{"id":6889,"date":"2026-07-07T16:03:16","date_gmt":"2026-07-07T09:03:16","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-07-15T21:24:58","modified_gmt":"2026-07-15T14:24:58","slug":"indonesia-medical-device-registration-kemenkes-guide","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/ja\/indonesia-medical-device-registration-kemenkes-guide\/","title":{"rendered":"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u533b\u7642\u6a5f\u5668\u767b\u9332\u304a\u3088\u3073Kemenkes\u6e96\u62e0\u306b\u95a2\u3059\u308b\u7dcf\u5408\u30de\u30cb\u30e5\u30a2\u30eb"},"content":{"rendered":"<p 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src=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/06\/Indonesia-Medical-Device-Registration-and-Kemenkes-Compliance-Guide-2.webp\" alt=\"CDAKB\u6e96\u62e0\u8a8d\u8a3c\" class=\"wp-image-6891\" style=\"aspect-ratio:1.9244446321479856;width:800px;height:auto\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/06\/Indonesia-Medical-Device-Registration-and-Kemenkes-Compliance-Guide-2.webp 712w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/06\/Indonesia-Medical-Device-Registration-and-Kemenkes-Compliance-Guide-2-300x156.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/06\/Indonesia-Medical-Device-Registration-and-Kemenkes-Compliance-Guide-2-18x9.webp 18w\" sizes=\"(max-width: 712px) 100vw, 712px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u4fdd\u5065\u7701\u306e\u8981\u4ef6\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u9032\u3081\u65b9<\/h2>\n\n\n\n<p 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href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">IDAK \u914d\u5e03\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u78ba\u4fdd<\/a> \u7ba1\u7406\u4f53\u5236\u304a\u3088\u3073\u4fdd\u7ba1\u65bd\u8a2d\u306e\u5b8c\u5168\u306a\u60c5\u5831\u958b\u793a\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u73fe\u5730\u65bd\u8a2d\u306b\u306f\u3001\u88fd\u54c1\u306e\u52a3\u5316\u3084\u5076\u767a\u7684\u306a\u6c5a\u67d3\u3092\u9632\u3050\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u5c02\u7528\u306e\u5b89\u5168\u306a\u533a\u57df\u3092\u8a2d\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u65bd\u8a2d\u306e\u7269\u7406\u7684\u306a\u30ec\u30a4\u30a2\u30a6\u30c8\u306f\u3001\u7701\u5e81\u306e\u627f\u8a8d\u3092\u5f97\u308b\u524d\u306b\u516c\u5f0f\u691c\u67fb\u306b\u5408\u683c\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IDAK\u6d41\u901a\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u67a0\u7d44\u307f\u306e\u4e0b\u3067\u8a8d\u53ef\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u696d\u52d9\u306f\u3001\u8a8d\u5b9a\u6280\u8853\u5c02\u9580\u5bb6\u304c\u76e3\u7763\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u5c02\u9580\u5bb6\u306f\u300c\u30da\u30ca\u30f3\u30b0\u30f3\u30fb\u30b8\u30e3\u30ef\u30d6\u30fb\u30c6\u30af\u30cb\u30b9\u300d\u3068\u547c\u3070\u308c\u3001\u627f\u8a8d\u3055\u308c\u305f\u5de5\u5b66\u307e\u305f\u306f\u533b\u5b66\u306e\u5b66\u4f4d\u3092\u4fdd\u6709\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5f7c\u3089\u306f\u3001\u3059\u3079\u3066\u306e\u88fd\u54c1\u304c\u56fd\u306e\u5b89\u5168\u6cd5\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">CDAKB\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8a8d\u8a3c\u306b\u3088\u308b\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u5353\u8d8a\u6027<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u7269\u6d41\u7ba1\u7406\u3092\u7dad\u6301\u3059\u308b\u306b\u306f\u3001\u56fd\u5bb6\u3068\u306e\u53b3\u683c\u306a\u9023\u643a\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">CDAKB\u6e96\u62e0\u8a8d\u8a3c<\/a> \u30d7\u30ed\u30c8\u30b3\u30eb\u3002\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u9069\u6b63\u6d41\u901a\u57fa\u6e96\uff08GDP\uff09\u306b\u76f8\u5f53\u3059\u308b\u56fd\u5185\u898f\u683c\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u56fd\u5185\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u3092\u901a\u3057\u3066\u88fd\u54c1\u306e\u69cb\u9020\u7684\u5b8c\u5168\u6027\u304c\u7dad\u6301\u3055\u308c\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p 