{"id":7771,"date":"2026-09-24T11:31:37","date_gmt":"2026-09-24T04:31:37","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=7771"},"modified":"2026-09-22T11:35:54","modified_gmt":"2026-09-22T04:35:54","slug":"registering-high-energy-therapeutic-equipment","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/ja\/registering-high-energy-therapeutic-equipment\/","title":{"rendered":"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\u306e\u767b\u9332\uff1a\u967d\u5b50\u7dda\u6cbb\u7642\u3001\u5bc6\u5c01\u5c0f\u7dda\u6e90\u6cbb\u7642\u3001\u30ea\u30cb\u30a2\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u307b\u3068\u3093\u3069\u306e\u75c5\u9662\u30b0\u30eb\u30fc\u30d7\u3084\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u967d\u5b50\u7dda\u6cbb\u7642\u3001\u5bc6\u5c01\u5c0f\u7dda\u6e90\u6cbb\u7642\u3001\u307e\u305f\u306f\u30ea\u30cb\u30a2\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u30b7\u30b9\u30c6\u30e0\u3092\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u5c0e\u5165\u3059\u308b\u969b\u306b\u6700\u3082\u96e3\u3057\u3044\u306e\u306f\u3001\u66f8\u985e\u624b\u7d9a\u304d\u305d\u306e\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u96e3\u3057\u3044\u306e\u306f\u30012\u3064\u306e\u7570\u306a\u308b\u898f\u5236\u6a5f\u95a2\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fd\u5bb6\u30a8\u30cd\u30eb\u30ae\u30fc\u30fb\u653e\u5c04\u7dda\u5e81\u3068\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\uff09\u304c\u3001\u5e02\u5834\u627f\u8a8d\u3068\u653e\u5c04\u7dda\u5b89\u5168\u6027\u3068\u3044\u3046\u5168\u304f\u7570\u306a\u308b\u8996\u70b9\u304b\u3089\u540c\u3058\u6a5f\u5668\u3092\u5be9\u67fb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3092\u3001\u65e9\u671f\u306b\u628a\u63e1\u3067\u304d\u3066\u3044\u306a\u3044\u3053\u3068\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u3046\u3057\u305f\u898b\u901a\u3057\u306e\u4e0d\u900f\u660e\u3055\u3053\u305d\u304c\u3001\u307b\u3068\u3093\u3069\u306e\u9045\u5ef6\u306e\u8d77\u70b9\u3068\u306a\u308b\u3002\u7533\u8acb\u8005\u306f\u307e\u305a\u30b1\u30e1\u30f3\u30b1\u30b9\u306e\u8ca9\u58f2\u627f\u8a8d\u3092\u53d6\u5f97\u3059\u308b\u304c\u3001\u305d\u306e\u5f8c\u3001\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u30d0\u30f3\u30ab\u30fc\u5efa\u8a2d\u8a31\u53ef\u304c\u3001\u307e\u3060\u6700\u7d42\u6c7a\u5b9a\u3055\u308c\u3066\u3044\u306a\u3044\u6a5f\u5668\u4ed5\u69d8\u306b\u57fa\u3065\u304f\u906e\u853d\u8a08\u7b97\u306b\u4f9d\u5b58\u3057\u3066\u3044\u308b\u3053\u3068\u306b\u6c17\u3065\u304f\u3053\u3068\u304c\u591a\u3044\u3002\u3053\u3046\u3057\u305f\u4e0d\u4e00\u81f4\u304c\u660e\u3089\u304b\u306b\u306a\u308b\u9803\u306b\u306f\u3001\u3059\u3067\u306b\u6570\u30f6\u6708\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u304c\u5931\u308f\u308c\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u30ac\u30a4\u30c9\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\u306e\u8f38\u5165\u307e\u305f\u306f\u65bd\u8a2d\u5efa\u8a2d\u3092\u8a08\u753b\u3057\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3001\u75c5\u9662\u30b0\u30eb\u30fc\u30d7\u3001\u304a\u3088\u3073\u8ca9\u58f2\u696d\u8005\u5411\u3051\u306b\u4f5c\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u627f\u8a8d\u3092\u7ba1\u7406\u3059\u308b\u6a5f\u95a2\u3001\u5206\u985e\u3068\u653e\u5c04\u7dda\u8a31\u53ef\u306e\u76f8\u4e92\u95a2\u4fc2\u3001\u305d\u3057\u3066\u66f8\u985e\u4e0a\u3060\u3051\u3067\u306a\u304f\u5b9f\u969b\u306b\u4e21\u65b9\u306e\u624b\u7d9a\u304d\u3092\u4e26\u884c\u3057\u3066\u9032\u3081\u308b\u3053\u3068\u304c\u65bd\u8a2d\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u5b88\u308b\u4e0a\u3067\u306a\u305c\u91cd\u8981\u306a\u306e\u304b\u3092\u89e3\u8aac\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u6700\u3082\u53b3\u3057\u3044\u767b\u9332\u30ab\u30c6\u30b4\u30ea\u30fc\u306e\u4e00\u3064\u3067\u3042\u308b\u7406\u7531<\/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\/High-Energy-Therapeutic-Equipment-Registration-in-Indonesia-2.webp\" alt=\"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\u306e\u767b\u9332\" class=\"wp-image-7773\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/High-Energy-Therapeutic-Equipment-Registration-in-Indonesia-2.webp 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/High-Energy-Therapeutic-Equipment-Registration-in-Indonesia-2-300x200.