{"id":2436,"date":"2025-09-22T16:40:14","date_gmt":"2025-09-22T09:40:14","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=2436"},"modified":"2025-12-10T22:12:14","modified_gmt":"2025-12-10T15:12:14","slug":"indonesia-medical-device-registration-process-with-asean-csdt-cheat-sheet","status":"publish","type":"post","link":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/indonesia-medical-device-registration-process-with-asean-csdt-cheat-sheet\/","title":{"rendered":"ASEAN CSDT\u30c1\u30fc\u30c8\u30b7\u30fc\u30c8\u3067\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u3092\u30de\u30b9\u30bf\u30fc\uff1a\u66f8\u985e\u4f5c\u6210\u3092\u52b9\u7387\u5316\u3057\u3001\u627f\u8a8d\u6642\u9593\u3092\u6570\u9031\u9593\u77ed\u7e2e"},"content":{"rendered":"<p>ASEAN\u306e\u7533\u8acb\u3092\u8abf\u548c\u3055\u305b\u3001\u91cd\u8907\u4f5c\u696d\u3092\u524a\u6e1b\u3059\u308b\u305f\u3081\u306b\u3001ASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u306f\u5171\u901a\u63d0\u51fa\u66f8\u985e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08CSDT\uff09\u3092\u5c0e\u5165\u3057\u305f\u3002<strong>. <\/strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\u306f\u73fe\u5728\u3001CSDT \u30ec\u30a4\u30a2\u30a6\u30c8\u3092\u53d7\u3051\u5165\u308c\u3001\u63a8\u5968\u3057\u3066\u304a\u308a\u3001\u533b\u7642\u6a5f\u5668\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u66f8\u985e\u53d7\u7406\u3078\u306e\u6700\u901f\u306e\u30eb\u30fc\u30c8\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>CSDT \u306b\u52a0\u76df\u3059\u308b\u3053\u3068\u3067\u3001\u4ed6\u306e ASEAN \u5e02\u5834\u3068\u540c\u3058\u898f\u5236\u300c\u8a00\u8a9e\u300d\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u3001\u3084\u308a\u53d6\u308a\u306e\u56de\u6570\u304c\u6e1b\u308a\u3001\u5be9\u67fb\u62c5\u5f53\u8005\u306e\u671f\u5f85\u304c\u3088\u308a\u660e\u78ba\u306b\u306a\u308a\u3001\u6700\u7d42\u7684\u306b\u306f NIE \u306e\u767a\u884c\u304c\u8fc5\u901f\u5316\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u30a4\u30f3\u30b5\u30a4\u30c0\u30fc\u30d2\u30f3\u30c8:<\/strong> \u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u306e\u5834\u5408\u3001NIE\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u53d6\u5f97\u3067\u304d\u308b\u306e\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u73fe\u5730\u6cd5\u4eba\u306e\u307f\u3067\u3042\u308b\u3053\u3068\u306b\u3054\u6ce8\u610f\u304f\u3060\u3055\u3044\u3002\u65e9\u3081\u306b\u73fe\u5730\u306e\u6b63\u5f0f\u306a\u4ee3\u7406\u4eba\u3092\u9078\u4efb\u3057\u3001\u516c\u8a3c\u6e08\u307f\u306e\u59d4\u4efb\u72b6\u3092\u4f5c\u6210\u3057\u3001\u66f8\u985e\u306b\u6dfb\u4ed8\u3057\u3066\u304f\u3060\u3055\u3044\u3002CSDT\u5f62\u5f0f\u3092\u4f7f\u7528\u3059\u308b\u3068\u3001\u4ed6\u306eASEAN\u5e02\u5834\uff08\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u3084\u30de\u30ec\u30fc\u30b7\u30a2\u306a\u3069\uff09\u306e\u6587\u66f8\u3092\u6700\u5c0f\u9650\u306e\u4fee\u6b63\u3067\u518d\u5229\u7528\u3067\u304d\u308b\u305f\u3081\u3001\u8907\u6570\u56fd\u3067\u306e\u627f\u8a8d\u624b\u7d9a\u304d\u304c\u8fc5\u901f\u5316\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ASEAN CSDT\u3068\u306f\u4f55\u3067\u3059\u304b?<\/h2>\n\n\n\n<p>CSDT \u306f\u3059\u3079\u3066\u306e\u4e3b\u8981\u306a\u30bb\u30af\u30b7\u30e7\u30f3\u3092\u7db2\u7f85\u3057\u305f\u69cb\u9020\u5316\u3055\u308c\u305f\u66f8\u985e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3067\u3042\u308a\u3001\u9069\u5207\u306b\u7d44\u307f\u7acb\u3066\u3089\u308c\u308b\u3068\u3084\u308a\u76f4\u3057\u3092\u907f\u3051\u308b\u305f\u3081\u306e\u300c\u30ab\u30f3\u30cb\u30f3\u30b0\u30da\u30fc\u30d1\u30fc\u300d\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u306f\u3069\u306e\u3088\u3046\u306b\u6a5f\u80fd\u3057\u307e\u3059\u304b?