{"id":2205,"date":"2025-08-29T03:21:11","date_gmt":"2025-08-29T03:21:11","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=2205"},"modified":"2025-12-10T22:12:15","modified_gmt":"2025-12-10T15:12:15","slug":"indonesias-medical-device-registration-guidelines-step-by-step-guide","status":"publish","type":"post","link":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/indonesias-medical-device-registration-guidelines-step-by-step-guide\/","title":{"rendered":"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff1a\u30b9\u30c6\u30c3\u30d7\u30d0\u30a4\u30b9\u30c6\u30c3\u30d7\u30ac\u30a4\u30c9"},"content":{"rendered":"<p>\u5916\u56fd\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306f\u6771\u5357\u30a2\u30b8\u30a2\u3067\u6700\u3082\u6d3b\u529b\u304c\u3042\u308a\u3001\u5c06\u6765\u6027\u306e\u9ad8\u3044\u30d8\u30eb\u30b9\u30b1\u30a2\u5e02\u5834\u306e\u4e00\u3064\u3067\u3059\u3002\u4e2d\u9593\u5c64\u306e\u5897\u52a0\u3068\u30d8\u30eb\u30b9\u30b1\u30a2\u6295\u8cc7\u306e\u5897\u52a0\u306b\u4f34\u3044\u3001\u8a3a\u65ad\u6a5f\u5668\u304b\u3089\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306b\u81f3\u308b\u307e\u3067\u3001\u8f38\u5165\u6a5f\u5668\u306e\u9700\u8981\u304c\u9ad8\u307e\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3057\u304b\u3057\u3001\u5e02\u5834\u306b\u6295\u5165\u3055\u308c\u308b\u524d\u306b\u3001\u3059\u3079\u3066\u306e\u88fd\u54c1\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\uff08MoH\uff09\u304c\u767a\u884c\u3059\u308b\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u533b\u7642\u6a5f\u5668\u767b\u9332\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u5358\u306a\u308b\u624b\u7d9a\u304d\u4e0a\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3067\u306f\u306a\u304f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u3001\u6587\u66f8\u5316\u3001\u6d41\u901a\u3001\u76e3\u8996\u65b9\u6cd5\u3092\u898f\u5b9a\u3059\u308b\u5305\u62ec\u7684\u306a\u898f\u5247\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u308f\u306a\u3044\u5834\u5408\u3001\u30b3\u30b9\u30c8\u306e\u304b\u304b\u308b\u9045\u5ef6\u3001\u88fd\u54c1\u306e\u4e0d\u5408\u683c\u3001\u3055\u3089\u306b\u306f\u5e02\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u62d2\u5426\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u8981\u70b9\u3092\u3001\u30ed\u30fc\u30ab\u30ea\u30bc\u30fc\u30b7\u30e7\u30f3\u8981\u4ef6\u3001Regalkes\u5236\u5ea6\u3001\u5e02\u8ca9\u5f8c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u4fdd\u5065\u7701\u306e\u898f\u5236\u3092\u7406\u89e3\u3057\u3001\u5fb9\u5e95\u7684\u306b\u6e96\u5099\u3059\u308b\u3053\u3068\u3067\u3001\u3088\u304f\u3042\u308b\u843d\u3068\u3057\u7a74\u3092\u56de\u907f\u3057\u3001\u5e02\u5834\u53c2\u5165\u3092\u52a0\u901f\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u898f\u5236\u5f53\u5c40\u3068\u6cd5\u7684\u67a0\u7d44\u307f<\/h2>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u898f\u5236\u306f\u3001\u4fdd\u5065\u7701\uff08Kementerian Kesehatan\u3001MoH\uff09\u304c\u7ba1\u8f44\u3057\u3066\u3044\u307e\u3059\u3002\u6cd5\u7684\u6839\u62e0\u306f\u4fdd\u5065\u5927\u81e3\u898f\u5247\u7b2c62\/2017\u53f7\u3067\u3042\u308a\u3001\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306f\u6d41\u901a\u307e\u305f\u306f\u8ca9\u58f2\u524d\u306b\u533b\u7642\u6a5f\u5668\u767b\u9332\u8a3c\uff08NIE\uff09\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306f ASEAN \u533b\u7642\u6a5f\u5668\u6307\u4ee4\u306b\u6e96\u62e0\u3057\u3066\u304a\u308a\u3001\u767b\u9332\u306b\u306f ASEAN \u5171\u901a\u63d0\u51fa\u66f8\u985e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8 (CSDT) \u3092\u4f7f\u7528\u3057\u3001\u4e16\u754c\u6a19\u6e96\u3068\u540c\u69d8\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u5206\u985e\u30b7\u30b9\u30c6\u30e0 (\u30af\u30e9\u30b9 A\uff5eD) \u3082\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3082 <strong>ASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08AMDD\uff09<\/strong>\u306f\u3001ASEAN\u8af8\u56fd\u9593\u306e\u898f\u5236\u6163\u884c\u3092\u8abf\u548c\u3055\u305b\u308b\u3082\u306e\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u4fdd\u5065\u7701\u306fAMDD\u306e\u898f\u5b9a\u3092\u5404\u56fd\u306e\u653f\u7b56\u306b\u5408\u308f\u305b\u3066\u8abf\u6574\u3059\u308b\u305f\u3081\u3001CE\u30de\u30fc\u30af\u3084FDA\u306e\u627f\u8a8d\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002&nbsp;<\/p>\n\n\n\n<p>\u73fe\u5728\u3001\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u306f\u3001\u7533\u8acb\u3001\u8a55\u4fa1\u3001\u627f\u8a8d\u3092\u7ba1\u7406\u3059\u308b\u4fdd\u5065\u7701\u306e\u30aa\u30f3\u30e9\u30a4\u30f3 \u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3042\u308b Regalkes \u30b7\u30b9\u30c6\u30e0\u306b\u4e00\u5143\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u898f\u5236\u306e\u4e0b\u3067\u306e\u5206\u985e\u306e\u4ed5\u7d44\u307f\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u306e\u8a18\u4e8b\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/types-of-medical-devices-and-their-classification-in-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u7a2e\u985e\u3068\u5206\u985e<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u304a\u3051\u308b\u30ed\u30fc\u30ab\u30ea\u30bc\u30fc\u30b7\u30e7\u30f3\u8981\u4ef6<\/h2>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u6700\u3082\u7279\u5fb4\u7684\u306a\u70b9\u306e\u4e00\u3064\u306f\u3001\u30ed\u30fc\u30ab\u30e9\u30a4\u30ba\u3092\u91cd\u8996\u3057\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002\u88fd\u54c1\u304c\u65e2\u306b\u6b27\u5dde\u3001\u7c73\u56fd\u3001\u4e2d\u56fd\u3067\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3067\u3082\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u57fa\u6e96\u306b\u9069\u5408\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8a00\u8a9e\u8981\u4ef6:<\/strong> \u3059\u3079\u3066\u306e\u30e9\u30d9\u30eb\u3001\u30d1\u30c3\u30b1\u30fc\u30b8\u3001\u4f7f\u7528\u8aac\u660e\u66f8\uff08IFU\uff09\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u306b\u7ffb\u8a33\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u5916\u56fd\u898f\u5236\u6587\u66f8\uff08CFS\u3001GMP\u8a3c\u660e\u66f8\u306a\u3069\uff09\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5927\u4f7f\u9928\u306b\u3088\u308b\u8a8d\u8a3c\u307e\u305f\u306f\u30a2\u30dd\u30b9\u30c6\u30a3\u30fc\u30e6\u304c\u5fc5\u8981\u3067\u3059\u3002 <em>\u8a8d\u53ef\u72b6\u306f\u767b\u9332\u306e\u6709\u52b9\u671f\u9593\u3068\u4e00\u81f4\u3059\u308b\u3088\u3046\u306b5\u5e74\u9593\u306e\u6709\u52b9\u671f\u9593\u3092\u30ab\u30d0\u30fc\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/em><\/li>\n\n\n\n<li><strong>\u5916\u56fd\u6587\u66f8\u306e\u8a8d\u8a3c\uff1a<\/strong> \u81ea\u7531\u8ca9\u58f2\u8a3c\u660e\u66f8 (CFS)\u3001\u9069\u6b63\u88fd\u9020\u898f\u7bc4 (GMP)\u3001\u8a8d\u53ef\u72b6 (LoA) \u306a\u3069\u306e\u8a3c\u660e\u66f8\u306f\u3001\u63d0\u51fa\u524d\u306b\u8a8d\u8a3c\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>\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306e\u9069\u5fdc:<\/strong> \u6280\u8853\u6587\u66f8\u306f\u3001\u73fe\u5730\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306b\u5f93\u3044\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5f62\u5f0f\u306e\u767b\u9332\u66f8\u985e\u306b\u307e\u3068\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u88fd\u9020\u696d\u8005\u304c\u65e2\u306bEU MDR\u307e\u305f\u306fFDA\u306e\u8981\u4ef6\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u5834\u5408\u3067\u3082\u3001\u30c7\u30d0\u30a4\u30b9\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\uff08DMF\uff09\u3068\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb\uff08PIF\uff09\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306b\u5f93\u3063\u3066\u69cb\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u554f\u984c\u70b9\u306e\u4f8b:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6b27\u5dde\uff08CE\u30de\u30fc\u30af\uff09\uff1a<\/strong> CE \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3067\u306f\u3001\u4f01\u696d\u306f\u8ffd\u52a0\u306e\u30ed\u30fc\u30ab\u30e9\u30a4\u30ba\u3055\u308c\u305f\u6587\u66f8\u306e\u63d0\u51fa\u304c\u514d\u9664\u3055\u308c\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/li>\n\n\n\n<li><strong>\u4e2d\u56fd\uff1a<\/strong> \u4f01\u696d\u306f\u3001\u5927\u4f7f\u9928\u3067\u306e\u6587\u66f8\u8a8d\u8a3c\u306e\u305f\u3081\u306b\u983b\u7e41\u306b\u9045\u5ef6\u306b\u76f4\u9762\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u7c73\u56fd\uff08FDA\uff09\uff1a<\/strong> FDA \u306e\u30e9\u30d9\u30eb\u5f62\u5f0f\u306f\u3001\u7279\u306b\u30d0\u30cf\u30b5\u8a9e\u306e\u7ffb\u8a33\u3068\u30ea\u30b9\u30af\u8b66\u544a\u306b\u3064\u3044\u3066\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5408\u308f\u305b\u3066\u8abf\u6574\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u533b\u7642\u6a5f\u5668\u767b\u9332\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u4e2d\u6838\u8981\u4ef6<\/h2>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u63d0\u51fa\u524d\u306b\u6e80\u305f\u3059\u3079\u304d\u5305\u62ec\u7684\u306a\u8981\u4ef6\u304c\u6982\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6cd5\u7684\u6587\u66f8:\n<ul class=\"wp-block-list\">\n<li>\u30e1\u30fc\u30ab\u30fc\u304b\u3089\u73fe\u5730\u4ee3\u7406\u5e97\u3078\u306e LoA<\/li>\n\n\n\n<li>\u81ea\u7531\u8ca9\u58f2\u8a3c\u660e\u66f8\uff08CFS\uff09<\/li>\n\n\n\n<li>GMP\u307e\u305f\u306fISO 13485\u8a3c\u660e\u66f8<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>\u88fd\u9020\u696d\u8005\u304b\u3089\u73fe\u5730\u4ee3\u7406\u5e97\u3078\u306e\u59d4\u4efb\u72b6\u306f\u3001\u5927\u4f7f\u9928\u306e\u8a8d\u8a3c\u3092\u53d7\u3051\u3001NIE\u306e\u6709\u52b9\u671f\u9593\u3092\u5168\u671f\u9593\u306b\u308f\u305f\u3063\u3066\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3001\u5c11\u306a\u304f\u3068\u30825\u5e74\u9593\u306e\u6709\u52b9\u671f\u9593\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u540c\u69d8\u306b\u3001\u73fe\u5730\u8ca9\u58f2\u4ee3\u7406\u5e97\u306eIDAK\u30e9\u30a4\u30bb\u30f3\u30b9\uff08\u8ca9\u58f2\u8a31\u53ef\u8a3c\uff09\u3082\u5fc5\u9808\u3067\u3059\u3002<\/p>\n\n\n\n<p>2024 \u5e74 7 \u6708\u73fe\u5728\u3001\u4fdd\u5065\u7701\u306f\u8ca9\u58f2\u696d\u8005\u304c\u516c\u5f0f\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96\u8a3c\u660e\u66f8 (CDAKB) \u3092\u4fdd\u6301\u3059\u308b\u3053\u3068\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u304a\u308a\u3001\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u3092\u767b\u9332\u3059\u308b\u524d\u306b\u5358\u306a\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6280\u8853\u6587\u66f8:\n<ul