{"id":6185,"date":"2026-05-18T08:44:00","date_gmt":"2026-05-18T01:44:00","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-07-15T21:25:17","modified_gmt":"2026-07-15T14:25:17","slug":"fast-track-medical-device-registration-process-in-indonesia","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/ja\/fast-track-medical-device-registration-process-in-indonesia\/","title":{"rendered":"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u73fe\u5730\u8a8d\u5b9a\u4ee3\u7406\u5e97\u3092\u901a\u3058\u305f\u533b\u7642\u6a5f\u5668\u306e\u8fc5\u901f\u767b\u9332\u624b\u7d9a\u304d\u306e\u7406\u89e3"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30d8\u30eb\u30b9\u30b1\u30a2\u5e02\u5834\u306b\u306f\u30d3\u30b8\u30cd\u30b9\u30c1\u30e3\u30f3\u30b9\u304c\u8c4a\u5bcc\u306b\u3042\u308b\u304c\u3001\u6226\u7565\u306a\u3057\u306b\u53c2\u5165\u3059\u308b\u5916\u56fd\u8f38\u51fa\u696d\u8005\u306b\u3068\u3063\u3066\u306f\u3001\u6642\u9593\u7684\u306a\u4f59\u88d5\u304c\u975e\u5e38\u306b\u9650\u3089\u308c\u3066\u3044\u308b\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306f\u533b\u7642\u6280\u8853\u3078\u306e\u9700\u8981\u304c\u6025\u5897\u3057\u3066\u3044\u308b\u3002\u56fd\u6c11\u5065\u5eb7\u4fdd\u967a\u5236\u5ea6\uff08JKN\uff09\u306f\u73fe\u5728\u3001\u4eba\u53e3\u306e\u7d04901,300\u4e07\u4eba\u3092\u30ab\u30d0\u30fc\u3057\u3066\u304a\u308a\u3001\u653f\u5e9c\u306e\u7121\u6599\u5065\u5eb7\u8a3a\u65ad\uff08CKG\uff09\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306f\u30012026\u5e74\u3060\u3051\u30671\u51043000\u4e07\u4eba\u306e\u53c2\u52a0\u8005\u3092\u76ee\u6a19\u3068\u3057\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6d77\u5916\u306e\u533b\u7642\u6a5f\u5668\u8f38\u51fa\u696d\u8005\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u306f\u660e\u78ba\u306a\u5e02\u5834\u30b7\u30b0\u30ca\u30eb\u3067\u3042\u308b\u3002\u8a3a\u65ad\u6a5f\u5668\u3001\u691c\u67fb\u6a5f\u5668\u3001\u624b\u8853\u5668\u5177\u3001\u60a3\u8005\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u653f\u5e9c\u652f\u63f4\u306b\u3088\u308b\u65fa\u76db\u306a\u9700\u8981\u304c\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3057\u304b\u3057\u3001\u898f\u5236\u4e0a\u306e\u9045\u5ef6\u304c\u767a\u751f\u3059\u308b\u3068\u3001\u3053\u306e\u597d\u6a5f\u306f\u3042\u3063\u3068\u3044\u3046\u9593\u306b\u5931\u308f\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002\u9069\u5207\u306a\u6e96\u5099\u304c\u306a\u3051\u308c\u3070\u3001\u4e2d\u30ea\u30b9\u30af\u304b\u3089\u9ad8\u30ea\u30b9\u30af\u306e\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u6a19\u6e96\u7684\u306aAKL\u767b\u9332\u306f\u30016\u30f6\u6708\u304b\u308918\u30f6\u6708\u3082\u304b\u304b\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fc5\u901f\u306b\u9032\u3081\u308b\u305f\u3081\u306b\u306f\u3001\u4fdd\u5065\u7701\uff08MoH\uff09\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332\u8fc5\u901f\u5316\u624b\u7d9a\u304d\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u3053\u306e\u4f53\u7cfb\u7684\u3067\u8fc5\u901f\u306a\u624b\u7d9a\u304d\u3092\u5229\u7528\u3059\u308c\u3070\u3001\u521d\u65e5\u304b\u3089\u9069\u5207\u306a\u73fe\u5730\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u4f53\u5236\u3092\u6d3b\u7528\u3059\u308c\u3070\u3001\u901a\u5e38\u306e\u624b\u7d9a\u304d\u671f\u9593\u3092\u6570\u30f6\u6708\u77ed\u7e2e\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u30ac\u30a4\u30c9\u3067\u306f\u3001\u5bfe\u8c61\u3068\u306a\u308b\u306e\u306f\u8ab0\u304b\u3001\u3069\u306e\u30c7\u30d0\u30a4\u30b9\u30ab\u30c6\u30b4\u30ea\u30fc\u304c\u512a\u5148\u3055\u308c\u308b\u306e\u304b\u3001\u305d\u3057\u3066\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u5236\u5ea6\u304c\u5b9f\u969b\u306b\u3069\u306e\u3088\u3046\u306b\u6a5f\u80fd\u3057\u3066\u5e02\u5834\u53c2\u5165\u3092\u52a0\u901f\u3055\u305b\u308b\u306e\u304b\u3092\u8a73\u3057\u304f\u89e3\u8aac\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u8fc5\u901f\u627f\u8a8d\u5236\u5ea6\u3068\u306f\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fc5\u901f\u5be9\u67fb\