{"id":7868,"date":"2026-10-06T11:24:08","date_gmt":"2026-10-06T04:24:08","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-10-06T11:28:47","modified_gmt":"2026-10-06T04:28:47","slug":"medical-device-risk-classification-indonesia","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/ja\/medical-device-risk-classification-indonesia\/","title":{"rendered":"\u30af\u30e9\u30b9A\u3001B\u3001C\u3001D\uff1a\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u30ea\u30b9\u30af\u5206\u985e\u304c\u4e0b\u6d41\u5de5\u7a0b\u5168\u4f53\u306b\u53ca\u307c\u3059\u5f71\u97ff"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u9032\u51fa\u3059\u308b\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u304c\u72af\u3059\u6700\u3082\u91cd\u5927\u306a\u9593\u9055\u3044\u306e1\u3064\u306f\u3001 <strong>\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e<\/strong> \u5358\u306a\u308b\u4e8b\u52d9\u7684\u306a\u30c1\u30a7\u30c3\u30af\u9805\u76ee\u3068\u3057\u3066\u6349\u3048\u3089\u308c\u3066\u3044\u308b\u3002\u4f01\u696d\u304c\u6d77\u5916\u306e\u53c2\u7167\u5e02\u5834\u304b\u3089\u5206\u985e\u3092\u305d\u306e\u307e\u307e\u30b3\u30d4\u30fc\u3057\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\u304c\u305d\u308c\u306b\u5408\u308f\u305b\u3066\u304f\u308c\u308b\u3060\u308d\u3046\u3068\u5b89\u6613\u306b\u8003\u3048\u3001\u4e88\u7b97\u3084\u767a\u58f2\u65e5\u304c\u78ba\u5b9a\u3057\u305f\u5f8c\u306b\u306a\u3063\u3066\u521d\u3081\u3066\u9593\u9055\u3044\u306b\u6c17\u3065\u304f\u3068\u3044\u3046\u30b1\u30fc\u30b9\u306f\u3001\u9a5a\u304f\u307b\u3069\u3088\u304f\u3042\u308b\u3053\u3068\u3060\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6a5f\u5668\u306e\u5206\u985e\u306f\u5358\u306a\u308b\u66f8\u985e\u624b\u7d9a\u304d\u3067\u306f\u306a\u304f\u3001\u73fe\u5730\u306e\u691c\u67fb\u8981\u4ef6\u306e\u53b3\u3057\u3055\u3092\u5de6\u53f3\u3057\u3001\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u9593\u306e\u5dee\u306f\u9a5a\u304f\u307b\u3069\u5927\u304d\u304f\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u79c1\u305f\u3061\u306f\u3001\u7d50\u6838\uff08TB\uff09\u8a3a\u65ad\u30ad\u30c3\u30c8\u3092\u767b\u9332\u3057\u305f\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306e\u4e8b\u4f8b\u3067\u3001\u3053\u306e\u3053\u3068\u3092\u8eab\u3092\u3082\u3063\u3066\u7d4c\u9a13\u3057\u307e\u3057\u305f\u3002\u305d\u306e\u88fd\u54c1\u306f\u5206\u985e\u4e0a\u3001\u4f4e\u30ea\u30b9\u30af\u6a5f\u5668\u3088\u308a\u3082\u306f\u308b\u304b\u306b\u53b3\u3057\u3044\u691c\u67fb\u7bc4\u56f2\u3092\u8ab2\u305b\u3089\u308c\u305f\u306e\u3067\u3059\u3002\u3053\u3046\u3057\u305f\u5883\u754c\u7dda\u3092\u4e8b\u524d\u306b\u7406\u89e3\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u3001\u627f\u8a8d\u307e\u3067\u306e\u671f\u9593\u304c\u969b\u9650\u306a\u304f\u9577\u5f15\u304f\u304b\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u4e88\u7b97\u5916\u306e\u5de8\u984d\u306e\u691c\u67fb\u8cbb\u7528\u304c\u767a\u751f\u3059\u308b\u304b\u306e\u5206\u304b\u308c\u76ee\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u30ac\u30a4\u30c9\u3067\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306eA\u30af\u30e9\u30b9\u304b\u3089D\u30af\u30e9\u30b9\u307e\u3067\u306e\u30b7\u30b9\u30c6\u30e0\u304c\u5b9f\u969b\u306b\u3069\u306e\u3088\u3046\u306b\u4e0b\u6d41\u5de5\u7a0b\u3067\u904b\u7528\u3055\u308c\u3066\u3044\u308b\u304b\u3001\u5404\u30af\u30e9\u30b9\u306b\u304a\u3051\u308b\u73fe\u5730\u3067\u306e\u691c\u67fb\u304c\u3069\u306e\u3088\u3046\u306b\u898f\u6a21\u62e1\u5927\u3055\u308c\u3066\u3044\u308b\u304b\u3001\u305d\u3057\u3066\u65e9\u671f\u306b\u9069\u5207\u306a\u5206\u985e\u3092\u884c\u3046\u3053\u3068\u304c\u5e02\u5834\u53c2\u5165\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u3069\u306e\u3088\u3046\u306b\u5b88\u308b\u304b\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u89e3\u8aac\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"667\" src=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification.jpg\" alt=\"\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\" class=\"wp-image-7869\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification.jpg 