/span><\/strong>\u307e\u3067\u8fd4\u4fe1\u304f\u3060\u3055\u3044\u3002<\/span><\/strong><\/strong><\/p>\n

 <\/span><\/p>\n

 <\/span><\/p>\n\n\n\n
\n

\u4f01\u696d\u540d\u3000\uff1a<\/span><\/strong><\/strong><\/p>\n

\u4ee3\u8868\u8005\u3000\uff1a<\/span><\/strong><\/strong><\/p>\n

\u30e1\u30f3\u30d0\u30fc\uff1a\u3000\u6c0f\u540d<\/span><\/strong><\/p>\n

\u30e1\u30fc\u30eb\u30a2\u30c9\u30ec\u30b9<\/span><\/strong><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n

\u73fe\u5728\u30d3\u30b8\u30cd\u30b9\u3092\u5c55\u958b\u3059\u308b\u4e0a\u3067\u56f0\u3063\u3066\u3044\u308b\u70b9\u3000\uff1a<\/span><\/strong><\/strong><\/p>\n

 <\/span><\/p>\n

 <\/span><\/p>\n

 <\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/p>\n

 <\/span><\/p>\n

\u7de0\u5207 <\/span><\/strong>\uff1a<\/span><\/strong> <\/span><\/strong>2013<\/span><\/strong>\u5e74<\/span><\/strong>8<\/span><\/strong>\u6708<\/span><\/strong>23<\/span><\/strong>\u65e5<\/span><\/strong>\uff08<\/span><\/strong>\u91d1<\/span><\/strong>\uff09<\/span><\/strong><\/strong><\/p>\n

 <\/span><\/p>\n

\u3054\u8cea\u554f\u306e\u3042\u308b\u65b9\u306f\u3001\u30c6\u30eb\u30e2\u306e\u85e4\u7530<\/span><\/strong> <\/span><\/strong>makoto.fujita@terumomedical.com<\/span><\/a> <\/span><\/strong>\u30e1\u30fc\u30eb\u30a2\u30c9\u30ec\u30b9 <\/span>\u307e\u3067\u3001\u304a\u6c17\u8efd\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002<\/span><\/strong><\/strong><\/p>\n

 <\/span><\/p>\n

\u4ee5\u4e0a<\/span><\/p>\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

CIR-072\/13 2013\u5e747\u670825\u65e5 \u4f1a\u54e1\u5404\u4f4d \u30e1\u30c7\u30a3\u30ab\u30eb\u5206\u79d1\u4f1a\uff08\u8cbf\u6613\u90e8\u4f1a\u6240\u5c5e\uff09 \u65e5\u672c\u5149\u96fb\u3000\u6817\u7530\u79c0\u4e00 \u5cf6\u6d25\u88fd\u4f5c\u6240\u3000\u52a0\u85e4\u5f70\u5f66 \u30c6\u30eb\u30e2\u3000\u3000\u85e4\u7530\u8aa0   \u300c\u30e1\u30c7\u30a3\u30ab\u30eb\u5206\u79d1\u4f1a\u300d\u30e1\u30f3\u30d0\uff0d\u52df\u96c6\u306e\u4ef6   \u3053\u306e\u5ea6 …<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[],"tags":[],"_links":{"self":[{"href":"https:\/\/camaradojapao.org.br\/old-jp\/wp-json\/wp\/v2\/posts\/38322"}],"collection":[{"href":"https:\/\/camaradojapao.org.br\/old-jp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/camaradojapao.org.br\/old-jp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/camaradojapao.org.br\/old-jp\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/camaradojapao.org.br\/old-jp\/wp-json\/wp\/v2\/comments?post=38322"}],"version-history":[{"count":0,"href":"https:\/\/camaradojapao.org.br\/old-jp\/wp-json\/wp\/v2\/posts\/38322\/revisions"}],"wp:attachment":[{"href":"https:\/\/camaradojapao.org.br\/old-jp\/wp-json\/wp\/v2\/media?parent=38322"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/camaradojapao.org.br\/old-jp\/wp-json\/wp\/v2\/categories?post=38322"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/camaradojapao.org.br\/old-jp\/wp-json\/wp\/v2\/tags?post=38322"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}