u5236\u5ea6\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\u304cRegalkes\u5236\u5ea6\u306e\u4e0b\u3067\u63d0\u4f9b\u3059\u308b\u3001\u533b\u7642\u6a5f\u5668\u306e\u5be9\u67fb\u3092\u8fc5\u901f\u5316\u3059\u308b\u4ed5\u7d44\u307f\u3067\u3042\u308b\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u5236\u5ea6\u306f\u666e\u904d\u7684\u306b\u5229\u7528\u3067\u304d\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u7dca\u6025\u306e\u516c\u8846\u885b\u751f\u4e0a\u306e\u30cb\u30fc\u30ba\u3001\u56fd\u5bb6\u4fdd\u5065\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u512a\u5148\u4e8b\u9805\u3001\u304a\u3088\u3073\u653f\u5e9c\u8abf\u9054\u76ee\u6a19\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u7279\u5b9a\u306e\u898f\u5236\u6761\u4ef6\u306e\u4e0b\u3067\u4ed8\u4e0e\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30da\u30e9\u30c8\u30a5\u30e9\u30f3 \u30e1\u30f3\u30c6\u30ea \u30b1\u30bb\u30cf\u30bf\u30f3 No. 62 \u30bf\u30d5\u30f3 2017 \u5e74\u4e0b (<a href=\"https:\/\/farmalkes.kemkes.go.id\/unduh\/permenkes-62-2017\/\" target=\"_blank\" rel=\"noopener\">\u4fdd\u5065\u5927\u81e3\u4ee4\u7b2c62\u53f7\uff082017\u5e74\uff09<\/a>\uff09\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u6cd5\u7684\u6839\u62e0\u304c\u78ba\u7acb\u3055\u308c\u308b\u3002\u3053\u306e\u67a0\u7d44\u307f\u306e\u4e2d\u3067\u3001\u4fdd\u5065\u7701\u306f\u3001\u91cd\u8981\u307e\u305f\u306f\u6226\u7565\u7684\u306b\u91cd\u8981\u3068\u307f\u306a\u3055\u308c\u308b\u6a5f\u5668\u306e\u5be9\u67fb\u671f\u9593\u3092\u77ed\u7e2e\u3059\u308b\u6a29\u9650\u3092\u6709\u3059\u308b\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u306e\u5f8c\u306e\u4fdd\u5065\u7701\u306e\u901a\u9054\u3084\u6280\u8853\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u5bfe\u8c61\u3068\u306a\u308b\u30ab\u30c6\u30b4\u30ea\u30fc\u3084\u6761\u4ef6\u304c\u3055\u3089\u306b\u660e\u78ba\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u901a\u5e38\u306e\u66f8\u985e\u5be9\u67fb\u30ad\u30e5\u30fc\u3092\u7d4c\u7531\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u63d0\u51fa\u3067\u306f\u3001\u3059\u3079\u3066\u306e\u6587\u66f8\u304c\u5b8c\u5168\u3067\u3001\u6b63\u3057\u304f\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3055\u308c\u3001\u63d0\u51fa\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001\u512a\u5148\u7684\u306b\u5be9\u67fb\u62c5\u5f53\u8005\u304c\u5272\u308a\u5f53\u3066\u3089\u308c\u3001\u8aac\u660e\u671f\u9593\u304c\u77ed\u7e2e\u3055\u308c\u307e\u3059\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/license-holder-service-in-indonesia\/\">\u8a8d\u5b9a\u3055\u308c\u305f\u5730\u5143\u306e\u514d\u8a31\u4fdd\u6301\u8005<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4fdd\u5065\u7701\u304b\u3089\u306e\u7279\u5225\u306a\u30a2\u30af\u30bb\u30b9\u8981\u4ef6<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4fdd\u5065\u7701\u306f\u81ea\u52d5\u7684\u306b\u512a\u5148\u5be9\u67fb\u3092\u8a8d\u3081\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u7533\u8acb\u304c\u627f\u8a8d\u3055\u308c\u308b\u306b\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u6761\u4ef6\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u3089\u306e\u8981\u4ef6\u306f\u3001\u767b\u9332\u5bfe\u8c61\u3068\u306a\u308b\u88fd\u54c1\u3068\u3001\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u4fdd\u6709\u3059\u308b\u73fe\u5730\u6cd5\u4eba\u53cc\u65b9\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. \u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6301\u8005\u306f\u5b8c\u5168\u306b\u6cd5\u4ee4\u3092\u9075\u5b88\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2024\u5e747\u67081\u65e5\u4ee5\u964d\u3001\u4fdd\u5065\u7701\u306f\u53b3\u683c\u306a\u898f\u5247\u3092\u65bd\u884c\u3057\u3066\u304a\u308a\u3001\u65b0\u898f\u533b\u7642\u6a5f\u5668\u767b\u9332\u3092\u7533\u8acb\u3059\u308b\u4f01\u696d\u306f\u6709\u52b9\u306aCDAKB\uff08Cara Distribusi Alat Kesehatan yang