{"id":7707,"date":"2026-09-10T16:13:55","date_gmt":"2026-09-10T09:13:55","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-09-10T16:13:57","modified_gmt":"2026-09-10T09:13:57","slug":"radioactive-ivd-registration-in-indonesia-inside-the-ivd-radiation-regulatory-pathway","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/ja\/radioactive-ivd-registration-in-indonesia-inside-the-ivd-radiation-regulatory-pathway\/","title":{"rendered":"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u653e\u5c04\u6027\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306e\u767b\u9332\uff1aIVD\u653e\u5c04\u7dda\u898f\u5236\u7d4c\u8def\u306e\u5185\u5e55"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u79c1\u305f\u3061\u304c\u6700\u3082\u3088\u304f\u906d\u9047\u3059\u308b\u9593\u9055\u3044\u306f\u3001\u4e00\u898b\u5358\u7d14\u305d\u3046\u306b\u898b\u3048\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u653e\u5c04\u6027\u6a19\u8b58\u3055\u308c\u305f\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u30ad\u30c3\u30c8\u3001\u30e9\u30b8\u30aa\u30a4\u30e0\u30ce\u30a2\u30c3\u30bb\u30a4\uff08RIA\uff09\u8a66\u85ac\u306a\u3069\u3092\u3001\u901a\u5e38\u306e\u8a3a\u65ad\u85ac\u3068\u540c\u3058\u3088\u3046\u306b\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\uff08Kemenkes\uff09\u306e\u6280\u8853\u6587\u66f8\u306e\u307f\u3092\u4f7f\u7528\u3057\u3066\u7533\u8acb\u3057\u307e\u3059\u3002\u30b1\u30e1\u30f3\u30b1\u30b9\u306e\u5be9\u67fb\u306f\u9806\u8abf\u306b\u9032\u307f\u3001\u5206\u985e\u3082\u4e88\u60f3\u901a\u308a\u306b\u884c\u308f\u308c\u307e\u3059\u3002\u3068\u3053\u308d\u304c\u3001\u8ca8\u7269\u304c\u56fd\u5883\u306b\u5230\u7740\u3059\u308b\u3068\u3001\u30ad\u30c3\u30c8\u306b\u542b\u307e\u308c\u308b\u540c\u4f4d\u4f53\u81ea\u4f53\u306b\u5225\u9014\u8a8d\u53ef\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u3057\u304b\u3082\u8ab0\u3082\u305d\u306e\u624b\u7d9a\u304d\u3092\u958b\u59cb\u3057\u3066\u3044\u306a\u304b\u3063\u305f\u3053\u3068\u304c\u5224\u660e\u3059\u308b\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001\u554f\u984c\u306e\u672c\u8cea\u306f\u66f8\u985e\u624b\u7d9a\u304d\u3067\u306f\u306a\u304f\u3001\u624b\u9806\u306e\u9806\u5e8f\u306b\u3042\u308b\u306e\u3067\u3059\u3002\u653e\u5c04\u6027IVD\u30ad\u30c3\u30c8\u306f\u30011\u3064\u306e\u30e9\u30d9\u30eb\u3092\u5171\u6709\u3059\u308b2\u3064\u306e\u88fd\u54c1\u3068\u3057\u3066\u7406\u89e3\u3059\u308b\u306e\u304c\u6700\u3082\u9069\u5207\u3067\u3059\u30021\u3064\u306fKemenkes\u304c\u5be9\u67fb\u3059\u308b\u8a3a\u65ad\u30ad\u30c3\u30c8\u672c\u4f53\u3001\u3082\u30461\u3064\u306f\u305d\u308c\u306b\u542b\u307e\u308c\u308b\u653e\u5c04\u6027\u7269\u8cea\u3067\u3001\u3053\u3061\u3089\u306f\u5168\u304f\u5225\u306e\u898f\u5236\u5f53\u5c40\u306e\u7ba1\u8f44\u4e0b\u306b\u3042\u308a\u307e\u3059\u3002\u4e21\u65b9\u306e\u66f8\u985e\u3092\u521d\u65e5\u304b\u3089\u6e96\u5099\u3059\u308c\u3070\u3001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306f\u304d\u3061\u3093\u3068\u6a5f\u80fd\u3057\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u9806\u756a\u306b\u6e96\u5099\u3057\u3066\u3044\u304f\u3068\u30012\u3064\u76ee\u306e\u66f8\u985e\u3067\u307b\u307c\u5fc5\u305a\u554f\u984c\u304c\u767a\u751f\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u308c\u304c\u307e\u3055\u306b\u305d\u306e\u80cc\u5f8c\u306b\u3042\u308b\u8ad6\u7406\u3067\u3059 <strong>IVD\u653e\u5c04\u7dda\u898f\u5236\u7d4c\u8def<\/strong> \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306f\u3001\u901a\u5e38\u306e\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fd\u5bb6\u653e\u5c04\u7dda\u9632\u8b77\u5c40\uff08Kemenkes\uff09\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3060\u3051\u3067\u3088\u3044\u306e\u306b\u5bfe\u3057\u3001\u653e\u5c04\u6027\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306f\u3001\u75c5\u9662\u3084\u691c\u67fb\u5ba4\u306e\u68da\u306b\u5408\u6cd5\u7684\u306b\u7f6e\u304b\u308c\u308b\u305a\u3063\u3068\u524d\u306b\u3001Kemenkes\u3068\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u4e21\u65b9\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u30ac\u30a4\u30c9\u3067\u306f\u3001\u307e\u3055\u306b\u305d\u306e\u70b9\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u89e3\u8aac\u3057\u3066\u3044\u307e\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u306b\u653e\u5c04\u6027\u4f53\u5916\u8a3a\u65ad\u30ad\u30c3\u30c8\u3092\u6295\u5165\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u898f\u5236\u95a2\u9023\u62c5\u5f53\u8005\u3001\u8ca9\u58f2\u696d\u8005\u3001\u8f38\u5165\u696d\u8005\u5411\u3051\u306b\u66f8\u304b\u308c\u3066\u304a\u308a\u3001\u521d\u3081\u3066\u306e\u7533\u8acb\u3067\u3042\u308d\u3046\u306810\u56de\u76ee\u306e\u7533\u8acb\u3067\u3042\u308d\u3046\u3068\u3001\u5b9f\u969b\u306b\u3069\u306e2\u3064\u306e\u898f\u5236\u5f53\u5c40\u304c\u95a2\u4e0e\u3059\u308b\u306e\u304b\u3001\u901a\u5e38\u306e\u4f53\u5916\u8a3a\u65ad\u30ad\u30c3\u30c8\u306e\u7533\u8acb\u3068\u3069\u306e\u3088\u3046\u306a\u70b9\u3067\u7570\u306a\u308b\u306e\u304b\u3001\u305d\u3057\u3066\u8ca8\u7269\u304c\u7a0e\u95a2\u306b\u5230\u7740\u3059\u308b\u305a\u3063\u3068\u524d\u306b\u6e96\u5099\u3057\u3066\u304a\u304f\u3079\u304d\u3053\u3068\u306f\u4f55\u304b\u306a\u3069\u3092\u7db2\u7f85\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305f\u3060\u3057\u3001\u88fd\u54c1\u306b\u653e\u5c04\u6027\u30c8\u30ec\u30fc\u30b5\u30fc\u304c\u542b\u307e\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u3001\u95a2\u9023\u8a18\u4e8b\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u65b9\u6cd5\u306e\u65b9\u304c\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002, <a