{"id":7027,"date":"2026-07-09T09:09:58","date_gmt":"2026-07-09T02:09:58","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-07-15T21:24:56","modified_gmt":"2026-07-15T14:24:56","slug":"idak-and-cdakb-medical-device-distribution-indonesia","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/ja\/idak-and-cdakb-medical-device-distribution-indonesia\/","title":{"rendered":"IDAK\u3068CDAKB\u3092\u7406\u89e3\u3059\u308b\uff1a\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u6d41\u901a\u306e\u4e8c\u5927\u67f1"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u533b\u7642\u6a5f\u5668\u306e\u8ca9\u58f2\u3092\u8a08\u753b\u3057\u3066\u3044\u308b\u4eba\u306f\u3001\u3059\u3050\u306b\u6b21\u306e2\u3064\u306e\u7565\u8a9e\u306b\u906d\u9047\u3059\u308b\u3067\u3057\u3087\u3046\u3002 <strong>\u30a4\u30c0\u30c3\u30af<\/strong> \u305d\u3057\u3066 <strong>CDAKB<\/strong>. \u3053\u308c\u3089\u306f\u3057\u3070\u3057\u3070\u4e00\u7dd2\u306b\u8a00\u53ca\u3055\u308c\u307e\u3059\u304c\u3001\u540c\u3058\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u4e00\u65b9\u306f\u55b6\u696d\u8a31\u53ef\u8a3c\u3001\u3082\u3046\u4e00\u65b9\u306f\u54c1\u8cea\u7ba1\u7406\u898f\u683c\u3067\u3059\u3002\u305d\u308c\u305e\u308c\u306e\u6280\u8853\u7684\u306a\u8a73\u7d30\u306b\u5165\u308b\u524d\u306b\u3001\u4e21\u8005\u306e\u9055\u3044\u3068\u9023\u643a\u306e\u4ed5\u7d44\u307f\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u7b2c\u4e00\u6b69\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"801\" height=\"484\" src=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2.webp\" alt=\"IDAK\u3068CDAKB\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u6d41\u901a\u898f\u5247\u306b\u3064\u3044\u3066\u89e3\u8aac\" class=\"wp-image-7029\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2.webp 801w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2-300x181.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2-768x464.webp 768w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2-18x12.webp 18w\" sizes=\"(max-width: 801px) 100vw, 801px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>IDAK\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u30a4\u30c0\u30c3\u30af<\/strong> \u306f <strong>\u30a4\u30b8\u30f3 \u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30b7 \u30a2\u30e9\u30c3\u30c8 \u30b1\u30bb\u30cf\u30bf\u30f3<\/strong>, \u3001 \u307e\u305f\u306f <strong>\u533b\u7642\u6a5f\u5668\u8ca9\u58f2\u30e9\u30a4\u30bb\u30f3\u30b9<\/strong>. \u3053\u308c\u306f\u3001\u4f01\u696d\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u533b\u7642\u6a5f\u5668\u3092\u5378\u58f2\u307e\u305f\u306f\u5c0f\u58f2\u898f\u6a21\u3092\u554f\u308f\u305a\u3001\u5408\u6cd5\u7684\u306b\u8abf\u9054\u3001\u4fdd\u7ba1\u3001\u6d41\u901a\u3001\u307e\u305f\u306f\u4f9b\u7d66\u3059\u308b\u524d\u306b\u53d6\u5f97\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u516c\u5f0f\u306e\u8a31\u53ef\u8a3c\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IDAK\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u30e9\u30a4\u30bb\u30f3\u30b9\u5236\u5ea6\u3092\u901a\u3058\u3066\u767a\u884c\u3055\u308c\u307e\u3059\u3002, <strong>OSS-RBA\uff08\u30aa\u30f3\u30e9\u30a4\u30f3\u5358\u4e00\u63d0\u51fa\u65b9\u5f0f - \u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1\uff09<\/strong>, \u4e8b\u696d\u5206\u985e\u30b3\u30fc\u30c9\u306b\u57fa\u3065\u304d <strong><a href=\"https:\/\/kbli.co.id\/id\/46691\" target=\"_blank\" rel=\"noopener\">KBLI 46691<\/a><\/strong>, \u3053\u308c\u306f\u3001\u533b\u85ac\u54c1\u3001\u691c\u67fb\u6a5f\u5668\u3001\u533b\u7642\u6a5f\u5668\u306e\u5927\u898f\u6a21\u53d6\u5f15\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u30e9\u30a4\u30bb\u30f3\u30b9\u81ea\u4f53\u306f\u3001\u6280\u8853\u627f\u8a8d\u3092\u5f97\u3066\u3001 <strong><a href=\"https:\/\/www.kemkes.go.id\/id\/home\" target=\"_blank\" rel=\"noopener\">\u4fdd\u5065\u7701\uff08Kemenkes\uff09<\/a><\/strong>, \u3092\u901a\u3058\u3066 <a href=\"https:\/\/farmalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\"><strong>\u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u7dcf\u5c40\uff08Ditjen Farmalkes\uff09<\/strong>.<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IDAK\u306f\u3001\u4ee5\u524d\u306f\u3053\u3046\u547c\u3070\u308c\u3066\u3044\u305f\u3082\u306e\u306e\u65b0\u3057\u3044\u7528\u8a9e\u3067\u3059\u3002 <strong>IPAK (\u30a4\u30b8\u30f3\u30fb\u30da\u30cb\u30e3\u30eb\u30fc\u30eb\u30fb\u30a2\u30e9\u30c3\u30c8\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3)<\/strong>, \u898f\u5236\u5bfe\u8c61 <strong>\u533b\u7642\u6a5f\u5668\u6d41\u901a\u306b\u95a2\u3059\u308b\u4fdd\u5065\u5927\u81e3\u4ee4\uff08Permenkes\uff09\u7b2c1191\/Menkes\/Per\/VIII\/2010\u53f7<\/strong>. \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u304c\u7d71\u5408OSS-RBA\u30e9\u30a4\u30bb\u30f3\u30b9\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u79fb\u884c\u3057\u305f\u969b\u3001\u3053\u308c\u306f <strong><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/203315\/permenkes-no-14-tahun-2021\" target=\"_blank\" rel=\"noopener\">2021\u5e74\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c14\u53f7<\/a> \u533b\u7642\u5206\u91ce\u306b\u304a\u3051\u308b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u4e8b\u696d\u514d\u8a31\u5236\u5ea6\u306b\u304a\u3051\u308b\u4e8b\u696d\u6d3b\u52d5\u304a\u3088\u3073\u88fd\u54c1\u306b\u95a2\u3059\u308b\u57fa\u6e96\u306b\u3064\u3044\u3066<\/strong>, \u3053\u308c\u306f\u73fe\u5728\u3001IDAK\u3092\u767a\u884c\u3059\u308b\u4e3b\u8981\u306a\u6cd5\u7684\u6839\u62e0\u3068\u306a\u3063\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IDAK\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\u3001\u4f01\u696d\u306f\u901a\u5e38\u3001\u4ee5\u4e0b\u306e\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u533b\u7642\u6a5f\u5668\u5206\u91ce\u3067\u306e\u6d3b\u52d5\u3092\u53cd\u6620\u3057\u305f\u6709\u52b9\u306a\u8a2d\u7acb\u8a3c\u66f8\u3092\u6709\u3059\u308b\u3001\u6cd5\u7684\u306b\u8a2d\u7acb\u3055\u308c\u305f\u4e8b\u696d\u4f53\uff08\u500b\u4eba\u4e8b\u696d\u4e3b\u307e\u305f\u306f\u5354\u540c\u7d44\u5408\uff09\u3002.