Baik\uff1a\u9069\u5207\u306a\u533b\u7642\u6a5f\u5668\u6d41\u901a\u65b9\u6cd5\uff09\u8a3c\u660e\u66f8\u3092\u4fdd\u6709\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u6709\u52b9\u306aCDAKB\u8a3c\u660e\u66f8\u3092\u6301\u305f\u306a\u3044\u4f01\u696d\u306f\u3001\u6a5f\u5668\u306e\u7dca\u6025\u6027\u3084\u5e02\u5834\u72b6\u6cc1\u306b\u95a2\u308f\u3089\u305a\u3001\u88fd\u54c1\u767b\u9332\u306e\u8cc7\u683c\u304c\u306a\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6d77\u5916\u306e\u8f38\u51fa\u696d\u8005\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u306f\u3001\u7533\u8acb\u524d\u306b\u9078\u5b9a\u3057\u305f\u73fe\u5730\u30d1\u30fc\u30c8\u30ca\u30fc\u304c\u65e2\u306b\u3053\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3092\u610f\u5473\u3059\u308b\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. \u521d\u56de\u63d0\u51fa\u6642\u306b\u5b8c\u5168\u306a\u66f8\u985e\u4e00\u5f0f\u3092\u63d0\u51fa\u3059\u308b<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u63d0\u51fa\u66f8\u985e\u304c\u4e0d\u5b8c\u5168\u306a\u5834\u5408\u3001\u8fc5\u901f\u5be9\u67fb\u306e\u6a29\u5229\u306f\u5931\u308f\u308c\u307e\u3059\u3002\u4fdd\u5065\u7701\u306f\u3001\u8907\u6570\u56de\u306e\u78ba\u8a8d\u304c\u5fc5\u8981\u306a\u66f8\u985e\u306b\u3064\u3044\u3066\u306f\u3001\u8fc5\u901f\u5be9\u67fb\u67a0\u3092\u78ba\u4fdd\u3057\u307e\u305b\u3093\u3002\u901a\u5e38\u3001\u5fc5\u8981\u306a\u66f8\u985e\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u9020\u5143\u304b\u3089\u306e\u627f\u8a8d\u66f8\uff08LoA\uff09<\/li>\n\n\n\n<li>\u539f\u7523\u56fd\u767a\u884c\u306e\u81ea\u7531\u8ca9\u58f2\u8a3c\u660e\u66f8\uff08CFS\uff09<\/li>\n\n\n\n<li>ISO 13485\u8a8d\u8a3c<\/li>\n\n\n\n<li>ASEAN\u5171\u901a\u63d0\u51fa\u66f8\u985e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08CSDT\uff09\u306b\u6e96\u62e0\u3057\u305f\u6280\u8853\u6587\u66f8<\/li>\n\n\n\n<li>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u306e\u30e9\u30d9\u30eb\u304a\u3088\u3073\u4f7f\u7528\u8aac\u660e\u66f8 (IFU)<\/li>\n\n\n\n<li>\u6a5f\u5668\u306e\u5206\u985e\u306b\u5fdc\u3058\u305f\u30ea\u30b9\u30af\u5206\u6790\u6587\u66f8<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3\uff0e\u6cd5\u7684\u8a3c\u660e\u6e08\u307f\u306e\u6dfb\u4ed8\u66f8\u985e<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">CFS\u3001GMP\u8a3c\u660e\u66f8\u3001LoA\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u5916\u56fd\u898f\u5236\u6587\u66f8\u306f\u3001Regalkes\u30dd\u30fc\u30bf\u30eb\u3067\u53d7\u7406\u3055\u308c\u308b\u524d\u306b\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5927\u4f7f\u9928\u306b\u3088\u308b\u516c\u8a3c\u304a\u3088\u3073\u8a8d\u8a3c\u3001\u307e\u305f\u306f\u30a2\u30dd\u30b9\u30c6\u30a3\u30fc\u30e6\u8a8d\u8a3c\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u624b\u7d9a\u304d\u3060\u3051\u3067\u3082\u3001\u958b\u59cb\u304c\u9045\u308c\u308b\u3068\u6570\u30f6\u6708\u304b\u304b\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. \u30c7\u30d0\u30a4\u30b9\u5206\u985e\u7cbe\u5ea6<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8aa4\u5206\u985e\u306f\u3001\u8fc5\u901f\u5be9\u67fb\u3067\u3042\u308d\u3046\u3068\u306a\u304b\u308d\u3046\u3068\u3001\u3042\u3089\u3086\u308b\u767b\u9332\u624b\u7d9a\u304d\u306b\u304a\u3051\u308b\u9045\u5ef6\u306e\u6700\u3082\u4e00\u822c\u7684\u306a\u539f\u56e0\u306e\u4e00\u3064\u3067\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306f\u3001ASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08AMDD\uff09\u306b\u6e96\u62e0\u3057\u305f\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u5206\u985e\u30b7\u30b9\u30c6\u30e0\u3092\u63a1\u7528\u3057\u3066\u304a\u308a\u3001\u533b\u7642\u6a5f\u5668\u3092\u30af\u30e9\u30b9A\uff08\u4f4e\u30ea\u30b9\u30af\uff09\u304b\u3089\u30af\u30e9\u30b9D\uff08\u9ad8\u30ea\u30b9\u30af\uff09\u307e\u3067\u5206\u985e\u3057\u3066\u3044\u307e\u3059\u3002\u8fc5\u901f\u5be9\u67fb\u306b\u3088\u308b\u533b\u7642\u6a5f\u5668\u30e9\u30a4\u30bb\u30f3\u30b9\u5be9\u67fb\u306f\u3001\u30af\u30e9\u30b9A\u304a\u3088\u3073\u30af\u30e9\u30b9B\u306e\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u306f\u6bd4\u8f03\u7684\u5bb9\u6613\u306b\u5229\u7528\u3067\u304d\u307e\u3059\u304c\u3001\u30af