class=\"wp-block-list\">\n<li>\u30c7\u30d0\u30a4\u30b9\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\uff08DMF\uff09<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08\u30af\u30e9\u30b9B\uff5eD\u6a5f\u5668\u7528\uff09<\/li>\n\n\n\n<li>\u751f\u4f53\u9069\u5408\u6027\u3001\u96fb\u6c17\u5b89\u5168\u6027\u3001\u304a\u3088\u3073\u4fdd\u5b58\u671f\u9593\u306e\u8a66\u9a13\u30ec\u30dd\u30fc\u30c8\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09<\/li>\n\n\n\n<li>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u306e\u88fd\u54c1\u30e9\u30d9\u30eb\u3068 IFU<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>\u30af\u30e9\u30b9 C \u304a\u3088\u3073 D \u306e\u30c7\u30d0\u30a4\u30b9\u306b\u3064\u3044\u3066\u306f\u3001MoH \u304c\u4fb5\u8972\u6027\u307e\u305f\u306f\u9ad8\u30ea\u30b9\u30af\u306e\u88fd\u54c1\u306b\u5bfe\u3057\u3066\u73fe\u5730\u3067\u306e\u81e8\u5e8a\u8a55\u4fa1\u307e\u305f\u306f\u5b89\u5168\u6027\u30c6\u30b9\u30c8\u3092\u8981\u6c42\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u8ffd\u52a0\u306e\u8a3c\u62e0\u307e\u305f\u306f\u73fe\u5730\u3067\u306e\u30c6\u30b9\u30c8 \u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3059\u308b\u6e96\u5099\u3092\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u73fe\u5730\u8ca9\u58f2\u4ee3\u7406\u5e97\u306e\u8981\u4ef6:\n<ul class=\"wp-block-list\">\n<li>\u8ca9\u58f2\u4ee3\u7406\u5e97\u306f IDAK \u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u4fdd\u6301\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059 (Izin Distribusi Alat Kesehatan)<\/li>\n\n\n\n<li>CDAKB\u8a8d\u8a3c\uff08\u533b\u7642\u6a5f\u5668\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96\uff09\u3078\u306e\u6e96\u62e0<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u8981\u4ef6\u306b\u3088\u308a\u3001\u5b89\u5168\u3067\u52b9\u679c\u7684\u304b\u3064\u9ad8\u54c1\u8cea\u306e\u88fd\u54c1\u306e\u307f\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u60a3\u8005\u306b\u5c4a\u304f\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u3001\u88fd\u9020\u696d\u8005\u3068\u8ca9\u58f2\u696d\u8005\u306e\u4e21\u65b9\u306b\u8aac\u660e\u8cac\u4efb\u304c\u8ab2\u305b\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"667\" src=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2025\/08\/regalkes.png\" alt=\"\u30ec\u30ac\u30eb\u30b1\u30b9\u30b7\u30b9\u30c6\u30e0\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\" class=\"wp-image-2217\" srcset=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2025\/08\/regalkes.png 1000w, https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2025\/08\/regalkes-300x200.png 300w, https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2025\/08\/regalkes-768x512.png 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Regalkes\u30b7\u30b9\u30c6\u30e0\uff1a\u767b\u9332\u306e\u30c7\u30b8\u30bf\u30eb\u30d0\u30c3\u30af\u30dc\u30fc\u30f3<\/h2>\n\n\n\n<p>\u305d\u306e <a href=\"https:\/\/regalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\">\u30ec\u30ac\u30eb\u30b1\u30b9\u30b7\u30b9\u30c6\u30e0<\/a> \u306f\u3001\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332\u3092\u51e6\u7406\u3059\u308b\u4e2d\u6838\u3068\u306a\u308b\u30c7\u30b8\u30bf\u30eb\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002\u7533\u8acb\u306e\u305f\u3081\u306e\u4f53\u7cfb\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3092\u63d0\u4f9b\u3057\u307e\u3059\u304c\u3001\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u7279\u6709\u306e\u8ab2\u984c\u3082\u751f\u3058\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Regalkes\u306e\u4e3b\u306a\u6a5f\u80fd:<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u63d0\u51fa\u30dd\u30fc\u30bf\u30eb:<\/strong> \u66f8\u985e\u3001\u8a3c\u660e\u66f8\u3001\u304a\u3088\u3073\u88cf\u4ed8\u3051\u66f8\u985e\u3092\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u8a55\u4fa1\u30ef\u30fc\u30af\u30d5\u30ed\u30fc:<\/strong> MoH \u306e\u30ec\u30d3\u30e5\u30fc\u62c5\u5f53\u8005\u306f\u3001\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u901a\u3058\u3066\u76f4\u63a5\u8aac\u660e\u8981\u6c42\u3092\u9001\u4fe1\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u6599\u91d1\u7ba1\u7406:<\/strong> \u653f\u5e9c\u624b\u6570\u6599\uff08PNBP\uff09\u306f\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u652f\u6255\u308f\u308c\u3001\u8ffd\u8de1\u3055\u308c\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u627f\u8a8d\u3068NIE\u767a\u884c:<\/strong> \u627f\u8a8d\u3055\u308c\u308b\u3068\u3001\u30b7\u30b9\u30c6\u30e0\u306b\u3088\u3063\u3066\u6b63\u5f0f\u306a\u767b\u9332\u8a3c\u660e\u66f8\u304c\u751f\u6210\u3055\u308c\u307e\u3059\u3002<\/li>\n<\/ol>\n\n\n\n<p>\u6ce8\u610f: Regalkes \u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u3067\u3001\u53b3\u683c\u306a\u30d5\u30a1\u30a4\u30eb\u547d\u540d\u898f\u5247\u304c\u3042\u308b\u305f\u3081\u3001\u6d77\u5916\u306e\u88fd\u9020\u696d\u8005\u306f\u73fe\u5730\u306e\u5c02\u9580\u5bb6\u3068\u7dca\u5bc6\u306b\u5354\u529b\u3057\u3066\u64cd\u4f5c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30e1\u30fc\u30ab\u30fc\u304c\u76f4\u9762\u3059\u308b\u8ab2\u984c:<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6280\u8853\u7684\u306a\u554f\u984c:<\/strong> \u30b7\u30b9\u30c6\u30e0\u306e\u30c0\u30a6\u30f3\u30bf\u30a4\u30e0\u3084\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9 \u30a8\u30e9\u30fc\u306b\u3088\u308a\u3001\u9001\u4fe1\u304c\u9045\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u660e\u78ba\u5316\u30b5\u30a4\u30af\u30eb:<\/strong> MoH \u306f\u983b\u7e41\u306b\u8aac\u660e\u3092\u6c42\u3081\u3066\u304a\u308a\u3001\u8a55\u4fa1\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u304c\u5ef6\u9577\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u306e\u53b3\u3057\u3055:<\/strong> \u30d5\u30a1\u30a4\u30eb\u306f\u53b3\u5bc6\u306a\u547d\u540d\u3068\u30b5\u30a4\u30ba\u306e\u8981\u4ef6\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u3042\u308b\u7a0b\u5ea6\u306e\u30d0\u30c3\u30d5\u30a1\u6642\u9593\u3092\u8a2d\u3051\u305f\u8a08\u753b\u306e\u63d0\u51fa \u2013 Regalkes \u30dd\u30fc\u30bf\u30eb\u3067\u306f\u3001\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u306b\u3088\u308b\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3 (\u4f8b: 2024 \u5e74 12 \u6708\u306e\u4e88\u5b9a\u9589\u9396) \u304c\u767a\u751f\u3059\u308b\u5834\u5408\u304c\u3042\u308a\u3001\u4e00\u6642\u7684\u306b\u65b0\u898f\u7533\u8acb\u304c\u505c\u6b62\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>MoH \u304b\u3089\u5c11\u306a\u304f\u3068\u3082 1 \u56de\u306f\u8aac\u660e\u3092\u6c42\u3081\u308b\u554f\u3044\u5408\u308f\u305b\u304c\u6765\u308b\u3053\u3068\u3092\u60f3\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u7533\u8acb\u3092\u9806\u8abf\u306b\u9032\u3081\u308b\u305f\u3081\u306b\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u30bf\u30a4\u30e0\u30ea\u30fc\u306b\u5fdc\u7b54\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<p>???? NIE\u304c\u3069\u306e\u3088\u3046\u306b\u6226\u7565\u7684\u306b\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u304b\u306b\u3064\u3044\u3066\u306e\u3088\u308a\u8a73\u3057\u3044\u8aac\u660e\u306b\u3064\u3044\u3066\u306f\u3001<a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/medical-device-registration-in-indonesia-nie-risk-classes-regulatory-strategy\/\"> \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\uff1aNIE\u3001\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u3001\u898f\u5236\u6226\u7565<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u57fa\u3065\u304f\u5e02\u8ca9\u5f8c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/h2>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u521d\u56de\u767b\u9332\u306b\u3068\u3069\u307e\u3089\u305a\u3001\u88fd\u9020\u696d\u8005\u3068\u8ca9\u58f2\u696d\u8005\u306f\u5e02\u8ca9\u5f8c\u306e\u7fa9\u52d9\u306b\u3064\u3044\u3066\u3082\u8cac\u4efb\u3092\u8ca0\u3044\u3001\u3053\u308c\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u76e3\u8996\u3068\u8b66\u6212:<\/strong> \u6709\u5bb3\u4e8b\u8c61\u307e\u305f\u306f\u88fd\u54c1\u969c\u5bb3\u3092\u4fdd\u5065\u7701\u306b\u5831\u544a\u3057\u307e\u3059 (\u91cd\u5927\u306a\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u306f\u901f\u3084\u304b\u306b\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u9045\u308c\u308b\u3068\u5236\u88c1\u3092\u53d7\u3051\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059)\u3002<\/li>\n\n\n\n<li><strong>NIE\u306e\u66f4\u65b0\uff1a<\/strong> \u3059\u3079\u3066\u306e\u767b\u9332\u306f <strong>5\u5e74<\/strong> \u66f4\u65b0\u304c\u5fc5\u8981\u3067\u3059\u3002NIE\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u6709\u52b9\u671f\u9593\u306f\u901a\u5e38\u6700\u95775\u5e74\u3067\u3059\uff08LoA\u306e\u6709\u52b9\u671f\u9650\u306b\u9023\u52d5\u3059\u308b\u5834\u5408\u306f\u3001\u305d\u308c\u3088\u308a\u77ed\u304f\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\uff09\u3002\u8ca9\u58f2\u8a8d\u53ef\u306e\u5931\u52b9\u3092\u9632\u3050\u305f\u3081\u3001\u6709\u52b9\u671f\u9650\u306e\u6570\u304b\u6708\u524d\u304b\u3089\u66f4\u65b0\u624b\u7d9a\u304d\u3092\u958b\u59cb\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n\n\n\n<li><strong>\u30e9\u30f3\u30c0\u30e0\u691c\u67fb:<\/strong> MoH \u306f\u8ca9\u58f2\u696d\u8005\u3092\u76e3\u67fb\u3057\u305f\u308a\u3001\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u306e\u66f4\u65b0\u3092\u8981\u6c42\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u7f70\u5247:<\/strong> \u9075\u5b88\u3057\u306a\u3044\u5834\u5408\u306f\u3001NIE \u306e\u505c\u6b62\u3001\u53d6\u308a\u6d88\u3057\u3001\u307e\u305f\u306f\u7f70\u91d1\u306e\u5bfe\u8c61\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u306e\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u3088\u308a\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u304c\u78ba\u4fdd\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u6700\u8fd1\u306e\u898f\u5236\u306b\u3088\u308a\u6bb5\u968e\u7684\u306b\u5c0e\u5165\u3055\u308c\u3066\u3044\u308b\u3001\u52d5\u7269\u7531\u6765\u306e\u90e8\u54c1\u3092\u4f7f\u7528\u3057\u305f\u30c7\u30d0\u30a4\u30b9\u306b\u5bfe\u3059\u308b\u30cf\u30e9\u30fc\u30eb\u8a8d\u8a3c\u306a\u3069\u306e\u65b0\u305f\u306a\u8981\u4ef6\u306b\u7559\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PRI\u306e\u5c02\u9580\u77e5\u8b58\u304c\u91cd\u8981\u306a\u7406\u7531<\/h2>\n\n\n\n<p>\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u516c\u958b\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