{"id":7762,"date":"2026-09-22T11:12:47","date_gmt":"2026-09-22T04:12:47","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=7762"},"modified":"2026-09-22T11:13:10","modified_gmt":"2026-09-22T04:13:10","slug":"orthopaedic-implant-registration","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/ja\/orthopaedic-implant-registration\/","title":{"rendered":"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u767b\u9332\uff1a\u30af\u30e9\u30b9C\u304a\u3088\u3073D\u306e\u7d4c\u8def"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u80a1\u95a2\u7bc0\u30d7\u30ed\u30c6\u30fc\u30bc\u3068\u810a\u690e\u56fa\u5b9a\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u540c\u3058\u4f5c\u696d\u53f0\u306b\u7f6e\u304b\u308c\u3066\u3044\u3066\u3082\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\uff08Kemenkes\uff09\u306b\u63d0\u51fa\u3055\u308c\u308b\u3068\u3001\u307e\u3063\u305f\u304f\u7570\u306a\u308b\u898f\u5236\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u5206\u985e\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u307b\u3068\u3093\u3069\u306e\u7533\u8acb\u3067\u4e88\u7b97\u306b\u8a08\u4e0a\u3055\u308c\u3066\u3044\u306a\u3044\u90e8\u5206\u3067\u3059\u3002\u88fd\u9020\u696d\u8005\u306f\u30af\u30e9\u30b9C\u306e\u7533\u8acb\u3092\u524d\u63d0\u306b\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3068\u4fa1\u683c\u3092\u8a2d\u5b9a\u3057\u3001\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u304c\u8a55\u4fa1\u8005\u306e\u673a\u306b\u5c4a\u304f\u307e\u3067\u306f\u3059\u3079\u3066\u9806\u8abf\u306b\u9032\u3093\u3067\u3044\u308b\u3088\u3046\u306b\u898b\u3048\u307e\u3059\u304c\u3001\u30c7\u30d0\u30a4\u30b9\u304c\u30af\u30e9\u30b9D\u306b\u518d\u5206\u985e\u3055\u308c\u3066\u8fd4\u9001\u3055\u308c\u3066\u304f\u308b\u3068\u3001\u5be9\u67fb\u306e\u30ab\u30a6\u30f3\u30c8\u30c0\u30a6\u30f3\u304c\u30ea\u30bb\u30c3\u30c8\u3055\u308c\u3001\u653f\u5e9c\u624b\u6570\u6599\u304c\u9ad8\u984d\u306b\u306a\u308a\u3001\u8a55\u4fa1\u8005\u306f\u8ab0\u3082\u6e96\u5099\u3059\u308b\u4e88\u5b9a\u306e\u306a\u304b\u3063\u305f\u81e8\u5e8a\u8a3c\u62e0\u3092\u8981\u6c42\u3057\u59cb\u3081\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u898f\u5236\u81ea\u4f53\u304c\u793a\u5506\u3059\u308b\u3088\u308a\u3082\u983b\u7e41\u306b\u767a\u751f\u3057\u307e\u3059\u3002\u306a\u305c\u306a\u3089\u30012017 \u5e74 Permenkes No. 62 \u306b\u306f\u3001\u3053\u306e\u518d\u5206\u985e\u304c\u898f\u5247\u3068\u3057\u3066\u660e\u8a18\u3055\u308c\u3066\u3044\u306a\u3044\u304b\u3089\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u8a55\u4fa1\u8005\u304c\u5b9f\u969b\u306b\u6a5f\u5668\u306e\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u3092\u3069\u306e\u3088\u3046\u306b\u8aad\u307f\u53d6\u308b\u304b\u3068\u3044\u3046\u70b9\u306b\u306e\u307f\u73fe\u308c\u3001\u307e\u3055\u306b\u7533\u8acb\u306e\u9014\u4e2d\u3067\u30c1\u30fc\u30e0\u304c\u4e0d\u610f\u3092\u7a81\u304b\u308c\u308b\u7a2e\u985e\u306e\u8a73\u7d30\u3067\u3059\u3002\u898f\u5236\u95a2\u9023\u30c1\u30fc\u30e0\u306b\u6240\u5c5e\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u6574\u5f62\u5916\u79d1\u30d6\u30e9\u30f3\u30c9\u306e\u6d41\u901a\u3092\u62c5\u5f53\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u307e\u305f\u306f\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3092\u88fd\u9020\u3057\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3092\u6b21\u306e\u5e02\u5834\u3068\u3057\u3066\u691c\u8a0e\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u3053\u308c\u306f\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306b\u30b3\u30df\u30c3\u30c8\u3059\u308b\u524d\u306b\u7406\u89e3\u3057\u3066\u304a\u304f\u3079\u304d\u5224\u65ad\u3067\u3042\u308a\u3001\u5f8c\u304b\u3089\u7406\u89e3\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u4ee5\u4e0b\u3067\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30af\u30e9\u30b9 C \u533b\u7642\u6a5f\u5668\u3068\u30af\u30e9\u30b9 D \u533b\u7642\u6a5f\u5668\u3092 Kemenkes \u304c\u3069\u306e\u3088\u3046\u306b\u533a\u5225\u3059\u308b\u304b\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u304c\u4e00\u65b9\u304b\u3089\u4ed6\u65b9\u306b\u79fb\u884c\u3059\u308b\u306e\u306f\u3069\u306e\u3088\u3046\u306a\u5834\u5408\u304b\u3001Regalkes \u3078\u306e\u63d0\u51fa\u81ea\u4f53\u304c\u3069\u306e\u3088\u3046\u306b\u5c55\u958b\u3059\u308b\u304b\u3001\u7533\u8acb\u524d\u306b\u8a08\u753b\u3059\u3079\u304d\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3001\u30b3\u30b9\u30c8\u3001\u5e02\u5834\u6a5f\u4f1a\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u307b\u3068\u3093\u3069\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u898f\u5236\u3067\u30af\u30e9\u30b9C\u306b\u5206\u985e\u3055\u308c\u308b\u7406\u7531<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"667\" src=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Orthopaedic-Implant-Registration-in-Indonesia-2.webp\" alt=\"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u767b\u9332\" class=\"wp-image-7764\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Orthopaedic-Implant-Registration-in-Indonesia-2.webp 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Orthopaedic-Implant-Registration-in-Indonesia-2-300x200.