{"id":2331,"date":"2025-09-08T13:39:10","date_gmt":"2025-09-08T06:39:10","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=2331"},"modified":"2025-09-02T14:10:43","modified_gmt":"2025-09-02T07:10:43","slug":"indonesia-medical-device-product-registration-explained","status":"publish","type":"post","link":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/indonesia-medical-device-product-registration-explained\/","title":{"rendered":"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u767b\u9332\u306b\u3064\u3044\u3066"},"content":{"rendered":"<p>\u591a\u304f\u306e\u56fd\u969b\u7684\u306a\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306fEU\u3001\u7c73\u56fd\u3001\u307e\u305f\u306f\u4e2d\u56fd\u3067\u306e\u627f\u8a8d\u53d6\u5f97\u5f8c\u3001\u6b21\u306a\u308b\u8ad6\u7406\u7684\u306a\u5e02\u5834\u62e1\u5927\u5148\u3068\u3057\u3066\u3057\u3070\u3057\u3070\u6319\u3052\u3089\u308c\u307e\u3059\u3002\u4e00\u898b\u3059\u308b\u3068\u3001\u305d\u306e\u30d3\u30b8\u30cd\u30b9\u30c1\u30e3\u30f3\u30b9\u306f\u660e\u767d\u306b\u898b\u3048\u307e\u3059\u3002\u8fd1\u4ee3\u7684\u306a\u533b\u7642\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3078\u306e\u9700\u8981\u306e\u9ad8\u307e\u308a\u3001\u5927\u898f\u6a21\u306a\u75c5\u9662\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3001\u305d\u3057\u3066\u533b\u7642\u6280\u8853\u3078\u306e\u653f\u5e9c\u652f\u51fa\u306e\u5897\u52a0\u3067\u3059\u3002&nbsp;<\/p>\n\n\n\n<p>\u3057\u304b\u3057\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306e\u767b\u9332\u306b\u306f\u4fdd\u5065\u7701\u306e\u72ec\u7279\u306a\u624b\u7d9a\u304d\u304c\u4f34\u3044\u3001\u65b0\u898f\u53c2\u5165\u8005\u3092\u9a5a\u304b\u305b\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4f01\u696d\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3078\u306e\u9032\u51fa\u3092\u691c\u8a0e\u3057\u59cb\u3081\u308b\u3068\u3001\u898f\u5236\u8981\u4ef6\u304c\u5e02\u5834\u53c2\u5165\u306e\u6700\u5927\u306e\u969c\u58c1\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u306b\u3059\u3050\u306b\u6c17\u4ed8\u304f\u3002 <a href=\"https:\/\/europa.eu\/youreurope\/business\/product-requirements\/labels-markings\/ce-marking\/index_en.htm\" target=\"_blank\" rel=\"noopener\">\u6b27\u5dde\u306eCE\u30de\u30fc\u30af<\/a> \u307e\u305f\u306f <a href=\"https:\/\/www.fda.gov\/medical-devices\" target=\"_blank\" rel=\"noopener\">\u7c73\u56fdFDA<\/a> \u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306f\u88fd\u9020\u696d\u8005\u304c\u4fdd\u5065\u7701\uff08MoH\uff09\u3067\u306e\u73fe\u5730\u767b\u9332\u624b\u7d9a\u304d\u3092\u7d4c\u308b\u3053\u3068\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3064\u307e\u308a\u3001\u5916\u56fd\u4f01\u696d\u306f\u7533\u8acb\u66f8\u985e\u3092\u518d\u69cb\u7bc9\u3057\u3001\u66f8\u985e\u3092\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u306b\u7ffb\u8a33\u3057\u3001\u73fe\u5730\u4ee3\u7406\u4eba\u3092\u4efb\u547d\u3057\u3001\u6d41\u901a\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u8981\u4ef6\u3092\u9075\u5b88\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u591a\u304f\u306e\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u3053\u3046\u3057\u305f\u8907\u96d1\u3055\u306f\u9045\u5ef6\u3001\u8ffd\u52a0\u30b3\u30b9\u30c8\u3001\u305d\u3057\u3066\u73fe\u5730\u306e\u5b98\u50da\u4e3b\u7fa9\u3078\u306e\u4e0d\u6e80\u306b\u3064\u306a\u304c\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u767b\u9332\u3092\u7406\u89e3\u3059\u308b\u3068\u3044\u3046\u3053\u3068\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3060\u3051\