\u30e9\u30b9C\u304a\u3088\u3073\u30af\u30e9\u30b9D\u306e\u7533\u8acb\u306b\u306f\u3001\u3088\u308a\u5f37\u529b\u306a\u81e8\u5e8a\u7684\u304a\u3088\u3073\u6280\u8853\u7684\u8a3c\u62e0\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u512a\u5148\u30ab\u30c6\u30b4\u30ea\u30fc\uff1a\u3069\u306e\u533b\u7642\u6a5f\u5668\u304c\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u304b\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4fdd\u5065\u7701\u306f\u3001\u56fd\u306e\u4fdd\u5065\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u76ee\u6a19\u306b\u5408\u81f4\u3059\u308b\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u3001\u8fc5\u901f\u306a\u5bfe\u5fdc\u3092\u884c\u3046\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4fdd\u5065\u7701\u306e\u73fe\u5728\u306e\u512a\u5148\u4e8b\u9805\u3068\u8abf\u9054\u9700\u8981\u306b\u57fa\u3065\u304d\u3001\u8fc5\u901f\u5be9\u67fb\u306e\u5bfe\u8c61\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u6700\u3082\u9ad8\u3044\u30ab\u30c6\u30b4\u30ea\u30fc\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u8a3a\u65ad\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\uff08IVD\uff09<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5373\u6642\u691c\u67fb\u30ad\u30c3\u30c8\u3001\u8840\u6db2\u5206\u6790\u88c5\u7f6e\u3001\u75c5\u7406\u691c\u67fb\u6a5f\u5668\u306f\u3001CKG\u304a\u3088\u3073JKN\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u76f4\u63a5\u7684\u306b\u652f\u63f4\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u88fd\u54c1\u306f\u3001\u516c\u7acb\u75c5\u9662\u3084\u5730\u57df\u4fdd\u5065\u30bb\u30f3\u30bf\u30fc\uff08\u30d7\u30b9\u30b1\u30b9\u30de\u30b9\uff09\u304b\u3089\u7a4d\u6975\u7684\u306b\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u753b\u50cf\u6a5f\u5668<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u653f\u5e9c\u304c\u5fc3\u81d3\u75c5\u5b66\u3001\u816b\u760d\u5b66\u3001\u96c6\u4e2d\u6cbb\u7642\u306e\u30a4\u30f3\u30d5\u30e9\u3092\u62e1\u5145\u3059\u308b\u306b\u3042\u305f\u308a\u3001X\u7dda\u88c5\u7f6e\u3001\u8d85\u97f3\u6ce2\u8a3a\u65ad\u88c5\u7f6e\u3001CT\/MRI\u95a2\u9023\u6a5f\u5668\u304c\u512a\u5148\u7684\u306b\u5c0e\u5165\u3055\u308c\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u60a3\u8005\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u30b7\u30b9\u30c6\u30e0<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30b8\u30e3\u30ef\u5cf6\u4ee5\u5916\u306e\u5404\u5dde\u3067\u65b0\u305f\u306a\u516c\u7acb\u75c5\u9662\u304c\u958b\u8a2d\u3055\u308c\u308b\u306b\u3064\u308c\u3001\u30d0\u30a4\u30bf\u30eb\u30b5\u30a4\u30f3\u30e2\u30cb\u30bf\u30fc\u3001\u5fc3\u96fb\u56f3\u88c5\u7f6e\u3001\u96c6\u4e2d\u6cbb\u7642\u5ba4\uff08ICU\uff09\u76e3\u8996\u88c5\u7f6e\u306e\u9700\u8981\u306f\u7d99\u7d9a\u7684\u306b\u9ad8\u307e\u3063\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u611f\u67d3\u5236\u5fa1\u304a\u3088\u3073\u6ec5\u83cc\u88c5\u7f6e<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u5f8c\u306e\u533b\u7642\u6539\u9769\u306b\u304a\u3051\u308b\u512a\u5148\u4e8b\u9805\u3092\u8e0f\u307e\u3048\u3001\u885b\u751f\u3001\u6ec5\u83cc\u3001\u611f\u67d3\u4e88\u9632\u3092\u652f\u63f4\u3059\u308b\u6a5f\u5668\u306f\u3001\u4fdd\u5065\u7701\u306e\u898b\u76f4\u3057\u512a\u5148\u9806\u4f4d\u30ea\u30b9\u30c8\u306b\u304a\u3044\u3066\u5f15\u304d\u7d9a\u304d\u9ad8\u3044\u4f4d\u7f6e\u3092\u5360\u3081\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u5916\u79d1\u7528\u304a\u3088\u3073\u57cb\u3081\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\uff08\u30af\u30e9\u30b9C\/D\uff09<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u3089\u306f\u3088\u308a\u53b3\u683c\u306a\u66f8\u985e\u4f5c\u6210\u3092\u5fc5\u8981\u3068\u3059\u308b\u3082\u306e\u306e\u3001\u6226\u7565\u7684\u306b\u91cd\u8981\u3067\u3042\u308a\u3001\u7533\u8acb\u3059\u308b\u514d\u8a31\u4fdd\u6709\u8005\u304c\u4fdd\u5065\u7701\u3068\u306e\u9593\u3067\u5b9f\u7e3e\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u8fc5\u901f\u306a\u51e6\u7406\u306e\u6069\u6075\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u73fe\u5