href=\"https:\/\/productregistrationindonesia.com\/ja\/indonesia-ivd-registration-vs-medical-device\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306e\u767b\u9332\uff1a\u533b\u7642\u6a5f\u5668\u3068\u306e\u767b\u9332\u7d4c\u8def\u306e\u9055\u3044<\/a>, \u3053\u308c\u306f\u3001\u30ea\u30b9\u30af\u5206\u985e\u3068\u3001\u30af\u30e9\u30b9D\u611f\u67d3\u75c7IVD\u306b\u5bfe\u3059\u308b\u8ffd\u52a0\u306e\u81e8\u5e8a\u7684\u8a3c\u62e0\u306e\u30b9\u30c6\u30c3\u30d7\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u533a\u5225\u306f\u5b8c\u5168\u306bKemenkes\u5185\u90e8\u3067\u884c\u308f\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u3053\u3067\u53d6\u308a\u4e0a\u3052\u308b\u306e\u306f2\u3064\u306e\u7570\u306a\u308b\u898f\u5236\u6a5f\u95a2\u306b\u307e\u305f\u304c\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u4ee5\u964d\u306e\u3059\u3079\u3066\u306e\u5185\u5bb9\u306f\u3053\u306e\u533a\u5225\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6839\u672c\u7684\u306a\u9055\u3044\uff1a1\u3064\u306e\u88fd\u54c1\u30012\u3064\u306e\u627f\u8a8d\u5bfe\u8c61<\/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\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2.webp\" alt=\"\u653e\u5c04\u6027\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306e\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u4e8c\u91cd\u898f\u5236\u6a5f\u95a2\u767b\u9332\u30ac\u30a4\u30c9 \" class=\"wp-image-7709\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2.webp 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2-300x200.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2-18x12.webp 18w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2-768x512.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u73fe\u5728\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u4f53\u5916\u8a3a\u65ad\uff08IVD\uff09\u6280\u8853\u306f\u3001\u5358\u7d14\u306a\u30e9\u30c6\u30e9\u30eb\u30d5\u30ed\u30fc\u8a66\u9a13\u7d19\u3088\u308a\u3082\u306f\u308b\u304b\u306b\u591a\u69d8\u3067\u3042\u308b\u3002\u4e00\u90e8\u306eIVD\u30ad\u30c3\u30c8\u306b\u306f\u6709\u52b9\u533b\u85ac\u54c1\u6210\u5206\u304c\u542b\u307e\u308c\u3066\u304a\u308a\u3001\u3088\u308a\u5c0f\u898f\u6a21\u306a\u304c\u3089\u3082\u6839\u5f37\u3044\u30ab\u30c6\u30b4\u30ea\u30fc\u3067\u306f\u3001\u653e\u5c04\u6027\u30c8\u30ec\u30fc\u30b5\u30fc\uff08\u591a\u304f\u306e\u5834\u5408\u3001\u30e8\u30a6\u7d20125\u306a\u3069\u306e\u540c\u4f4d\u4f53\uff09\u304c\u542b\u307e\u308c\u3066\u304a\u308a\u3001\u30db\u30eb\u30e2\u30f3\u3084\u816b\u760d\u30de\u30fc\u30ab\u30fc\u691c\u67fb\u7528\u306e\u30e9\u30b8\u30aa\u30a4\u30e0\u30ce\u30a2\u30c3\u30bb\u30a4\uff08RIA\uff09\u30ad\u30c3\u30c8\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306e\u66f8\u985e\u3092\u6e96\u5099\u3057\u3066\u304d\u305f\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001\u653e\u5c04\u6027IVD\u30ad\u30c3\u30c8\u306e\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3092\u5be9\u67fb\u3059\u308b\u30b1\u30e1\u30f3\u30b1\u30b9\u306e\u8a55\u4fa1\u62c5\u5f53\u8005\u306f\u3001\u7533\u8acb\u8005\u304c\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u6709\u52b9\u306a\u307e\u305f\u306f\u51e6\u7406\u4e2d\u306e\u627f\u8a8d\u756a\u53f7\u3092\u63d0\u793a\u3067\u304d\u308b\u307e\u3067\u3001\u30d5\u30a1\u30a4\u30eb\u3092\u30ad\u30e5\u30fc\u6bb5\u968e\u306b\u4fdd\u7559\u3059\u308b\u306e\u304c\u901a\u4f8b\u3067\u3059\u3002 <a href=\"https:\/\/farmalkes.kemkes.go.id\/unduh\/permenkes-62-2017\/\" target=\"_blank\" rel=\"noopener\">Permenkes No. 62 Tahun 2017<\/a> \u6838\u5175\u5668\u95a2\u9023\u306e\u8cc7\u683c\u8a3c\u660e\u66f8\u306f\u3001\u898f\u5b9a\u306e\u5fc5\u9808\u66f8\u985e\u3068\u3057\u3066\u660e\u8a18\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002\u76f8\u4e92\u30c1\u30a7\u30c3\u30af\u306f\u3001\u5370\u5237\u3055\u308c\u305f\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u9805\u76ee\u3068\u3057\u3066\u3067\u306f\u306a\u304f\u3001\u5be9\u67fb\u62c5\u5f53\u8005\u306e\u6163\u884c\u3068\u3057\u3066\u884c\u308f\u308c\u308b\u305f\u3081\u3001\u521d\u3081\u3066\u7533\u8acb\u3059\u308b\u4eba\u304c\u898f\u5247\u306e\u6761\u6587\u3060\u3051\u304b\u3089\u671f\u5f85\u3059\u308b\u3088\u3046\u306a\u8a73\u7d30\u306a\u60c5\u5831\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3057\u305f\u304c\u3063\u3066\u3001\u653e\u5c04\u6027 IVD \u30ad\u30c3\u30c8\u306f\u30012 \u3064\u306e\u5225\u3005\u306e\u898f\u5236\u5f53\u5c40\u306b\u3088\u3063\u3066\u4fdd\u6301\u3055\u308c\u308b 2 \u3064\u306e\u5225\u3005\u306e\u627f\u8a8d\u30aa\u30d6\u30b8\u30a7\u30af\u30c8\u3068\u3057\u3066\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002 Kemenkes \u306f\u3001Direktorat Jenderal Farmasi dan Alat Kesehatan (Ditjen Farmalkes) \u3092\u901a\u3058\u3066\u3001\u3053\u306e\u30ad\u30c3\u30c8\u3092\u4f53\u5916\u8a3a\u65ad\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u8a55\u4fa1\u3057\u307e\u3057\u305f\u3002 <a href=\"https:\/\/farmalkes.kemkes.go.id\/unduh\/permenkes-62-2017\/\" target=\"_blank\" rel=\"noopener\">\u30da\u30e9\u30c8\u30a5\u30e9\u30f3 \u30e1\u30f3\u30c6\u30ea \u30b1\u30bb\u30cf\u30bf\u30f3 (\u30da\u30eb\u30e1\u30f3\u30b1\u30b9) No. 62 \u30bf\u30d5\u30f3 2017<\/a> \u30c6\u30f3\u30bf\u30f3\u30fb\u30a4\u30b8\u30f3\u30fb\u30a8\u30c0\u30eb\u30fb\u30a2\u30e9\u30c3\u30c8\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3\u3001\u30a2\u30e9\u30c3\u30c8\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3\u306e\u4f53\u5916\u8a3a\u65ad\u3001\u30da\u30eb\u30d9\u30ab\u30e9\u30f3\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3\u30fb\u30eb\u30de\u30fb\u30bf\u30f3\u30ac\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u307e\u305f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306f\u3001\u540c\u3058\u30ad\u30c3\u30c8\u306e\u653e\u5c04\u6027\u7269\u8cea\u542b\u6709\u91cf\u3092\u898f\u5236\u5bfe\u8c61\u653e\u5c04\u6027\u7269\u8cea\u3068\u3057\u3066\u8a55\u4fa1\u3057\u3066\u3044\u308b\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/45931\" target=\"_blank\" rel=\"noopener\">\u30a6\u30f3\u30c0\u30f3\u30fb\u30a6\u30f3\u30c0\u30f3 No. 10 \u30bf\u30d5\u30f3 1997<\/a> \u30b1\u30c6\u30ca\u30ac\u30cc\u30af\u30ea\u30e9\u30f3\u3068\u305d\u306e\u5b9f\u65bd\u898f\u5247\u306b\u95a2\u3059\u308b2\u756a\u76ee\u306e\u30c8\u30e9\u30c3\u30af\u3002 <strong>\u539f\u5b50\u529b\u898f\u5236\u9075\u5b88IVD<\/strong> \u5fdc\u52df\u8005\u306f\u3001\u4ee5\u4e0b\u306b\u8a73\u8ff0\u3059\u308b\u4e8b\u9805\u306b\u3064\u3044\u3066\u8a08\u753b\u3092\u7acb\u3066\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Kemenkes\u306b\u3088\u308b\u6a19\u6e96IVD\u767b\u9332\u30c8\u30e9\u30c3\u30af<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u306b\u51fa\u56de\u308b\u3059\u3079\u3066\u306eIVD\u88fd\u54c1\u306f\u3001\u653e\u5c04\u6027\u7269\u8cea\u3092\u542b\u3080\u304b\u5426\u304b\u306b\u304b\u304b\u308f\u3089\u305a\u3001\u307e\u305a\u6700\u521d\u306b\u4ee5\u4e0b\u306e\u5be9\u67fb\u3092\u53d7\u3051\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 <strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306e\u767b\u9332<\/strong> 2017\u5e74\u653f\u4ee4\u7b2c62\u53f7\u306b\u57fa\u3065\u304d\u3001\u7533\u8acb\u8005\u306f\u6280\u8853\u6587\u66f8\u3092\u63d0\u51fa\u3059\u308b\u3002 <a href=\"https:\/\/regalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\">\u30ec\u30ac\u30eb\u30b1\u30b9<\/a> \u96fb\u5b50\u30b7\u30b9\u30c6\u30e0\u7ba1\u7406 <a href=\"https:\/\/farmalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\">\u30c7\u30a3\u30c3\u30c1\u30a7\u30f3\u30fb\u30d5\u30a1\u30fc\u30de\u30eb\u30b1\u30b9<\/a>, ASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u52a0\u76df\u56fd\u5168\u4f53\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308bASEAN\u5171\u901a\u63d0\u51fa\u66f8\u985e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306b\u6982\u306d\u6cbf\u3063\u305f\u69cb\u6210\u3068\u306a\u3063\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u63d0\u51fa\u3055\u308c\u305f\u66f8\u985e\u306f\u3001\u88fd\u54c1\u306e\u30ea\u30b9\u30af\u30af\u30e9\u30b9\uff08\u6700\u3082\u30ea\u30b9\u30af\u306e\u4f4e\u3044\u30af\u30e9\u30b9A\u304b\u3089\u3001\u6700\u3082\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u30af\u30e9\u30b9D\u307e\u3067\uff09\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fd\u5185\u3067\u30ad\u30c3\u30c8\u306e\u8ca9\u58f2\u3092\u8a31\u53ef\u3059\u308b\u6d41\u901a\u756a\u53f7\u3067\u3042\u308bNomor Izin Edar\uff08NIE\uff09\u304c\u767a\u884c\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u5de5\u7a0b\u306f\u3001\u30ad\u30c3\u30c8\u306b\u653e\u5c04\u6027\u30c8\u30ec\u30fc\u30b5\u30fc\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u306b\u95a2\u308f\u3089\u305a\u540c\u3058\u3067\u3059\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u767b\u9332<\/a> \u30b5\u30fc\u30d3\u30b9\u304c\u3053\u308c\u3092\u7ba1\u7406\u3057\u307e\u3059 <a