u306e\u554f\u984c\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/medical-device-registration-in-indonesia-nie-risk-classes-regulatory-strategy\/#elementor-toc__heading-anchor-6\">\u3088\u308a\u30b9\u30e0\u30fc\u30ba\u306a\u5e02\u5834\u53c2\u5165\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3060<\/a>\u88fd\u54c1\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u7ba1\u7406\u3092\u7dad\u6301\u3057\u3001\u6771\u5357\u30a2\u30b8\u30a2\u6700\u5927\u306e\u7d4c\u6e08\u570f\u3067\u9577\u671f\u7684\u306a\u6210\u529f\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u88fd\u54c1\u767b\u9332\u306e\u6226\u7565\u7684\u5f79\u5272<\/strong><\/h2>\n\n\n\n<p>\u3069\u306e\u533b\u7642\u6a5f\u5668\u4f1a\u793e\u306b\u3068\u3063\u3066\u3082\u3001\u88fd\u54c1\u767b\u9332\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30d8\u30eb\u30b9\u30b1\u30a2\u5e02\u5834\u3078\u306e\u5165\u308a\u53e3\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4fdd\u5065\u7701\u304c\u767a\u884c\u3059\u308b\u516c\u5f0f\u306e Nomor Izin Edar (NIE) \u304c\u306a\u3051\u308c\u3070\u3001\u533b\u7642\u6a5f\u5668\u3092\u5408\u6cd5\u7684\u306b\u8f38\u5165\u3001\u6d41\u901a\u3001\u8ca9\u58f2\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002<\/li>\n\n\n\n<li>\u88fd\u54c1\u767b\u9332\u306b\u3088\u308a\u3001\u653f\u5e9c\u306e\u5165\u672d\u306b\u4e0d\u53ef\u6b20\u3067\u3042\u308a\u3001\u75c5\u9662\u306e\u8abf\u9054\u306b\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u56fd\u5bb6\u8abf\u9054\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3042\u308b LKPP \u306e e-Katalog \u306b\u4f01\u696d\u304c\u53c2\u52a0\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3082\u6c7a\u307e\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u30d3\u30b8\u30cd\u30b9\u306e\u89b3\u70b9\u304b\u3089\u898b\u308b\u3068\u3001\u5f37\u529b\u306a\u767b\u9332\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u4fdd\u8a3c\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u5730\u5143\u306e\u8ca9\u58f2\u696d\u8005\u3084\u533b\u7642\u63d0\u4f9b\u8005\u9593\u306e\u4fe1\u983c\u3082\u9ad8\u3081\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u3064\u307e\u308a\u3001\u88fd\u54c1\u767b\u9332\u3092\u6210\u529f\u3055\u305b\u308b\u306b\u306f\u3001\u6cd5\u5f8b\u3092\u9075\u5b88\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u771f\u306e\u30d3\u30b8\u30cd\u30b9\u30c1\u30e3\u30f3\u30b9\u3092\u958b\u62d3\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>ASEAN\u306e\u8abf\u548c\u3068\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u9069\u5fdc<\/strong><\/h2>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306f\u3001\u6771\u5357\u30a2\u30b8\u30a2\u5168\u57df\u306e\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u8abf\u548c\u3092\u76ee\u6307\u3059ASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08AMDD\uff09\u306e\u52a0\u76df\u56fd\u3067\u3059\u3002\u7406\u8ad6\u7684\u306b\u306f\u3001\u3053\u306e\u9023\u643a\u306b\u3088\u308a\u3001CE\u30de\u30fc\u30af\u307e\u305f\u306fFDA\u306e\u627f\u8a8d\u3092\u53d6\u5f97\u3057\u305f\u30e1\u30fc\u30ab\u30fc\u304c\u3053\u306e\u5730\u57df\u306b\u9032\u51fa\u3057\u3084\u3059\u304f\u306a\u308b\u306f\u305a\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u3057\u304b\u3057\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306f\u3053\u308c\u3089\u306e\u56fd\u969b\u57fa\u6e96\u3092\u72ec\u81ea\u306b\u8abf\u6574\u3057\u305f\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u9069\u7528\u3057\u3066\u3044\u307e\u3059\u3002CE\u30de\u30fc\u30af\u3084FDA\u306e\u627f\u8a8d\u306e\u6709\u7121\u306b\u304b\u304b\u308f\u3089\u305a\u3001\u5404\u6a5f\u5668\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u72ec\u81ea\u306e\u30ea\u30b9\u30af\u5206\u985e\u3068\u4fdd\u5065\u7701\u306e\u5be9\u67fb\u3092\u53d7\u3051\u3001\u73fe\u5730\u57fa\u6e96\u3078\u306e\u9069\u5408\u3092\u78ba\u4fdd\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30ed\u30fc\u30ab\u30ea\u30bc\u30fc\u30b7\u30e7\u30f3\u8981\u4ef6:<\/strong> \u4f7f\u7528\u8aac\u660e\u66f8 (IFU) \u3092\u542b\u3080\u3059\u3079\u3066\u306e\u6587\u66f8\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u306b\u7ffb\u8a33\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u5408\u6cd5\u5316:<\/strong> \u81ea\u7531\u8ca9\u58f2\u8a3c\u660e\u66f8 (CFS) \u3084\u9069\u6b63\u88fd\u9020\u898f\u7bc4 (GMP) \u306a\u3069\u306e\u8a3c\u660e\u66f8\u306f\u3001\u5408\u6cd5\u5316\u307e\u305f\u306f\u30a2\u30dd\u30b9\u30c6\u30a3\u30fc\u30e6\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u72ec\u81ea\u306e\u66f8\u985e\u5f62\u5f0f:<\/strong> \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u898f\u5236\u306b\u5f93\u3063\u3066\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3092\u518d\u7de8\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002 <a href=\"https:\/\/regalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\">\u30ec\u30ac\u30eb\u30b1\u30b9\u30b7\u30b9\u30c6\u30e0<\/a> \u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306f\u3001EU MDR \u307e\u305f\u306f FDA \u306e\u69cb\u9020\u3068\u7570\u306a\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u610f\u5473\u3059\u308b\u3068\u3053\u308d\u306f\u660e\u3089\u304b\u3067\u3059\u3002\u5916\u56fd\u3067\u306e\u627f\u8a8d\u306f\u3001\u5fc5\u305a\u3057\u3082\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306e\u53d7\u3051\u5165\u308c\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5404\u88fd\u54c1\u306f\u3001\u4fdd\u5065\u7701\u306e\u57fa\u6e96\u306b\u9069\u5408\u3059\u308b\u305f\u3081\u306b\u3001\u73fe\u5730\u3067\u306e\u8a55\u4fa1\u3068\u9069\u5fdc\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u88fd\u54c1\u767b\u9332\u306e\u5fc5\u9808\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8<\/strong><\/h2>\n\n\n\n<p>\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306f\u3001\u6280\u8853\u7684\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306b\u7126\u70b9\u3092\u5f53\u3066\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u5404\u767b\u9332\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u30d3\u30b8\u30cd\u30b9\u4e0a\u306e\u91cd\u8981\u6027\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u3088\u308a\u6709\u7528\u3067\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u6210\u5206<\/strong><\/td><td><strong>\u76ee\u7684<\/strong><\/td><td><strong>\u30d3\u30b8\u30cd\u30b9\u3078\u306e\u5f71\u97ff<\/strong><\/td><\/tr><tr><td><strong>\u30c7\u30d0\u30a4\u30b9\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\uff08DMF\uff09<\/strong><\/td><td>\u88fd\u54c1\u306e\u8a2d\u8a08\u3001\u5b89\u5168\u6027\u3001\u6027\u80fd\u306b\u95a2\u3059\u308b\u8a73\u7d30\u306a\u6280\u8853\u6587\u66f8<\/td><td>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u54c1\u8cea\u3092\u5b9f\u8a3c\u3057\u3001\u898f\u5236\u5f53\u5c40\u3068\u8ca9\u58f2\u696d\u8005\u306e\u4fe1\u983c\u3092\u9ad8\u3081\u308b<\/td><\/tr><tr><td><strong>\u5730\u57df\u4ee3\u8868<\/strong><\/td><td>\u4fdd\u5065\u7701\u306b\u767b\u9332\u3055\u308c\u305f\u73fe\u5730\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u307e\u305f\u306f\u8ca9\u58f2\u4ee3\u7406\u5e97\u306