730\u8a8d\u5b9a\u4ee3\u7406\u5e97\u5236\u5ea6<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u521d\u3081\u3066\u9032\u51fa\u3059\u308b\u307b\u3068\u3093\u3069\u306e\u5916\u56fd\u8f38\u51fa\u696d\u8005\u304c\u3064\u307e\u305a\u304f\u90e8\u5206\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u6cd5\u5f8b\u306f\u660e\u78ba\u3067\u3059\u3002\u5916\u56fd\u306e\u88fd\u9020\u696d\u8005\u306f\u3001\u81ea\u793e\u540d\u7fa9\u3067\u533b\u7642\u6a5f\u5668\u3092\u767b\u9332\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u767b\u9332\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u6cd5\u4eba\u306b\u3088\u3063\u3066\u884c\u308f\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u6cd5\u4eba\u306f\u3001\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3057\u3066\u3001\u898f\u5236\u9075\u5b88\u3001\u5e02\u8ca9\u5f8c\u306e\u7fa9\u52d9\u3001\u304a\u3088\u3073\u4fdd\u5065\u7701\u3068\u306e\u9023\u7d61\u306b\u3064\u3044\u3066\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f93\u6765\u3001\u307b\u3068\u3093\u3069\u306e\u8f38\u51fa\u696d\u8005\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u8ca9\u58f2\u4ee3\u7406\u5e97\u3092\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u3068\u3057\u3066\u6307\u5b9a\u3059\u308b\u3053\u3068\u3067\u3053\u306e\u554f\u984c\u3092\u89e3\u6c7a\u3057\u3066\u304d\u305f\u3002\u3053\u306e\u65b9\u6cd5\u306f\u73fe\u5728\u3067\u3082\u4e00\u822c\u7684\u3060\u304c\u3001\u6df1\u523b\u306a\u5546\u696d\u4e0a\u306e\u8106\u5f31\u6027\u3092\u751f\u307f\u51fa\u3059\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8ca9\u58f2\u4ee3\u7406\u5e97\u3068\u306e\u95a2\u4fc2\u304c\u60aa\u5316\u3057\u305f\u5834\u5408\u3001\u307e\u305f\u306f\u88fd\u9020\u696d\u8005\u304c\u65b0\u305f\u306a\u8ca9\u58f2\u30c1\u30e3\u30cd\u30eb\u3078\u306e\u62e1\u5927\u3092\u5e0c\u671b\u3059\u308b\u5834\u5408\u3001\u767b\u9332\u6e08\u307f\u306e\u30e9\u30a4\u30bb\u30f3\u30b9\u306f\u8ca9\u58f2\u4ee3\u7406\u5e97\u306b\u5e30\u5c5e\u3057\u307e\u3059\u3002\u30e9\u30a4\u30bb\u30f3\u30b9\u6240\u6709\u8005\u3092\u5909\u66f4\u3059\u308b\u306b\u306f\u518d\u7533\u8acb\u304c\u5fc5\u8981\u3068\u306a\u308a\u3001AKL\u767b\u9332\u306e\u624b\u7d9a\u304d\u306f\u6700\u521d\u304b\u3089\u3084\u308a\u76f4\u3057\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u73fe\u5730\u8a8d\u5b9a\u4ee3\u7406\u4eba\u306f\u3069\u306e\u3088\u3046\u306b\u696d\u52d9\u3092\u884c\u3046\u306e\u3067\u3059\u304b\uff1f<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u72ec\u7acb\u3057\u305f\u73fe\u5730\u8a8d\u5b9a\u4ee3\u7406\u4eba\u307e\u305f\u306f\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6301\u8005\u3068\u3057\u3066\u3001\u5f53\u793e\u306fIDAK\u3092\u5b8c\u5168\u306b\u5099\u3048\u305f\u73fe\u5730\u767b\u9332\u4f01\u696d\u3067\u3059\uff08<em>\u30a4\u30b8\u30f3 \u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30b7 \u30a2\u30e9\u30c3\u30c8 \u30b1\u30bb\u30cf\u30bf\u30f3<\/em>\uff09\u304a\u3088\u3073CDAKB\u8a8d\u5b9a\u8cc7\u683c\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u306e\u88fd\u54c1\u306e\u516c\u5f0f\u767b\u9332\u6a5f\u95a2\u3068\u3057\u3066\u6a5f\u80fd\u3057\u307e\u3059\u304c\u3001\u8ca9\u58f2\u3001\u6d41\u901a\u3001\u307e\u305f\u306f\u5546\u696d\u4ea4\u6e09\u306b\u306f\u4e00\u5207\u95a2\u4e0e\u3057\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u5206\u96e2\u3053\u305d\u304c\u6700\u5927\u306e\u5229\u70b9\u3067\u3059\u3002\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u306f\u8907\u6570\u306e\u8ca9\u58f2\u4ee3\u7406\u5e97\u3092\u6307\u5b9a\u3057\u305f\u308a\u3001\u81ea\u7531\u306b\u4ea4\u6e09\u3057\u305f\u308a\u3001\u5f8c\u3005\u81ea\u793e\u306e\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u6cd5\u4eba\u306b\u79fb\u884c\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u3057\u304b\u3082\u88fd\u54c1\u306e\u767b\u9332\u72b6\u6cc1\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f53\u793e\u306f\u4ee5\u4e0b\u306e\u3082\u306e\u3092\u7ba1\u7406\u3057\u3066\u3044\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u66f8\u985e\u4f5c\u6210\u304a\u3088\u3073Regalkes\u3078\u306e\u63d0\u51fa<\/li>\n\n\n\n<li>\u653f\u5e9c\u624b\u6570\u6599\uff08PNBP\uff09\u306e\u652f\u6255\u3044\u3068\u8ffd\u8de1<\/li>\n\n\n\n<li>\u4fdd\u5065\u7701\u306e\u91c8\u660e\u56de\u7b54\u304a\u3088\u3073\u5be9\u67fb\u54e1\u3068\u306e\u9023\u7d61<\/li>\n\n\n\n<li>\u5e02\u8ca9\u5f8c\u76e3\u8996\u5831\u544a<\/li>\n\n\n\n<li>\u514d\u8a31\u66f4\u65b0\uff085\u5e74\u3054\u3068\uff09<\/li>\n\n\n\n<li>\u30e9\u30a4\u30bb\u30f3\u30b9\u306f\u6e96\u5099\u304c\u6574\u3044\u6b21\u7b2c\u3001\u88fd\u9020\u696d\u8005\u81ea\u8eab\u306e\u6cd5\u4eba\u3078\u8b72\u6e21\u3055\u308c\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u5236\u5ea6\u3092\u652f\u3048\u308b\u898f\u5236\u67a0\u7d44\u307f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6cd5\u7684\u6839\u62e0\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3001\u8f38\u51fa\u696d\u8005\u306f\u81ea\u4fe1\u3092\u6301\u3063\u3066\u6e96\u5099\u3092\u9032\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u30da\u30e9\u30c8\u30a5\u30e9\u30f3 \u30e1\u30f3\u30c6\u30ea \u30b1\u30bb\u30cf\u30bf\u30f3 2017 \u5e74\u7b2c 62 \u53f7<\/strong> \u3053\u308c\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u4e3b\u8981\u306a\u6cd5\u7684\u6839\u62e0\u3067\u3042\u308a\u7d9a\u3051\u3066\u3044\u308b\u3002\u3053\u306e\u6cd5\u5f8b\u306f\u3001NIE\uff08Nomor Izin Edar\uff1a\u533b\u7642\u6a5f\u5668\u767b\u9332\u756a\u53f7\uff09\u3092\u3001\u3042\u3089\u3086\u308b\u6a5f\u5668\u306e\u8f38\u5165\u3001\u8ca9\u58f2\u3001\u307e\u305f\u306f\u6d41\u901a\u524d\u306b\u5fc5\u9808\u3068\u306a\u308b\u627f\u8a8d\u3068\u3057\u3066\u5b9a\u3081\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2021\u5e74\u5927\u7d71\u9818\u4ee4\u7b2c10\u53f7<\/strong> \u3053\u308c\u306b\u3088\u308a\u3001\u5916\u56fd\u4eba\u6295\u8cc7\u5bb6\u304c\u533b\u7642\u6a5f\u5668\u306e\u8f38\u5165\u30fb\u767b\u9332\u3092\u884c\u3046\u4f01\u696d\u306e\u904e\u534a\u6570\u307e\u305f\u306f\u5168\u682a\u5f0f\u3092\u4fdd\u6709\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u3063\u305f\u3002\u3053\u306e\u305f\u3081\u3001PT PMA\uff08\u5916\u56fd\u8cc7\u672c\u306e\u73fe\u5730\u6cd5\u4eba\uff09\u306f\u3001\u8a2d\u7acb\u6bb5\u968e\u306b\u304a\u3044\u3066\u72ec\u7acb\u3057\u305f\u73fe\u5730\u516c\u8a8d\u4ee3\u7406\u5e97\u304c\u6a4b\u6e21\u3057\u5f79\u3092\u679c\u305f\u3059\u3053\u3068\u3067\u3001\u3088\u308a\u5b9f\u73fe\u53ef\u80fd\u306a\u9577\u671f\u7684\u306a\u5e02\u5834\u53c2\u5165\u30eb\u30fc\u30c8\u3068\u306a\u3063\u305f\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>ASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08AMDD\uff09<\/strong> \u6574\u5408\u3068\u306f\u3001CE\u30de\u30fc\u30af\u307e\u305f\u306fFDA\u306e\u627f\u8a8d\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u88fd\u9020\u696d\u8005\u306f\u3001\u65e2\u306b\u6587\u66f8\u5316\u306e\u57fa\u76e4\u3092\u6301\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u304c\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306e\u5b8c\u5168\u306a\u767b\u9332\u306f\u4f9d\u7136\u3068\u3057\u3066\u5fc5\u8981\u3067\u3059\u3002CE\u30de\u30fc\u30af\u307e\u305f\u306fFDA\u306e\u627f\u8a8d\u3060\u3051\u3067\u306f\u3001\u5e02\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u306f\u4fdd\u8a3c\u3055\u308c\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>CDAKB\u306e\u57f7\u884c\u72b6\u6cc1\uff082024\u5e74\u66f4\u65b0\uff09\uff1a<\/strong> 2024\u5e74\u534a\u3070\u4ee5\u964d\u3001\u4fdd\u5065\u7701\u306f\u65b0\u898f\u767b\u9332\u3059\u3079\u3066\u306b\u5bfe\u3057\u3001CDAKB\uff08\u533b\u85ac\u54c1\u30fb\u5316\u7ca7\u54c1\u30fb\u5316\u7ca7\u54c1\u898f\u5236\u5f53\u5c40\uff09\u306b\u3088\u308b\u53b3\u683c\u306a\u4e8b\u524d\u8a8d\u8a3c\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u308b\u3002\u6700\u8fd1\u306e\u53b3\u683c\u306a\u57f7\u884c\u306b\u3088\u308a\u3001\u76e3\u67fb\u3092\u53d7\u3051\u3066\u3044\u306a\u3044\u56fd\u5185\u8ca9\u58f2\u696d\u8005\u3092\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u3068\u3057\u3066\u5229\u7528\u3059\u308b\u3053\u3068\u306f\u4e0d\u53ef\u80fd\u3068\u306a\u308a\u3001