<\/h2>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e Regalkes \u30e9\u30a4\u30bb\u30f3\u30b9\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u30ed\u30fc\u30ab\u30eb\u30e9\u30d9\u30eb\u8981\u4ef6\u3084\u30d0\u30cf\u30b5\u8a9e\u7ffb\u8a33\u306a\u3069\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fa\u6709\u306e\u9805\u76ee\u3092\u88dc\u8db3\u3059\u308b\u3053\u3068\u3092\u6761\u4ef6\u306b\u3001CSDT \u3092\u63a8\u5968\u5f62\u5f0f\u3068\u3057\u3066\u660e\u793a\u7684\u306b\u53c2\u7167\u3057\u3066\u3044\u307e\u3059 (<a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Regulasi%20Lisensi%20Produk.pdf\" target=\"_blank\" rel=\"noopener\">Regalkes Kemenkes PDF<\/a>).<\/p>\n\n\n\n<p><strong>CSDT \u3092\u52b9\u679c\u7684\u306b\u4f7f\u7528\u3059\u308b\u65b9\u6cd5\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u884c\u653f\u30c7\u30fc\u30bf\n<ul class=\"wp-block-list\">\n<li>MoH\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u5b8c\u6210\u3055\u305b\u308b\uff08\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u306f\u3053\u3061\u3089\uff09 <a href=\"https:\/\/regalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\">\u30ec\u30ac\u30eb\u30b1\u30b9<\/a> \u30b5\u30a4\u30c8\uff09\u3002<\/li>\n\n\n\n<li>\u30d5\u30a3\u30fc\u30eb\u30c9\u306e\u9806\u5e8f\u3092\u5909\u66f4\u305b\u305a\u306b CSDT \u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3 \u30d5\u30a9\u30fc\u30e0\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u59d4\u4efb\u72b6\uff1a\u5916\u56fd\u88fd\u9020\u696d\u8005\u306f\u3001\u4fdd\u5065\u7701\u306e\u898f\u5b9a\u306b\u5f93\u3044\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u306b\u5bfe\u3057\u3066\u516c\u8a3c\u3055\u308c\u305f\u59d4\u4efb\u72b6\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u533b\u7642\u6a5f\u5668\u306e\u8aac\u660e\u3068\u5206\u985e\n<ul class=\"wp-block-list\">\n<li>AMDD \u306b\u5f93\u3063\u3066\u30c7\u30d0\u30a4\u30b9\u306e ASEAN \u30ea\u30b9\u30af \u30af\u30e9\u30b9 (A \uff5e D) \u3092\u6307\u5b9a\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u30b0\u30ed\u30fc\u30d0\u30eb \u30e2\u30c7\u30eb\u756a\u53f7\u3068\u30ed\u30fc\u30ab\u30eb \u30e2\u30c7\u30eb\u756a\u53f7\u306e\u4e21\u65b9\u3092\u542b\u3081\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u6280\u8853\u6587\u66f8\n<ul class=\"wp-block-list\">\n<li>\u8a2d\u8a08\u66f8\u985e\u3092 IFU \u5185\u306e\u5404\u30af\u30ec\u30fc\u30e0\u306b\u30ea\u30f3\u30af\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u300c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u88dc\u8db3\u4e8b\u9805\u300d\u3092\u4ed8\u3057\u305f\u30ea\u30b9\u30af\u7ba1\u7406\u30ec\u30dd\u30fc\u30c8\uff08ISO 14971\uff09\u3092\u63d0\u51fa\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\n<ul class=\"wp-block-list\">\n<li>ISO 13485 \u8a3c\u660e\u66f8 (\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u306e\u5834\u5408\u306f\u5fc5\u9808) \u3068\u6700\u8fd1\u306e\u76e3\u67fb\u30ec\u30dd\u30fc\u30c8\u3092\u6dfb\u4ed8\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n\n\n\n<li>\u00a0ISO 13485 \u3092\u53d6\u5f97\u3057\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u3001\u540c\u7b49\u306e QMS \u306e\u8a3c\u62e0 (\u516c\u5f0f GMP \u8a3c\u660e\u66f8\u3068 CAPA \u8a18\u9332\u306a\u3069) \u3092\u63d0\u793a\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u305f\u3060\u3057\u3001\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u30c7\u30d0\u30a4\u30b9\u3067\u306f\u3053\u308c\u304c\u53d7\u3051\u5165\u308c\u3089\u308c\u306a\u3044\u5834\u5408\u304c\u3042\u308b\u3053\u3068\u306b\u6ce8\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3068\u5b89\u5168\u6027\u30c7\u30fc\u30bf\n<ul class=\"wp-block-list\">\n<li>\u30d9\u30f3\u30c1\u30c6\u30b9\u30c8\u3068\u751f\u4f53\u9069\u5408\u6027\u30c6\u30b9\u30c8\u3092 1 \u3064\u306e\u4ed8\u9332\u306b\u307e\u3068\u3081\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u91cd\u8981\u306a\u5b89\u5168\u306b\u95a2\u3059\u308b\u58f0\u660e\u3092\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u306b\u7ffb\u8a33\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u30e9\u30d9\u30eb\u3068\u6dfb\u4ed8\u6587\u66f8\n<ul class=\"wp-block-list\">\n<li>\u898f\u5236\u30c1\u30a7\u30c3\u30af\uff1a\u88fd\u54c1\u30e9\u30d9\u30eb\u304c\u4fdd\u5065\u7701\uff08MoH\uff09\u306e\u6700\u65b0\u306e\u8981\u4ef6\u3092\u3059\u3079\u3066\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u308c\u306b\u306f\u3001\u30cf\u30e9\u30fc\u30eb\u30de\u30fc\u30af\uff08\u30c7\u30d0\u30a4\u30b9\u306e\u6750\u6599\u306b\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u306a\u3069\u306e\u65b0\u3057\u3044\u898f\u5247\u3084\u3001\u30e9\u30d9\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u8ca9\u58f2\u696d\u8005\u306e\u60c5\u5831\u3082\u542b\u307e\u308c\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8a73\u7d30\u304c\u4e0d\u8db3\u3057\u3066\u3044\u308b\u3068\u3001\u8a55\u4fa1\u4e2d\u306b\u6700\u7d42\u6bb5\u968e\u3067\u306e\u4fee\u6b63\u3084\u5374\u4e0b\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li>IFU \u306b\u73fe\u5730\u306e\u8a00\u8a9e\u306b\u3088\u308b\u6307\u793a\u3068\u5ec3\u68c4\u60c5\u5831\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<p>\u30c1\u30fc\u30c8\u30b7\u30fc\u30c8 \u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092 CSDT \u6982\u8981\u306b\u76f4\u63a5\u7d71\u5408\u3059\u308b\u3068\u3001\u30d7\u30ed\u30bb\u30b9\u304c\u5408\u7406\u5316\u3055\u308c\u3001\u30bb\u30af\u30b7\u30e7\u30f3\u9593\u306e\u5207\u308a\u66ff\u3048\u304c\u4e0d\u8981\u306a\u5358\u4e00\u306e\u9023\u7d9a\u3057\u305f\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u304c\u4f5c\u6210\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u30a4\u30f3\u30b5\u30a4\u30c0\u30fc\u30d2\u30f3\u30c8:<\/strong> \u7533\u8acb\u66f8\u985e\u306f\u5fc5\u305a\u6700\u7d42\u78ba\u8a8d\u3092\u5fb9\u5e95\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3059\u3079\u3066\u306e\u66f8\u985e\u304c\u6700\u65b0\u306e\u72b6\u614b\u3067\u3042\u308b\u3053\u3068\uff08\u671f\u9650\u5207\u308c\u306e\u8a3c\u660e\u66f8\u3084\u53e4\u3044\u8a66\u9a13\u5831\u544a\u66f8\u304c\u306a\u3044\u3053\u3068\uff09\u3068\u3001\u3059\u3079\u3066\u306e\u5185\u5bb9\u304c\u88fd\u54c1\u306b\u5408\u81f4\u3057\u3001\u4e00\u8cab\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u3054\u78ba\u8a8d\u304f\u3060\u3055\u3044\u3002\u7533\u8acb\u66f8\u985e\u306b\u671f\u9650\u5207\u308c\u306eISO\u8a3c\u660e\u66f8\u304c\u542b\u307e\u308c\u3066\u3044\u305f\u308a\u3001\u30b3\u30d4\u30fc\uff06\u30da\u30fc\u30b9\u30c8\u3055\u308c\u305f\u30c6\u30ad\u30b9\u30c8\u3067\u8aa4\u3063\u305f\u88fd\u54c1\uff0f\u56fd\u540d\u304c\u53c2\u7167\u3055\u308c\u3066\u3044\u305f\u308a\u3059\u308b\u3068\u3001\u7533