href=\"https:\/\/www.kemkes.go.id\/eng\/home\" target=\"_blank\" rel=\"noopener\">\u30b1\u30e1\u30f3\u30b1\u30b9<\/a> \u6700\u521d\u304b\u3089\u6700\u5f8c\u307e\u3067\u8ffd\u8de1\u3057\u307e\u3059\u3002\u540c\u4e00\u3067\u306f\u306a\u3044\u306e\u306f\u3001\u30d5\u30a1\u30a4\u30eb\u304c\u5148\u306b\u9032\u3080\u524d\u306b\u30b1\u30e1\u30f3\u30b1\u30b9\u6587\u66f8\u3068\u4e26\u3079\u3066\u7f6e\u304b\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3082\u306e\u3067\u3001\u3053\u308c\u306f\u5f8c\u8ff0\u3059\u308b2\u756a\u76ee\u306e\u8ffd\u8de1\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u7b2c2\u30c8\u30e9\u30c3\u30af\uff1a\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306b\u304a\u3051\u308b\u539f\u5b50\u529b\u898f\u5236\u9075\u5b88<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>IVD\u306b\u304a\u3051\u308b\u539f\u5b50\u529b\u898f\u5236\u9075\u5b88<\/strong> \u653e\u5c04\u6027\u7269\u8cea\u3092\u542b\u3080\u30ad\u30c3\u30c8\u306f\u3001\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u6a5f\u95a2\u306e\u7ba1\u8f44\u4e0b\u306b\u3042\u308a\u3001Kemenkes\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u653e\u5c04\u7dda\u885b\u751f\u5c40\uff09\u306e\u7ba1\u8f44\u4e0b\u306b\u306f\u306a\u304f\u3001\u5225\u306e\u6cd5\u7684\u6839\u62e0\u306b\u57fa\u3065\u3044\u3066\u904b\u55b6\u3055\u308c\u3066\u3044\u308b\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u653e\u5c04\u6027\u7269\u8cea\u306e\u5229\u7528\uff08\u8f38\u5165\u3092\u542b\u3080\uff09\u306b\u306f\u3001\u7b2c17\u6761\u7b2c1\u9805\u306b\u57fa\u3065\u304d\u3001\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u6a5f\u95a2\u304b\u3089\u306e\u8a31\u53ef\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/45931\" target=\"_blank\" rel=\"noopener\">\u30a6\u30f3\u30c0\u30f3\u30fb\u30a6\u30f3\u30c0\u30f3 No. 10 \u30bf\u30d5\u30f3 199<\/a>7 tentang Ketenaganukliran.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u96fb\u96e2\u653e\u5c04\u7dda\u6e90\u304a\u3088\u3073\u6838\u7269\u8cea\u306e\u5229\u7528\u306b\u95a2\u3059\u308b\u8a31\u53ef\u624b\u7d9a\u304d\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/4842\/pp-no-29-tahun-2008\" target=\"_blank\" rel=\"noopener\">\u30da\u30e9\u30c8\u30a5\u30e9\u30f3 \u30da\u30e1\u30ea\u30f3\u30bf No. 29 \u30bf\u30d5\u30f3 2008<\/a> \u30c6\u30f3\u30bf\u30f3 \u30da\u30ea\u30b8\u30ca\u30f3 \u30da\u30de\u30f3\u30d5\u30a1\u30fc\u30bf\u30f3 \u30b9\u30f3\u30d9\u30eb \u30e9\u30c7\u30a3\u30a2\u30b7 \u30da\u30f3\u30ae\u30aa\u30f3 \u30c0\u30f3 \u30d0\u30cf\u30f3 \u30cc\u30af\u30ea\u30eb\u3002\u653e\u5c04\u7dda\u306e\u5b89\u5168\u6027\u3068\u653e\u5c04\u7dda\u6e90\u306e\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u8981\u4ef6\u306f\u3001\u4ee5\u4e0b\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/265188\/pp-no-45-tahun-2023\" target=\"_blank\" rel=\"noopener\">\u30da\u30e9\u30c8\u30a5\u30e9\u30f3 \u30da\u30e1\u30ea\u30f3\u30bf No. 45 \u30bf\u30d5\u30f3 2023<\/a> \u30c6\u30f3\u30bf\u30f3\u30fb\u30b1\u30bb\u30e9\u30de\u30bf\u30f3\u30fb\u30e9\u30c7\u30a3\u30a2\u30b7\u30fb\u30da\u30f3\u30ae\u30aa\u30f3\u30fb\u30c0\u30f3\u30fb\u30b1\u30a2\u30de\u30ca\u30f3\u30fb\u30b6\u30c3\u30c8\u30fb\u30e9\u30b8\u30aa\u30a2\u30af\u30c6\u30a3\u30d5\u3001\u3053\u308c\u306f\u4ee5\u524d\u306e\u3082\u306e\u306b\u53d6\u3063\u3066\u4ee3\u308f\u3089\u308c\u308b <a href=\"https:\/\/jdih.bapeten.go.id\/id\/dokumen\/peraturan\/peraturan-pemerintah-no-33-tahun-2007-tentang-keselamatan-radiasi-pengion-dan-keamanan-zat-radioaktif\" target=\"_blank\" rel=\"noopener\">\u30da\u30e9\u30c8\u30a5\u30e9\u30f3 \u30da\u30e1\u30ea\u30f3\u30bf No. 33 \u30bf\u30d5\u30f3 2007<\/a> \u540c\u3058\u30c6\u30fc\u30de\u306b\u3064\u3044\u3066\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8981\u3059\u308b\u306b\u3001\u653e\u5c04\u6027IVD\u30ad\u30c3\u30c8\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\u306e\u8a31\u53ef\u8a3c\uff08Isin Edar\uff09\u3060\u3051\u3067\u306f\u5408\u6cd5\u7684\u306b\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u6301\u3061\u8fbc\u3080\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u8f38\u5165\u696d\u8005\u3001\u307e\u305f\u306f\u305d\u306e\u6307\u5b9a\u8a31\u53ef\u8a3c\u4fdd\u6301\u8005\u306f\u3001\u653e\u5c04\u6027\u7269\u8cea\u81ea\u4f53\u3092\u5bfe\u8c61\u3068\u3059\u308b\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u8a31\u53ef\u3082\u53d6\u5f97\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u305d\u306e\u8a31\u53ef\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u898f\u5236\u3068\u7d71\u5408\u3055\u308c\u305f\u72ec\u81ea\u306e\u30aa\u30f3\u30e9\u30a4\u30f3\u8a31\u53ef\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u51e6\u7406\u3055\u308c\u307e\u3059\u3002 <a href=\"https:\/\/oss.go.id\/en\" target=\"_blank\" rel=\"noopener\">\u30aa\u30f3\u30e9\u30a4\u30f3\u5358\u4e00\u63d0\u51fa\uff08OSS\uff09<\/a> \u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0 <a href=\"https:\/\/jdih.bapeten.go.id\/id\/dokumen\/peraturan\/peraturan-kepala-badan-no-3-tahun-2021-tentang-standar-kegiatan-usaha-dan-standar-produk-pada-penyelenggaraan-perizinan-berusaha-berbasis-risiko-sektor-ketenaganukliran\" target=\"_blank\" rel=\"noopener\">\u898f\u5247\u7b2c3\u53f7 2021\u5e74<\/a> \u30c6\u30f3\u30bf\u30f3 \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 \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 \u30bb\u30af\u30bf\u30fc \u30b1\u30c6\u30ca\u30ac\u30cc\u30af\u30ea\u30f3\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u8f38\u5165\u306f\u539f\u5b50\u529b\u898f\u5236\u5f53\u5c40\u306e\u8981\u4ef6\u306b\u5f93\u3046<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u653e\u5c04\u6027\u7269\u8cea\u306e\u8f38\u5165\u306f\u3001\u8f38\u5165\u696d\u8005\u304c\u8a2d\u5b9a\u3057\u305f\u4e00\u822c\u7684\u306a\u901a\u95a2\u624b\u7d9a\u304d\u3067\u306f\u306a\u304f\u3001\u3042\u3089\u3086\u308b\u6bb5\u968e\u3067\u56fd\u306e\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u5b9a\u3081\u308b\u624b\u7d9a\u304d\u8981\u4ef6\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8ca8\u7269\u306e\u8aac\u660e\u3001\u68b1\u5305\u3001\u73fe\u5834\u306e\u653e\u5c04\u7dda\u9632\u8b77\u8a2d\u5099\u3001\u653e\u5c04\u6027\u7269\u8cea\u306e\u4fdd\u7ba1\u65bd\u8a2d\u306a\u3069\u3001\u3059\u3079\u3066\u304c\u56fd\u306e\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u3092\u5f97\u3089\u308c\u308b\u3088\u3046\u6587\u66f8\u5316\u3055\u308c\u3066\u521d\u3081\u3066\u3001\u8ca8\u7269\u306e\u56fd\u5185\u3078\u306e\u642c\u5165\u304c\u8a31\u53ef\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u624b\u7d9a\u304d\u306f\u3001\u975e\u653e\u5c04\u6027\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u8f38\u9001\u306b\u9069\u7528\u3055\u308c\u308b\u901a\u95a2\u624b\u7d9a\u304d\u3068\u306f\u5225\u500b\u306e\u3082\u306e\u3067\u3042\u308a\u3001\u305d\u308c\u306b\u52a0\u3048\u3066\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u901a\u5e38\u306e\u8a66\u85ac\u8f38\u9001\u306b\u4f7f\u7528\u3059\u308b\u66f8\u985e\u3068\u540c\u3058\u3082\u306e\u3092\u4f7f\u3063\u3066\u958b\u59cb\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\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=\"KqX6cAX3RK\"><a href=\"https:\/\/productregistrationindonesia.com\/ja\/bapeten-import-license-amendment\/\">BAPETEN\u8f38\u5165\u8a31\u53ef\u8a3c\u306e\u5909\u66f4\uff1a\u65b0\u3057\u3044\u653e\u5c04\u7dda\u6a5f\u5668\u30e2\u30c7\u30eb\u3092\u8ffd\u52a0\u3059\u308b\u3068\u51fa\u8377\u304c\u9045\u308c\u308b\u7406\u7531<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u300cBAPETEN\u8f38\u5165\u8a31\u53ef\u8a3c\u306e\u5909\u66f4\uff1a\u65b0\u3057\u3044\u653e\u5c04\u7dda\u6a5f\u5668\u30e2\u30c7\u30eb\u3092\u8ffd\u52a0\u3059\u308b\u3068\u51fa\u8377\u304c\u6ede\u308b\u7406\u7531\u300d\u2014\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u88fd\u54c1\u767b\u9332\" src=\"https:\/\/productregistrationindonesia.com\/bapeten-import-license-amendment\/embed\/#?secret=EzG7wV98Gp#?secret=KqX6cAX3RK\" data-secret=\"KqX6cAX3RK\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u3053\u306e2\u3064\u306e\u30c8\u30e9\u30c3\u30af\u306f\u4e92\u63db\u6027\u304c\u3042\u308a\u307e\u305b\u3093<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30b1\u30e1\u30f3\u30b1\u30b9\uff08Kemenkes\uff09\u306e\u8f38\u5165\u8a31\u53ef\u8a3c\uff08izin edar\uff09\u3092\u4fdd\u6709\u3057\u3066\u3044\u308b\u3060\u3051\u3067\u306f\u3001\u653e\u5c04\u6027\u30c8\u30ec\u30fc\u30b5\u30fc\u306e\u8f38\u5165\u306f\u8a8d\u3081\u3089\u308c\u305a\u3001\u307e\u305f\u3001\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u8f38\u5165\u8a31\u53ef\u8a3c\u3092\u4fdd\u6709\u3057\u3066\u3044\u308b\u3060\u3051\u3067\u306f\u3001\u5b8c\u6210\u3057\u305f\u4f53\u5916\u8a3a\u65ad\u7528\u30ad\u30c3\u30c8\u306e\u5546\u696d\u7684\u6d41\u901a\u306f\u8a8d\u3081\u3089\u308c\u307e\u305b\u3093\u3002\u51fa\u8377\u304c\u5408\u6cd5\u3068\u306a\u308b\u305f\u3081\u306b\u306f\u3001\u4e21\u65b9\u306e\u8a31\u53ef\u8a3c\u304c\u6709\u52b9\u3067\u3042\u308a\u3001\u304b\u3064\u540c\u4e00\u306e\u88fd\u54c1\u304a\u3088\u3073\u540c\u4e00\u306e\u6cd5\u4eba\u306b\u7d10\u3065\u3044\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\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=\"5PtkY4eHzq\"><a href=\"https:\/\/productregistrationindonesia.com\/ja\/radiation-medical-device-distributor\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u653e\u5c04\u7dda\u533b\u7642\u6a5f\u5668\u8ca9\u58f2\u696d\u8005\uff1a\u5bfe\u8c61\u3068\u306a\u308b\u9867\u5ba2\u5c64\u304c\u60f3\u50cf\u3088\u308a\u5c11\u306a\u3044\u7406\u7531<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u300c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u653e\u5c04\u7dda\u533b\u7642\u6a5f\u5668\u8ca9\u58f2\u696d\u8005\uff1a\u9069\u683c\u8005\u306e\u7bc4\u56f2\u304c\u60f3\u50cf\u3088\u308a\u72ed\u3044\u7406\u7531\u300d\u2014\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u88fd\u54c1\u767b\u9332\" src=\"https:\/\/productregistrationindonesia.com\/radiation-medical-device-distributor\/embed\/#?secret=KPmk8UiKKM#?secret=5PtkY4eHzq\" data-secret=\"5PtkY4eHzq\" 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>\u6a19\u6e96IVD\u3068\u653e\u5c04\u6027IVD\uff1a\u5fb9\u5e95\u6bd4\u8f03<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u306e\u8868\u306f\u30012\u3064\u306e\u7d4c\u8def\u304c\u4e26\u884c\u3057\u3066\u9032\u3080\u7b87\u6240\u3068\u3001\u653e\u5c04\u6027\u4f53\u5916\u8a3a\u65ad\u30ad\u30c3\u30c8\u306b\u8ffd\u52a0\u306e\u8981\u4ef6\u304c\u8ab2\u3055\u308c\u308b\u7b87\u6240\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u5074\u9762<\/strong><\/td><td><strong>\u6a19\u6e96IVD<\/strong><\/td><td><strong>\u653e\u5c04\u6027IVD<\/strong><\/td><\/tr><tr><td>\u4e3b\u8981\u898f\u5236\u5f53\u5c40<\/td><td>Kemenkes (Ditjen Farmalkes)<\/td><td>\u30b1\u30e1\u30f3\u30b1\u30b9\u3068\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40<\/td><\/tr><tr><td>\u6cd5\u7684\u6839\u62e0<\/td><td>\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c62\/2017\u53f7<\/td><td>\u30da\u30eb\u30e1\u30f3\u30b1\u30b9 No. 62\/2017 \u304a\u3088\u3073 UU No. 10\/1997\u3001PP No. 29\/2008\u3001PP No. 45\/2023<\/td><\/tr><tr><td>\u627f\u8a8d\u5bfe\u8c61<\/td><td>IVD\u30ad\u30c3\u30c8\u5168\u4f53<\/td><td>IVD\u30ad\u30c3\u30c8\uff08\u30b1\u30e1\u30f3\u30b1\u30b9\uff09\u3068\u305d\u308c\u306b\u542b\u307e\u308c\u308b\u653e\u5c04\u6027\u7269\u8cea\u306f\u3001\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306b\u3088\u3063\u3066\u500b\u5225\u306b\u8a55\u4fa1\u3055\u308c\u308b\u3002<\/td><\/tr><tr><td>\u6295\u7a3f\u30b7\u30b9\u30c6\u30e0<\/td><td>\u30ec\u30ac\u30eb\u30b1\u30b9\u3068\u30d0\u30ea\u30b9\u30b7\u30b9\u30c6\u30e0<\/td><td>\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u30aa\u30f3\u30e9\u30a4\u30f3\u30b7\u30b9\u30c6\u30e0\u3067\u3042\u308bREGALKES\uff08\u30b1\u30e1\u30f3\u30b1\u30b9\uff09\u304a\u3088\u3073BALIS SYSTEM\u306f\u3001OSS-RBA\u3068\u7d71\u5408\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/td><\/tr><tr><td>\u30a4\u30f3\u30dd\u30fc\u30c8\u624b\u9806<\/td><td>\u6a19\u6e96\u7684\u306a\u901a\u95a2\u304a\u3088\u3073\u8f38\u5165\u66f8\u985e<\/td><td>\u653e\u5c04\u6027\u7269\u8cea\u306b\u95a2\u3059\u308b\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u8ffd\u52a0\u8f38\u5165\u8a31\u53ef<\/td><\/tr><tr><td>\u8a2d\u5099\u8981\u4ef6<\/td><td>\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c62\/2017\u53f7\u306b\u57fa\u3065\u304f\u4e00\u822c\u4fdd\u7ba1<\/td><td>\u653e\u5c04\u7dda\u9632\u8b77\u4fdd\u7ba1\u304a\u3088\u3073\u5b89\u5168\u306b\u95a2\u3059\u308b\u6587\u66f8\u306f\u3001\u56fd\u306e\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306b\u3088\u3063\u3066\u5be9\u67fb\u6e08\u307f\u3067\u3042\u308b\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u767b\u9332\u624b\u7d9a\u304d\u4e2d\u306b2\u3064\u306e\u7d4c\u8def\u304c\u4ea4\u5dee\u3059\u308b\u5834\u6240<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u77ed\u3044\u8aac\u660e\u6587\u306b\u3088\u3063\u3066\u3001\u7279\u5b9a\u306e\u88fd\u54c1\u304c\u3069\u306e\u7d4c\u8def\u3092\u305f\u3069\u308b\u306e\u304b\u3001\u305d\u3057\u30662\u3064\u306e\u898f\u5236\u5f53\u5c40\u306e\u8981\u4ef6\u304c\u3069\u3053\u3067\u4ea4\u308f\u308b\u306e\u304b\u304c\u660e\u78ba\u306b\u306a\u308b\u3002.<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>IVD\u30ad\u30c3\u30c8\u306b\u306f\u653e\u5c04\u6027\u540c\u4f4d\u4f53\u307e\u305f\u306f\u30c8\u30ec\u30fc\u30b5\u30fc\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u304b\uff1f\u542b\u307e\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u30012017\u5e74\u653f\u4ee4\u7b2c62\u53f7\u306b\u57fa\u3065\u304f\u3001Kemenkes\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\uff09\u306e\u307f\u306b\u3088\u308b\u6a19\u6e96\u7684\u306a\u7d4c\u8def\u306b\u5f93\u3044\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u306f\u3044\u306e\u5834\u5408\u3001\u7533\u8acb\u8005\u306f\u540c\u4f4d\u4f53\u306e\u7a2e\u985e\u3068\u653e\u5c04\u80fd\u30ec\u30d9\u30eb\u3092\u7279\u5b9a\u3057\u3066\u3044\u307e\u3059\u304b\uff1f\u3053\u306e\u60c5\u5831\u306b\u3088\u3063\u3066\u3001\u30ad\u30c3\u30c8\u304c\u8a72\u5f53\u3059\u308b\u898f\u5236\u5f53\u5c40\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u304c\u6c7a\u307e\u308a\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u5f53\u8a72\u653e\u5c04\u6027\u7269\u8cea\u306b\u95a2\u3059\u308b\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u8a8d\u53ef\u306f\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\uff08\u30b1\u30e1\u30f3\u30b1\u30b9\uff09\u3078\u306e\u7533\u8acb\u66f8\u985e\u3068\u4e26\u884c\u3057\u3066\u53d6\u5f97\u6e08\u307f\u3001\u3042\u308b\u3044\u306f\u5c11\u306a\u304f\u3068\u3082\u7533\u8acb\u624b\u7d9a\u304d\u304c\u958b\u59cb\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f\u5f0a\u793e\u306e\u7d4c\u9a13\u3067\u306f\u3001\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u8a72\u5f53\u3059\u308b\u53c2\u7167\u60c5\u5831\u304c\u306a\u3044\u30d5\u30a1\u30a4\u30eb\u306f\u3001\u6280\u8853\u66f8\u985e\u81ea\u4f53\u304c\u5b8c\u6210\u3057\u3066\u3044\u3066\u3082\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\u306e\u5be9\u67fb\u6bb5\u968e\u3067\u4fdd\u7559\u3055\u308c\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u8f38\u5165\u8005\u3068\u3057\u3066\u767b\u9332\u3055\u308c\u3066\u3044\u308b\u6cd5\u4eba\u540d\u306f\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\u30fb\u30a4\u30b8\u30f3\u30fb\u30a8\u30c0\u30eb\uff08Kemenkes izin edar\uff09\u3068\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u8a31\u53ef\u8a3c\u306e\u4e21\u65b9\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u6cd5\u4eba\u3068\u540c\u4e00\u3067\u3059\u304b\uff1f\u3053\u308c\u30892\u3064\u306e\u66f8\u985e\u306e\u4e0d\u4e00\u81f4\u306f\u3001\u5f53\u793e\u304c\u906d\u9047\u3059\u308b\u8ca8\u7269\u306e\u5dee\u3057\u6b62\u3081\u539f\u56e0\u3068\u3057\u3066\u6700\u3082\u983b\u7e41\u306b\u898b\u3089\u308c\u308b\u3082\u306e\u306e1\u3064\u3067\u3059\u3002.