e\u4efb\u547d<\/td><td>\u5408\u6cd5\u7684\u306a\u5e02\u5834\u53c2\u5165\u306b\u306f\u5fc5\u9808\u3002\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u9078\u629e\u306f\u9577\u671f\u7684\u306a\u67d4\u8edf\u6027\u306b\u5f71\u97ff\u3057\u307e\u3059\u3002\u73fe\u5730\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u306f\u3001\u6709\u52b9\u306a\u8ca9\u58f2\u30e9\u30a4\u30bb\u30f3\u30b9\uff08IDAK\uff09\u3092\u6301\u3064\u4fdd\u5065\u7701\u767b\u9332\u8ca9\u58f2\u696d\u8005\u3067\u3042\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/td><\/tr><tr><td><strong>\u6cd5\u7684\u6587\u66f8\uff08LoA\u3001CFS\u3001GMP\uff09<\/strong><\/td><td>\u8a8d\u53ef\u3068\u88fd\u54c1\u306e\u5b89\u5168\u6027\u306e\u8a3c\u660e<\/td><td>\u8a8d\u8a3c\u306e\u9045\u308c\u306f\u3001\u30ea\u30ea\u30fc\u30b9\u306e\u9045\u308c\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002\u7279\u306b\u4e2d\u56fd\u3084\u7c73\u56fd\u306e\u4f01\u696d\u306b\u5f53\u3066\u306f\u307e\u308a\u307e\u3059\u3002\uff08\u30d2\u30f3\u30c8\uff1a\u7c73\u56fd\u3084\u4e2d\u56fd\u306a\u3069\u306e\u56fd\u3067\u306f\u3001\u5927\u4f7f\u9928\u3084\u30a2\u30dd\u30b9\u30c6\u30a3\u30fc\u30e6\u306e\u624b\u7d9a\u304d\u306b\u6570\u9031\u9593\u304b\u304b\u308b\u3053\u3068\u304c\u3042\u308b\u305f\u3081\u3001\u65e9\u3081\u306b\u66f8\u985e\u306e\u8a8d\u8a3c\u624b\u7d9a\u304d\u3092\u958b\u59cb\u3057\u3066\u304f\u3060\u3055\u3044\u3002\uff09<\/td><\/tr><tr><td><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u3067\u306e\u30e9\u30d9\u30eb\u8868\u793a<\/strong><\/td><td>\u4f7f\u3044\u3084\u3059\u3055\u3068\u60a3\u8005\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd<\/td><td>\u75c5\u9662\u3084\u30e6\u30fc\u30b6\u30fc\u3068\u306e\u4fe1\u983c\u95a2\u4fc2\u3092\u69cb\u7bc9\u3057\u307e\u3059\u3002\u975e\u6e96\u62e0\u306e\u30e9\u30d9\u30eb\u306f\u62d2\u5426\u307e\u305f\u306f\u30ea\u30b3\u30fc\u30eb\u306e\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002<\/td><\/tr><tr><td><strong>CDAKB\u8a8d\u5b9a\uff08\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\uff09<\/strong><\/td><td>\u533b\u7642\u6a5f\u5668\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96<\/td><td>\u6d41\u901a\u696d\u8005\u306e\u4fe1\u983c\u6027\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u3082\u306e\u3067\u3001\u7269\u6d41\u304a\u3088\u3073\u4fdd\u7ba1\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u9075\u5b88\u306b\u5fc5\u9808\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96\uff08GDP\uff09\u306f\u3001\u6d41\u901a\u696d\u8005\u306e\u4fe1\u983c\u6027\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u3082\u306e\u3067\u30012024\u5e747\u6708\u73fe\u5728\u3001 <a href=\"https:\/\/regalkes.kemkes.go.id\/index.php\/home\/fileDownload\/BERITA_FILE.pdf\/1000943\" target=\"_blank\" rel=\"noopener\">\u4fdd\u5065\u7701\u306f\u3001\u3059\u3079\u3066\u306e\u8ca9\u58f2\u696d\u8005\u306bCDAKB\u8a3c\u660e\u66f8\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u308b\u3002<\/a> \u88fd\u54c1\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u767a\u884c\u3059\u308b\u524d\u306b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u8981\u4ef6\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u8f38\u5165\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306f\u3001\u56fd\u969b\u7684\u306a\u54c1\u8cea\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3064\u3064\u3001\u73fe\u5730\u306e\u30cb\u30fc\u30ba\u306b\u3082\u9069\u5fdc\u3057\u305f\u3082\u306e\u3068\u306a\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u3089\u306e\u8981\u4ef6\u3092\