<\/li>\n\n\n\n<li>KBLI 46691\u306b\u57fa\u3065\u304f\u4e8b\u696d\u8b58\u5225\u756a\u53f7\uff08NIB\uff09\u3002.<\/li>\n\n\n\n<li>\u6d41\u901a\u57fa\u6e96\u3092\u6e80\u305f\u3059\u7269\u7406\u7684\u306a\u65bd\u8a2d\uff08\u30aa\u30d5\u30a3\u30b9\u304a\u3088\u3073\u5009\u5eab\uff09\u304c\u5fc5\u8981\u3067\u3059\uff08\u30d0\u30fc\u30c1\u30e3\u30eb\u30aa\u30d5\u30a3\u30b9\u306f\u3053\u306e\u76ee\u7684\u306b\u306f\u8a8d\u3081\u3089\u308c\u307e\u305b\u3093\uff09\u3002\u91cd\u8981\u306a\u70b9\u3068\u3057\u3066\u3001\u30e9\u30a4\u30bb\u30f3\u30b9\u306f\u3053\u306e\u7279\u5b9a\u306e\u767b\u9332\u4f4f\u6240\u306b\u7d10\u3065\u3044\u3066\u3044\u308b\u305f\u3081\u3001\u5f8c\u65e5\u30aa\u30d5\u30a3\u30b9\u3084\u5009\u5eab\u3092\u79fb\u8ee2\u3059\u308b\u5834\u5408\u306f\u3001\u65e2\u5b58\u306e\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u65b0\u3057\u3044\u5834\u6240\u306b\u305d\u306e\u307e\u307e\u5f15\u304d\u7d99\u3050\u306e\u3067\u306f\u306a\u304f\u3001IDAK\u3092\u9069\u5207\u306b\u66f4\u65b0\u307e\u305f\u306f\u518d\u51e6\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/li>\n\n\n\n<li>A <strong>Penanggung Jawab Teknis (PJT)<\/strong>, \u307e\u305f\u306f\u3001\u85ac\u5b66\u3001\u96fb\u6c17\u533b\u5b66\u5de5\u5b66\u3001\u81e8\u5e8a\u691c\u67fb\u6280\u8853\u3001\u516c\u8846\u885b\u751f\u306a\u3069\u306e\u95a2\u9023\u6559\u80b2\u80cc\u666f\u3092\u6301\u3061\u3001\u4fdd\u5065\u7701\u306e\u60c5\u5831\u30b7\u30b9\u30c6\u30e0\u306b\u767b\u9332\u3055\u308c\u3066\u3044\u308b\u8cac\u4efb\u6280\u8853\u8005\u3002.<\/li>\n\n\n\n<li>\u9075\u5b88 <strong>CDAKB<\/strong>, \u4ee5\u4e0b\u3067\u8aac\u660e\u3059\u308b\u9069\u6b63\u6d41\u901a\u57fa\u6e96\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">IDAK\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u533b\u7642\u6a5f\u5668\u8a8d\u8a3c\u6a5f\u95a2\uff09\u306e\u8a8d\u53ef\u304c\u306a\u3051\u308c\u3070\u3001\u4f01\u696d\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fd\u5185\u3067\u533b\u7642\u6a5f\u5668\u3092\u5408\u6cd5\u7684\u306b\u8f38\u5165\u3001\u4fdd\u7ba1\u3001\u307e\u305f\u306f\u6d41\u901a\u3055\u305b\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u3053\u308c\u306b\u9055\u53cd\u3059\u308b\u3068\u3001\u7121\u8a31\u53ef\u6d41\u901a\u3068\u307f\u306a\u3055\u308c\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u4fdd\u5065\u6cd5\u306b\u57fa\u3065\u304d\u884c\u653f\u51e6\u5206\u307e\u305f\u306f\u6cd5\u7684\u5236\u88c1\u306e\u5bfe\u8c61\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>CDAKB\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>CDAKB<\/strong> \u306f <strong>Cara Distribusi Alat Kesehatan yang Baik<\/strong>, \u3001 \u307e\u305f\u306f <strong>\u533b\u7642\u6a5f\u5668\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96<\/strong>. IDAK\u306f <em>\u55b6\u696d\u8a31\u53ef\u8a3c<\/em>, CDAKB\u306f <em>\u904b\u7528\u304a\u3088\u3073\u54c1\u8cea\u57fa\u6e96<\/em> \u8ca9\u58f2\u696d\u8005\u304c\u5b9f\u969b\u306b\u904b\u7528\u3092\u958b\u59cb\u3057\u305f\u5f8c\u306b\u9075\u5b88\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u4e8b\u9805\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">CDAKB\u306e\u6cd5\u7684\u6839\u62e0\u306f <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/116710\/permenkes-no-4-tahun-2014\" target=\"_blank\" rel=\"noopener\"><strong>\u533b\u7642\u6a5f\u5668\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96\u306b\u95a2\u3059\u308b\u4fdd\u5065\u5927\u81e3\u4ee4\uff08Permenkes\uff09\u7b2c4\u53f7\uff082014\u5e74\uff09<\/strong>. <\/a>\u4fdd\u5065\u7701\u304c\u516c\u8868\u3057\u305f\u3053\u306e\u898f\u5236\u306b\u95a2\u3059\u308b\u30e2\u30b8\u30e5\u30fc\u30eb\u306b\u3088\u308b\u3068\u3001\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c4\/2014\u53f7\u7b2c2\u6761\u7b2c1\u9805\u3067\u306f\u3001\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u8ca9\u58f2\u696d\u8005\u304a\u3088\u3073\u8ca9\u58f2\u696d\u8005\u306e\u3059\u3079\u3066\u306e\u652f\u5e97\u306f\u3001\u6d41\u901a\u6d3b\u52d5\u3092\u884c\u3046\u969b\u306bCDAKB\u3092\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u898f\u5b9a\u3057\u3066\u3044\u308b\u3002\u4fdd\u5065\u7701\u306f\u3001CDAKB\u306f\u56fd\u969b\u6a19\u6e96\u3092\u30e2\u30c7\u30eb\u306b\u3057\u3066\u3044\u308b\u3068\u6307\u6458\u3057\u3066\u3044\u308b\u3002 <strong>\u9069\u6b63\u6d41\u901a\u57fa\u6e96\uff08GDP\uff09<\/strong>, \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u898f\u5236\u72b6\u6cc1\u306b\u5408\u308f\u305b\u3066\u8abf\u6574\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">CDAKB\u306f\u3001\u3068\u308a\u308f\u3051\u4ee5\u4e0b\u306e\u4e8b\u9805\u306b\u95a2\u3059\u308b\u8981\u4ef6\u3092\u5b9a\u3081\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/strong>, \u6587\u66f8\u5316\u3055\u308c\u3001\u4f53\u7cfb\u5316\u3055\u308c\u3001\u4e00\u8cab\u3057\u3066\u9069\u7528\u3055\u308c\u308b\u3002.<\/li>\n\n\n\n<li><strong>\u4eba\u4e8b\u7ba1\u7406<\/strong>, \u3053\u308c\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u3092\u53d6\u308a\u6271\u3046\u8077\u54e1\u306e\u80fd\u529b\u304a\u3088\u3073\u7814\u4fee\u8a18\u9332\u3082\u542b\u307e\u308c\u307e\u3059\u3002.<\/li>\n\n\n\n<li><strong>\u65bd\u8a2d\u304a\u3088\u3073\u30a4\u30f3\u30d5\u30e9<\/strong>, \u640d\u50b7\u3084\u6c5a\u67d3\u3092\u9632\u3050\u305f\u3081\u306e\u9069\u5207\u306a\u4fdd\u7ba1\u6761\u4ef6\u3002.<\/li>\n\n\n\n<li><strong>\u8abf\u9054\u3001\u4fdd\u7ba1\u3001\u8f38\u9001<\/strong>, \u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u3092\u901a\u3057\u3066\u30c7\u30d0\u30a4\u30b9\u306e\u5b8c\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3002.<\/li>\n\n\n\n<li><strong>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/strong>, \u88fd\u54c1\u306e\u79fb\u52d5\u3092\u8ffd\u8de1\u3059\u308b\u6a5f\u80fd\u306b\u3088\u308a\u3001\u771f\u6b63\u6027\u304c\u78ba\u4fdd\u3055\u308c\u3001\u507d\u9020\u54c1\u3084\u898f\u683c\u5916\u306e\u6a5f\u5668\u304c\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u306e\u624b\u306b\u6e21\u308b\u306e\u3092\u9632\u3050\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/li>\n\n\n\n<li><strong>\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u