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/High-Energy-Therapeutic-Equipment-Registration-in-Indonesia-2-768x512.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u767b\u9332\u3055\u308c\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306e\u4e2d\u3067\u3001\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\u306f\u3001\u5e02\u5834\u6295\u5165\u304c\u6700\u3082\u56f0\u96e3\u306a\u6a5f\u5668\u306e\u4e00\u3064\u3067\u3042\u308b\u3002\u967d\u5b50\u7dda\u6cbb\u7642\u30b7\u30b9\u30c6\u30e0\u3001\u5bc6\u5c01\u5c0f\u7dda\u6e90\u6cbb\u7642\u7528\u30a2\u30d5\u30bf\u30fc\u30ed\u30fc\u30c0\u30fc\u3001\u30ea\u30cb\u30a2\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u306f\u3001\u533b\u7642\u6a5f\u5668\u8ca9\u58f2\u627f\u8a8d\u3068\u539f\u5b50\u529b\u653e\u5c04\u7dda\u5b89\u5168\u30e9\u30a4\u30bb\u30f3\u30b9\u3068\u3044\u30462\u3064\u306e\u898f\u5236\u5236\u5ea6\u3092\u540c\u6642\u306b\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u304c\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u9069\u7528\u3059\u308b\u6280\u8853\u7684\u5be9\u67fb\u306f\u3001\u6b27\u5dde\u9023\u5408\u5168\u4f53\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u8a55\u4fa1\u3068\u540c\u7b49\u306e\u53b3\u683c\u3055\u3092\u5099\u3048\u3066\u3044\u308b\u304c\u3001\u4e21\u30b7\u30b9\u30c6\u30e0\u306f\u4e92\u63db\u6027\u304c\u3042\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u67a0\u7d44\u307f\u306f\u3001\u4e3b\u306bASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u3092\u306f\u3058\u3081\u3068\u3059\u308b\u4e16\u754c\u7684\u306b\u8abf\u548c\u3055\u308c\u305f\u57fa\u6e96\u306b\u57fa\u3065\u3044\u3066\u69cb\u7bc9\u3055\u308c\u3066\u304a\u308a\u3001ASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u81ea\u4f53\u3082EU\u304a\u3088\u3073IMDRF\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u5206\u985e\u30e2\u30c7\u30eb\u304b\u3089\u591a\u304f\u306e\u8981\u7d20\u3092\u53d6\u308a\u5165\u308c\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\u3092\u767b\u9332\u3059\u308b\u306b\u306f\u4f55\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\u3092\u767b\u9332\u3059\u308b\u306b\u306f\u30012\u3064\u306e\u5225\u3005\u306e\u653f\u5e9c\u8a8d\u53ef\u304c\u5fc5\u8981\u3067\u3059\u30021\u3064\u76ee\u306f\u3001Kemenkes\u306e\u8ca9\u58f2\u8a8d\u53ef\u3067\u3042\u308bNomor Izin Edar (NIE)\u3067\u3001 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112243\/permenkes-no-62-tahun-2017\" target=\"_blank\" rel=\"noopener\">\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c62\/2017\u53f7<\/a>, \u3053\u308c\u3089\u306e\u6a5f\u5668\u306f\u3001\u4eba\u4f53\u306b\u96fb\u96e2\u653e\u5c04\u7dda\u3092\u542b\u3080\u5371\u967a\u306a\u30a8\u30cd\u30eb\u30ae\u30fc\u3092\u4f9b\u7d66\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u4e00\u822c\u7684\u306b\u30af\u30e9\u30b9C\u307e\u305f\u306f\u30af\u30e9\u30b9D\u3068\u8a55\u4fa1\u3055\u308c\u308b\u3002\u7b2c\u4e8c\u306b\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u591a\u6bb5\u968e\u653e\u5c04\u7dda\u8a31\u53ef\u8a3c <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/4842\/pp-no-29-tahun-2008\" target=\"_blank\" rel=\"noopener\">PP No. 29\/2008<\/a> \u305d\u3057\u3066 