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Orthopaedic-Implant-Registration-in-Indonesia-2-768x512.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112243\/permenkes-no-62-tahun-2017\" target=\"_blank\" rel=\"noopener\">Permenkes No. 62 Tahun 2017<\/a> tentang Izin Edar Alat Kesehatan\u3001Alat Kesehatan In Vitro Diagnostik dan Perbekalan Kesehatan Rumah Tanga\u3001\u767a\u884c <a href=\"https:\/\/kemkes.go.id\/eng\/home\" target=\"_blank\" rel=\"noopener\">\u4fdd\u5065\u7701\uff08Kemenkes\uff09<\/a>, \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332\u306b\u9069\u7528\u3055\u308c\u308b4\u6bb5\u968e\u306e\u30ea\u30b9\u30af\u5206\u985e\u3092\u5b9a\u3081\u3066\u3044\u308b\u3002\u30af\u30e9\u30b9A\uff08\u4f4e\u30ea\u30b9\u30af\uff09\u3001\u30af\u30e9\u30b9B\uff08\u4f4e\uff5e\u4e2d\u30ea\u30b9\u30af\uff09\u3001\u30af\u30e9\u30b9C\uff08\u4e2d\uff5e\u9ad8\u30ea\u30b9\u30af\uff09\u3001\u30af\u30e9\u30b9D\uff08\u9ad8\u30ea\u30b9\u30af\uff09\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30d7\u30ec\u30fc\u30c8\u3001\u30cd\u30b8\u3001\u9ac4\u5185\u91d8\u3001\u5358\u95a2\u7bc0\u30d7\u30ed\u30c6\u30fc\u30bc\u306a\u3069\u306e\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306f\u3001\u4fb5\u8972\u6027\u304c\u3042\u308a\u3001\u9577\u671f\u306b\u308f\u305f\u3063\u3066\u63a5\u89e6\u3059\u308b\u533b\u7642\u6a5f\u5668\u3067\u3059\u30022017\u5e74\u653f\u4ee4\u7b2c62\u53f7\u306e\u5206\u985e\u4ed8\u5c5e\u66f8\u306b\u3088\u308c\u3070\u3001\u3053\u308c\u3089\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306f\u901a\u5e38\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u767b\u9332\u306b\u304a\u3044\u3066\u3001\u30af\u30e9\u30b9C\u533b\u7642\u6a5f\u5668\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u30af\u30e9\u30b9C\u306f\u3001\u5b8c\u5168\u306a\u6280\u8853\u8a55\u4fa1\u3092\u5fc5\u8981\u3068\u3059\u308b\u3082\u306e\u306e\u3001\u30af\u30e9\u30b9D\u533b\u7642\u6a5f\u5668\u3088\u308a\u3082\u516c\u958b\u5be9\u67fb\u671f\u9593\u304c\u77ed\u3044\u4e2d\u9593\u30ab\u30c6\u30b4\u30ea\u30fc\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30af\u30e9\u30b9D\u533b\u7642\u6a5f\u5668\u30b9\u30c6\u30fc\u30bf\u30b9\u306b\u79fb\u884c\u3059\u308b\u5834\u5408<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8907\u6570\u306e\u95a2\u7bc0\u3001\u8907\u6570\u306e\u624b\u8853\u624b\u6280\u3001\u307e\u305f\u306f\u4ed6\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u7d44\u307f\u5408\u308f\u305b\u3067\u306e\u4f7f\u7528\u304c\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u591a\u81e8\u5e8a\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306f\u3001\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u767b\u9332\u306b\u304a\u3044\u3066\u3001\u6700\u3082\u983b\u7e41\u306b\u30af\u30e9\u30b9D\u306b\u518d\u5206\u985e\u3055\u308c\u308b\u30b0\u30eb\u30fc\u30d7\u3067\u3059\u3002\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001\u3053\u308c\u306f\u3001\u7269\u7406\u7684\u306a\u30c7\u30d0\u30a4\u30b9\u3084\u6750\u6599\u304c\u3001\u65e2\u306b\u4ed6\u306e\u5834\u6240\u3067\u767b\u9332\u3055\u308c\u3066\u3044\u308b\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30af\u30e9\u30b9C\u533b\u7642\u6a5f\u5668\u3068\u5909\u308f\u3089\u306a\u3044\u5834\u5408\u3067\u3082\u3001\u4f7f\u7528\u76ee\u7684\u306e\u8a18\u8ff0\u304c\u5e83\u7bc4\u306b\u306a\u308b\u3053\u3068\u3067\u3001\u8a55\u4fa1\u8005\u304c\u8a55\u4fa1\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u304c\u4e0a\u6607\u3059\u308b\u305f\u3081\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2017\u5e74\u4fdd\u5065\u7701\u4ee4\u7b2c62\u53f7\u7b2c7\u9805\u3067\u306f\u3001\u30af\u30e9\u30b9D\u3092\u60a3\u8005\u306b\u9ad8\u3044\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3059\u533b\u7642\u6a5f\u5668\u3068\u5b9a\u7fa9\u3057\u3066\u3044\u308b\u304c\u3001\u4fdd\u5065\u7701\u306e\u5206\u985e\u6307\u91dd\u3067\u306f\u3001\u5883\u754c\u57df\u3001\u8907\u5408\u3001\u304a\u3088\u3073\u591a\u9069\u5fdc\