3055\u308c\u305f\u6d3b\u52d5\u306b\u5bfe\u3059\u308b\u7ba1\u7406<\/strong>, \u7b2c\u4e09\u8005\u304c\u6d41\u901a\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u90e8\u306b\u95a2\u4e0e\u3057\u3066\u3044\u308b\u5834\u5408\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">CDAKB\u306f\u3001\u898f\u5236\u5bfe\u8c61\u3068\u306a\u308b\u533b\u7642\u6a5f\u5668\u306e\u4e3b\u8981\u306a\u30ab\u30c6\u30b4\u30ea\u30fc\u3001\u3059\u306a\u308f\u3061\u3001\u653e\u5c04\u7dda\u3092\u4f7f\u7528\u3059\u308b\u96fb\u6c17\u533b\u7642\u6a5f\u5668\u3001\u653e\u5c04\u7dda\u3092\u4f7f\u7528\u3057\u306a\u3044\u96fb\u6c17\u533b\u7642\u6a5f\u5668\u3001\u6ec5\u83cc\u6e08\u307f\u306e\u975e\u96fb\u6c17\u533b\u7642\u6a5f\u5668\u3001\u975e\u6ec5\u83cc\u306e\u975e\u96fb\u6c17\u533b\u7642\u6a5f\u5668\u3001\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u6a5f\u5668\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>IDAK\u3068CDAKB\u306e\u9023\u643a\u65b9\u6cd5<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b21\u306e\u3088\u3046\u306b\u8003\u3048\u3066\u307f\u308b\u3068\u5206\u304b\u308a\u3084\u3059\u3044\u3067\u3057\u3087\u3046\u3002 <strong>IDAK\u306f\u8ca9\u58f2\u4ee3\u7406\u5e97\u306b\u306a\u308b\u305f\u3081\u306e\u8a31\u53ef\u8a3c\u3067\u3042\u308a\u3001CDAKB\u306f\u8ca9\u58f2\u4ee3\u7406\u5e97\u304c\u9069\u5207\u306a\u8ca9\u58f2\u65b9\u6cd5\u3092\u77e5\u3063\u3066\u3044\u308b\u3053\u3068\u306e\u8a3c\u660e\u3067\u3059\u3002.<\/strong> \u5b9f\u969b\u306b\u306f\u3001IDAK\u3092\u7533\u8acb\u3059\u308b\u4f01\u696d\u306f\u3001\u30e9\u30a4\u30bb\u30f3\u30b9\u53d6\u5f97\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u74b0\u3068\u3057\u3066CDAKB\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u306a\u305c\u306a\u3089\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\uff08Kemenkes\uff09\u306f\u904b\u7528\u57fa\u6e96\u3092\u30e9\u30a4\u30bb\u30f3\u30b9\u81ea\u4f53\u306b\u7d10\u4ed8\u3051\u3066\u3044\u308b\u304b\u3089\u3067\u3042\u308b\u3002\u4f01\u696d\u306f\u3001\u6a5f\u5668\u306e\u4fdd\u7ba1\u3084\u8f38\u9001\u65b9\u6cd5\u3092\u5b9f\u969b\u306b\u7121\u8996\u3057\u3066\u6cd5\u7684\u8a31\u53ef\u3060\u3051\u3092\u4fdd\u6301\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u306a\u3044\u3002\u66f8\u985e\u4f5c\u6210\u304b\u3089\u5009\u5eab\u306e\u73fe\u5834\u306b\u81f3\u308b\u307e\u3067\u3001\u4e21\u8005\u306f\u5358\u4e00\u306e\u8cac\u4efb\u30b7\u30b9\u30c6\u30e0\u3068\u3057\u3066\u6a5f\u80fd\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u9023\u643a\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u80cc\u5f8c\u306b\u3042\u308b\u3088\u308a\u5e83\u7bc4\u306a\u610f\u56f3\u3092\u53cd\u6620\u3057\u3066\u3044\u308b\u3002\u3059\u306a\u308f\u3061\u3001\u75c5\u9662\u3001\u8a3a\u7642\u6240\u3001\u307e\u305f\u306f\u60a3\u8005\u306b\u5c4a\u304f\u3059\u3079\u3066\u306e\u6a5f\u5668\u304c\u3001\u8f38\u5165\u307e\u305f\u306f\u88fd\u9020\u306e\u6642\u70b9\u304b\u3089\u4f7f\u7528\u306e\u6642\u70b9\u307e\u3067\u3001\u8a8d\u53ef\u3055\u308c\u3001\u76e3\u8996\u3055\u308c\u3001\u54c1\u8cea\u7ba1\u7406\u3055\u308c\u305