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class=\"wp-block-paragraph\">\u3053\u306e\u72ec\u7acb\u3057\u305f\u7d44\u7e54\u69cb\u9020\u306b\u3088\u308a\u3001\u8cb4\u793e\u306e\u56fd\u969b\u672c\u793e\u306f\u7fa4\u5cf6\u5168\u57df\u3067\u5b8c\u5168\u306a\u5546\u696d\u7684\u67d4\u8edf\u6027\u3092\u78ba\u4fdd\u3067\u304d\u307e\u3059\u3002\u8ca9\u58f2\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306e\u5909\u66f4\u3084\u7269\u6d41\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u5909\u66f4\u3082\u3001\u4e3b\u8981\u88fd\u54c1\u306e\u767b\u9332\u3092\u640d\u306a\u3046\u3053\u3068\u306a\u304f\u53ef\u80fd\u3067\u3059\u3002\u307e\u305f\u3001\u8cb4\u793e\u306e\u9577\u671f\u7684\u306a\u4f01\u696d\u8cc7\u7523\u306f\u3001\u8cb4\u793e\u306e\u76f4\u63a5\u7684\u306a\u7ba1\u7406\u4e0b\u3067\u5b8c\u5168\u306b\u5b89\u5168\u306b\u4fdd\u8b77\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u7d4c\u8def\u306e\u6bd4\u8f03<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e0b\u8a18\u306e\u8868\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u56fd\u969b\u8f38\u5165\u306b\u304a\u3051\u308b\u3001\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u5225\u306e\u904b\u7528\u8981\u4ef6\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\"><tbody><tr><td><strong>\u6280\u8853\u30d1\u30e9\u30e1\u30fc\u30bf<\/strong><\/td><td><strong>\u30af\u30e9\u30b9A\uff08\u4f4e\u30ea\u30b9\u30af\uff09<\/strong><\/td><td><strong>\u30af\u30e9\u30b9B\uff0fC\uff08\u4e2d\u30ea\u30b9\u30af\uff09<\/strong><\/td><td><strong>\u30af\u30e9\u30b9D\uff08\u9ad8\u30ea\u30b9\u30af\uff09<\/strong><\/td><\/tr><tr><td><strong>\u4e00\u6b21\u627f\u8a8d<\/strong><\/td><td>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332<\/td><td>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332<\/td><td>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332<\/td><\/tr><tr><td><strong>\u30b7\u30b9\u30c6\u30e0\u30af\u30ea\u30a2\u30e9\u30f3\u30b9<\/strong><\/td><td>Kemenkes REGALKES Portal<\/td><td>Kemenkes REGALKES Portal<\/td><td>Kemenkes REGALKES Portal<\/td><\/tr><tr><td><strong>\u54c1\u8cea\u306b\u95a2\u3059\u308b\u7fa9\u52d9<\/strong><\/td><td>ISO 13485 \/ GMP<\/td><td>ISO 13485\u304a\u3088\u3073\u6280\u8853\u30d5\u30a1\u30a4\u30eb<\/td><td>ISO 13485\u3068\u81e8\u5e8a\u8a66\u9a13<\/td><\/tr><tr><td><strong>\u7269\u6d41\u30eb\u30fc\u30eb<\/strong><\/td><td>IDAK\u8ca9\u58f2\u30e9\u30a4\u30bb\u30f3\u30b9<\/td><td>IDAK\u8ca9\u58f2\u30e9\u30a4\u30bb\u30f3\u30b9<\/td><td>IDAK\u8ca9\u58f2\u30e9\u30a4\u30bb\u30f3\u30b9<\/td><\/tr><tr><td><strong>\u54c1\u8cea\u57fa\u6e96<\/strong><\/td><td>CDAKB\u6e96\u62e0\u8a8d\u8a3c<\/td><td>CDAKB\u6e96\u62e0\u8a8d\u8a3c<\/td><td>CDAKB\u6e96\u62e0\u8a8d\u8a3c<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Moh\u304b\u3089\u306e\u53c2\u7167: <a href=\"https:\/\/farmalkes.kemkes.go.id\/unduh\/pedoman-klasifikasi-alat-kesehatan\/\" target=\"_blank\" rel=\"noopener\">\u30da\u30c9\u30de\u30f3 \u30af\u30e9\u30d5\u30a3\u30ab\u30b7 \u30a2\u30e9\u30c3\u30c8 \u30b1\u30bb\u30cf\u30bf\u30f3<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u30ea\u30fc\u30c0\u30fc\u4f01\u696d\u5411\u3051\u306b\u7279\u5316\u3057\u305f\u898f\u5236\u5bfe\u5fdc\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6cd5\u4ee4\u9075\u5b88\u306b\u57fa\u3065\u3044\u305f\u9ad8\u6027\u80fd\u306a\u533b\u7642\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3092\u69cb\u7bc9\u3059\u308b\u306b\u306f\u3001\u73fe\u5730\u306e\u533b\u7642\u95a2\u9023\u6cd5\u898f\u3068\u30c7\u30b8\u30bf\u30eb\u30dd\u30fc\u30bf\u30eb\u306b\u95a2\u3059\u308b\u5c02\u9580\u77e5\u8b58\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002Product Registration Indonesia\u306f\u3001\u65e5\u672c\u4f01\u696d\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u3092\u5186\u6ed1\u306b\u9032\u3081\u3089\u308c\u308b\u3088\u3046\u3001\u5305\u62ec\u7684\u306a\u6280\u8853\u30b5\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u5f53\u793e\u306e\u5c02\u9580\u5bb6\u304c\u3001\u304a\u5ba2\u69d8\u306e\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u304c\u3059\u3079\u3066\u306e\u73fe\u884c\u7701\u5e81\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3044\u305f\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f53\u793e\u30c1\u30fc\u30e0\u306f\u3001\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u4f01\u696d\u30b5\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b\u3057\u3001IDAK\u6d41\u901a\u30e9\u30a4\u30bb\u30f3\u30b9\u95a2\u9023\u66f8\u985e\u306e\u4f5c\u6210\u3092\u652f\u63f4\u3059\u308b\u3068\u3068\u3082\u306b\u3001\u304a\u5ba2\u69d8\u306e\u5404\u62e0\u70b9\u304cCDAKB\u306e\u5b8c\u5168\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8a8d\u8a3c\u3092\u53d6\u5f97\u3067\u304d\u308b\u3088\u3046\u6307\u5c0e\u3044\u305f\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Product