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u6271\u3044\u306b\u3064\u3044\u3066\u306f\u3001\u56fa\u5b9a\u3055\u308c\u305f\u516c\u5f0f\u3067\u306f\u306a\u304f\u3001\u8a55\u4fa1\u8005\u306e\u5224\u65ad\u306b\u59d4\u306d\u3066\u3044\u308b\u3002\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u88fd\u9020\u696d\u8005\u306e\u5206\u985e\u306b\u95a2\u3059\u308b\u60f3\u5b9a\u3068\u4fdd\u5065\u7701\u306e\u5b9f\u969b\u306e\u5224\u65ad\u304c\u98df\u3044\u9055\u3046\u306e\u306f\u3001\u307e\u3055\u306b\u3053\u306e\u5224\u65ad\u306b\u59d4\u306d\u3089\u308c\u3066\u3044\u308b\u70b9\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3044\u3066\u3001\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u304c\u30af\u30e9\u30b9C\u304b\u30af\u30e9\u30b9D\u304b\u3092\u6c7a\u5b9a\u3059\u308b\u8981\u56e0\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u5206\u985e\u306f\u3001\u305d\u306e\u4f7f\u7528\u76ee\u7684\u3001\u4fb5\u8972\u6027\u3001\u304a\u3088\u3073\u8eab\u4f53\u3068\u306e\u63a5\u89e6\u671f\u9593\u306b\u57fa\u3065\u3044\u3066\u304a\u308a\u3001Kemenkes \u304c 4 \u6bb5\u968e\u30b7\u30b9\u30c6\u30e0\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3057\u307e\u3059\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112243\/permenkes-no-62-tahun-2017\" target=\"_blank\" rel=\"noopener\">Permenkes No. 62 Tahun 2017<\/a>. \u5358\u4e00\u9069\u5fdc\u75c7\u3001\u5358\u4e00\u95a2\u7bc0\u7528\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306f\u3001\u4e00\u822c\u7684\u306b\u30af\u30e9\u30b9C\u3068\u3057\u3066\u767b\u9332\u3055\u308c\u307e\u3059\u3002\u8907\u6570\u306e\u95a2\u7bc0\u3001\u8907\u6570\u306e\u624b\u8853\u624b\u6280\u3001\u307e\u305f\u306f\u4ed6\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u4f75\u7528\u3092\u76ee\u7684\u3068\u3057\u305f\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306f\u3001\u591a\u304f\u306e\u5834\u5408\u30af\u30e9\u30b9D\u306b\u5206\u985e\u3055\u308c\u3001\u5be9\u67fb\u6642\u9593\u3001\u8ffd\u52a0\u306e\u81e8\u5e8a\u8a3c\u62e0\u3001\u304a\u3088\u3073PNBP\u6599\u91d1\u306e\u4e0a\u6607\u304c\u767a\u751f\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30b1\u30e1\u30f3\u30b1\u30b9\u72ec\u81ea\u306e\u5206\u985e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3060\u3051\u3067\u306a\u304f\u3001\u3042\u3089\u3086\u308b\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u8a55\u4fa1\u8005\u304c\u8003\u616e\u3059\u308b\u5177\u4f53\u7684\u306a\u8981\u7d20\u304c\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u5177\u4f53\u7684\u306b\u306f\u3001\u8eab\u4f53\u3068\u306e\u63a5\u89e6\u671f\u9593\u3001\u4fb5\u8972\u6027\u306e\u7a0b\u5ea6\u3068\u7d4c\u8def\u3001\u4ed6\u306e\u533b\u7642\u6a5f\u5668\u3068\u306e\u4f75\u7528\u306e\u6709\u7121\u3001\u4f7f\u7528\u76ee\u7684\u3001\u5c40\u6240\u7684\u304b\u5168\u8eab\u7684\u304b\u3001\u4f53\u5185\u3067\u306e\u4f5c\u7528\u6a5f\u5e8f\u3001\u305d\u3057\u3066\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u751f\u7269\u5b66\u7684\u52b9\u679c\u306a\u3069\u3067\u3059\u3002\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u5834\u5408\u3001\u4f75\u7528\u3068\u591a\u9069\u5fdc\u75c7\u3068\u3044\u3046\u8981\u7d20\u304c\u3001\u901a\u5e38\u3001\u7533\u8acb\u3092\u30af\u30e9\u30b9C\u304b\u3089\u30af\u30e9\u30b9D\u306b\u62bc\u3057\u4e0a\u3052\u308b\u8981\u56e0\u3068\u306a\u308a\u307e\u3059\u3002\u8aa4\u3063\u305f\u81ea\u5df1\u7533\u544a\u306b\u3088\u308b\u30af\u30e9\u30b9\u306f\u884c\u653f\u4e0a\u306e\u5374\u4e0b\u306e\u4e00\u822c\u7684\u306a\u539f\u56e0\u3068\u306a\u308b\u305f\u3081\u3001\u88fd\u9020\u696d\u8005\u306f\u7533\u8acb\u524d\u306b\u30ec\u30ac\u30eb\u30b1\u30b9\u306b\u63d0\u51fa\u3059\u308b\u81ea\u5df1\u8a55\u4fa1\u3092\u901a\u3058\u3066\u30af\u30e9\u30b9\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30af\u30e9\u30b9C\u3068\u30af\u30e9\u30b9D\u306e\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u767b\u9332\u306e\u6982\u8981<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u306e\u8868\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u969b\u306b\u3001\u30af\u30e9\u30b9C\u304a\u3088\u3073\u30af\u30e9\u30b9D\u306e\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u7533\u8acb\u66f8\u985e\u304c\u76f4\u9762\u3059\u308b\u5b9f\u969b\u7684\u306a\u9055\u3044\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u57fa\u6e96<\/strong><\/th><th><strong>\u30af\u30e9\u30b9C<\/strong><\/th><th><strong>\u30af\u30e9\u30b9D<\/strong><\/th><\/tr><\/thead><tbody><tr><td>\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\uff08\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c