\u5c02\u9580\u306e\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u4f01\u696d\u306e\u91cd\u8981\u6027\u304c\u9ad8\u307e\u3063\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>AKL\u767b\u9332\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306e\u73fe\u5b9f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u591a\u304f\u306e\u6d77\u5916\u8f38\u51fa\u696d\u8005\u306f\u3001\u898f\u5236\u624b\u7d9a\u304d\u3092\u3069\u308c\u307b\u3069\u65e9\u304f\u958b\u59cb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u3092\u904e\u5c0f\u8a55\u4fa1\u3057\u3066\u3044\u307e\u3059\u3002AKL\u767b\u9332\u306e\u624b\u7d9a\u304d\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u8ca9\u58f2\u6e96\u5099\u304c\u6574\u3063\u305f\u6642\u70b9\u304b\u3089\u59cb\u307e\u308b\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3078\u306e\u9032\u51fa\u3092\u6c7a\u5b9a\u3057\u305f\u77ac\u9593\u3001\u3042\u308b\u3044\u306f\u305d\u308c\u4ee5\u524d\u304b\u3089\u59cb\u307e\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7406\u7531\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5927\u4f7f\u9928\u3067\u306e\u8a8d\u8a3c\u3068\u66f8\u985e\u306e\u30a2\u30dd\u30b9\u30c6\u30a3\u30fc\u30e6\u8a8d\u8a3c\u306b\u306f\u3001\u767a\u884c\u56fd\u306b\u3088\u3063\u30662\uff5e6\u30f6\u6708\u304b\u304b\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li>ISO 13485\u8a8d\u8a3c\u306e\u691c\u8a3c\u306b\u306f\u3001\u8a8d\u8a3c\u306e\u305f\u3081\u306b\u8ffd\u52a0\u306e\u6642\u9593\u304c\u5fc5\u8981\u3067\u3059\u3002<\/li>\n\n\n\n<li>LoA\u306e\u6709\u52b9\u671f\u9593\u306f\u3001NIE\u767b\u9332\u306e\u6709\u52b9\u671f\u9593\u3068\u4e00\u81f4\u3055\u305b\u308b\u305f\u3081\u30015\u5e74\u9593\u5168\u4f53\u3092\u30ab\u30d0\u30fc\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u30af\u30e9\u30b9C\u304a\u3088\u3073D\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001\u73fe\u5730\u3067\u306e\u81e8\u5e8a\u7684\u8a3c\u62e0\u307e\u305f\u306f\u691c\u67fb\u5ba4\u3067\u306e\u8a66\u9a13\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u30013\uff5e6\u304b\u6708\u8ffd\u52a0\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u653f\u5e9c\u8abf\u9054\u3084LKPP\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u3092\u30bf\u30fc\u30b2\u30c3\u30c8\u3068\u3059\u308b\u8f38\u51fa\u696d\u8005\u306b\u3068\u3063\u3066\u3001NIE\uff08\u56fd\u5bb6\u8f38\u5165\u8005\u756a\u53f7\uff09\u306e\u767b\u9332\u306f\u5fc5\u9808\u6761\u4ef6\u3067\u3059\u3002\u3053\u308c\u3092\u56de\u907f\u3059\u308b\u8fd1\u9053\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u552f\u4e00\u771f\u306b\u8fc5\u901f\u306a\u5bfe\u5fdc\u7b56\u306f\u3001\u65e9\u671f\u306b\u6e96\u5099\u3092\u958b\u59cb\u3057\u3001\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u304c\u6e96\u5099\u4e07\u7aef\u3067\u3001\u8a8d\u8a3c\u3092\u53d7\u3051\u3001\u7d4c\u9a13\u8c4a\u5bcc\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-product-registration-indonesia wp-block-embed-product-registration-indonesia\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"wZbjztJhXa\"><a href=\"https:\/\/productregistrationindonesia.com\/ja\/the-process-of-registering-medical-devices-in-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u30d7\u30ed\u30bb\u30b9<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u300c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u30d7\u30ed\u30bb\u30b9\u300d\u2014\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u88fd\u54c1\u767b\u9332\" src=\"https:\/\/productregistrationindonesia.com\/the-process-of-registering-medical-devices-in-indonesia\/embed\/#?secret=P4BhycHHv9#?secret=wZbjztJhXa\" data-secret=\"wZbjztJhXa\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u88fd\u54c1\u767b\u9332\u6a5f\u95a2\u306f\u3001\u8fc5\u901f\u306a\u7533\u8acb\u624b\u7d9a\u304d\u3092\u3069\u306e\u3088\u3046\u306b\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u88fd\u54c1\u767b\u9332\u6a5f\u95a2\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u306b\u5bfe\u3057\u3001\u72ec\u7acb\u3057\u305f\u4e2d\u7acb\u7684\u306a\