{"id":1375,"date":"2024-12-08T14:26:45","date_gmt":"2024-12-08T14:26:45","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=1375"},"modified":"2026-03-09T13:47:54","modified_gmt":"2026-03-09T06:47:54","slug":"types-of-medical-devices-and-their-classification-in-indonesia","status":"publish","type":"post","link":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/types-of-medical-devices-and-their-classification-in-indonesia\/","title":{"rendered":"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u7a2e\u985e\u3068\u5206\u985e"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"1375\" class=\"elementor elementor-1375\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b8f501b e-flex e-con-boxed e-con e-parent\" data-id=\"b8f501b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div 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data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><\/p>\n<p>\u533b\u7642\u6a5f\u5668\u306f\u3001\u8a3a\u65ad\u3001\u4e88\u9632\u3001\u6cbb\u7642\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u30ea\u30cf\u30d3\u30ea\u30c6\u30fc\u30b7\u30e7\u30f3\u306a\u3069\u306e\u6a5f\u80fd\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u7642\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u307e\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306f\u4fdd\u5065\u7701\uff08MoH\uff09\u306b\u3088\u3063\u3066\u898f\u5236\u3055\u308c\u3066\u304a\u308a\u3001\u305d\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u54c1\u8cea\u304c\u4fdd\u8a3c\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u898f\u5236\u67a0\u7d44\u307f\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u3092\u30ea\u30b9\u30af\u306b\u57fa\u3065\u3044\u3066\u69d8\u3005\u306a\u30af\u30e9\u30b9\u306b\u5206\u985e\u3057\u3001\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u3001\u767b\u9332\u8981\u4ef6\u3001\u76e3\u7763\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u3053\u308c\u3089\u306e\u5206\u985e\u3001\u305d\u308c\u305e\u308c\u306e\u57fa\u6e96\u3001\u305d\u3057\u3066\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u95a2\u9023\u3059\u308b\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u8aac\u660e\u3057\u307e\u3059\u3002<\/p>\n<p><\/p>\n<h3 class=\"wp-block-heading\"><b>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e<\/b><\/h3>\n<p><\/p>\n<p><a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668<\/a> \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u30af\u30e9\u30b9\u5206\u3051\u306f\u3001\u69d8\u3005\u306a\u533b\u7642\u6a5f\u5668\u306e\u95a2\u9023\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304f\u898f\u5236\u67a0\u7d44\u307f\u3092\u5b9a\u7fa9\u3059\u308b\u4e0a\u3067\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u3001GHTF\uff08Global Harmonization Task Force\uff09\u3084AMDD\uff08ASEAN Medical Devices Directive\uff09\u306a\u3069\u306e\u56fd\u969b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3057\u3066\u304a\u308a\u3001\u5730\u57df\u306e\u30cb\u30fc\u30ba\u306b\u5bfe\u5fdc\u3057\u306a\u304c\u3089\u56fd\u969b\u7684\u306a\u8abf\u548c\u3092\u78ba\u4fdd\u3057\u3066\u3044\u307e\u3059\u3002\u30af\u30e9\u30b9I\u3001II\u3001III\u3078\u306e\u5206\u985e\u306f\u5358\u306a\u308b\u5206\u985e\u3067\u306f\u306a\u304f\u3001\u767b\u9332\u306e\u8907\u96d1\u3055\u3001\u9069\u7528\u3055\u308c\u308b\u5be9\u67fb\u3001\u95a2\u9023\u30b3\u30b9\u30c8\u306a\u3069\u3001\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u57fa\u672c\u7684\u306a\u8981\u7d20\u3067\u3059\u3002\u5404\u5206\u985e\u306b\u306f\u5177\u4f53\u7684\u306a\u898f\u5236\u8981\u4ef6\u304c\u898f\u5b9a\u3055\u308c\u3066\u304a\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306b\u57fa\u3065\u3044\u3066\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u304c\u9069\u5207\u306b\u8a55\u4fa1\u3055\u308c\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><\/p>\n<figure