62\/2017\u53f7\uff09<\/td><td>\u4e2d\u7a0b\u5ea6\u304b\u3089\u9ad8\u30ea\u30b9\u30af<\/td><td>\u9ad8\u30ea\u30b9\u30af<\/td><\/tr><tr><td>\u5178\u578b\u7684\u306a\u6574\u5f62\u5916\u79d1\u306e\u4f8b<\/td><td>\u30d7\u30ec\u30fc\u30c8\u3001\u30cd\u30b8\u3001\u9ac4\u5185\u91d8\u3001\u5358\u95a2\u7bc0\u30d7\u30ed\u30c6\u30fc\u30bc<\/td><td>\u591a\u9069\u5fdc\u95a2\u7bc0\u30b7\u30b9\u30c6\u30e0\u3001\u591a\u81e8\u5e8a\u810a\u690e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u8907\u5408\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>\u30ec\u30d3\u30e5\u30fc\u5bfe\u8c61\u3001\u56fd\u5185\u30c7\u30d0\u30a4\u30b9<\/td><td>30\u55b6\u696d\u65e5<\/td><td>40\u55b6\u696d\u65e5<\/td><\/tr><tr><td>\u30ec\u30d3\u30e5\u30fc\u5bfe\u8c61\u3001\u8f38\u5165\u30c7\u30d0\u30a4\u30b9<\/td><td>40\u55b6\u696d\u65e5<\/td><td>55\u55b6\u696d\u65e5<\/td><\/tr><tr><td>\u81e8\u5e8a\u7684\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u57fa\u6e96<\/td><td>\u6587\u732e\u306b\u57fa\u3065\u304f\u81e8\u5e8a\u8a55\u4fa1\u306f\u901a\u5e38\u53d7\u3051\u5165\u308c\u3089\u308c\u3066\u3044\u308b<\/td><td>\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c63\/2017\u53f7\u306b\u57fa\u3065\u304f\u5b8c\u5168\u306a\u8a55\u4fa1\u3001\u591a\u304f\u306e\u5834\u5408\u30ed\u30fc\u30ab\u30eb\u30c7\u30fc\u30bf<\/td><\/tr><tr><td>PNBP\u653f\u5e9c\u624b\u6570\u6599<\/td><td>\u4f4e\u6599\u91d1\u533a\u5206<\/td><td>\u3088\u308a\u9ad8\u3044\u95a2\u7a0e\u533a\u5206\uff08PP No. 64\/2019\uff09<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u30ec\u30d3\u30e5\u30fc\u65e5\u306e\u76ee\u6a19\u306f\u30012017 \u5e74 Permenkes No. 62 \u306b\u63b2\u8f09\u3055\u308c\u305f\u30b5\u30fc\u30d3\u30b9\u57fa\u6e96\u3092\u53cd\u6620\u3057\u3066\u304a\u308a\u3001\u6700\u521d\u306e\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u65e5\u304b\u3089\u3067\u306f\u306a\u304f\u3001\u56fa\u5b9a\u306e\u53d7\u9818 (tanda terima tetap) \u65e5\u304b\u3089\u30ab\u30a6\u30f3\u30c8\u3055\u308c\u307e\u3059\u3002\u6280\u8853\u7684\u306a\u554f\u3044\u5408\u308f\u305b\u3078\u306e\u5bfe\u5fdc\u306b\u8cbb\u3084\u3057\u305f\u6642\u9593\u306f\u9664\u5916\u3055\u308c\u307e\u3059\u3002\u30b5\u30fc\u30d3\u30b9\u57fa\u6e96\u3068\u6599\u91d1\u4f53\u7cfb\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u624b\u6bb5\u306b\u3088\u3063\u3066\u5b9a\u671f\u7684\u306b\u66f4\u65b0\u3055\u308c\u307e\u3059\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/335213\/permenkes-no-11-tahun-2025\" target=\"_blank\" rel=\"noopener\">Permenkes No. 11 Tahun 2025<\/a>, \u305d\u306e\u305f\u3081\u3001\u9867\u5ba2\u5411\u3051\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3092\u8a2d\u5b9a\u3059\u308b\u524d\u306b\u3001\u73fe\u5728\u306eSLA\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u767b\u9332\u306e\u6cd5\u7684\u6839\u62e0<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u767b\u9332\u3092\u898f\u5b9a\u3059\u308b\u4ee5\u4e0b\u306e\u6587\u66f8\u306f\u3001\u5c02\u9580\u5bb6\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u62c5\u5f53\u8005\u304c\u51fa\u7248\u524d\u306b\u78ba\u8a8d\u3059\u3079\u304d\u4e3b\u8981\u306a\u53c2\u8003\u8cc7\u6599\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.kemkes.go.id\/id\/undang-undang-republik-indonesia-nomor-17-tahun-2023-tentang-kesehatan\" target=\"_blank\" rel=\"noopener\"><strong>\u30a6\u30f3\u30c0\u30f3\u30fb\u30a6\u30f3\u30c0\u30f3 No. 17 \u30bf\u30d5\u30f3 2023<\/strong><\/a> <strong>\u30c6\u30f3\u30bf\u30f3\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3 (\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u30fb\u30da\u30e1\u30ea\u30f3\u30bf\u5171\u548c\u56fd):<\/strong> Pasal 143\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u3092\u88fd\u9020\u307e\u305f\u306f\u8ca9\u58f2\u3059\u308b\u8005\u306f\u3001\u4e2d\u592e\u653f\u5e9c\u307e\u305f\u306f\u5730\u65b9\u653f\u5e9c\u304b\u3089\u95a2\u9023\u3059\u308bizin edar\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u304a\u308a\u3001\u3053\u308c\u306f\u672c\u7a3f\u5168\u4f53\u3092\u901a\u3057\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u308bizin edar\u8981\u4ef6\u306e\u5305\u62ec\u7684\u306a\u6cd5\u7684\u6839\u62e0\u3068\u306a\u3063\u3066\u3044\u308b\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112243\/permenkes-no-62-tahun-2017\" target=\"_blank\" rel=\"noopener\"><strong>Permenkes No. 62 Tahun 2017<\/strong><\/a> <strong>(Kementerian Kesehatan):<\/strong> Izin Edar Alat Kesehatan\u3001Alat Kesehatan In Vitro Diagnostik dan Perbekalan Kesehatan Rumah