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification-300x200.jpg 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification-768x512.jpg 768w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification-18x12.jpg 18w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3068\u306f\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3067\u306f\u3001\u5404\u6a5f\u5668\u304c\u60a3\u8005\u3084\u4f7f\u7528\u8005\u306b\u53ca\u307c\u3059\u30ea\u30b9\u30af\u306b\u57fa\u3065\u3044\u3066\u3001A\u3001B\u3001C\u3001D\u306e4\u3064\u306e\u30af\u30e9\u30b9\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u30af\u30e9\u30b9A\u306f\u4f4e\u30ea\u30b9\u30af\u3001\u30af\u30e9\u30b9B\u306f\u4f4e\uff5e\u4e2d\u30ea\u30b9\u30af\u3001\u30af\u30e9\u30b9C\u306f\u4e2d\uff5e\u9ad8\u30ea\u30b9\u30af\u3001\u30af\u30e9\u30b9D\u306f\u9ad8\u30ea\u30b9\u30af\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e4\u6bb5\u968e\u306e\u533b\u7642\u6a5f\u5668\u30ea\u30b9\u30af\u5206\u985e\u306f\u3001\u4fdd\u5065\u7701\uff08Kemenkes\uff09\u304c\u767a\u884c\u3057\u305f\u4fdd\u5065\u5927\u81e3\u898f\u5247\uff08Permenkes\uff09\u7b2c62\/2017\u53f7\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/TataCaraKlasifikasi1.pdf\" target=\"_blank\" rel=\"noopener\">\u5206\u985e\u30ac\u30a4\u30c0\u30f3\u30b9<\/a> \u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u88fd\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306e\u5834\u5408\u3001\u5206\u985e\u57fa\u6e96\u3067\u306f\u500b\u4eba\u30ea\u30b9\u30af\u3068\u516c\u8846\u885b\u751f\u30ea\u30b9\u30af\u3092\u7dcf\u5408\u7684\u306b\u8a55\u4fa1\u3057\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u611f\u67d3\u75c7\u691c\u67fb\u306f\u3001\u30ea\u30b9\u30af\u306e\u4f4e\u3044\u5358\u306a\u308b\u88dc\u52a9\u5668\u5177\u306e\u3088\u3046\u306b\u8a55\u4fa1\u3055\u308c\u308b\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u88681\uff0e\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306e\u6982\u8981<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u30af\u30e9\u30b9<\/strong><\/th><th><strong>\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\uff08\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c62\/2017\u53f7\uff09<\/strong><\/th><th><strong>\u6211\u3005\u306e\u7d4c\u9a13\u3067\u306f\u3001\u5178\u578b\u7684\u306a\u4e0b\u6d41\u52b9\u679c<\/strong><\/th><\/tr><\/thead><tbody><tr><td>A<\/td><td>\u4f4e\u3044<\/td><td>\u6700\u3082\u7c21\u5358\u306a\u30ec\u30d3\u30e5\u30fc\u7d4c\u8def\u3067\u306f\u3042\u308b\u304c\u3001\u30af\u30e9\u30b9\u304c\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u7167\u3089\u3057\u3066\u30c1\u30a7\u30c3\u30af\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/td><\/tr><tr><td>B<\/td><td>\u4f4e\uff5e\u4e2d\u7a0b\u5ea6<\/td><td>\u6587\u66f8\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u304c\u4e3b\u6d41\u3002\u30c6\u30b9\u30c8\u306e\u5fc5\u8981\u6027\u306f\u30c7\u30d0\u30a4\u30b9\u306e\u7a2e\u985e\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u3002<\/td><\/tr><tr><td>C<\/td><td>\u4e2d\u7a0b\u5ea6\u304b\u3089\u9ad8\u3044<\/td><td>\u3088\u308a\u8a73\u7d30\u306a\u8a3c\u62e0\u3068\u3001\u65e9\u671f\u306b\u7bc4\u56f2\u3092\u5b9a\u3081\u308b\u5fc5\u8981\u304c\u3042\u308b\u5730