class=\"wp-block-image aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"576\" class=\"wp-image-1377\" src=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-Classification-of-medical-devices-1024x576.png\" alt=\"\" srcset=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-Classification-of-medical-devices-1024x576.png 1024w, https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-Classification-of-medical-devices-300x169.png 300w, https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-Classification-of-medical-devices-768x432.png 768w, https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-Classification-of-medical-devices.png 1380w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\n<p>\u00a0<\/p>\n<figcaption class=\"wp-element-caption\"><strong>\u5f62 <\/strong>\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u3002<\/figcaption>\n<\/figure>\n<p><\/p>\n<h4 class=\"wp-block-heading\">\u30af\u30e9\u30b9I\uff08\u4f4e\u30ea\u30b9\u30af\u30c7\u30d0\u30a4\u30b9\uff09<\/h4>\n<p><\/p>\n<p>\u30af\u30e9\u30b9 I \u6a5f\u5668\u306f 3 \u3064\u306e\u5206\u985e\u306e\u4e2d\u3067\u6700\u3082\u5358\u7d14\u3067\u3001\u30e6\u30fc\u30b6\u30fc\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u304c\u6700\u5c0f\u9650\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u6a5f\u5668\u306f\u4e00\u822c\u306b\u3001\u5b89\u5168\u304b\u3064\u6709\u52b9\u3067\u3042\u308b\u305f\u3081\u306b\u6ec5\u83cc\u72b6\u614b\u3084\u7279\u5225\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u5fc5\u8981\u3068\u3057\u307e\u305b\u3093\u3002\u30af\u30e9\u30b9 I \u6a5f\u5668\u306e\u4e00\u822c\u7684\u306a\u4f8b\u3068\u3057\u3066\u306f\u3001\u5358\u7d14\u306a\u5305\u5e2f\u3001\u975e\u6e2c\u5b9a\u8074\u8a3a\u5668\u3001\u677e\u8449\u6756\u3001\u624b\u8853\u7528\u624b\u888b\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u5206\u985e\u306e\u57fa\u6e96\u306f\u3001\u3053\u308c\u3089\u306e\u6a5f\u5668\u306e\u4f4e\u30ea\u30b9\u30af \u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u975e\u4fb5\u8972\u6027\u3067\u3042\u308a\u3001\u4f53\u5185\u306b\u5165\u3063\u305f\u308a\u76ae\u819a\u3092\u8cab\u901a\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u306a\u304f\u3001\u9069\u5207\u306b\u6a5f\u80fd\u3059\u308b\u305f\u3081\u306b\u76f4\u63a5\u6e2c\u5b9a\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30af\u30e9\u30b9 I \u6a5f\u5668\u306e\u898f\u5236\u8981\u4ef6\u306f\u6bd4\u8f03\u7684\u7c21\u5358\u3067\u3059\u3002\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u306f\u5408\u7406\u5316\u3055\u308c\u3066\u304a\u308a\u3001\u901a\u5e38\u7d04 15 \u65e5\u304b\u304b\u308a\u3001\u6a5f\u5668\u306e\u30e9\u30d9\u30eb\u3001\u88fd\u9020\u5143\u60c5\u5831\u3001\u57fa\u672c\u7684\u306a\u30ea\u30b9\u30af\u5206\u6790\u306a\u3069\u306e\u6700\u5c0f\u9650\u306e\u6587\u66f8\u5316\u304c\u5fc5\u8981\u3067\u3059\u3002\u30af\u30e9\u30b9 I \u6a5f\u5668\u306e\u767b\u9332\u306b\u95a2\u9023\u3059\u308b\u6599\u91d1\u3082\u4f4e\u304f\u3001\u7d04 IDR 1,500,000 (US$115) \u3067\u3059\u3002<\/p>\n<p><\/p>\n<h4 