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u8981\u3059\u308b\u306b\u3001\u653e\u5c04\u6027IVD\u30ad\u30c3\u30c8\u306b\u306f\u30012017\u5e74\u653f\u4ee4\u7b2c62\u53f7\u306b\u57fa\u3065\u304fKemenkes izin edar\u3068\u3001\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u5bfe\u5fdc\u3059\u308b\u8a8d\u53ef\u304c\u5fc5\u8981\u3067\u3059\u3002<\/em> <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/45931\" target=\"_blank\" rel=\"noopener\"><em>UU No. 10 Tahun 1997<\/em><\/a><em>, \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u5408\u6cd5\u7684\u306b\u8f38\u5165\u304a\u3088\u3073\u6d41\u901a\u3055\u305b\u308b\u306b\u306f\u3001\u540c\u4e00\u306e\u6cd5\u4eba\u306b\u3088\u3063\u3066\u4fdd\u6709\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u653e\u5c04\u6027\u4f53\u5916\u8a3a\u65ad\u85ac\u306e\u767b\u9332\u3067\u3088\u304f\u898b\u3089\u308c\u308b\u9593\u9055\u3044<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u8a8d\u53ef\u3092\u3001Kemenkes izin edar\uff08\u30b1\u30e1\u30f3\u30b1\u30b9\u30fb\u30a4\u30b8\u30f3\u30fb\u30a8\u30c0\u30eb\uff09\u306e\u767a\u884c\u5f8c\u306b\u624b\u914d\u3059\u308b\u5f62\u5f0f\u7684\u306a\u3082\u306e\u3068\u3057\u3066\u6271\u3044\u3001\u6700\u521d\u304b\u3089\u4e26\u884c\u3057\u3066\u9032\u3081\u308b\u3079\u304d\u3067\u306f\u306a\u3044\u3002.<\/li>\n\n\n\n<li>\u975e\u653e\u5c04\u6027\u88fd\u54c1\u306e\u8f38\u5165\u306b\u65e2\u306b\u5229\u7528\u3055\u308c\u3066\u3044\u308b\u8f38\u5165\u696d\u8005\u306f\u3001\u653e\u5c04\u6027\u7269\u8cea\u306e\u8f38\u5165\u8cc7\u683c\u3092\u81ea\u52d5\u7684\u306b\u6709\u3059\u308b\u3068\u4eee\u5b9a\u3059\u308b\u3002.<\/li>\n\n\n\n<li>\u653e\u5c04\u6027\u7269\u8cea\u306e\u4fdd\u7ba1\u306b\u95a2\u3057\u3066\u3001\u56fd\u306e\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304c\u6c42\u3081\u308b\u65bd\u8a2d\u6587\u66f8\u3092\u904e\u5c0f\u8a55\u4fa1\u3057\u3066\u3044\u308b\u3002\u3053\u308c\u306f\u3001\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u57fa\u6e96\u306b\u57fa\u3065\u304f\u9069\u6b63\u6d41\u901a\u57fa\u6e96\u306b\u304a\u3051\u308b\u4e00\u822c\u7684\u306a\u5009\u5eab\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u306f\u7570\u306a\u308b\u57fa\u6e96\u3067\u3042\u308b\u3002.<\/li>\n\n\n\n<li>\u300c\u30ad\u30c3\u30c8\u306b\u306f\u653e\u5c04\u6027\u7269\u8cea\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u300d\u3068\u3044\u3046\u8a18\u8ff0\u3060\u3051\u3067\u5341\u5206\u306a\u60c5\u5831\u3068\u307f\u306a\u3059\u306e\u306f\u8aa4\u308a\u3067\u3042\u308b\u3002\u5b9f\u969b\u306b\u306f\u3001\u540c\u4f4d\u4f53\u306e\u7a2e\u985e\u3068\u653e\u5c04\u80fd\u30ec\u30d9\u30eb\u306b\u3088\u3063\u3066\u3001\u3069\u306e\u56fd\u306e\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u8981\u4ef6\u304c\u9069\u7528\u3055\u308c\u308b\u304b\u304c\u6c7a\u307e\u308b\u306e\u3060\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b63\u78ba\u306a\u5206\u985e\u3068\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u5fc5\u8981\u306a\u53c2\u7167\u60c5\u5831\u306f\u3001\u540c\u4f4d\u4f53\u3001\u653e\u5c04\u80fd\u30ec\u30d9\u30eb\u3001\u304a\u3088\u3073\u4f7f\u7528\u76ee\u7684\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u305f\u3081\u3001\u3053\u306e\u6c7a\u5b9a\u306f\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\u793e\u306e\u7533\u8acb\u3068\u306f\u5207\u308a\u96e2\u3057\u3066\u89e3\u6c7a\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u63d0\u51fa\u671f\u9650\u304c\u78ba\u5b9a\u3059\u308b\u524d\u306b\u898f\u5236\u5f53\u5c40\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u306b\u76f8\u8ac7\u3057\u3066\u304a\u304f\u65b9\u304c\u4e00\u822c\u7684\u306b\u8ce2\u660e\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u653e\u5c04\u7dda\u533b\u7642\u6a5f\u5668\u767b\u9332\u30b5\u30fc\u30d3\u30b9\uff1a\u653e\u5c04\u6027\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\uff08IVD\uff09\u306e\u7533\u8acb\u3092\u3069\u306e\u3088\u3046\u306b\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u304b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u88fd\u54c1\u767b\u9332 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/radiation-medical-device-registration-in-indonesia\/\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u653e\u5c04\u7dda\u533b\u7642\u6a5f\u5668\u767b\u9332\u30b5\u30fc\u30d3\u30b9<\/strong><\/a> \u6a19\u6e96IVD\u30c8\u30e9\u30c3\u30af\u3068\u8ffd\u52a0\u30c8\u30e9\u30c3\u30af\u306e\u4e21\u65b9\u3092\u30ab\u30d0\u30fc\u3059\u308b <strong>\u539f\u5b50\u529b\u898f\u5236\u9075\u5b88IVD<\/strong> \u7533\u8acb\u8005\u306f\u3001\u30ad\u30c3\u30c8\u306b\u653e\u5c04\u6027\u30c8\u30ec\u30fc\u30b5\u30fc\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u5834\u5408\u306b\u906d\u9047\u3059\u308b\u554f\u984c\u306b\u76f4\u9762\u3057\u307e\u3059\u3002\u79c1\u305f\u3061\u306f\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\uff08\u30b1\u30e1\u30f3\u30b1\u30b9\uff09\u306e\u6280\u8853\u6587\u66f8\u3068\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u8a8d\u53ef\u3092\u3001\u5225\u3005\u306e\u30c1\u30fc\u30e0\u304c\u62c5\u5f53\u3059\u308b2\u3064\u306e\u72ec\u7acb\u3057\u305f\u7533\u8acb\u3068\u3057\u3066\u3067\u306f\u306a\u304f\u3001\u5358\u4e00\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3068\u3057\u3066\u8abf\u6574\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u3089\u306e\u30ad\u30c3\u30c8\u3068\u4f75\u7528\u3055\u308c\u308b\u30ac\u30f3\u30de\u30ab\u30a6\u30f3\u30bf\u30fc\u306a\u3069\u306e\u653e\u5c04\u7dda\u653e\u51fa\u8a08\u6e2c\u6a5f\u5668\u3082\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306b\u542b\u3080\u30e1\u30fc\u30ab\u30fc\u306e\u5834\u5408\u3001 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/radiation-medical-device-registration-in-indonesia\/\">\u653e\u5c04\u7dda\u533b\u7642\u6a5f\u5668\u767b\u9332<\/a> \u3053\u306e\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u540c\u4e00\u8ca8\u7269\u306e\u6a5f\u5668\u5074\u3092\u62c5\u5f53\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u653e\u5c04\u7dda\u95a2\u9023\u533b\u7642\u88fd\u54c1\u306b\u5bfe\u3059\u308b\u56fd\u5bb6\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u3068\u30b1\u30e1\u30f3\u30b1\u30b9\u306b\u3088\u308b\u627f\u8a8d\u306e\u9806\u5e8f\u306b\u3064\u3044\u3066\u3088\u308a\u8a73\u3057\u304f\u77e5\u308a\u305f\u3044\u5834\u5408\u306f\u3001\u95a2\u9023\u8a18\u4e8b\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/radiation-emitting-medical-device-registration-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u653e\u5c04\u7dda\u653e\u51fa\u578b\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332<\/a>. \u975e\u653e\u5c04\u6027IVD\u306b\u9069\u7528\u3055\u308c\u308b\u5206\u985e\u306b\u57fa\u3065\u304f\u5dee\u7570\uff08\u30af\u30e9\u30b9D\u611f\u67d3\u75c7\u6709\u52b9\u6027\u30b9\u30c6\u30c3\u30d7\u3092\u542b\u3080\uff09\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u3092\u53c2\u7167\u306e\u3053\u3068\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/indonesia-ivd-registration-vs-medical-device\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306e\u767b\u9332\uff1a\u533b\u7642\u6a5f\u5668\u3068\u306e\u767b\u9332\u7d4c\u8def\u306e\u9055\u3044<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u76f8\u8ac7\u306e\u4e88\u7d04\u3092\u3059\u308b<\/strong> \u5f0a\u793e\u306e <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u767b\u9332<\/a> \u8f38\u5165\u3084\u767a\u58f2\u65e5\u3092\u6c7a\u5b9a\u3059\u308b\u524d\u306b\u3001\u304a\u5ba2\u69d8\u306e\u7279\u5b9a\u306e\u653e\u5c04\u6027\u4f53\u5916\u8a3a\u65ad\u30ad\u30c3\u30c8\u306b\u95a2\u3059\u308b\u30b1\u30e1\u30f3\u30b1\u30b9\uff08Kemenkes\uff09\u304a\u3088\u3073\u5404\u56fd\u306e\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u8981\u4ef6\u3092\u628a\u63e1\u3059\u308b\u305f\u3081\u306b\u3001\u5f53\u793e\u306e\u30c1\u30fc\u30e0\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>The mistake we run into most often is deceptively simple. A company files a radiolabeled IVD kit, a radioimmunoassay (RIA) reagent, say, exactly the way it would file an ordinary diagnostic, using nothing but a Kemenkes technical dossier. The Kemenkes review goes fine. The classification lands where expected. Then the shipment reaches the border, and it turns out the isotope inside the kit needed a clearance of its own, one that nobody had started. In our experience, the fix isn&#8217;t really about paperwork at all. It&#8217;s about sequencing. A radioactive IVD kit is best understood as two products sharing a single label: the diagnostic itself, which Kemenkes reviews, and the [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":7708,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7707","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\/7707","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\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=7707"}],"version-history":[{"count":1,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7707\/revisions"}],"predecessor-version":[{"id":7712,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7707\/revisions\/7712"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/7708"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=7707"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=7707"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=7707"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=7707"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}