Tangga;\u57fa\u672c\u7684\u306a\u5206\u985e\u3068\u30e9\u30a4\u30bb\u30f3\u30b9\u898f\u5236\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112244\/permenkes-no-63-tahun-2017\" target=\"_blank\" rel=\"noopener\"><strong>Permenkes No. 63 Tahun 2017<\/strong><\/a> <strong>(Kementerian Kesehatan):<\/strong> \u30ab\u30e9\u30fb\u30a6\u30b8\u30fb\u30af\u30ea\u30cb\u30c3\u30af\u30fb\u30a2\u30e9\u30c3\u30c8\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3\u30fb\u30e4\u30f3\u30fb\u30d0\u30af\u3002\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306b\u9069\u7528\u3055\u308c\u308b\u81e8\u5e8a\u8a3c\u62e0\u3068\u9069\u6b63\u81e8\u5e8a\u5b9f\u65bd\u57fa\u6e96\u3092\u898f\u5b9a\u3057\u307e\u3059\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/335213\/permenkes-no-11-tahun-2025\" target=\"_blank\" rel=\"noopener\"><strong>Permenkes No. 11 Tahun 2025<\/strong><\/a> <strong>(Kementerian Kesehatan)\u30012025 \u5e74 10 \u6708 3 \u65e5\u767a\u52b9:<\/strong> \u30b9\u30bf\u30f3\u30c0\u30fc\u30eb \u30b1\u30ae\u30a2\u30bf\u30f3 \u30a6\u30b5\u30cf \u30c0\u30f3 \u30b9\u30bf\u30f3\u30c0\u30fc\u30eb \u30d7\u30ed\u30c0\u30af\u30c8\/\u30b8\u30e3\u30b5 \u30d1\u30c0 \u30da\u30cb\u30a8\u30ec\u30f3\u30ac\u30e9\u30fc\u30f3 \u30da\u30ea\u30b8\u30ca\u30f3 \u30d9\u30eb\u30b5\u30cf \u30d9\u30eb\u30d0\u30b7\u30b9 \u30ea\u30b7\u30b3 \u30b5\u30d6\u30bb\u30af\u30bf\u30fc \u30b1\u30bb\u30cf\u30bf\u30f3\u3002\u73fe\u5728\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u30e9\u30a4\u30bb\u30f3\u30b9\u57fa\u6e96\u306f\u3001Regalkes \u3092\u901a\u3058\u3066\u51e6\u7406\u3055\u308c\u308b Izin Edar \u624b\u9806\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/120630\/pp-no-64-tahun-2019\" target=\"_blank\" rel=\"noopener\"><strong>PP No. 64 Tahun 2019<\/strong><\/a> <strong>(\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u30fb\u30da\u30e1\u30ea\u30f3\u30bf\u5171\u548c\u56fd):<\/strong> \u30b8\u30a7\u30cb\u30b9\u30fb\u30c0\u30f3\u30fb\u30bf\u30ea\u30d5\u30fb\u30a2\u30bf\u30b9\u30fb\u30da\u30cd\u30ea\u30de\u30f3\u30fb\u30cd\u30ac\u30e9\u30fb\u30d6\u30ab\u30f3\u30fb\u30d1\u30b8\u30e3\u30af\u30fb\u30e4\u30f3\u30fb\u30d9\u30eb\u30e9\u30af\u30fb\u30d1\u30c0\u30fb\u30b1\u30e1\u30f3\u30c6\u30ea\u30a2\u30f3\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3\u3002\u30c7\u30d0\u30a4\u30b9 \u30af\u30e9\u30b9\u306b\u3088\u3063\u3066\u53c2\u7167\u3055\u308c\u308b PNBP \u6599\u91d1\u4f53\u7cfb\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/asean.org\/book\/asean-medical-device-directive\/\" target=\"_blank\" rel=\"noopener\"><strong>ASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4<\/strong><\/a> <strong>\uff08AMDD\uff09\u3001\u9644\u5c5e\u66f84\uff1a<\/strong> ASEAN\u5171\u901a\u63d0\u51fa\u66f8\u985e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08CSDT\uff09\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u304cRegalkes\u63d0\u51fa\u306b\u8981\u6c42\u3059\u308b\u66f8\u985e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3067\u3059\u3002.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Regalkes\u306b\u3088\u308b\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u767b\u9332\u7533\u8acb\u30d7\u30ed\u30bb\u30b9<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Regalkes\u306e\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u3042\u3089\u3086\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u30c7\u30b8\u30bf\u30eb\u57fa\u76e4\u3067\u3042\u308a\u3001\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306f5\u3064\u306e\u6bb5\u968e\u3092\u7d4c\u3066\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u901a\u904e\u3059\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. \u5730\u65b9\u81ea\u6cbb\u4f53\u3001IDAK\u3001\u304a\u3088\u3073CDAKB<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u6d77\u5916\u306e\u6574\u5f62\u5916\u79d1\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81ea\u793e\u3067Izin Edar\uff08\u533b\u7642\u6a5f\u5668\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u8a8d\u8a3c\uff09\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u6709\u52b9\u306aIDAK\uff08\u533b\u7642\u6a5f\u5668\u8ca9\u58f2\u696d\u8005\u8a8d\u8a3c\uff09\u304a\u3088\u3073CDAKB\uff08\u533b\u7642\u6a5f\u5668\u9069\u6b63\u6d41\u901a\u57fa\u6e96\uff09\u8a3c\u660e\u66f8\u3092\u4fdd\u6709\u3059\u308b\u3001\u73fe\u5730\u306b\u62e0\u70b9\u3092\u7f6e\u304f\u8ca9\u58f2\u4ee3\u7406\u5e97\u304c\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u3068\u306a\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306f\u30af\u30e9\u30b9C\u307e\u305f\u306fD\u306b\u5206\u985e\u3055\u308c\u308b\u305f\u3081\u3001\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306e\u5be9\u67fb\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001Kemenkes\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\uff09\u306f\u73fe\u5730\u4ee3\u7406\u5e97\u306eCDAKB\u30b9\u30c6\u30fc\u30bf\u30b9\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. ASEAN