class=\"wp-block-heading\">\u30af\u30e9\u30b9II\uff08\u4e2d\u7b49\u5ea6\u30ea\u30b9\u30af\u6a5f\u5668\uff09<\/h4>\n<p><\/p>\n<p>\u30af\u30e9\u30b9II\u306b\u79fb\u884c\u3059\u308b\u3068\u3001\u30c7\u30d0\u30a4\u30b9\u306f\u30af\u30e9\u30b9I\u3068\u6bd4\u8f03\u3057\u3066\u3088\u308a\u9ad8\u3044\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3059\u3068\u307f\u306a\u3055\u308c\u3001\u3088\u308a\u53b3\u683c\u306a\u898f\u5236\u76e3\u7763\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u306f\u3001\u8f38\u6db2\u30dd\u30f3\u30d7\u3001\u5fc3\u96fb\u56f3\u88c5\u7f6e\u3001X\u7dda\u88c5\u7f6e\u3001\u9ebb\u9154\u5668\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u30af\u30e9\u30b9II\u30c7\u30d0\u30a4\u30b9\u306e\u57fa\u6e96\u306f\u3001\u4fb5\u8972\u6027\u304c\u3042\u308b\u304b\u3001\u30e6\u30fc\u30b6\u30fc\u3068\u76f4\u63a5\u63a5\u89e6\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u6ce8\u610f\u6df1\u3044\u76e3\u8996\u3068\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u6ec5\u83cc\u3092\u5fc5\u8981\u3068\u3059\u308b\u3001\u4e2d\u7a0b\u5ea6\u306e\u5065\u5eb7\u30ea\u30b9\u30af\u3092\u53cd\u6620\u3057\u3066\u3044\u307e\u3059\u3002\u30af\u30e9\u30b9II\u30c7\u30d0\u30a4\u30b9\u306e\u898f\u5236\u8981\u4ef6\u306b\u306f\u3001\u901a\u5e38\u7d0430\u65e5\u304b\u304b\u308b\u3001\u3088\u308a\u5305\u62ec\u7684\u306a\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u6587\u66f8\u3001\u9069\u6b63\u88fd\u9020\u57fa\u6e96\uff08GMP\uff09\u8a3c\u660e\u66f8\u3092\u542b\u3080\u8a73\u7d30\u306a\u8a55\u4fa1\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u95a2\u9023\u6599\u91d1\u306f\u3001\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u5bfe\u3059\u308b\u76e3\u8996\u3068\u898f\u5236\u8981\u4ef6\u306e\u5f37\u5316\u3092\u53cd\u6620\u3057\u3066\u3001\u7d043,000,000 IDR\uff08US$230\uff09\u3068\u9ad8\u984d\u3067\u3059\u3002<\/p>\n<p><\/p>\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" width=\"500\" height=\"332\" class=\"wp-image-1376\" src=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-2.-An-electrocardiogram-ECG-machine.jpg\" alt=\"\" srcset=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-2.-An-electrocardiogram-ECG-machine.jpg 500w, https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-2.-An-electrocardiogram-ECG-machine-300x199.jpg 300w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\n<p>\u00a0<\/p>\n<figcaption class=\"wp-element-caption\"><strong>\u56f32.<\/strong> \u5fc3\u96fb\u56f3\uff08ECG\uff09\u88c5\u7f6e\u3002\uff08\u51fa\u5178\uff1a <a href=\"https:\/\/www.usamedicalsurgical.com\/blog\/ekg-ecg-machine-buyers-guide\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.usamedicalsurgical.com\/blog\/ekg-ecg-machine-buyers-guide\/<\/a>)<\/figcaption>\n<\/figure>\n<p><\/p>\n<h4 class=\"wp-block-heading\">\u30af\u30e9\u30b9III\uff08\u9ad8\u30ea\u30b9\u30af\u6a5f\u5668\uff09<\/h4>\n<p><\/p>\n<p>\u30af\u30e9\u30b9III\u306f\u6700\u3082\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u30ab\u30c6\u30b4\u30ea\u30fc\u3067\u3001\u6545\u969c\u3057\u305f\u5834\u5408\u306b\u91cd\u50b7\u3084\u6b7b\u4ea1\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u6a5f\u5668\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u30da\u30fc\u30b9\u30e1\u30fc\u30ab\u30fc\u3001\u9664\u7d30\u52d5\u5668\u3001\u7fa9\u80a2\u306a\u3069\u306e\u57cb\u3081\u8fbc\u307f\u578b\u6a5f\u5668\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u30af\u30e9\u30b9III\u6a5f\u5668\u306e\u57fa\u6e96\u306f\u3001\u901a\u5e38\u57cb\u3081\u8fbc\u307f\u578b\u3067\u3042\u308b\u304b\u3001\u6cbb\u7642\u4e0a\u306e\u6c7a\u5b9a\u306b\u5fc5\u8981\u306a\u91cd\u8981\u306a\u6e2c\u5b9a\u5024\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u3001\u305d\u306e\u9ad8\u30ea\u30b9\u30af\u6027\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u898f\u5236\u8981\u4ef6\u306f\u6700\u3082\u53b3\u683c\u3067\u3001\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u6700\u592745\u65e5\u304b\u304b\u308a\u307