f\u7ba1\u7406\u4f53\u5236\u3092\u7d4c\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u3078\u306e\u53c2\u5165\u3092\u691c\u8a0e\u3057\u3066\u3044\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u304c\u306a\u305c\u91cd\u8981\u306a\u306e\u304b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5916\u56fd\u306e\u88fd\u9020\u696d\u8005\u3068\u56fd\u5185\u306e\u8ca9\u58f2\u696d\u8005\u306e\u4e21\u65b9\u306b\u3068\u3063\u3066\u3001IDAK\u3068CDAKB\u306f\u4efb\u610f\u306e\u5f62\u5f0f\u3067\u306f\u306a\u304f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u30bb\u30af\u30bf\u30fc\u3067\u5408\u6cd5\u7684\u306b\u4e8b\u696d\u3092\u884c\u3046\u305f\u3081\u306e\u524d\u63d0\u6761\u4ef6\u3067\u3042\u308a\u3001 <strong>\u88fd\u54c1\u306e\u8ca9\u58f2\u627f\u8a8d\uff08Izin Edar\uff09<\/strong> \u540c\u69d8\u306b\u3001\u3044\u305a\u308c\u304b\u306e\u8981\u4ef6\u3092\u898b\u843d\u3068\u3057\u305f\u4f01\u696d\u306f\u3001\u696d\u52d9\u958b\u59cb\u5f8c\u306b\u9045\u5ef6\u3001\u7533\u8acb\u5374\u4e0b\u3001\u307e\u305f\u306f\u898f\u5236\u63aa\u7f6e\u306e\u30ea\u30b9\u30af\u3092\u8ca0\u3046\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3069\u3061\u3089\u306e\u67a0\u7d44\u307f\u3082\u8a73\u7d30\u306a\u6280\u8853\u7684\u3001\u7ba1\u7406\u7684\u3001\u304a\u3088\u3073\u4eba\u7684\u8cc7\u6e90\u306b\u95a2\u3059\u308b\u8981\u4ef6\u3092\u4f34\u3046\u305f\u3081\u3001\u4f01\u696d\u306fOSS-RBA\u306e\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u3092\u5186\u6ed1\u306b\u9032\u3081\u3001\u4e8b\u696d\u904b\u55b6\u304c\u521d\u65e5\u304b\u3089CDAKB\u306b\u6e96\u62e0\u3059\u308b\u3088\u3046\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u7d4c\u9a13\u8c4a\u5bcc\u306a\u898f\u5236\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u5354\u529b\u3059\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>IDAK\u304a\u3088\u3073CDAKB\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u78ba\u4fdd\u3067\u304a\u56f0\u308a\u3067\u3059\u304b\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">IDAK\u30e9\u30a4\u30bb\u30f3\u30b9\u53d6\u5f97\u3068CDAKB\u8a8d\u8a3c\u53d6\u5f97\u306f\u3001\u9069\u5207\u306a\u73fe\u5730\u306e\u5c02\u9580\u77e5\u8b58\u304c\u306a\u3051\u308c\u3070\u3001\u6b63\u3057\u3044SOP\u306e\u4f5c\u6210\u304b\u3089\u3001\u8cc7\u683c\u306e\u3042\u308b\u6280\u8853\u62c5\u5f53\u5b98\u306e\u4efb\u547d\u3001Kemenkes\u306e\u8a55\u4fa1\u5408\u683c\u307e\u3067\u3001\u591a\u304f\u306e\u6642\u9593\u3068\u52b4\u529b\u3092\u8981\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002. <strong><a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u88fd\u54c1\u767b\u9332<\/a><\/strong> \u6d77\u5916\u306e\u88fd\u9020\u696d\u8005\u3084\u73fe\u5730\u306e\u8ca9\u58f2\u696d\u8005\u304c\u3001OSS-RBA\u30e9\u30a4\u30bb\u30f3\u30b9\u53d6\u5f97\u304b\u3089CDAKB\u3078\u306e\u6e96\u5099\u3001\u533b\u7642\u6a5f\u5668\u8ca9\u58f2\u627f\u8a8d\uff08Izin