\u57df\u691c\u67fb\u306e\u73fe\u5b9f\u7684\u306a\u53ef\u80fd\u6027<\/td><\/tr><tr><td>D<\/td><td>\u9ad8\u3044\uff08\u4f8b\u3048\u3070\u3001\u5fc3\u81d3\u30b9\u30c6\u30f3\u30c8\u3084\u30da\u30fc\u30b9\u30e1\u30fc\u30ab\u30fc\u306a\u3069\uff09<\/td><td>\u6700\u3082\u5f37\u529b\u306a\u30a8\u30d3\u30c7\u30f3\u30b9\u304c\u6c42\u3081\u3089\u308c\u308b\u3002\u4e88\u7b97\u7de8\u6210\u524d\u306b\u691c\u67fb\u3068\u81e8\u5e8a\u7bc4\u56f2\u3092\u8a08\u753b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u73fe\u5728\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3092\u898f\u5b9a\u3059\u308b\u898f\u5236\u306f\u3069\u308c\u3067\u3059\u304b\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6cd5\u7684\u6839\u62e0\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5171\u548c\u56fd\u304c\u5236\u5b9a\u3057\u305f2023\u5e74\u4fdd\u5065\u6cd5\u7b2c17\u53f7\u3001\u304a\u3088\u3073\u305d\u308c\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u5927\u7d71\u9818\u4ee4\uff08PP\uff09\u7b2c28\u53f7\uff082024\u5e74\uff09\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/jdih.kemkes.go.id\/documents\/peraturan-menteri-kesehatan-nomor-5-tahun-2026\" target=\"_blank\" rel=\"noopener\">\u4fdd\u5065\u7528\u54c1\u306b\u95a2\u3059\u308b\u653f\u4ee4\u7b2c5\/2026\u53f7<\/a>, 2026\u5e744\u670817\u65e5\u306b\u4fdd\u5065\u7701\u306b\u3088\u3063\u3066\u5236\u5b9a\u3055\u308c\u30012026\u5e745\u67084\u65e5\u306b\u516c\u5e03\u3055\u308c\u305f\u3053\u306e\u6cd5\u5f8b\u306f\u3001\u73fe\u5728\u3001\u533b\u7642\u6a5f\u5668\u306e\u6d41\u901a\u3092\u898f\u5236\u3057\u3066\u304a\u308a\u3001Permenkes No. 62\/2017\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308b\u3082\u306e\u3067\u3059\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u307e\u305f\u3001\u5206\u985e\u5909\u66f4\u3092\u7533\u8acb\u3059\u308b\u305f\u3081\u306e\u624b\u7d9a\u304d\u3082\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u898f\u5236\u306f\u6bd4\u8f03\u7684\u65b0\u3057\u3044\u305f\u3081\u3001\u7533\u8acb\u3092\u884c\u3046\u524d\u306b\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306b\u95a2\u3059\u308b\u898f\u5b9a\u3084\u7d4c\u904e\u63aa\u7f6e\u306b\u3064\u3044\u3066\u3001\u8cc7\u683c\u3092\u6709\u3059\u308b\u898f\u5236\u5c02\u9580\u5bb6\u306b\u3088\u308b\u78ba\u8a8d\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u9069\u6b63\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u306b\u95a2\u3059\u308b Permenkes No. 63\/2017 (CUKAKB\u3001Cara Uji Klinik Alat Kesehatan yang Baik) \u30ea\u30f3\u30af <a href=\"https:\/\/regulasi.bkpk.kemkes.go.id\/detail\/5b1b45eb-a075-4112-8401-fc42567fe927\/unduh\" target=\"_blank\" rel=\"noopener\">\u81e8\u5e8a\u691c\u67fb<\/a> \u30af\u30e9\u30b9C\u3001\u30af\u30e9\u30b9D\u3001\u304a\u3088\u3073\u65b0\u898f\u30c7\u30d0\u30a4\u30b9\u306b\u95a2\u3057\u3066\u3001\u653f\u4ee4\u7b2c5\/2026\u53f7\u306f\u307b\u3068\u3093\u3069\u306e\u6761\u9805\u3092\u5ec3\u6b62\u3057\u307e\u3057\u305f\u3002\u3069\u306e\u6761\u9805\u304c\u6b8b\u3063\u3066\u3044\u308b\u304b\u306f\u5c02\u9580\u5bb6\u306b\u3088\u308b\u78ba\u8a8d\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u533b\u7642\u6a5f\u5668\u30ea\u30b9\u30af\u5206\u985e\u304c\u4e0b\u6d41\u5de5\u7a0b\u306e\u3042\u3089\u3086\u308b\u30b9\u30c6\u30c3\u30d7\u3092\u3069\u306e\u3088\u3046\u306b\u5de6\u53f3\u3059\u308b\u304b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b9f\u969b\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306f\u6700\u521d\u306e\u30c9\u30df\u30ce\u5012\u3057\u306e\u3088\u3046\u306b\u6a5f\u80fd\u3057\u307e\u3059\u3002\u4e00\u5ea6\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u304c\u8a2d\u5b9a\u3055\u308c\u308b\u3068\u3001\u5be9\