e\u3059\u3002\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u3067\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3001\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u3001\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u306a\u3069\u306e\u5305\u62ec\u7684\u306a\u6587\u66f8\u5316\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u30af\u30e9\u30b9III\u6a5f\u5668\u306e\u767b\u9332\u6599\u3082\u6700\u3082\u9ad8\u304f\u3001\u7d045,000,000\u30eb\u30d4\u30a2\uff08US$340\uff09\u3068\u3001\u60a3\u8005\u306e\u5b89\u5168\u306b\u3068\u3063\u3066\u3053\u308c\u3089\u306e\u6a5f\u5668\u304c\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3053\u3068\u3092\u53cd\u6620\u3057\u3066\u3044\u307e\u3059\u3002\u53b3\u683c\u306a\u8981\u4ef6\u306b\u3088\u308a\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u304c\u5b9f\u8a3c\u3055\u308c\u305f\u6a5f\u5668\u306e\u307f\u304c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306e\u4f7f\u7528\u304c\u627f\u8a8d\u3055\u308c\u307e\u3059\u3002<\/p>\n<p><\/p>\n<h3 class=\"wp-block-heading\"><b>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u624b\u7d9a\u304d<\/b><\/h3>\n<p><\/p>\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u308b\u524d\u306b\u3001\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u8907\u6570\u306e\u30b9\u30c6\u30c3\u30d7\u304b\u3089\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30d7\u30ed\u30bb\u30b9\u306f\u6a5f\u5668\u306e\u5206\u985e\uff08\u30af\u30e9\u30b9I\u3001II\u3001III\uff09\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u3001\u305d\u308c\u305e\u308c\u306b\u72ec\u81ea\u306e\u8981\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u3078\u306e\u53c2\u5165\u3092\u76ee\u6307\u3059\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u3053\u308c\u3089\u306e\u30b9\u30c6\u30c3\u30d7\u306b\u3088\u3063\u3066\u3001\u5fc5\u8981\u306a\u66f8\u985e\u3001\u5404\u6a5f\u5668\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u95a2\u9023\u3059\u308b\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3001\u305d\u3057\u3066\u30b3\u30b9\u30c8\u304c\u6c7a\u307e\u308b\u304b\u3089\u3067\u3059\u3002<\/p>\n<p><\/p>\n<h4 class=\"wp-block-heading\">\u5e02\u5834\u524d\u767b\u9332<\/h4>\n<p><\/p>\n<p>\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u8a8d\u53ef\u3092\u53d7\u3051\u305f\u73fe\u5730\u8f38\u5165\u696d\u8005\u307e\u305f\u306f\u8ca9\u58f2\u696d\u8005\u3092\u901a\u3058\u3066\u4fdd\u5065\u7701\uff08MoH\uff09\u306b\u7533\u8acb\u66f8\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u304b\u3089\u59cb\u307e\u308a\u307e\u3059\u3002\u3053\u306e\u7533\u8acb\u66f8\u306b\u306f\u3001\u6a5f\u5668\u306e\u7528\u9014\u3001\u8a2d\u8a08\u4ed5\u69d8\u3001\u81e8\u5e8a\u8a55\u4fa1\u306a\u3069\u3001\u6a5f\u5668\u306b\u95a2\u3059\u308b\u5305\u62ec\u7684\u306a\u60c5\u5831\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u7533\u8acb\u8005\u306f\u3001\u6a5f\u5668\u306e\u76ee\u7684\u3068\u5229\u70b9\u3092\u6982\u8aac\u3057\u305f\u6982\u8981\u3068\u3001\u4f7f\u7528\u65b9\u6cd5\u3001\u7981\u5fcc\u3001\u8b66\u544a\u3001\u6ce8\u610f\u4e8b\u9805\u3092\u542b\u3080\u8a73\u7d30\u306a\u30e9\u30d9\u30eb\u60c5\u5831\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u7533\u8acb\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u898f\u683c\u3067\u3042\u308bISO 