Registration Indonesia\u306f\u3001\u304a\u5ba2\u69d8\u306e\u72ec\u7acb\u3057\u305f\u73fe\u5730\u8a8d\u5b9a\u4ee3\u7406\u4eba\u3068\u3057\u3066\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u5e02\u5834\u8cc7\u7523\u3092\u78ba\u5b9f\u306b\u4fdd\u8b77\u3059\u308b\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u3057\u3066\u3082\u6a5f\u80fd\u3057\u307e\u3059\u3002\u5730\u57df\u898f\u5236\u306e\u67a0\u7d44\u307f\u3092\u6700\u9069\u5316\u3059\u308b\u305f\u3081\u306b\u3001\u4eca\u3059\u3050Product Registration Indonesia\u306b\u3054\u9023\u7d61\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6771\u5357\u30a2\u30b8\u30a2\u6700\u5927\u306e\u533b\u7642\u6280\u8853\u5e02\u5834\u3067\u4e3b\u5c0e\u7684\u306a\u5730\u4f4d\u3092\u78ba\u7acb\u3059\u308b\u306b\u306f\u3001\u73fe\u5730\u306e\u5b89\u5168\u57fa\u6e96\u3092\u53b3\u5b88\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332\u3092\u6210\u529f\u3055\u305b\u308b\u3053\u3068\u3067\u3001\u6025\u6210\u9577\u3092\u9042\u3052\u308b\u3053\u306e\u7d4c\u6e08\u570f\u306b\u304a\u3044\u3066\u3001\u8cb4\u793e\u306f\u6cd5\u4ee4\u9075\u5b88\u306b\u57fa\u3065\u3044\u305f\u4e8b\u696d\u5c55\u958b\u3092\u5b9f\u73fe\u3067\u304d\u307e\u3059\u3002\u4f53\u7cfb\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30e2\u30c7\u30eb\u3092\u901a\u3058\u3066\u6280\u8853\u8cc7\u7523\u3092\u4fdd\u8b77\u3059\u308b\u3053\u3068\u3067\u3001\u9577\u671f\u7684\u306a\u4e8b\u696d\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8ca9\u58f2\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u53d6\u5f97\u3057\u3001\u72ec\u7acb\u3057\u305f\u4ee3\u7406\u5e97\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u65e5\u672c\u306e\u4f01\u696d\u306f\u8ca9\u58f2\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3092\u6700\u5927\u9650\u306e\u67d4\u8edf\u6027\u3092\u3082\u3063\u3066\u7ba1\u7406\u3067\u304d\u307e\u3059\u3002\u9ad8\u5ea6\u306a\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u81a8\u5927\u306a\u9700\u8981\u306f\u3001\u6cd5\u4ee4\u9075\u5b88\u4f01\u696d\u306b\u3068\u3063\u3066\u5927\u304d\u306a\u7d4c\u6e08\u7684\u5229\u76ca\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u3002\u3053\u3046\u3057\u305f\u898f\u5236\u4e0a\u306e\u63aa\u7f6e\u3092\u771f\u5263\u306b\u8b1b\u3058\u308b\u3053\u3068\u306f\u3001\u6301\u7d9a\u7684\u306a\u30d6\u30e9\u30f3\u30c9\u6210\u9577\u306e\u305f\u3081\u306e\u5f37\u56fa\u306a\u57fa\u76e4\u3092\u7bc9\u304f\u3053\u3068\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>Accessing the expanding hospital and clinic networks in Southeast Asia requires a solid regulatory strategy. For Japanese MedTech executives, navigating the process of Indonesia medical device registration represents the vital first step toward capturing sustainable market share. This system evaluates safety, engineering standards, and medical efficacy. The Indonesian Ministry of Health, known locally as Kemenkes, supervises all medical imports strictly. The regulatory environment has modernized significantly to match international standards, creating a highly organized digital submission portal. This modernization helps international manufacturers who maintain excellent technical files. Entering this vibrant market requires deep synchronization between your engineering team in Japan and local regulatory specialists. Understanding the administrative expectations prevents long [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":6890,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-6889","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","country-indonesia"],"acf":[],"_links":{"self":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/6889","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\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=6889"}],"version-history":[{"count":3,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/6889\/revisions"}],"predecessor-version":[{"id":6909,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/6889\/revisions\/6909"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/6890"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=6889"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=6889"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=6889"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=6889"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}