u67fb\u7d4c\u8def\u3001\u8a3c\u62e0\u30d5\u30a1\u30a4\u30eb\u3001\u6599\u91d1\u3001\u8a66\u9a13\u7bc4\u56f2\u306a\u3069\u304c\u3059\u3079\u3066\u305d\u308c\u306b\u7d9a\u304f\u305f\u3081\u3001\u3053\u306e\u6bb5\u968e\u3067\u306e\u8aa4\u308a\u306f\u5f8c\u3005\u5927\u304d\u306a\u554f\u984c\u3078\u3068\u767a\u5c55\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u3001\u304a\u3088\u3073\u6599\u91d1<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u540c\u7701\u306e\u6307\u91dd\u306b\u3088\u308b\u3068\u3001\u975e\u8ab2\u7a0e\u56fd\u5bb6\u53ce\u5165\uff08PNBP\uff09\u306f\u3001\u7533\u8acb\u8005\u304c\u9078\u629e\u3057\u305f\u30ea\u30b9\u30af\u3068\u30af\u30e9\u30b9\u306b\u57fa\u3065\u3044\u3066\u8ab2\u3055\u308c\u308b\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3092\u8aa4\u308b\u3068\u3001\u691c\u67fb\u958b\u59cb\u524d\u306b\u8cbb\u7528\u306b\u5f71\u97ff\u304c\u51fa\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001\u4e0a\u4f4d\u30af\u30e9\u30b9\u306e\u533b\u7642\u6a5f\u5668\u306b\u306f\u3001\u3088\u308a\u8a73\u7d30\u306a\u6280\u8853\u8cc7\u6599\u3001\u7279\u306b\u6027\u80fd\u3068\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u3088\u308a\u5f37\u529b\u306a\u8a3c\u62e0\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u30af\u30e9\u30b9C\u306e\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u30af\u30e9\u30b9B\u306e\u8a3c\u62e0\u3092\u7528\u3044\u308b\u306a\u3069\u3001\u8aa4\u3063\u305f\u533b\u7642\u6a5f\u5668\u30ea\u30b9\u30af\u5206\u985e\u306b\u57fa\u3065\u3044\u3066\u8a08\u753b\u3092\u7acb\u3066\u305f\u30c1\u30fc\u30e0\u306f\u3001\u901a\u5e38\u3001\u8cc7\u6599\u306e\u4e00\u90e8\u3092\u3084\u308a\u76f4\u3059\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3068\u73fe\u5730\u3067\u306e\u8a66\u9a13\u8cbb\u7528<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u304c\u9069\u5207\u306b\u6271\u308f\u308c\u306a\u3044\u5834\u5408\u3001\u6700\u3082\u6df1\u523b\u306a\u554f\u984c\u304c\u751f\u3058\u308b\u306e\u306f\u307e\u3055\u306b\u3053\u306e\u70b9\u3067\u3059\u3002\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001\u5206\u985e\u3054\u3068\u306e\u73fe\u5730\u3067\u306e\u691c\u67fb\u7d50\u679c\u306b\u306f\u5927\u304d\u306a\u5dee\u304c\u3042\u308a\u3001\u5148\u306b\u8ff0\u3079\u305f\u7d50\u6838\u6cbb\u7642\u85ac\u306f\u3001\u79c1\u305f\u3061\u304c\u6271\u3063\u305f\u4e2d\u3067\u6700\u3082\u5206\u304b\u308a\u3084\u3059\u3044\u4e8b\u4f8b\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u306e\u9867\u5ba2\u306e\u88fd\u54c1\u306f\u3001\u4f4e\u4fa1\u683c\u5e2f\u306e\u88fd\u54c1\u3088\u308a\u3082\u306f\u308b\u304b\u306b\u53b3\u683c\u306a\u73fe\u5730\u8a66\u9a13\u3092\u5fc5\u8981\u3068\u3057\u305f\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306e\u691c\u67fb\u8cbb\u7528\u306f\u9ad8\u984d\u3067\u3042\u308b\u305f\u3081\u3001\u305d\u306e\u5fc5\u8981\u6027\u304c\u5f8c\u306b\u306a\u3063\u3066\u5224\u660e\u3059\u308b\u3068\u3001\u975e\u5e38\u306b\u5927\u304d\u306a\u4e88\u671f\u305b\u306c\u30b3\u30b9\u30c8\u304c\u767a\u751f\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u304b\u3001\u305d\u308c\u3068\u3082\u9045\u3005\u3068\u3057\u3066\u9032\u307e\u306a\u3044\u304b\u3092\u5206\u3051\u308b\u306e\u306f\u3001\u7684\u78ba\u306a\u5224\u65ad\u529b\u3067\u3059\u3002\u307e\u305a\u3001\u30af\u30e9\u30b9\u3092\u6b63\u78ba\u306b\u7279\u5b9a\u3057\u3001\u6b21\u306b\u30c6\u30b9\u30c8\u7bc4\u56f2\u3092\u6b63\u78ba\u306b\u5b9a\u7fa9\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3069\u3061\u3089\u306e\u5224\u65ad\u3082\u3001\u5916\u56fd\u306e\u8a3c\u660e\u66f8\u306b\u5370\u5237\u3055\u308c\u3066\u3044\u308b\u30e9\u30d9\u30eb\u3067\u306f\u306a\u304f\u3001\u898f\u5236\u4e0a\