CSDT \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u533b\u7642\u6a5f\u5668\u7533\u8acb\u66f8\u985e\u4f5c\u6210<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u7533\u8acb\u66f8\u985e\u306f\u3001AMDD\u306e\u9644\u5c5e\u66f84\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u308bASEAN\u5171\u901a\u63d0\u51fa\u66f8\u985e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3001\u307e\u305f\u306fASEAN CSDT\u533b\u7642\u6a5f\u5668\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5f62\u5f0f\u306b\u6e96\u62e0\u3057\u3066\u304a\u308a\u3001\u884c\u653f\u30c7\u30fc\u30bf\u3001\u6a5f\u5668\u306e\u8aac\u660e\u3068\u5206\u985e\u3001\u6280\u8853\u6587\u66f8\u3001ISO 13485\u8a8d\u8a3c\u306a\u3069\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u8a3c\u62e0\u3001\u6027\u80fd\u304a\u3088\u3073\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u3001\u30e9\u30d9\u30eb\u8868\u793a\u304a\u3088\u3073\u4f7f\u7528\u8aac\u660e\u66f8\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u7533\u8acb\u66f8\u985e\u3067\u306f\u6280\u8853\u6587\u66f8\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u304c\u6700\u3082\u4fee\u6b63\u3092\u5fc5\u8981\u3068\u3059\u308b\u5834\u5408\u304c\u591a\u304f\u3001\u3053\u308c\u306f\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u7533\u8acb\u66f8\u985e\u306b\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u306e\u30e9\u30d9\u30eb\u8868\u793a\u3084\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\u304c\u671f\u5f85\u3059\u308b\u73fe\u5730\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u306b\u95a2\u3059\u308b\u88dc\u8db3\u8cc7\u6599\u304c\u307b\u3068\u3093\u3069\u542b\u307e\u308c\u3066\u3044\u306a\u3044\u305f\u3081\u3067\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3. \u63d0\u51fa\u304a\u3088\u3073PNBP\u652f\u6255\u3044<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b8c\u6210\u3057\u305fCSDT\u7533\u8acb\u66f8\u985e\u306f\u3001regalkes.kemkes.go.id\u306eRegalkes\u63d0\u51fa\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u3055\u308c\u307e\u3059\u3002\u81ea\u5df1\u7533\u544a\u3055\u308c\u305f\u30af\u30e9\u30b9\u304c\u78ba\u8a8d\u3055\u308c\u308b\u3068\u3001\u7533\u8acb\u8005\u306f\u30b7\u30b9\u30c6\u30e0\u304c\u8a2d\u5b9a\u3057\u305f\u652f\u6255\u3044\u671f\u9593\u5185\u306bPNBP\u624b\u6570\u6599\u3092\u652f\u6255\u3044\u3001\u305d\u306e\u5f8c\u3001\u78ba\u5b9a\u9818\u53ce\u66f8\u304c\u767a\u884c\u3055\u308c\u3001\u6280\u8853\u8a55\u4fa1\u306e\u30ab\u30a6\u30f3\u30c8\u30c0\u30a6\u30f3\u304c\u958b\u59cb\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>4. \u6280\u8853\u8a55\u4fa1\u304a\u3088\u3073\u554f\u3044\u5408\u308f\u305b<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u7279\u306b\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u5834\u5408\u3001\u8a55\u4fa1\u8005\u306f\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u306e\u7bc4\u56f2\u3001\u6ec5\u83cc\u691c\u8a3c\u3001\u304a\u3088\u3073\u30af\u30e9\u30b9D\u306e\u7533\u8acb\u66f8\u985e\u306b\u3064\u3044\u3066\u306f\u30012017\u5e74\u653f\u4ee4\u7b2c63\u53f7\u306b\u57fa\u3065\u3044\u3066\u63d0\u51fa\u3055\u308c\u305f\u81e8\u5e8a\u7684\u8a3c\u62e0\u306e\u6df1\u3055\u306b\u3064\u3044\u3066\u8cea\u554f\u3059\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u8cea\u554f\u3078\u306e\u56de\u7b54\u3054\u3068\u306b\u5be9\u67fb\u671f\u9593\u304c\u30ea\u30bb\u30c3\u30c8\u3055\u308c\u308b\u305f\u3081\u3001\u56de\u7b54\u306e\u901f\u3055\u306f\u6700\u521d\u306e\u7533\u8acb\u66f8\u985e\u306e\u8cea\u3068\u540c\u3058\u304f\u3089\u3044\u91cd\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>5. NIE\u306e\u767a\u884c\u3068\u6709\u52b9\u6027<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a55\u4fa1\u304c\u5b8c\u4e86\u3059\u308b\u3068\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\uff08Kemenkes\uff09\u306f\u627f\u8a8d\u756a\u53f7\uff08Nomor Izin