u5b9f\u969b\u306b\u904b\u7528\u3059\u308b\u306e\u306f\u8907\u96d1\u3067\u3059\u3002\u3088\u304f\u3042\u308b\u969c\u58c1\u3068\u3057\u3066\u306f\u3001\u6587\u66f8\u306e\u8a8d\u8a3c\u3001Regalkes\u3078\u306e\u63d0\u51fa\u30a8\u30e9\u30fc\u3001\u73fe\u5730\u3067\u306e\u4ee3\u7406\u6a29\u306e\u554f\u984c\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u88fd\u54c1\u767b\u9332\uff08PRI\uff09<\/strong> \u30e1\u30fc\u30ab\u30fc\u3092\u6b21\u306e\u3088\u3046\u306b\u652f\u63f4\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5b8c\u5168\u304b\u3064\u6e96\u62e0\u3057\u305f\u66f8\u985e\u3092\u6e96\u5099\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u73fe\u5730\u306e\u4ee3\u8868\u8005\u304a\u3088\u3073\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u3068\u3057\u3066\u6d3b\u52d5\u3057\u3001\u67d4\u8edf\u306a\u8ca9\u58f2\u4ee3\u7406\u5e97\u7ba1\u7406\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u4fdd\u5065\u7701\u3068\u9023\u643a\u3057\u3001\u7591\u554f\u70b9\u3092\u8fc5\u901f\u306b\u89e3\u6c7a\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u304a\u3088\u3073\u66f4\u65b0\u8981\u4ef6\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u79c1\u305f\u3061\u306f\u4fdd\u5065\u7701\u306e\u65b0\u3057\u3044\u898f\u5236\uff08\u4f8b\u3048\u3070\u3001 <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/halal-certification\/\">\u6700\u65b0\u306e\u30cf\u30e9\u30fc\u30eb\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/a> \u4e0d\u610f\u3092\u7a81\u304b\u308c\u306a\u3044\u3088\u3046\u306b\u3001\u5fc5\u305a\uff08\u7fa9\u52d9\uff09\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\u5358\u4e00\u306e\u8ca9\u58f2\u4ee3\u7406\u5e97\u306b\u4f9d\u5b58\u3059\u308b\u5834\u5408\u3068\u306f\u7570\u306a\u308a\u3001PRI\u306f\u304a\u5ba2\u69d8\u306b\u4ee3\u308f\u3063\u3066\u88fd\u54c1\u30e9\u30a4\u30bb\u30f3\u30b9\uff08NIE\uff09\u3092\u4fdd\u6709\u3057\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u304a\u5ba2\u69d8\u306f\u767b\u9332\u3092\u30ea\u30b9\u30af\u306b\u3055\u3089\u3059\u3053\u3068\u306a\u304f\u3001\u8ca9\u58f2\u4ee3\u7406\u5e97\u3092\u7ba1\u7406\u307e\u305f\u306f\u5909\u66f4\u3059\u308b\u67d4\u8edf\u6027\u3092\u7dad\u6301\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5f53\u793e\u306e\u73fe\u5730\u30c1\u30fc\u30e0\u306f Regalkes \u30b7\u30b9\u30c6\u30e0\u3068 MoH \u306e\u671f\u5f85\u4e8b\u9805\u3092\u719f\u77e5\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u8aac\u660e\u8981\u6c42\u3092\u8fc5\u901f\u306b\u89e3\u6c7a\u3057\u3001\u88fd\u54c1\u3092\u3088\u308a\u65e9\u304f\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h1 class=\"wp-block-heading\">\u7d50\u8ad6<\/h1>\n\n\n\n<p>\u305d\u306e <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/medical-device-registration-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332<\/a> \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u5b89\u5168\u3067\u52b9\u679c\u7684\u304b\u3064\u9ad8\u54c1\u8cea\u306a\u533b\u7642\u6a5f\u5668\u306e\u307f\u304c\u60a3\u8005\u306b\u5c4a\u304f\u3088\u3046\u306b\u3059\u308b\u305f\u3081\u306e\u8a73\u7d30\u306a\u67a0\u7d44\u307f\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u6a5f\u4f1a\u3067\u3042\u308b\u3068\u540c\u6642\u306b\u8ab2\u984c\u3067\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p><em>\u898f\u5236\u306f\u4eca\u5f8c\u3082\u9032\u5316\u3057\u7d9a\u3051\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306f\u7279\u5b9a\u306e\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u30