Edar\uff09\u306b\u81f3\u308b\u307e\u3067\u306e\u5168\u30d7\u30ed\u30bb\u30b9\u3092\u7ba1\u7406\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3059\u308b\u3053\u3068\u3067\u3001\u898f\u5236\u4e0a\u306e\u554f\u984c\u306b\u60a9\u307e\u3055\u308c\u308b\u3053\u3068\u306a\u304f\u3001\u88fd\u54c1\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u306b\u53c2\u5165\u3057\u3001\u5e02\u5834\u306b\u7559\u307e\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u60c5\u5831\u6e90<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5171\u548c\u56fd\u4fdd\u5065\u7701\u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u7dcf\u5c40\uff08Ditjen Farmalkes Kemenkes RI\uff09, <em>\u533b\u7642\u6a5f\u5668\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96\u306b\u95a2\u3059\u308b\u30e2\u30b8\u30e5\u30fc\u30eb<\/em>, farmalkes.kemkes.go.id<\/li>\n\n\n\n<li>\u533b\u7642\u6a5f\u5668\u306e\u9069\u6b63\u6d41\u901a\u6163\u884c\u306b\u95a2\u3059\u308b\u4fdd\u5065\u5927\u81e3\u898f\u5247 (Permenkes) 2014 \u5e74\u7b2c 4 \u53f7 (Cara Distribusi Alat Kesehatan yang Baik)<\/li>\n\n\n\n<li>\u533b\u7642\u6a5f\u5668\u6d41\u901a\u306b\u95a2\u3059\u308b\u4fdd\u5065\u5927\u81e3\u4ee4\uff08Permenkes\uff09\u7b2c1191\/Menkes\/Per\/VIII\/2010\u53f7<\/li>\n\n\n\n<li>\u4fdd\u5065\u5927\u81e3\u4ee4\uff08Permenkes\uff092021\u5e74\u7b2c14\u53f7\uff1a\u4fdd\u5065\u5206\u91ce\u306b\u304a\u3051\u308b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u4e8b\u696d\u514d\u8a31\u5236\u5ea6\u306b\u304a\u3051\u308b\u4e8b\u696d\u6d3b\u52d5\u304a\u3088\u3073\u88fd\u54c1\u306e\u57fa\u6e96\u306b\u3064\u3044\u3066<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Anyone planning to distribute medical devices in Indonesia will quickly run into two acronyms: IDAK and CDAKB. They are often mentioned together, but they are not the same thing. One is a business license, the other is a quality management standard. Understanding the difference, and how they work together is the first step before diving into the technical details of each one. What Is IDAK? IDAK stands for Izin Distribusi Alat Kesehatan, or Medical Device Distribution License. It is the official permit a business entity must hold before it is legally allowed to procure, store, distribute, or supply medical devices in Indonesia, whether at wholesale or retail scale. IDAK is [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":7028,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7027","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","country-indonesia"],"acf":[],"_links":{"self":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7027","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=7027"}],"version-history":[{"count":2,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7027\/revisions"}],"predecessor-version":[{"id":7031,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7027\/revisions\/7031"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/7028"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=7027"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=7027"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=7027"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=7027"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}