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/4755\/pp-no-33-tahun-2007\" target=\"_blank\" rel=\"noopener\">PP No. 33\/2007<\/a>, \u96fb\u96e2\u653e\u5c04\u7dda\u6e90\u306e\u65bd\u8a2d\u5efa\u8a2d\u304a\u3088\u3073\u81e8\u5e8a\u904b\u7528\u3092\u7db2\u7f85\u3059\u308b\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u8ffd\u8de1<\/strong><\/td><td><strong>\u7d71\u6cbb\u6a5f\u95a2<\/strong><\/td><td><strong>\u6cd5\u7684\u6839\u62e0<\/strong><\/td><td><strong>\u5185\u5bb9<\/strong><\/td><td><strong>\u4ee3\u8868\u7684\u306a\u30c7\u30d0\u30a4\u30b9<\/strong><\/td><\/tr><tr><td>\u30b1\u30e1\u30f3\u30b1\u30b9\u306e\u8ca9\u58f2\u627f\u8a8d<\/td><td>\u4fdd\u5065\u7701\u533b\u7642\u6a5f\u5668\u8a55\u4fa1\u5c40<\/td><td>\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c62\/2017\u53f7<\/td><td>\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3001\u54c1\u8cea\u3001\u304a\u3088\u3073\u4fbf\u76ca\u306e\u8a55\u4fa1\u3001\u306a\u3089\u3073\u306bNomor Izin Edar\uff08NIE\uff09\u306e\u767a\u884c<\/td><td>\u30ea\u30cb\u30a2\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u3001\u5bc6\u5c01\u5c0f\u7dda\u6e90\u6cbb\u7642\u7528\u30a2\u30d5\u30bf\u30fc\u30ed\u30fc\u30c0\u30fc\u3001\u967d\u5b50\u7dda\u6cbb\u7642\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>BAPETEN\u653e\u5c04\u7dda\u8a31\u53ef\u8a3c<\/td><td>\u30d0\u30c0\u30f3 \u30da\u30f3\u30ac\u30ef\u30b9 \u30c6\u30ca\u30ac \u30cc\u30af\u30ea\u30eb (BAPETEN)<\/td><td>PP No. 29\/2008; PP No. 33\/2007;\u30da\u30eb\u30ab \u30d0\u30da\u30c6\u30f3 No. 3\/2013<\/td><td>\u653e\u5c04\u7dda\u5b89\u5168\u5be9\u67fb\u3001\u30d0\u30f3\u30ab\u30fc\u5efa\u8a2d\u8a31\u53ef\u3001\u64cd\u696d\u8a31\u53ef<\/td><td>\u30b0\u30eb\u30fc\u30d7A\u306e\u96fb\u96e2\u653e\u5c04\u7dda\u6e90\u5229\u7528\u3068\u3057\u3066\u8a55\u4fa1\u3055\u308c\u305f\u540c\u3058\u30c7\u30d0\u30a4\u30b9<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">\u30b1\u30e1\u30f3\u30b1\u30b9\u5206\u985e\u3068NIE\u7d4c\u8def<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30da\u30eb\u30e1\u30f3\u30b1\u30b9\u7b2c62\/2017\u53f7\u3068\u540c\u6642\u306b\u767a\u884c\u3055\u308c\u305f\u5206\u985e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3088\u308b\u3068\u3001\u4eba\u4f53\u3068\u30a8\u30cd\u30eb\u30ae\u30fc\u3092\u4ea4\u63db\u3059\u308b\u80fd\u52d5\u7684\u306a\u6cbb\u7642\u6a5f\u5668\u306f\u3001\u4e00\u822c\u7684\u306b\u30af\u30e9\u30b9B\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u96fb\u96e2\u653e\u5c04\u7dda\u3092\u542b\u3080\u3001\u305d\u306e\u30a8\u30cd\u30eb\u30ae\u30fc\u4ea4\u63db\u306e\u6027\u8cea\u3001\u5bc6\u5ea6\u3001\u9069\u7528\u90e8\u4f4d\u306a\u3069\u3092\u8003\u616e\u3057\u3066\u3001\u6f5c\u5728\u7684\u306b\u5371\u967a\u306a\u5834\u5408\u3001\u5f53\u8a72\u6a5f\u5668\u306f\u3088\u308a\u9ad8\u3044\u30af\u30e9\u30b9\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u306e\u305f\u3081\u3001\u967d\u5b50\u7dda\u6cbb\u7642\u30b7\u30b9\u30c6\u30e0\u3001\u5bc6\u5c01\u5c0f\u7dda\u6e90\u6cbb\u7642\u7528\u30a2\u30d5\u30bf\u30fc\u30ed\u30fc\u30c0\u30fc\u3001\u30ea\u30cb\u30a2\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u306f\u3001\u901a\u5e38\u306e\u80fd\u52d5\u6cbb\u7642\u6a5f\u5668\u3067\u306f\u306a\u304f\u3001\u9ad8\u30ea\u30b9\u30af\u6a5f\u5668\u3068\u3057\u3066\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002\u7533\u8acb\u6bb5\u968e\u3067\u306e\u5206\u985e\u30df\u30b9\u306f\u518d\u63d0\u51fa\u3092\u4f59\u5100\u306a\u304f\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u7533\u8acb\u66f8\u985e\u306e\u4f5c\u6210\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u767b\u9332\u6e08\u307f\u306e\u898f\u5236\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306b\u6b63\u78ba\u306a\u5206\u985e\u3068\u88cf\u4ed8\u3051\u3068\u306a\u308b\u8a3c\u62e0\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8f38\u5165\u3001\u8ca9\u58f2\u3001\u307e\u305f\u306f\u6d41\u901a\u3092\u884c\u3046\u524d\u306b\u3001Permenkes