u306e\u5224\u65ad\u306b\u57fa\u3065\u3044\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3068\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u30ea\u30b9\u30af<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u88fd\u54c1\u3084\u5be9\u67fb\u5f85\u3061\u306e\u9806\u756a\u306b\u3088\u3063\u3066\u671f\u9593\u304c\u7570\u306a\u308b\u305f\u3081\u3001\u5177\u4f53\u7684\u306a\u671f\u9593\u306f\u63d0\u793a\u3057\u3066\u304a\u308a\u307e\u305b\u3093\u3002\u305f\u3060\u3057\u3001\u5f53\u793e\u306e\u7d4c\u9a13\u4e0a\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u304c\u5be9\u67fb\u9014\u4e2d\u3067\u7570\u8b70\u7533\u3057\u7acb\u3066\u3092\u53d7\u3051\u305f\u5834\u5408\u3001\u8a3c\u62e0\u30d5\u30a1\u30a4\u30eb\u3084\u8a66\u9a13\u8a08\u753b\u306e\u518d\u69cb\u7bc9\u304c\u5fc5\u8981\u306b\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u9032\u884c\u304c\u6700\u3082\u9045\u304f\u306a\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\uff1a\u5206\u985e\u306e\u9069\u7528\u7bc4\u56f2<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u306f\u3001\u307e\u305a\u4f7f\u7528\u76ee\u7684\u3001\u6b21\u306b\u5206\u985e\u3001\u305d\u3057\u3066\u305d\u306e\u5206\u985e\u306b\u5408\u81f4\u3059\u308b\u8a3c\u62e0\u66f8\u985e\u3068\u8a66\u9a13\u8a08\u753b\u66f8\u306e\u63d0\u51fa\u304b\u3089\u59cb\u307e\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306e\u624b\u9806\u3092\u6025\u3050\u3053\u3068\u304c\u3001\u6700\u3082\u983b\u7e41\u306b\u518d\u4f5c\u696d\u306e\u539f\u56e0\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u6a5f\u5668\u3001\u305d\u306e\u4f7f\u7528\u76ee\u7684\u3001\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\uff08IVD\uff09\u6a5f\u80fd\u306b\u3064\u3044\u3066\u5b9a\u7fa9\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n<li>\u8a72\u5f53\u3059\u308b\u30b1\u30e1\u30f3\u30b1\u30b9\u898f\u5247\u306b\u57fa\u3065\u304d\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306b\u3088\u3063\u3066\u30af\u30e9\u30b9\u3092\u5272\u308a\u5f53\u3066\u308b\u3002.<\/li>\n\n\n\n<li>\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3068\u30c6\u30b9\u30c8\u8a08\u753b\u3092\u8a72\u5f53\u3059\u308b\u30af\u30e9\u30b9\u306b\u7167\u5408\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n<li>Kemenkes\u306e\u767b\u9332\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u63d0\u51fa\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n<li>\u6d41\u901a\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u7fa9\u52d9\u3092\u6e96\u5099\u3059\u308b\u3002.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\u5404\u30b9\u30c6\u30c3\u30d7\u306b\u306f\u3001\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3067\u306f\u89e3\u6c7a\u3067\u304d\u306a\u3044\u5224\u65ad\u304c\u4f34\u3044\u307e\u3059\u3002 <strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u624b\u7d9a\u304d<\/strong> \u5168\u884c\u7a0b\u3092\u7db2\u7f85\u3057\u3001Product Registration Indonesia\u306e <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668\u767b\u9332\u30b5\u30fc\u30d3\u30b9<\/a> \u5404\u6bb5\u968e\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002.<\/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=\"tR6QTMBbLx\"><a href=\"https:\/\/productregistrationindonesia.com\/ja\/the-process-of-registering-medical-devices-in-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u30d7\u30ed\u30bb\u30b9<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u300c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u30d7\u30ed\u30bb\u30b9\u300d\u2014\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u88fd\u54c1\u767b\u9332\" src=\"https:\/\/productregistrationindonesia.com\/the-process-of-registering-medical-devices-in-indonesia\/embed\/#?secret=o0tazzfkSu#?secret=tR6QTMBbLx\" data-secret=\"tR6QTMBbLx\" 