u52b9\u679c\u7684\u306b\u7ba1\u7406\u3059\u308b\u3053\u3068\u304c\u3001\u5e02\u5834\u53c2\u5165\u3092\u52a0\u901f\u3055\u305b\u308b\u9375\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u88fd\u54c1\u767b\u9332\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. \u65e9\u3081\u306b\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u4f5c\u6210\u3092\u59cb\u3081\u308b<\/strong><\/h3>\n\n\n\n<p>\u5927\u4f7f\u9928\u3067\u306e\u8a8d\u8a3c\u3068LoA\u3001CFS\u3001GMP\u306a\u3069\u306e\u6587\u66f8\u306e\u7ffb\u8a33\u306b\u306f\u6570\u30f6\u6708\u304b\u304b\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u6bb5\u968e\u3067\u306e\u9045\u5ef6\u304c\u3001\u627f\u8a8d\u304c\u9045\u308c\u308b\u6700\u3082\u4e00\u822c\u7684\u306a\u539f\u56e0\u3067\u3059\u3002\u65e9\u3081\u306b\u6e96\u5099\u3059\u308b\u3053\u3068\u3067\u3001Regalkes\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u63d0\u51fa\u304c\u30b9\u30e0\u30fc\u30ba\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. \u6226\u7565\u7684\u306b\u88fd\u54c1\u3092\u30d0\u30f3\u30c9\u30eb\u3059\u308b<\/strong><\/h3>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306f\u3001\u8907\u6570\u306e\u30c7\u30d0\u30a4\u30b9\u3092\u985e\u4f3c\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u767b\u9332\u3059\u308b\u88fd\u54c1\u30b0\u30eb\u30fc\u30d7\u5316\u6226\u7565\u304c\u8a8d\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u9069\u5207\u306b\u5b9f\u65bd\u3059\u308c\u3070\u3001\u7279\u306b\u6d88\u8017\u54c1\u306e\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u304c\u8c4a\u5bcc\u306a\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u6642\u9593\u3068\u30b3\u30b9\u30c8\u306e\u4e21\u65b9\u3092\u7bc0\u7d04\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3. \u4e2d\u7acb\u7684\u306a\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6301\u3092\u4f7f\u7528\u3059\u308b<\/strong><\/h3>\n\n\n\n<p>\u591a\u304f\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u88fd\u54c1\u767b\u9332\u3092\u5358\u4e00\u306e\u8ca9\u58f2\u4ee3\u7406\u5e97\u306b\u76f4\u63a5\u30ea\u30f3\u30af\u3055\u305b\u308b\u306e\u3067\u306f\u306a\u304f\u3001Product Registration Indonesia\u306e\u3088\u3046\u306a\u4e2d\u7acb\u7684\u306a\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u3092\u9078\u629e\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u3088\u308a\u3001\u4ee5\u4e0b\u306e\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u54c1\u767b\u9332\u306e\u6240\u6709\u6a29\u306f\u88fd\u9020\u5143\u304c\u4fdd\u6301\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u5e02\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u5931\u3046\u3053\u3068\u306a\u304f\u8ca9\u58f2\u696d\u8005\u3092\u5909\u66f4\u3067\u304d\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u914d\u4fe1\u5951\u7d04\u306e\u4ea4\u6e09\u6642\u306b\u4ea4\u6e09\u529b\u304c\u9ad8\u307e\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>4. \u73fe\u5730\u5e02\u5834\u306e\u671f\u5f85\u306b\u5fdc\u3048\u308b<\/strong><\/h3>\n\n\n\n<p>\u6280\u8853\u7684\u306a\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3060\u3051\u3067\u306f\u5341\u5206\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u88fd\u54c1\u306e\u8a34\u6c42\u5185\u5bb9\u3001\u30e9\u30d9\u30eb\u3001\u3055\u3089\u306b\u306f\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u30d3\u30b8\u30e5\u30a2\u30eb\u307e\u3067\u3082\u304c\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u6587\u5316\u3084\u898f\u5236\u306e\u8981\u4ef6\u306b\u9069\u5408\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u4f8b\