No. 62\/2017 \u306b\u57fa\u3065\u304f\u6709\u52b9\u306a NIE \u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u304c\u5fc5\u9808\u3067\u3042\u308a\u3001\u767a\u884c\u65e5\u304b\u3089\u6700\u9577 5 \u5e74\u9593\u6709\u52b9\u3067\u3059\u3002NIE \u306a\u3057\u3067\u6d41\u901a\u3055\u305b\u308b\u3053\u3068\u306f\u3001Undang-Undang No. 17\/2023 tentang Kesehatan, Pasal 143 ayat (1) \u306b\u9055\u53cd\u3057\u3001\u884c\u653f\u51e6\u5206\u304c\u79d1\u305b\u3089\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u5b89\u5168\u8a31\u53ef\u8a3c<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5916\u90e8\u7167\u5c04\u7642\u6cd5\u304a\u3088\u3073\u9060\u9694\u5f8c\u88c5\u586b\u5bc6\u5c01\u5c0f\u7dda\u6e90\u7642\u6cd5\u3092\u542b\u3080\u653e\u5c04\u7dda\u7642\u6cd5\u6d3b\u52d5\u306f\u3001\u4ee5\u4e0b\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/4842\/pp-no-29-tahun-2008\" target=\"_blank\" rel=\"noopener\">PP No. 29 Tahun 2008<\/a> \u30b0\u30eb\u30fc\u30d7 A \u96fb\u96e2\u653e\u5c04\u7dda\u5229\u7528\u3068\u3057\u3066\u306e Tenang Perizinan Pemanfaatan Sumber Radiasi Pengion dan Bahan Nuklir\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u6700\u3082\u53b3\u683c\u306a\u30e9\u30a4\u30bb\u30f3\u30b9\u968e\u5c64\u306e\u4e0b\u306b\u7f6e\u304b\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/jdih.bapeten.go.id\/id\/dokumen\/peraturan\/peraturan-kepala-badan-pengawas-tenaga-nuklir-nomor-3-tahun-2013-tentang-keselamatan-radiasi-dalam-penggunaan-radioterapi\" target=\"_blank\" rel=\"noopener\">\u30da\u30eb\u30ab \u30d0\u30da\u30c6\u30f3 No. 3 \u30bf\u30d5\u30f3 2013<\/a> \u653e\u5c04\u7dda\u6cbb\u7642\u306b\u304a\u3051\u308b\u653e\u5c04\u7dda\u5b89\u5168\u306b\u95a2\u3059\u308b\u898f\u5247\uff08tentan Keselamatan Radiasi Dalam Penggunaan Radioterapi\uff09\u306f\u3001\u653e\u5c04\u7dda\u6cbb\u7642\u306b\u7279\u6709\u306e\u653e\u5c04\u7dda\u5b89\u5168\u8981\u4ef6\u3001\u8a8d\u53ef\u6761\u4ef6\u3001\u304a\u3088\u3073\u5831\u544a\u7fa9\u52d9\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002\u8a8d\u53ef\u306f\u6bb5\u968e\u7684\u306b\u884c\u308f\u308c\u3001\u307e\u305a\u6cbb\u7642\u7528\u30d0\u30f3\u30ab\u30fc\u306e\u5efa\u8a2d\u8a31\u53ef\u304c\u4e0b\u308a\u3001\u305d\u306e\u5f8c\u3001\u65bd\u8a2d\u304c\u73fe\u5834\u691c\u8a3c\u306b\u5408\u683c\u3059\u308b\u3068\u3001\u5225\u9014\u904b\u7528\u8a31\u53ef\u304c\u4e0b\u308a\u308b\u4ed5\u7d44\u307f\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PP No. 33 Tahun 2007 tentang Keselamatan Radiasi Pengion dan Keamanan Sumber Radioaktif \u306f\u3001\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u304c\u5efa\u8a2d\u6bb5\u968e\u3068\u904b\u7528\u5be9\u67fb\u6bb5\u968e\u306e\u4e21\u65b9\u306b\u9069\u7528\u3059\u308b\u57fa\u790e\u3068\u306a\u308b\u653e\u5c04\u7dda\u306e\u5b89\u5168\u6027\u3068\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u57fa\u6e96\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u6b27\u5dde\u3067\u627f\u8a8d\u3055\u308c\u305f\u6a5f\u5668\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u3082\u767b\u9332\u3067\u304d\u307e\u3059\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">CE\u30de\u30fc\u30af\u3001\u3064\u307e\u308a\u6b27\u5dde\u9023\u5408\u3067\u65e2\u306b\u53d6\u5f97\u6e08\u307f\u306e\u627f\u8a8d\u306f\u3001\u81ea\u52d5\u7684\u306b\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u5f15\u304d\u7d99\u304c\u308c\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u5206\u985e\u30b7\u30b9\u30c6\u30e0\u306f\u56fd\u969b\u7684\u306a\u67a0\u7d44\u307f\u3068\u8abf\u548c\u3057\u3066\u3044\u308b\u305f\u3081\u3001EU\u3067\u3057\u3063\u304b\u308a\u3068\u3057\u305f\u6280\u8853\u6587