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>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u533b\u7642\u6a5f\u5668\u5e02\u5834\u53c2\u5165\u6226\u7565\uff1a\u4e88\u7b97\u7de8\u6210\u524d\u306b\u5206\u985e\u3092<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u5e02\u5834\u53c2\u5165\u6226\u7565\u306f\u3001\u4fa1\u683c\u8868\u3084\u8ca9\u58f2\u4ee3\u7406\u5e97\u3068\u306e\u4ea4\u6e09\u3067\u306f\u306a\u304f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u304b\u3089\u59cb\u3081\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306f\u3001\u3042\u3089\u3086\u308b\u5546\u696d\u7684\u4eee\u5b9a\u306e\u6839\u62e0\u3068\u306a\u308b\u30a8\u30d3\u30c7\u30f3\u30b9\u3001\u8a66\u9a13\u3001\u304a\u3088\u3073\u6599\u91d1\u4f53\u7cfb\u3092\u5b9a\u3081\u308b\u3082\u306e\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u88682\uff0e\u533b\u7642\u6a5f\u5668\u30ea\u30b9\u30af\u5206\u985e\u306e\u305f\u3081\u306e\u610f\u601d\u6c7a\u5b9a\u30ac\u30a4\u30c9<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u72b6\u6cc1<\/strong><\/th><th><strong>\u53d6\u308a\u6271\u3044\u3092\u8aa4\u308b\u3068\u30ea\u30b9\u30af\u304c\u751f\u3058\u308b<\/strong><\/th><th><strong>\u8ce2\u660e\u306a\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/strong><\/th><\/tr><\/thead><tbody><tr><td>\u5916\u56fd\u4eba\u30af\u30e9\u30b9\u306f\u30af\u30e9\u30b9C\u307e\u305f\u306fD\u3067\u3059<\/td><td>\u5730\u57df\u306b\u304a\u3051\u308b\u691c\u67fb\u3068\u8a3c\u62e0\u53ce\u96c6\u306f\u3001\u8a08\u753b\u3088\u308a\u3082\u91cd\u304f\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002<\/td><td>\u4e88\u7b97\u7de8\u6210\u524d\u306b\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u30ec\u30d3\u30e5\u30fc\u3092\u4f9d\u983c\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/td><\/tr><tr><td>\u672c\u88fd\u54c1\u306f\u3001\u7d50\u6838\u306a\u3069\u306e\u611f\u67d3\u75c7\u306b\u5bfe\u3059\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u3067\u3042\u308b\u3002<\/td><td>\u8a66\u9a13\u7bc4\u56f2\u306f\u4e88\u60f3\u4ee5\u4e0a\u306b\u5e83\u304f\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b<\/td><td>\u5c02\u9580\u5bb6\u3068\u65e9\u671f\u306b\u5730\u57df\u691c\u67fb\u306e\u7bc4\u56f2\u3092\u5b9a\u3081\u308b<\/td><\/tr><tr><td>\u3053\u306e\u88fd\u54c1\u306f2\u3064\u306e\u30af\u30e9\u30b9\u306e\u4e2d\u9593\u306b\u4f4d\u7f6e\u3059\u308b\u3002<\/td><td>\u6388\u696d\u306f\u30ec\u30d3\u30e5\u30fc\u306e\u9014\u4e2d\u3067\u7570\u8b70\u3092\u5531\u3048\u3089\u308c\u305f<\/td><td>\u7533\u8acb\u524d\u306b\u5c02\u9580\u5bb6\u306b\u3088\u308b\u5206\u985e\u610f\u898b\u3092\u6c42\u3081\u3066\u304f\u3060\u3055\u3044\u3002<\/td><\/tr><tr><td>\u30c7\u30d0\u30a4\u30b9\u304c\u5358\u7d14\u306a\u305f\u3081\u3001\u30af\u30e9\u30b9A\u3068\u307f\u306a\u3055\u308c\u308b<\/td><td>\u610f\u56f3\u3055\u308c\u305f\u4f7f\u7528\u306b\u95a2\u3059\u308b\u6587\u8a00\u306f\u30af\u30e9\u30b9\u3092\u5f15\u304d\u4e0a\u3052\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059<\/td><td>\u307e\u305a\u3001\u4e3b\u5f35\u3068\u4f7f\u7528\u76ee\u7684\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u9ad8\u30ea\u30b9\u30af\u6a5f\u5668\u306f\u7279\u5225\u306a\u30b1\u30fc\u30b9\u3067\u3059\u3002\u5206\u6790\u7d50\u679c\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/navigating-high-risk-medical-device-registration-indonesias-class-3-d-vs-global-standards\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30af\u30e9\u30b93\/D\u8981\u4ef6\u3068\u56fd\u969b\u57fa\u6e96\u3068\u306e\u6bd4\u8f03<\/a> \u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