\u8acb\u304c\u9045\u308c\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30df\u30b9\u306f\u3001\u7533\u8acb\u524d\u306e\u76e3\u67fb\u3067\u767a\u898b\u3067\u304d\u307e\u3059\u3002CSDT\u306bQA\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u7d44\u307f\u8fbc\u3080\u3053\u3068\u3067\u3001\u3053\u308c\u3089\u306e\u554f\u984c\u3092\u65e9\u671f\u306b\u767a\u898b\u3057\u3001\u7533\u8acb\u304c\u6ede\u308b\u524d\u306b\u4fee\u6b63\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u8fc5\u901f\u306a\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3068\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9<\/h2>\n\n\n\n<p>\u66f8\u985e\u306b\u6b20\u9665\u304c\u306a\u304b\u3063\u305f\u3068\u3057\u3066\u3082\u3001\u6b63\u3057\u3044\u624b\u9806\u3092\u77e5\u3063\u3066\u304a\u304f\u3053\u3068\u3067\u3001\u627f\u8a8d\u307e\u3067\u306e\u671f\u9593\u3092\u6570\u9031\u9593\u77ed\u7e2e\u3067\u304d\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>CSDT\u5f62\u5f0f\u3067\u65e9\u3044\u6bb5\u968e\u3067\u66f8\u985e\u4f5c\u6210\u3092\u958b\u59cb\u3059\u308b\u3053\u3068\u3067\u3001\u7ffb\u8a33\u3001\u6280\u8853\u30ec\u30d3\u30e5\u30fc\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u3092\u4e26\u884c\u3057\u3066\u9032\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u4e00\u5ea6\u306b1\u3064\u306e\u30d0\u30c8\u30f3\u3092\u6e21\u3059\u306e\u3067\u306f\u306a\u304f\u3001\u8907\u6570\u306e\u30ec\u30fc\u30f3\u3092\u8d70\u308b\u3088\u3046\u306a\u3082\u306e\u3060\u3068\u8003\u3048\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u5178\u578b\u7684\u306a\u9ad8\u901f\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>0\u9031\u76ee: <\/strong>\u73fe\u5730\u306e\u62c5\u5f53\u8005\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u5fc5\u8981\u306a\u30e9\u30a4\u30bb\u30f3\u30b9\uff08\u6709\u52b9\u306aIDAK\/IPAK\u914d\u5e03\u30e9\u30a4\u30bb\u30f3\u30b9\u3068\u9069\u6b63\u914d\u5e03\u57fa\u6e96\uff08CDAKB\uff09\u8a3c\u660e\u66f8\uff09\u3092\u3059\u3079\u3066\u4fdd\u6709\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>1\uff5e2\u9031\u76ee:<\/strong> \u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u30c6\u30b9\u30c8 \u30ec\u30dd\u30fc\u30c8\u3092\u53ce\u96c6\u3057\u3001\u540c\u6642\u306b\u30d0\u30cf\u30b5\u8a9e\u306e\u7ffb\u8a33\u3092\u958b\u59cb\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u7b2c3\u9031:<\/strong> CSDT \u30bb\u30af\u30b7\u30e7\u30f3\u3092\u7d44\u307f\u7acb\u3066\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3068\u7167\u5408\u3057\u3001\u4e8b\u524d\u5be9\u67fb\u306e\u305f\u3081\u306b OSS \u306b\u30c9\u30e9\u30d5\u30c8\u3092\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u7b2c4\u9031:<\/strong> NIE \u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u9001\u4fe1\u3057\u307e\u3059\u3002\u5be9\u67fb\u5b98\u304b\u3089\u306e\u8efd\u5fae\u306a\u8cea\u554f\u306b\u306f\u6570\u65e5\u4ee5\u5185\u306b\u56de\u7b54\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<\/ul>\n\n\n\n<p><strong>\u30a4\u30f3\u30b5\u30a4\u30c0\u30fc\u30d2\u30f3\u30c8:<\/strong> 