\u66f8\u3092\u6301\u3064\u6a5f\u5668\u306f\u6709\u5229\u306a\u7acb\u5834\u306b\u3042\u308a\u307e\u3059\u304c\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\uff08Kemenkes\uff09\u306f\u4f9d\u7136\u3068\u3057\u3066\u5b8c\u5168\u306b\u73fe\u5730\u5316\u3055\u308c\u305f\u6587\u66f8\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u306e\u73fe\u5730\u5411\u3051\u66f8\u985e\u306b\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u8a9e\u306e\u30e9\u30d9\u30eb\u8868\u793a\u3001\u6307\u5b9a\u3055\u308c\u305f\u73fe\u5730\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6301\u8005\u3001\u305d\u3057\u3066EU\u533b\u7642\u6a5f\u5668\u898f\u5247\u306e\u69cb\u9020\u3067\u306f\u306a\u304f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u72ec\u81ea\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306b\u6e96\u62e0\u3057\u305f\u6587\u66f8\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u3067\u3082\u540c\u69d8\u3067\u3001EU\u307e\u305f\u306f\u65e5\u672c\u306e\u4e8b\u524d\u627f\u8a8d\u306e\u6709\u7121\u306b\u95a2\u308f\u3089\u305a\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u5b89\u5168\u898f\u5236\u306b\u57fa\u3065\u3044\u3066\u653e\u5c04\u7dda\u6e90\u3068\u906e\u853d\u8a2d\u8a08\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\u5e02\u5834\u306f\u3069\u308c\u304f\u3089\u3044\u306e\u898f\u6a21\u306a\u306e\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u9ad8\u5ea6\u306a\u653e\u5c04\u7dda\u6cbb\u7642\u80fd\u529b\u3078\u306e\u9700\u8981\u306f\u5927\u304d\u304f\u3001\u73fe\u5728\u3082\u767a\u5c55\u9014\u4e0a\u306b\u3042\u308b\u3002\u30a8\u30ab\u75c5\u9662\u306e\u30a8\u30ab\u30fb\u30c1\u30d7\u30bf\u30fb\u30a6\u30a3\u30b8\u30e3\u30e4\u304c\u3093\u30bb\u30f3\u30bf\u30fc\u306b\u3088\u308b\u3068\u30012025\u5e7412\u6708\u6642\u70b9\u3067\u3001\u967d\u5b50\u7dda\u6cbb\u7642\u6280\u8853\u306f\u56fd\u5185\u306e\u3069\u3053\u306b\u3082\u81e8\u5e8a\u7684\u306b\u5229\u7528\u53ef\u80fd\u3067\u306f\u306a\u304f\u3001\u540c\u30bb\u30f3\u30bf\u30fc\u306f2027\u5e74\u306e\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u521d\u306e\u967d\u5b50\u7dda\u6cbb\u7642\u30bb\u30f3\u30bf\u30fc\u306e\u7a3c\u50cd\u3092\u76ee\u6307\u3057\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u307e\u305f\u3001RS Kanker Dharmais\u306f\u3001\u65e5\u672c\u306e\u30e1\u30c7\u30a3\u30dd\u30ea\u30b9\u967d\u5b50\u7dda\u6cbb\u7642\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\u3068\u6280\u8853\u79fb\u8ee2\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u3092\u7de0\u7d50\u3057\u3001\u56fd\u5185\u3067\u306e\u967d\u5b50\u7dda\u6cbb\u7642\u80fd\u529b\u306e\u69cb\u7bc9\u3092\u76ee\u6307\u3057\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u53d6\u308a\u7d44\u307f\u306f\u3044\u305a\u308c\u3082\u3001\u540c\u3058\u6839\u672c\u7684\u306a\u8981\u56e0\u306b\u57fa\u3065\u3044\u3066\u3044\u308b\u3002\u305d\u308c\u306f\u3001\u73fe\u5728\u3001\u591a\u304f\u306e\u764c\u60a3\u8005\u304c\u81ea\u56fd\u3067\u306f\u53d7\u3051\u3089\u308c\u306a\u3044\u6cbb\u7642\u3092\u53d7\u3051\u308b\u305f\u3081\u306b\u3001\u4e3b\u306b\u65e5\u672c\u3001\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u3001\u30de\u30ec\u30fc\u30b7\u30a2\u3068\u3044\u3063\u305f\u6d77\u5916\u3078\u6e21\u822a\u3057\u3066\u3044\u308b\u3068\u3044\u3046\u73fe\u72b6\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7279\u306b\u30ea\u30cb\u30a2\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u3068\u5bc6\u5c01\u5c0f\u7dda\u6e90\u6cbb\u7642\u7528\u30a2\u30d5\u30bf\u30fc\u30ed\u30fc\u30c0\u30fc\u306b\u95a2\u3057\u3066\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u62e1\u5927\u3092\u7d9a\u3051\u308b\u304c\u3093\u30bb\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u5168\u4f53\u3067\u65e2\u306b\u6a19\u6e96\u6cbb\u7642\u3068\u306a\u3063\u3066