u3092\u3054\u89a7\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\u533b\u7642\u6a5f\u5668\u306e\u627f\u8a8d\u5f8c\u306e\u898f\u5236\u9075\u5b88<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u9075\u5b88\u306f\u3001\u627f\u8a8d\u5f8c\u3082\u7d99\u7d9a\u3055\u308c\u307e\u3059\u3002\u653f\u4ee4\u7b2c5\/2026\u53f7\u306f\u533b\u7642\u7528\u54c1\u306e\u7ba1\u7406\u30fb\u76e3\u7763\u3082\u898f\u5b9a\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u767b\u9332\u8005\u306f\u88fd\u54c1\u304c\u5e02\u5834\u306b\u51fa\u56de\u3063\u305f\u5f8c\u3082\u8cac\u4efb\u3092\u8ca0\u3044\u7d9a\u3051\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4fdd\u5065\u30b5\u30d6\u30bb\u30af\u30bf\u30fc\u306e\u4e8b\u696d\u8a31\u53ef\u306f\u3001\u4fdd\u5065\u7701\u306ePermenkes No. 11\/2025\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u57fa\u6e96\u306b\u5f93\u3063\u3066\u51e6\u7406\u3055\u308c\u3001 <a href=\"https:\/\/oss.go.id\/\" target=\"_blank\" rel=\"noopener\">\u30aa\u30f3\u30e9\u30a4\u30f3\u5358\u4e00\u63d0\u51fa\uff08OSS\uff09<\/a> \u30b7\u30b9\u30c6\u30e0\u3002\u901a\u5e38\u3001\u8ca9\u58f2\u4ee3\u7406\u5e97\u306b\u306f\u533b\u7642\u6a5f\u5668\u8ca9\u58f2\u30e9\u30a4\u30bb\u30f3\u30b9 (IDAK\u3001Izin Distribusi Alat Kesehatan) \u3082\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001\u627f\u8a8d\u5f8c\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u9055\u53cd\u306f\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u5f53\u521d\u306e\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306b\u8d77\u56e0\u3057\u3066\u3044\u307e\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u8868\u793a\u3001\u6d41\u901a\u3001\u304a\u3088\u3073\u76e3\u8996\u306b\u95a2\u3059\u308b\u7fa9\u52d9\u304c\u3001\u8aa4\u3063\u305f\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u306b\u57fa\u3065\u3044\u3066\u8a08\u753b\u3055\u308c\u3066\u3044\u305f\u304b\u3089\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306b\u304a\u3051\u308b5\u3064\u306e\u3088\u304f\u3042\u308b\u9593\u9055\u3044<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4ed6\u56fd\u306e\u8a3c\u660e\u66f8\u304b\u3089\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3092\u3001\u73fe\u5730\u3067\u306e\u78ba\u8a8d\u306a\u3057\u306b\u30b3\u30d4\u30fc\u3059\u308b\u3053\u3068\u3002.<\/li>\n\n\n\n<li>\u6388\u696d\u6599\u3084\u8a66\u9a13\u8cbb\u7528\u3092\u524a\u6e1b\u3059\u308b\u305f\u3081\u306b\u4f4e\u3044\u30af\u30e9\u30b9\u3092\u9078\u629e\u3057\u305f\u304c\u3001\u305d\u306e\u5f8c\u518d\u8a55\u4fa1\u306b\u76f4\u9762\u3059\u308b\u3002.<\/li>\n\n\n\n<li>\u73fe\u5730\u3067\u306e\u8a66\u9a13\u7bc4\u56f2\u306e\u6c7a\u5b9a\u306f\u3001\u7533\u8acb\u66f8\u985e\u304c\u63d0\u51fa\u3055\u308c\u305f\u5f8c\u306b\u884c\u3046\u3002.<\/li>\n\n\n\n<li>\u8a3c\u62e0\u304c\u88cf\u4ed8\u3051\u308b\u7bc4\u56f2\u3092\u8d85\u3048\u3066\u3001\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u95a2\u3059\u308b\u4e3b\u5f35\u3092\u8a18\u8ff0\u3059\u308b\u3053\u3068\u3002.<\/li>\n\n\n\n<li>\u898f\u5236\u5909\u66f4\u3001\u7279\u306b\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c62\/2017\u53f7\u306e\u6539\u8a02\u3092\u7121\u8996\u3059\u308b\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3092\u6226\u7565\u7684\u306a\u610f\u601d\u6c7a\u5b9a\u3068\u3057\u3066\u6349\u3048\u3001\u65e9\u671f\u306b\u5b9f\u65bd\u3057\u3001\u5c02\u9580\u5bb6\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u3092\u53d7\u3051\u308c\u3070\u3001\u3042\u3089\u3086\u308b\u30df\u30b9\u306f\u56de\u907f\u3067\u304d\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u7d50\u8ad6\uff1a\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306f\u6700\u521d\u304b\u3089