13485\u8a8d\u8a3c\u306a\u3069\u3001\u88fd\u9020\u696d\u8005\u306b\u95a2\u3059\u308b\u8a73\u7d30\u60c5\u5831\u3082\u5fc5\u8981\u3067\u3042\u308a\u3001\u88fd\u9020\u306b\u304a\u3051\u308b\u56fd\u969b\u7684\u306a\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3078\u306e\u6e96\u62e0\u3092\u5b9f\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6a5f\u5668\u306e\u4f7f\u7528\u306b\u4f34\u3046\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3059\u308b\u306b\u306f\u3001\u30ea\u30b9\u30af\u5206\u6790\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u793a\u3059\u81e8\u5e8a\u8a66\u9a13\u304a\u3088\u3073\u7814\u7a76\u306b\u57fa\u3065\u304f\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u3082\u5fc5\u8981\u3067\u3059\u3002\u3055\u3089\u306b\u3001\u6a5f\u5668\u304c\u56fd\u969b\u5e02\u5834\u3067\u53d7\u3051\u5165\u308c\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u3001\u88fd\u9020\u696d\u8005\u306e\u56fd\u304c\u767a\u884c\u3059\u308b\u81ea\u7531\u8ca9\u58f2\u8a3c\u660e\u66f8\uff08FSC\uff09\u304c\u5fc5\u8981\u3067\u3059\u3002\u6a5f\u5668\u306e\u6750\u6599\u304c\u4eba\u4f53\u3078\u306e\u4f7f\u7528\u306b\u5b89\u5168\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u3059\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u306e\u6587\u66f8\u3082\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u767b\u9332\u6599\u306f\u6a5f\u5668\u306e\u5206\u985e\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u30af\u30e9\u30b9I\u306e\u6a5f\u5668\u306f\u3001\u7d041,500,000\u30eb\u30d4\u30a2\uff08US$115\uff09\u3068\u4f4e\u6599\u91d1\u3067\u3059\u3002\u30af\u30e9\u30b9II\u304a\u3088\u3073III\u306e\u6a5f\u5668\u306f\u3001\u8907\u96d1\u3055\u3068\u66f8\u985e\u63d0\u51fa\u306e\u8981\u4ef6\u304c\u5897\u3059\u305f\u3081\u3001\u8cbb\u7528\u304c\u9ad8\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n<p><\/p>\n<h4 class=\"wp-block-heading\">\u5e02\u8ca9\u5f8c\u767b\u9332<\/h4>\n<p><\/p>\n<p>\u4fdd\u5065\u7701\u304c\u63d0\u51fa\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u66f8\u985e\u3092\u5be9\u67fb\u3057\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3092\u5b9f\u65bd\u3057\u305f\u5f8c\u3001\u88fd\u54c1\u30e9\u30a4\u30bb\u30f3\u30b9\u3068\u767b\u9332\u756a\u53f7\u304c\u767a\u884c\u3055\u308c\u307e\u3059\u3002\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u306f\u3001\u8f38\u5165\u696d\u8005\u307e\u305f\u306f\u8ca9\u58f2\u696d\u8005\u306e\u3044\u305a\u308c\u304b\u306e\u73fe\u5730\u6cd5\u4eba\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u767b\u9332\u3092\u7dad\u6301\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u88fd\u54c1\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u6709\u52b9\u671f\u9593\u306f\u3001\u6a5f\u5668\u306e\u7a2e\u985e\u3068\u8a8d\u53ef\u72b6\uff08LOA\uff09\u306b\u5fdc\u3058\u3066\u3001\u901a\u5e382\u5e74\u304b\u30895\u5e74\u3067\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u6a5f\u5668\u3092\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3057\u7d9a\u3051\u308b\u306b\u306f\u3001\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u6709\u52b9\u671f\u9650\u524d\u306b\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u5e02\u8ca9\u5f8c\u6bb5\u968e\u306f\u3001\u7279\u306b\u6a5f\u5668\u306e\u5305\u88c5\u3001\u30e9\u30d9\u30eb\u3001\u307e\u305f\u306f\u6280\u8853\u4ed5\u69d8\u306b\u5909\u66f4\u304c\u3042\u3063\u305f\u5834\u5408\u3001\u898f\u5236\u57fa\u6e96\u3078\u306e\u9069\u5408\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u8efd\u5fae\u306a\u5909\u66f4\u306b\u3064\u3044\u3066\u306f\u4fee\u6b63\u7533\u8acb\u3092\u63d0\u51fa\u3067\u304d\u307e\u3059\u304c\u3001\u5927\u5e45\u306a\u5909\u66f4\u306b\u306f\u65b0\u898f\u767b\u9332\u304c\u5fc5\u8981\u306b\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u73fe\u5730\u6cd5\u4eba\u306f\u3001\u3059\u3079\u3066\u306e\u66f4\u65b0\u3068\u4fee\u6b63\u3092\u901f\u3084\u304b\u306b\u4fdd\u5065\u7701\u306b\u901a\u77e5\u3057\u3001\u5e02\u5834\u3067\u306e\