\u3044\u308b\u305f\u3081\u3001\u9700\u8981\u306f\u3088\u308a\u78ba\u7acb\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u5206\u91ce\u306b\u53c2\u5165\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u3084\u8ca9\u58f2\u696d\u8005\u306f\u3001\u65b0\u305f\u306a\u5e02\u5834\u30ab\u30c6\u30b4\u30ea\u30fc\u3092\u958b\u62d3\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5f7c\u3089\u306f\u3001\u6d3b\u767a\u3067\u53b3\u3057\u304f\u898f\u5236\u3055\u308c\u305f\u5e02\u5834\u3067\u30b7\u30a7\u30a2\u3092\u4e89\u3063\u3066\u304a\u308a\u3001\u8ca9\u58f2\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u6a5f\u5668\u306b\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fd\u5bb6\u653e\u5c04\u7dda\u7ba1\u7406\u5c40\uff08Kemenkes\uff09\u306e\u8a8d\u53ef\u3068\u653e\u5c04\u7dda\u8a31\u53ef\u8a3c\u306e\u63d0\u51fa\u304c\u4f9d\u7136\u3068\u3057\u3066\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u767b\u9332\u624b\u7d9a\u304d\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\uff1a\u9045\u5ef6\u306e\u672c\u5f53\u306e\u539f\u56e0\u3068\u306f\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306e\u60a3\u8005\u306b\u304a\u3051\u308b\u30b1\u30e1\u30f3\u30b1\u30b9\u3068\u653e\u5c04\u7dda\u6cbb\u7642\u306e\u4f75\u7528\u306b\u304b\u304b\u308b\u671f\u9593\u3092\u6c7a\u5b9a\u3059\u308b\u4e3b\u306a\u8981\u56e0\u306f\u6b21\u306e3\u3064\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30b1\u30e1\u30f3\u30b1\u30b9NIE\u306e\u66f8\u985e\u3068\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u5efa\u8a2d\u8a31\u53ef\u304c\u4e26\u884c\u3057\u3066\u63d0\u51fa\u3055\u308c\u308b\u304b\u3001\u305d\u308c\u3068\u3082\u9806\u6b21\u63d0\u51fa\u3055\u308c\u308b\u304b<\/li>\n\n\n\n<li>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\uff08\u967d\u5b50\u7dda\u6cbb\u7642\u3001\u5bc6\u5c01\u5c0f\u7dda\u6e90\u6cbb\u7642\u3001\u30ea\u30cb\u30a2\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u306a\u3069\uff09\u3092\u767b\u9332\u3059\u308b\u969b\u306b\u3001\u8a2d\u7f6e\u4e88\u5b9a\u306e\u533a\u57df\u306b\u4e0d\u9069\u5207\u306a\u5834\u6240\u3002.\u00a0<\/li>\n\n\n\n<li>\u906e\u853d\u3068\u30d0\u30f3\u30ab\u30fc\u306e\u8a2d\u8a08\u304c\u3001\u6a5f\u5668\u4ed5\u69d8\u304c\u88fd\u9020\u696d\u8005\u3068\u78ba\u5b9a\u3059\u308b\u524d\u306b\u6700\u7d42\u6c7a\u5b9a\u3055\u308c\u308b\u304b\u3001\u5f8c\u306b\u6c7a\u5b9a\u3055\u308c\u308b\u304b\u306b\u95a2\u308f\u3089\u305a\u3001<\/li>\n\n\n\n<li>\u7533\u8acb\u8005\u304c\u65e2\u306b\u8a8d\u5b9a\u3055\u308c\u305f\u73fe\u5730\u514d\u8a31\u4fdd\u6301\u8005\u3068\u653e\u5c04\u7dda\u9632\u8b77\u8cac\u4efb\u8005\u306e\u4f53\u5236\u3092\u6574\u3048\u3066\u3044\u308b\u304b\u3001\u3042\u308b\u3044\u306f\u65b0\u305f\u306b\u69cb\u7bc9\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u3089\u306e\u8981\u56e0\u306f\u3044\u305a\u308c\u3082\u3001\u898f\u5236\u3060\u3051\u3067\u56fa\u5b9a\u3055\u308c\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u7533\u8acb\u6226\u7565\u304c\u6700\u521d\u304b\u3089\u3069\u306e\u3088\u3046\u306b\u69cb\u7bc9\u3055\u308c\u308b\u304b\u306b\u5de6\u53f3\u3055\u308c\u308b\u305f\u3081\u3001\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u8a08\u753b\u306f\u3001\u5358\u72ec\u3067\u898b\u7a4d\u3082\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u898f\u5236\u5f53\u5c40\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u5354\u529b\u3057\u3066\u884c\u3046\u3079\u304d\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3067\u3088\u304f\u898b\u3089\u308c\u308b\u843d\u3068\u3057\u7a74<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30b1\u30e1\u30f3\u30b1\u30b9\u3068\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u306e\u7533\u8acb\u3092\u3001\u6cd5\u7684\u306b\u3082\u624b\u7d9a\u304d\u7684\u306b\u3082\u5225\u3005\u306e\u7533\u8acb\u3067\u3042\u308a\u3001\u5be9\u67fb\u62c5\u5f53\u8005\u3082\u7570\u306a\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u4e00\u3064\u306e\u7d71\u5408\u3055\u308c\u305f\u30d7\u30ed\u30bb\u30b9\u3068\u3057\u3066\u6271\u3046\u3053\u3068<\/li>\n\n\n\n<li>CE\u30de\u30fc\u30af\u4ed8\u304d\u6a5f\u5668\u306f\u7ffb\u8a33\u306e\u307f\u304c\u5fc5\u8981\u306a\u5834\u5408\u3067\u3082\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u66f8\u985e\u69cb\u9020\u81ea\u4f53\u304cEU