cf\u30e9\u30fc\u30eb\u88fd\u54c1\u4fdd\u8a3c\u3092\u5c0e\u5165\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u60c5\u5831\u3092\u5165\u624b\u3057\u3001\u898f\u5236\u306b\u6e96\u62e0\u3057\u7d9a\u3051\u308b\u3053\u3068\u306f\u7d99\u7d9a\u7684\u306a\u53d6\u308a\u7d44\u307f\u3068\u306a\u308a\u307e\u3059\u3002<\/em> \u3057\u304b\u3057\u3001\u5c02\u9580\u5bb6\u306e\u6307\u5c0e\u304c\u3042\u308c\u3070\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u81ea\u4fe1\u3092\u6301\u3063\u3066\u3053\u308c\u3089\u306e\u5909\u5316\u3092\u4e57\u308a\u8d8a\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u30ed\u30fc\u30ab\u30ea\u30bc\u30fc\u30b7\u30e7\u30f3\u8981\u4ef6\u3092\u7406\u89e3\u3057\u3001Regalkes \u30b7\u30b9\u30c6\u30e0\u3092\u7fd2\u5f97\u3057\u3001\u5e02\u8ca9\u5f8c\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u53d6\u308a\u7d44\u3080\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u627f\u8a8d\u3092\u78ba\u4fdd\u3057\u3001\u9577\u671f\u7684\u306a\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>Product Registration Indonesia \u3067\u306f\u3001\u6587\u66f8\u306e\u6e96\u5099\u304b\u3089\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u4fdd\u6301\u3001\u5e02\u8ca9\u5f8c\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u307e\u3067\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u3042\u3089\u3086\u308b\u30b9\u30c6\u30c3\u30d7\u3092\u901a\u3058\u3066\u4f01\u696d\u3092\u6307\u5c0e\u3059\u308b\u3053\u3068\u306b\u7279\u5316\u3057\u3066\u3044\u307e\u3059\u3002 <strong><a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/contact\/\">\u7121\u6599\u76f8\u8ac7\u306f\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/a><\/strong> \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u3078\u306e\u53c2\u5165\u3092\u7c21\u7d20\u5316\u3057\u307e\u3059\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>For foreign medical device manufacturers, Indonesia represents one of Southeast Asia\u2019s most dynamic and promising healthcare markets. With a growing middle class and increased healthcare investment, demand for imported devices from diagnostic tools to implantables is on the rise. But before entering the market, every product must comply with the Indonesia medical device registration guidelines issued by the Ministry of Health (MoH). These guidelines are not simply procedural checklists; they are comprehensive rules that shape how medical devices are classified, documented, distributed, and monitored. Failing to follow these guidelines can result in costly delays, product rejections, or even denial of market access. This article will walk you through the essentials [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":2216,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-2205","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\/2205","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\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=2205"}],"version-history":[{"count":4,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/2205\/revisions"}],"predecessor-version":[{"id":4102,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/2205\/revisions\/4102"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/2216"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=2205"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=2205"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=2205"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=2205"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}