u3048\u3070\u3001\u5b97\u6559\u7684\u307e\u305f\u306f\u502b\u7406\u7684\u306a\u610f\u5473\u5408\u3044\u3092\u6301\u3064\u6a5f\u5668\uff08\u52d5\u7269\u7531\u6765\u306e\u7d20\u6750\u3092\u542b\u3080\u88fd\u54c1\u306a\u3069\uff09\u306f\u3001\u5e02\u5834\u306e\u5b89\u5fc3\u611f\u3092\u9ad8\u3081\u308b\u305f\u3081\u306b\u30cf\u30e9\u30fc\u30eb\u8a8d\u8a3c\u304c\u5fc5\u8981\u3068\u306a\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5b9f\u969b\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306f\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u30cf\u30e9\u30fc\u30eb\u8a8d\u8a3c\u3092\u6bb5\u968e\u7684\u306b\u5c0e\u5165\u3057\u3066\u304a\u308a\uff08\u4f8b\uff1a2026\u5e74\u307e\u3067\u306b\u30af\u30e9\u30b9A\u6a5f\u5668\uff09\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u3053\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u5bfe\u7b56\u306b\u5099\u3048\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">5. \u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u6e96\u5099<\/h3>\n\n\n\n<p>\u88fd\u54c1\u306e\u6027\u80fd\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u3001\u304a\u3088\u3073\u56fd\u5185\u306b\u304a\u3051\u308b\u5e02\u8ca9\u5f8c\u8a66\u9a13\u8981\u4ef6\u306e\u9075\u5b88\u3092\u76e3\u8996\u3059\u308b\u305f\u3081\u306e\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3057\u307e\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\u306f\u3001\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3057\u3001\u627f\u8a8d\u5f8c\u306e\u6a5f\u5668\u306e\u7a4d\u6975\u7684\u306a\u76e3\u8996\u3092\u307e\u3059\u307e\u3059\u5f37\u304f\u6c42\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>PRI\u304c\u30d7\u30ed\u30bb\u30b9\u3092\u7c21\u7d20\u5316\u3059\u308b\u65b9\u6cd5<\/strong> \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u767b\u9332\u3068\u306f?<\/h2>\n\n\n\n<p>\u3067 <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u88fd\u54c1\u767b\u9332\uff08PRI\uff09<\/a>\u5f0a\u793e\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3060\u3051\u3067\u306f\u306a\u304f\u3001\u6226\u7565\u3082\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u767b\u9332\u30b5\u30dd\u30fc\u30c8:<\/strong> \u30ea\u30b9\u30af\u5206\u985e\u304b\u3089\u30c7\u30d0\u30a4\u30b9\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u306e\u6e96\u5099\u3001Regalkes \u306e\u63d0\u51fa\u307e\u3067\u3002<\/li>\n\n\n\n<li><strong>\u4e2d\u7acb\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709:<\/strong> \u88fd\u54c1\u306e\u6240\u6709\u6a29\u3092 1 \u3064\u306e\u8ca9\u58f2\u696d\u8005\u306b\u7e1b\u3089\u308c\u308b\u3053\u3068\u306a\u304f\u3001\u304a\u5ba2\u69d8\u306e\u624b\u5143\u306b\u4fdd\u6301\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u6226\u7565\u7684\u30d1\u30fc\u30c8\u30ca\u30fc\u30cd\u30c3\u30c8\u30ef\u30fc\u30af:<\/strong> \u5730\u5143\u306e\u8ca9\u58f2\u4ee3\u7406\u5e97\u304c CDAKB \u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u30d3\u30b8\u30cd\u30b9\u6307\u5411\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<\/strong> \u30e1\u30fc\u30ab\u30fc\u304c MoH \u306e\u8a55\u4fa1\u306b\u5408\u683c\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3084\u8ca9\u58f2\u4ee3\u7406\u5e97\u3068\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u3092\u78ba\u7acb\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>PRI \u3092\u5229\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u306f\u8907\u96d1\u306a\u898f\u5236\u8981\u4ef6\u3092\u30b9\u30e0\u30fc\u30ba\u3067\u30d3\u30b8\u30cd\u30b9\u4e3b\u5c0e\u306e\u53c2\u5165\u6226\u7565\u306b\u5909\u63db\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u7d50\u8ad6<\/strong><\/h2>\n\n\n\n<p><a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/medical-device-registration-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u767b\u9332<\/a> \u5358\u306a\u308b\u4e8b\u52d9\u4f5c\u696d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30a2\u30b8\u30a2\u3067\u6700\u3082\u6709\u671b\u306a\u30d8\u30eb\u30b9\u30b1\u30a2\u5e02\u5834\u306e\u4e00\u3064\u306b\u304a\u3044\u3066\u3001\u5e02\u5834\u53c2\u5165\u3001\u8ca9\u58f2\u4ee3\u7406\u5e97\u3068\u306e\u95a2\u4fc2\u69cb\u7bc9\u3001\u305d\u3057\u3066\u9577\u671f\u7684\u306a\u6210\u529f\u3078\u306e\u5165\u308a\u53e3\u3068\u306a\u308b\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<p>ASEAN \u306e\u8abf\u548c\u3092\u7406\u89e3\u3057\u3001\u6587\u66f8\u3092\u6226\u7565\u7684\u306b\u7ba1\u7406\u3057\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3092\u8a08\u753b\u3057\u3001\u4e2d\u7acb\u7684\u306a\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u306a\u3069\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u6b27\u5dde\u3001\u4e2d\u56fd\u3001\u7c73\u56fd\u306e\u88fd\u9020\u696d\u8005\u306f\u81ea\u4fe1\u3092\u6301\u3063\u3066\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u53c2\u5165\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>Product Registration Indonesia \u306f\u3001\u88fd\u54c1\u767b\u9332\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u7c21\u7d20\u5316\u3059\u308b\u3053\u3068\u306b\u7279\u5316\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/contact\/\">\u4eca\u3059\u3050\u7121\u6599\u76f8\u8ac7\u306b\u3054\u9023\u7d61\u304f\u3060\u3055\u3044<\/a> \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u53c2\u5165\u6226\u7565\u3092\u7ba1\u7406\u3057\u307e\u3057\u3087\u3046\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>For many international medical device manufacturers, Indonesia often appears as the next logical market expansion after securing approvals in the EU, US, or China. On paper, the opportunity looks straightforward: a growing demand for modern healthcare solutions, a large network of hospitals, and increasing government spending on medical technology.&nbsp; However, Indonesia medical device product registration involves a unique Ministry of Health process that can surprise new entrants. Once companies begin exploring entry into Indonesia, they quickly realize that regulatory requirements can become the biggest barrier to market access. Unlike Europe\u2019s CE Mark or the US FDA approval, Indonesia requires manufacturers to undergo a localized registration process with the Ministry of [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":2332,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-2331","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-articles"],"acf":[],"_links":{"self":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/2331","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=2331"}],"version-history":[{"count":2,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/2331\/revisions"}],"predecessor-version":[{"id":2334,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/2331\/revisions\/2334"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/2332"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=2331"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=2331"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=2331"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=2331"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}