MDR\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u5f62\u5f0f\u3068\u7570\u306a\u308b\u5834\u5408\u306f\u3001<\/li>\n\n\n\n<li>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u6cbb\u7642\u6a5f\u5668\uff08\u967d\u5b50\u7dda\u6cbb\u7642\u3001\u5bc6\u5c01\u5c0f\u7dda\u6e90\u6cbb\u7642\u3001\u30ea\u30cb\u30a2\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u306a\u3069\uff09\u306e\u767b\u9332\u306b\u5411\u3051\u305f\u3001\u30be\u30fc\u30cb\u30f3\u30b0\u898f\u5236\u306b\u9069\u5408\u3057\u305f\u8a2d\u7f6e\u5834\u6240\u306e\u9078\u5b9a\u3092\u6700\u7d42\u6c7a\u5b9a\u3059\u308b\u3002\u00a0<\/li>\n\n\n\n<li>\u30d0\u30f3\u30ab\u30fc\u306e\u69cb\u9020\u3092\u6700\u7d42\u6c7a\u5b9a\u3057\u305f\u5f8c\u3001\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u6700\u7d42\u7684\u306a\u30d3\u30fc\u30e0\u30a8\u30cd\u30eb\u30ae\u30fc\u3068\u5149\u6e90\u4ed5\u69d8\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/li>\n\n\n\n<li>NIE\u3068\u653e\u5c04\u7dda\u8a31\u53ef\u8a3c\u306e\u4e21\u65b9\u304c\u767a\u884c\u3055\u308c\u305f\u5f8c\u306e\u3001\u73fe\u5730\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u306e\u7d99\u7d9a\u7684\u306a\u5831\u544a\u7fa9\u52d9\u3092\u904e\u5c0f\u8a55\u4fa1\u3057\u3066\u3044\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u30b1\u30e1\u30f3\u30b1\u30b9\u653e\u5c04\u7dda\u30ec\u30ae\u30e5\u30ec\u30fc\u30bf\u30fc\u306e\u30b7\u30fc\u30b1\u30f3\u30b9\u3092\u6b63\u3057\u304f\u884c\u3046<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3092\u9069\u5207\u306b\u51e6\u7406\u3059\u308b\u306b\u306f\u3001\u7279\u5b9a\u306e\u7533\u8acb\u66f8\u985e\u3088\u308a\u3082\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fd\u5bb6\u74b0\u5883\u7ba1\u7406\u5c40\uff08Kemenkes\uff09\u3068\u653e\u5c04\u7dda\u898f\u5236\u5f53\u5c40\u3068\u306e\u9023\u643a\u6226\u7565\u3092\u3069\u308c\u3060\u3051\u65e9\u671f\u306b\u69cb\u7bc9\u3067\u304d\u308b\u304b\u304c\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002\u4e21\u65b9\u306e\u624b\u7d9a\u304d\u3092\u6700\u521d\u304b\u3089\u9806\u5e8f\u7acb\u3066\u3066\u9032\u3081\u308b\u7533\u8acb\u8005\u306f\u3001\u5148\u306b\u7533\u8acb\u3057\u3066\u5f8c\u304b\u3089\u8abf\u6574\u3059\u308b\u7533\u8acb\u8005\u3088\u308a\u3082\u3001\u4e00\u8cab\u3057\u3066\u8fc5\u901f\u306b\u624b\u7d9a\u304d\u3092\u9032\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u306e\u624b\u9806\u306b\u306f\u3001\u66f8\u985e\u4f5c\u6210\u4ee5\u4e0a\u306e\u3053\u3068\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u305d\u308c\u306f\u3001\u30d0\u30f3\u30ab\u30fc\u306e\u69cb\u9020\u304c\u6700\u7d42\u6c7a\u5b9a\u3055\u308c\u308b\u524d\u306b\u3001\u88fd\u9020\u5143\u3068\u30d3\u30fc\u30e0\u30a8\u30cd\u30eb\u30ae\u30fc\u3068\u7dda\u6e90\u306e\u4ed5\u69d8\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3001\u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u5730\u5143\u306e\u514d\u8a31\u4fdd\u6301\u8005\u3068\u653e\u5c04\u7dda\u9632\u8b77\u8cac\u4efb\u8005\u306e\u4f53\u5236\u3092\u65e9\u671f\u306b\u6574\u3048\u308b\u3053\u3068\u3001\u305d\u3057\u3066\u30b1\u30e1\u30f3\u30b1\u30b9\u6587\u66f8\u3068\u653e\u5c04\u7dda\u8a31\u53ef\u7533\u8acb\u66f8\u3092\u3001\u7121\u95a2\u4fc2\u306a2\u3064\u306e\u66f8\u985e\u3067\u306f\u306a\u304f\u30011\u3064\u306e\u9023\u643a\u3057\u305f\u6226\u7565\u3068\u3057