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u3068\u3057\u3066\u306e\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f53\u793e\u306fIDAK\u304a\u3088\u3073CDAKB\u306e\u6709\u52b9\u306a\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u8cc7\u683c\u306e\u306a\u3044\u5730\u5143\u306e\u8ca9\u58f2\u4ee3\u7406\u5e97\u304c\u76f4\u9762\u3059\u308b\u5f85\u6a5f\u671f\u9593\u306a\u3057\u306b\u3001\u76f4\u3061\u306b\u65b0\u898f\u767b\u9332\u3092\u63d0\u51fa\u3059\u308b\u6a29\u9650\u3092\u5b8c\u5168\u306b\u6709\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f53\u793e\u306e\u898f\u5236\u30c1\u30fc\u30e0\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u306e\u3042\u3089\u3086\u308b\u6bb5\u968e\u306b\u5bfe\u5fdc\u3057\u3066\u304a\u308a\u3001\u521d\u671f\u88fd\u54c1\u5206\u985e\u3084\u7533\u8acb\u66f8\u985e\u306e\u30ae\u30e3\u30c3\u30d7\u5206\u6790\u304b\u3089\u3001Regalkes\u3078\u306e\u63d0\u51fa\u3001\u4fdd\u5065\u7701\u3078\u306e\u8aac\u660e\u8cac\u4efb\u7ba1\u7406\u3001NIE\u306e\u767a\u884c\u307e\u3067\u3092\u62c5\u3063\u3066\u3044\u307e\u3059\u3002.&nbsp;<\/p>\n\n\n\n<p 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href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u30d7\u30ed\u30bb\u30b9<\/a> \u958b\u59cb\u306e\u9045\u308c\u3001\u66f8\u985e\u306e\u4e0d\u5099\u3001\u4e0d\u9069\u5207\u306a\u73fe\u5730\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u306e\u63d0\u643a\u306f\u5bb9\u8d66\u3057\u306a\u3044\u3002\u8fc5\u901f\u627f\u8a8d\u5236\u5ea6\u306f\u5b58\u5728\u3059\u308b\u3002\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u5236\u5ea6\u306f\u6a5f\u80fd\u3059\u308b\u3002.&nbsp;<\/p>\n\n\n\n<p 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class=\"wp-block-paragraph\">\u81ea\u4fe1\u3092\u6301\u3063\u3066\u3001\u660e\u78ba\u306b\u3001\u305d\u3057\u3066\u8fc5\u901f\u306b\u4e8b\u696d\u3092\u9032\u3081\u305f\u3044\u6d77\u5916\u8f38\u51fa\u4f01\u696d\u306e\u305f\u3081\u306b\u3001\u5f53\u793e\u306f\u5275\u696d\u521d\u65e5\u304b\u3089\u3001\u304a\u5ba2\u69d8\u306e\u30c7\u30d0\u30a4\u30b9\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306b\u6700\u9069\u306a\u9053\u7b4b\u3092\u63cf\u304f\u304a\u624b\u4f1d\u3044\u3092\u3059\u308b\u6e96\u5099\u304c\u3067\u304d\u3066\u3044\u307e\u3059\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>There is no shortage of opportunity in Indonesia\u2019s healthcare market, but there is a very real shortage of time for foreign exporters entering without a strategy.&nbsp; Indonesia\u2019s demand for medical technology is surging. The national health insurance program (JKN) now covers approximately 90% of the population, and the government\u2019s Cek Kesehatan Gratis (CKG) health screening initiative targets a massive 130 million participants in 2026 alone. For foreign medical device exporters, this is a clear market signal. Diagnostic equipment, laboratory devices, surgical tools, and patient monitoring systems are in active, government-backed demand. However, this window of opportunity closes quickly if regulatory delays occur. Without proper preparation, a standard AKL registration for [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":6186,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-6185","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-articles"],"acf":[],"_links":{"self":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/6185","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\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=6185"}],"version-history":[{"count":4,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/6185\/revisions"}],"predecessor-version":[{"id":6485,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/6185\/revisions\/6485"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/6186"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=6185"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=6185"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=6185"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=6185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}