Edar\u3001NIE\uff09\u3092\u767a\u884c\u3057\u307e\u3059\u3002\u3053\u306e\u627f\u8a8d\u306f\u767a\u884c\u65e5\u304b\u30895\u5e74\u9593\u6709\u52b9\u3067\u3001\u305d\u306e\u5f8c\u3001\u627f\u8a8d\u8005\u306f\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3092\u5e02\u5834\u3067\u8ca9\u58f2\u3057\u7d9a\u3051\u308b\u305f\u3081\u306b\u3001\u6709\u52b9\u671f\u9650\u524d\u306b\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u95a2\u3059\u308b\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u8981\u4ef6<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u5bfe\u3059\u308b\u671f\u5f85\u306f\u3001\u30af\u30e9\u30b9\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u30af\u30e9\u30b9C\u306e\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306f\u3001\u78ba\u7acb\u3055\u308c\u305f\u5b89\u5168\u6027\u5b9f\u7e3e\u306e\u3042\u308b\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3068\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u3042\u308c\u3070\u3001\u30d9\u30f3\u30c1\u30c6\u30b9\u30c8\u3068\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u306b\u3088\u3063\u3066\u88cf\u4ed8\u3051\u3089\u308c\u305f\u6587\u732e\u306b\u57fa\u3065\u304f\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u306b\u4f9d\u62e0\u3067\u304d\u308b\u5834\u5408\u304c\u591a\u3044\u3067\u3059\u3002\u30af\u30e9\u30b9D\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u7279\u306b\u30de\u30eb\u30c1\u30af\u30ea\u30cb\u30ab\u30eb\u30b7\u30b9\u30c6\u30e0\u306f\u30012017\u5e74\u653f\u4ee4\u7b2c63\u53f7\u306e\u512a\u826f\u81e8\u5e8a\u5b9f\u65bd\u57fa\u6e96\u306b\u7167\u3089\u3057\u3066\u8a55\u4fa1\u3055\u308c\u3001\u8a55\u4fa1\u8005\u306f\u3001\u4ed6\u306e\u5e02\u5834\u304b\u3089\u306e\u30c7\u30fc\u30bf\u306e\u307f\u306b\u57fa\u3065\u304f\u30c7\u30fc\u30bf\u3067\u306f\u306a\u304f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u60a3\u8005\u306b\u304a\u3051\u308b\u5b9f\u969b\u306e\u4f7f\u7528\u3092\u53cd\u6620\u3057\u305f\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u6c42\u3081\u308b\u3053\u3068\u304c\u591a\u304f\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p 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class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u88fd\u54c1\u767b\u9332\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u5546\u696d\u9762\u3068\u898f\u5236\u9762\u306e\u4e21\u65b9\u304b\u3089\u3053\u306e\u53d6\u308a\u7d44\u307f\u3092\u652f\u63f4\u3057\u3066\u3044\u307e\u3059\u3002\u4e8b\u524d\u5be9\u67fb\u306b\u3088\u308b\u5206\u985e\u30ec\u30d3\u30e5\u30fc\u306f\u3001\u30af\u30e9\u30b9D\u3078\u306e\u518d\u5206\u985e\u304c\u767a\u58f2\u65e5\u3092\u72c2\u308f\u305b\u308b\u524d\u306b\u767a\u898b\u3067\u304d\u308b\u3088\u3046\u8a2d\u8a08\u3055\u308c\u3066\u304a\u308a\u3001\u9805\u76ee\u5225\u30b3\u30b9\u30c8\u898b\u7a4d\u3082\u308a\u306b\u3088\u308a\u3001\u88fd\u9020\u696d\u8005\u306e\u8ca1\u52d9\u30c1\u30fc\u30e0\u3068\u4e8b\u696d\u958b\u767a\u30c1\u30fc\u30e0\u306f\u3001\u696d\u754c\u5e73\u5747\u3067\u306f\u306a\u304f\u5b9f\u969b\u306e\u6570\u5024\u306b\u57fa\u3065\u3044\u3066\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u306e\u53ef\u80fd\u6027\u3092\u30e2\u30c7\u30eb\u5316\u3067\u304d\u307e\u3059\u3002\u5b9f\u969b\u3001\u521d\u56de\u304b\u3089\u9069\u5207\u306a\u66f8\u985e\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u6c7a\u5b9a\u3067\u3042\u308b\u3068\u540c\u6642\u306b\u3001\u5e02\u5834\u53c2\u5165\u306e\u30b9\u30d4\u30fc\u30c9\u3092\u5de6\u53f3\u3059\u308b\u91cd\u8981\u306a\u6c7a\u5b9a\u3067\u3082\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u88fd\u54c1\u767b\u9332\u30b5\u30fc\u30d3\u30b9\u304c\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u767b\u9332\u306b\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3064\u304b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u79c1\u305f\u3061\u306e <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668\u767b\u9332<\/a> \u672c\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3092\u542b\u3080\u30af\u30e9\u30b9A\u304b\u3089\u30af\u30e9\u30b9D\u307e\u3067\u306e\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308bASEAN CSDT\u7533\u8acb\u66f8\u985e\u306e\u4f5c\u6210\u3001Regalkes\u63d0\u51fa\u3001\u304a\u3088\u3073\u6280\u8853\u7684\u306a\u554f\u3044\u5408\u308f\u305b\u7ba1\u7406\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u62e0\u70b9\u3092\u6301\u305f\u306a\u3044\u88fd\u9020\u696d\u8005\u5411\u3051\u306b\u3001 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/license-holder-service-in-indonesia\/\">\u30e9\u30a4\u30bb\u30f3\u30b9\u30db\u30eb\u30c0\u30fc\u30b5\u30fc\u30d3\u30b9<\/a> \u5f0a\u793e\u3092\u3001\u304a\u5ba2\u69d8\u306e\u5730\u57df\u306b\u304a\u3051\u308bIDAK\/CDAKB\u4fdd\u6709\u4ee3\u7406\u4eba\u304a\u3088\u3073Izin Edar\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u3068\u3057\u3066\u6d3b\u52d5\u3055\u305b\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u304c\u4e0a\u8a18\u306e\u30af\u30e9\u30b9D\u591a\u81e8\u5e8a\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u8a72\u5f53\u3059\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u3044\u5834\u5408\u3001\u7533\u8acb\u671f\u9650\u3092\u6c7a\u5b9a\u3059\u308b\u524d\u306b\u3001\u5f53\u793e\u306e\u30c1\u30fc\u30e0\u304c\u4e8b\u524d\u5206\u985e\u30ec\u30d3\u30e5\u30fc\u3092\u5b9f\u65bd\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u5f53\u793e\u306e\u898f\u5b9a\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u306e\u3068\u540c\u3058\u66f8\u985e\u4f5c\u6210\u624b\u9806\u306b\u5f93\u3044\u307e\u3059\u3002 <strong>ASEAN CSDT\u533b\u7642\u6a5f\u5668\u767b\u9332\u65e9\u898b\u8868<\/strong>.