\u3066\u4f5c\u6210\u3059\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9806\u5e8f\u4ed8\u3051\u3092\u6b63\u3057\u304f\u884c\u3046\u3053\u3068\u306e\u91cd\u8981\u6027\u3092\u8003\u3048\u308b\u3068\u3001\u6700\u3082\u78ba\u5b9f\u306a\u65b9\u6cd5\u306f\u3001\u30ec\u30d3\u30e5\u30fc\u306e\u9014\u4e2d\u3067\u554f\u984c\u304c\u6d6e\u4e0a\u3057\u305f\u5f8c\u3067\u306f\u306a\u304f\u3001\u5358\u4e00\u306e\u6587\u66f8\u3092\u63d0\u51fa\u3059\u308b\u524d\u306b\u4e21\u65b9\u306e\u7d4c\u8def\u3092\u8a08\u753b\u3057\u3066\u304a\u304f\u3053\u3068\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u3088\u3046\u306a\u30b7\u30fc\u30b1\u30f3\u30b9\u306f\u307e\u3055\u306b <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/radiation-medical-device-registration-in-indonesia\/\">\u653e\u5c04\u7dda\u533b\u7642\u6a5f\u5668\u767b\u9332\u30b5\u30fc\u30d3\u30b9<\/a> \u3053\u306e\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u7279\u306b\u9ad8\u30a8\u30cd\u30eb\u30ae\u30fc\u304a\u3088\u3073\u653e\u5c04\u7dda\u653e\u51fa\u6a5f\u5668\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u69cb\u7bc9\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u653e\u5c04\u7dda\u30e9\u30a4\u30bb\u30f3\u30b9\u3068\u4e26\u884c\u3057\u3066\u3001\u3088\u308a\u5e83\u7bc4\u306a\u30af\u30e9\u30b9C\u304a\u3088\u3073\u30af\u30e9\u30b9D\u6a5f\u5668\u306e\u7d4c\u8def\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u308b\u88fd\u9020\u696d\u8005\u306f\u3001\u5f53\u793e\u306e\u30b5\u30fc\u30d3\u30b9\u3067\u5fc5\u8981\u306a\u7bc4\u56f2\u304c\u30ab\u30d0\u30fc\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3059\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668\u767b\u9332\u30b5\u30fc\u30d3\u30b9<\/a>, 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class=\"wp-embedded-content\" data-secret=\"zdg3a7VGcc\"><a href=\"https:\/\/productregistrationindonesia.com\/ja\/radioactive-ivd-registration-in-indonesia-inside-the-ivd-radiation-regulatory-pathway\/\">\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<\/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\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\u300d \u2014 \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u88fd\u54c1\u767b\u9332\" 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therapy, brachytherapy, or linear accelerator systems into Indonesia is not the paperwork itself. It is not knowing, early enough, that two separate regulators (Kemenkes and the Radiation Regulator) will need to review the same equipment through two very different lenses: one for market approval, one for radiation safety. That gap in visibility is where most delays start. Applicants often secure Kemenkes marketing authorization first, only to discover that the Radiation Regulator&#8217;s bunker construction permit depends on shielding calculations tied to equipment specifications that are still being finalized. By the time the mismatch surfaces, months of schedule are already [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":7772,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7771","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\/7771","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=7771"}],"version-history":[{"count":1,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7771\/revisions"}],"predecessor-version":[{"id":7775,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7771\/revisions\/7775"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/7772"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=7771"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=7771"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=7771"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=7771"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}