\u6b63\u3057\u304f\u884c\u3046\u3079\u304d\u3067\u3042\u308b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u306f\u3001\u8a66\u9a13\u7bc4\u56f2\u304b\u3089\u30b3\u30b9\u30c8\u3001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306b\u81f3\u308b\u307e\u3067\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u3078\u306e\u53c2\u5165\u3092\u5de6\u53f3\u3059\u308b\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002\u5e78\u3044\u306a\u3053\u3068\u306b\u3001\u30ea\u30b9\u30af\u5206\u985e\u306f\u7ba1\u7406\u53ef\u80fd\u3067\u3059\u3002\u5c02\u9580\u5bb6\u306b\u3088\u308b\u65e9\u671f\u30ec\u30d3\u30e5\u30fc\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3067\u3001\u307b\u3068\u3093\u3069\u306e\u554f\u984c\u306f\u9ad8\u984d\u306a\u8cbb\u7528\u304c\u767a\u751f\u3059\u308b\u524d\u306b\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Product Registration Indonesia\uff08PRI\uff09\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u696d\u8005\u304a\u3088\u3073\u8f38\u5165\u696d\u8005\u304c\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u5206\u985e\u3092\u78ba\u8a8d\u3057\u3001\u73fe\u5730\u3067\u306e\u8a66\u9a13\u7bc4\u56f2\u3092\u5b9a\u3081\u3001\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u306b\u5408\u3063\u305f\u767b\u9332\u30d5\u30a1\u30a4\u30eb\u3092\u4f5c\u6210\u3059\u308b\u306e\u3092\u652f\u63f4\u3057\u307e\u3059\u3002\u8cb4\u793e\u306e\u6a5f\u5668\u306b\u3064\u3044\u3066\u3001\u559c\u3093\u3067\u3054\u76f8\u8ac7\u306b\u5fdc\u3058\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u8cbb\u7528\u304c\u767a\u751f\u3059\u308b\u524d\u306b\u3001\u3054\u81ea\u8eab\u306e\u30af\u30e9\u30b9\u3092\u78ba\u5b9a\u3057\u305f\u3044\u3067\u3059\u304b\uff1f\u4e0b\u8a18\u306e\u554f\u3044\u5408\u308f\u305b\u30d5\u30a9\u30fc\u30e0\u306b\u3054\u8a18\u5165\u304f\u3060\u3055\u3044\u3002\u5f0a\u793e\u306e\u898f\u5236\u62c5\u5f53\u30c1\u30fc\u30e0\u304c\u3054\u9023\u7d61\u3057\u3001\u304a\u5ba2\u69d8\u306e\u30af\u30e9\u30b9\u5206\u985e\u3068\u8a66\u9a13\u7bc4\u56f2\u306b\u3064\u3044\u3066\u3054\u6848\u5185\u3044\u305f\u3057\u307e\u3059\u3002.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>One of the most critical missteps foreign manufacturers make when entering Indonesia is treating medical device risk classification as a mere administrative box to tick. It is surprisingly common for companies to copy a classification directly from a foreign reference market, assume Kemenkes will simply align, and only realize their mistake after budgets and launch dates are already locked in. Classifying a device is not just about paperwork, it dictates the weight of your local testing requirements, and the gap between risk tiers can be staggering. We saw this firsthand with a client registering a tuberculosis (TB) diagnostic kit: because of its class, the product faced an exponentially stricter testing [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":7870,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7868","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\/7868","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=7868"}],"version-history":[{"count":2,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7868\/revisions"}],"predecessor-version":[{"id":7873,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7868\/revisions\/7873"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/7870"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=7868"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=7868"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=7868"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=7868"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}