<\/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=\"vsVsUtu4we\"><a href=\"https:\/\/productregistrationindonesia.com\/ja\/indonesia-medical-device-registration-process-with-asean-csdt-cheat-sheet\/\">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<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u300cASEAN 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\u300d\u2014\u88fd\u54c1\u767b\u9332\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\" src=\"https:\/\/productregistrationindonesia.com\/indonesia-medical-device-registration-process-with-asean-csdt-cheat-sheet\/embed\/#?secret=dKGZqt9KCc#?secret=vsVsUtu4we\" data-secret=\"vsVsUtu4we\" 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>\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u767b\u9332\u306b\u95a2\u3059\u308b\u5c02\u9580\u5bb6\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u53d7\u3051\u307e\u3057\u3087\u3046<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e00\u822c\u7684\u306a\u696d\u754c\u6307\u6a19\u304b\u3089\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e\u3084\u4e88\u7b97\u3092\u63a8\u6e2c\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668\u767b\u9332<\/a> \u5f53\u30c1\u30fc\u30e0\u306f\u3001Regalkes\u306b\u66f8\u985e\u3092\u63d0\u51fa\u3059\u308b\u524d\u306b\u3001\u6a5f\u5668\u306e\u5206\u985e\u3092\u78ba\u8a8d\u3057\u3001\u7533\u8acb\u66f8\u985e\u306e\u8981\u4ef6\u3092\u660e\u78ba\u306b\u3057\u3001\u73fe\u5b9f\u7684\u306a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u8a2d\u5b9a\u3059\u308b\u305f\u3081\u306b\u3001\u88fd\u9020\u696d\u8005\u3084\u8ca9\u58f2\u696d\u8005\u3068\u65e5\u3005\u9023\u643a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u624b\u7d9a\u304d\u3092\u9032\u3081\u308b\u6e96\u5099\u306f\u3067\u304d\u307e\u3057\u305f\u304b\uff1f\u4e0b\u8a18\u306e\u30d5\u30a9\u30fc\u30e0\u306b\u3054\u8a18\u5165\u306e\u4e0a\u3001\u62c5\u5f53\u30c1\u30fc\u30e0\u306b\u3054\u9023\u7d61\u304f\u3060\u3055\u3044\u3002\u5f53\u793e\u306e\u898f\u5236\u5c02\u9580\u5bb6\u304c\u3001\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u767b\u9332\u306b\u95a2\u3059\u308b\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u306b\u3064\u3044\u3066\u3054\u6848\u5185\u3044\u305f\u3057\u307e\u3059\u3002.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>A hip prosthesis and a spinal fixation system can sit on the same workbench and still land in two completely different regulatory categories once they reach Kemenkes. That&#8217;s the part most filings don&#8217;t budget for. A manufacturer builds its timeline and pricing around a Class C submission, and everything looks routine, until the technical file reaches the evaluator&#8217;s desk and the device comes back reclassified as Class D. The review clock resets, the government fee jumps to a higher tariff, and the evaluator starts asking for clinical evidence nobody planned to prepare. It happens more often than the regulation itself would suggest, because nowhere in Permenkes No. 62 Tahun 2017 [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":7763,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7762","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-articles","country-indonesia"],"acf":[],"_links":{"self":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7762","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=7762"}],"version-history":[{"count":1,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7762\/revisions"}],"predecessor-version":[{"id":7766,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7762\/revisions\/7766"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/7763"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=7762"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=7762"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=7762"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=7762"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}