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href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/medical-device-registration-in-indonesia-nie-risk-classes-regulatory-strategy\/\">NIE\u627f\u8a8d<\/a> \u6570\u304b\u6708\u3067\u306f\u306a\u304f\u6570\u9031\u9593\u3067\u3002<\/p>\n\n\n\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u898f\u5236\u74b0\u5883\u306f\u6025\u901f\u306b\u5909\u5316\u3057\u3066\u304a\u308a\u3001CSDT\u306f\u4e00\u6b69\u5148\u3092\u884c\u304f\u305f\u3081\u306e\u79d8\u8a23\u3067\u3059\u3002CSDT\u306b\u57fa\u3065\u3044\u3066\u7533\u8acb\u66f8\u985e\u3092\u69cb\u9020\u5316\u3059\u308b\u3053\u3068\u3067\u3001ASEAN\u8af8\u56fd\u3068\u306e\u6574\u5408\u6027\u304c\u53d6\u308c\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u5be9\u67fb\u30b5\u30a4\u30af\u30eb\u3084\u3084\u308a\u53d6\u308a\u306e\u56de\u6570\u3092\u5927\u5e45\u306b\u524a\u6e1b\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u63d0\u643a\u3059\u308b\u3053\u3068\u3067 <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\"><strong>\u88fd\u54c1\u767b\u9332\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2.com<\/strong>,<\/a> \u5f53\u793e\u3067\u306f\u3001\u6700\u65b0\u306e CSDT \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fa\u6709\u306e\u88dc\u8db3\u8cc7\u6599\u306e\u4f7f\u7528\u3092\u304a\u624b\u4f1d\u3044\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u8aa4\u89e3\u3092\u907f\u3051\u308b\u305f\u3081\u306b\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u306e\u6587\u66f8\u306e\u63d0\u4f9b\u3084\u3001\u5c02\u9580\u30c1\u30fc\u30e0\u306b\u3088\u308b OSS \u30dd\u30fc\u30bf\u30eb \u30b5\u30dd\u30fc\u30c8\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u6709\u52b9\u306a\u8a3c\u660e\u66f8\u304b\u3089\u6b63\u78ba\u306a\u7ffb\u8a33\u307e\u3067\u3001\u6587\u66f8\u306e\u54c1\u8cea\u3092\u5e38\u306b\u78ba\u8a8d\u3059\u308b\u3053\u3068\u306f\u3001CSDT\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u306e\u9075\u5b88\u3068\u540c\u3058\u304f\u3089\u3044\u91cd\u8981\u3067\u3059\u3002\u9069\u5207\u306a\u6e96\u5099\u3068\u5c02\u9580\u5bb6\u306e\u6307\u5c0e\u304c\u3042\u308c\u3070\u3001\u3088\u304f\u3042\u308b\u843d\u3068\u3057\u7a74\u3092\u56de\u907f\u3057\u3001\u3088\u308a\u8fc5\u901f\u306b\u627f\u8a8d\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>To harmonize ASEAN filings and reduce redundant work, the ASEAN Medical Device Directive introduced the Common Submission Dossier Template (CSDT). Indonesia\u2019s Ministry of Health now accepts and prefers the CSDT layout, making it your fastest route to dossier acceptance in the medical device registration process. By aligning with the CSDT, you speak the same regulatory \u201clanguage\u201d as other ASEAN markets\u2014ensuring fewer back-and-forths, clearer reviewer expectations, and ultimately, a speedier NIE issuance. Insider Tip: If you\u2019re a foreign manufacturer, remember that only a local Indonesian entity can hold the NIE license. Appoint an authorized local representative early and prepare a notarized Letter of Authorization to include in your dossier. Using the [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":2437,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-2436","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\/2436","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=2436"}],"version-history":[{"count":3,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/2436\/revisions"}],"predecessor-version":[{"id":4099,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/2436\/revisions\/4099"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/2437"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=2436"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=2436"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=2436"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=2436"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}