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u9069\u5408\u6027\u3092\u7dad\u6301\u3059\u308b\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u3059\u3002\u3053\u306e\u767b\u9332\u5f8c\u306e\u898f\u5236\u76e3\u7763\u306f\u3001\u7d99\u7d9a\u7684\u306a\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u3066\u304a\u308a\u3001\u4fdd\u5065\u7701\u306f\u6709\u5bb3\u4e8b\u8c61\u3092\u76e3\u8996\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u88fd\u54c1\u4ed5\u69d8\u3092\u66f4\u65b0\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><\/p>\n<h3 class=\"wp-block-heading\"><b>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u767b\u9332<\/b><\/h3>\n<p><\/p>\n<p>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u653f\u5e9c\u306b\u3088\u308b\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165\u306f\u3001 <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668<\/a> \u767b\u9332\u30fb\u8abf\u9054\u304c\u53ef\u80fd\u306a\u533b\u7642\u6a5f\u5668\u306f\u3001\u3053\u306e\u30aa\u30f3\u30e9\u30a4\u30f3\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u901a\u3058\u3066\u767b\u9332\u30fb\u8abf\u9054\u3055\u308c\u307e\u3059\u3002\u767b\u9332\u6e08\u307f\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001\u533b\u7642\u63d0\u4f9b\u8005\u3084\u653f\u5e9c\u8abf\u9054\u6a5f\u95a2\u304c\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u3088\u3046\u30ea\u30b9\u30c8\u5316\u3055\u308c\u3001\u8abf\u9054\u30d7\u30ed\u30bb\u30b9\u304c\u52b9\u7387\u5316\u3055\u308c\u307e\u3059\u3002\u6a5f\u5668\u3092\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u306b\u63b2\u8f09\u3059\u308b\u306b\u306f\u3001\u4fdd\u5065\u7701\uff08MoH\uff09\u304c\u5b9a\u3081\u308b\u7279\u5b9a\u306e\u57fa\u6e96\u3068\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u5fb9\u5e95\u7684\u306a\u8a55\u4fa1\u304c\u5fc5\u8981\u3067\u3059\u3002\u88fd\u54c1\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u53d6\u5f97\u5f8c\u3001\u8a8d\u53ef\u3092\u53d7\u3051\u305f\u73fe\u5730\u8f38\u5165\u696d\u8005\u3092\u901a\u3058\u3066\u6a5f\u5668\u3092\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u306b\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u6982\u8981\u3001\u8a73\u7d30\u306a\u30e9\u30d9\u30eb\u60c5\u5831\u3001\u30ea\u30b9\u30af\u5206\u6790\u3001\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306a\u3069\u306e\u5fc5\u8981\u66f8\u985e\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3001\u6a5f\u5668\u306fISO 13485\u8a8d\u8a3c\u3092\u542b\u3080\u73fe\u5730\u306e\u54c1\u8cea\u7ba1\u7406\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><\/p>\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" width=\"766\" height=\"289\" class=\"wp-image-1378\" src=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-E-catalogue-of-medical-devices-in-Indonesia.png\" alt=\"\" srcset=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-E-catalogue-of-medical-devices-in-Indonesia.png 766w, https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2024\/12\/Figure-E-catalogue-of-medical-devices-in-Indonesia-300x113.png 300w\" sizes=\"(max-width: 766px) 100vw, 766px\" \/>\n<p>\u00a0<\/p>\n<figcaption class=\"wp-element-caption\"><strong>\u5f62 <\/strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u306e\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u3002<\/figcaption>\n<\/figure>\n<p><\/p>\n<p>\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u3078\u306e\u6a5f\u5668\u63b2\u8f09\u306e\u30e1\u30ea\u30c3\u30c8\u306f\u591a\u5c90\u306b\u308f\u305f\u308a\u307e\u3059\u3002\u8abf\u9054\u30d7\u30ed\u30bb\u30b9\u3092\u5358\u4e00\u306e\u30c7\u30b8\u30bf\u30eb\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306b\u7d71\u5408\u3059\u308b\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u3068\u533b\u7642\u63d0\u4f9b\u8005\u306e\u4e8b\u52d9\u8ca0\u62c5\u304c\u8efd\u6e1b\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u8cfc\u8cb7\u30d7\u30ed\u30bb\u30b9\u304c\u8fc5\u901f\u5316\u3055\u308c\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u9593\u306e\u7af6\u4e89\u304c\u6fc0\u5316\u3059\u308b\u3053\u3068\u3067\u8abf\u9054\u30b3\u30b9\u30c8\u304c\u524a\u6e1b\u3055\u308c\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u30b7\u30b9\u30c6\u30e0\u306f\u900f\u660e\u6027\u3092\u9ad8\u3081\u3001\u6280\u8853\u4ed5\u69d8\u3001\u4fa1\u683c\u3001\u5b89\u5168\u6027\u8a18\u9332\u306b\u57fa\u3065\u3044\u305f\u6a5f\u5668\u306e\u6bd4\u8f03\u3092\u5bb9\u6613\u306b\u3057\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u3078\u306e\u63b2\u8f09\u306f\u3001\u7279\u306b\u5916\u56fd\u4f01\u696d\u306b\u3068\u3063\u3066\u5e02\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3068\u8a8d\u77e5\u5ea6\u3092\u5927\u5e45\u306b\u5411\u4e0a\u3055\u305b\u307e\u3059\u3002\u653f\u5e9c\u6a5f\u95a2\u304c\u5fc5\u8981\u306a\u6a5f\u5668\u3092\u8fc5\u901f\u306b\u7279\u5b9a\u30fb\u8abf\u9054\u3059\u308b\u305f\u3081\u306e\u4e00\u5143\u7684\u306a\u62e0\u70b9\u3068\u306a\u308a\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u30b5\u30fc\u30d3\u30b9\u5168\u4f53\u306e\u6539\u5584\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/p>\n<p><\/p>\n<h3 class=\"wp-block-heading\"><b>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u8ab2\u984c\u3068\u691c\u8a0e\u4e8b\u9805<\/b><\/h3>\n<p><\/p>\n<p>\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u30b7\u30b9\u30c6\u30e0\u306b\u306f\u591a\u304f\u306e\u5229\u70b9\u304c\u3042\u308b\u4e00\u65b9\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u4e57\u308a\u8d8a\u3048\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u8ab2\u984c\u3082\u5b58\u5728\u3057\u307e\u3059\u3002\u4e3b\u306a\u30cf\u30fc\u30c9\u30eb\u306e\u4e00\u3064\u306f\u3001\u5916\u56fd\u30e1\u30fc\u30ab\u30fc\u304c\u767b\u9332\u7533\u8acb\u3092\u884c\u3046\u969b\u306b\u3001\u8a8d\u53ef\u3092\u53d7\u3051\u305f\u73fe\u5730\u8f38\u5165\u696d\u8005\u3092\u7d4c\u7531\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u306e\u4ef2\u4ecb\u5f79\u306f\u3001\u30d7\u30ed\u30bb\u30b9\u306b\u8ffd\u52a0\u306e\u30b3\u30b9\u30c8\u3068\u8907\u96d1\u3055\u3092\u3082\u305f\u3089\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u73fe\u5730\u4ee3\u7406\u4eba\u306e\u95a2\u4e0e\u306b\u3088\u308a\u3001\u73fe\u5730\u898f\u5236\u3078\u306e\u6e96\u62e0\u304c\u78ba\u4fdd\u3055\u308c\u307e\u3059\u3002\u4fdd\u5065\u7701\u3068\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u5186\u6ed1\u306b\u306a\u308a\u307e\u3059\u304c\u3001\u8f38\u5165\u696d\u8005\u306e\u898f\u5236\u8981\u4ef6\u306b\u5bfe\u3059\u308b\u7406\u89e3\u304c\u4e0d\u8db3\u3057\u3066\u3044\u308b\u5834\u5408\u3084\u3001\u95a2\u4fc2\u8005\u9593\u306e\u8abf\u6574\u304c\u4e0d\u5341\u5206\u306a\u5834\u5408\u306f\u3001\u9045\u5ef6\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u4fdd\u5065\u7701\u3068\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u3082\u3046\u4e00\u3064\u306e\u91cd\u8981\u306a\u8ab2\u984c\u3067\u3059\u3002\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u8ffd\u52a0\u60c5\u5831\u3084\u4fee\u6b63\u306e\u4f9d\u983c\u306a\u3069\u3001\u8907\u6570\u56de\u306e\u3084\u308a\u53d6\u308a\u304c\u5fc5\u8981\u306b\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u63d0\u51fa\u3055\u308c\u305f\u66f8\u985e\u304c\u4e0d\u5b8c\u5168\u3067\u3042\u3063\u305f\u308a\u3001\u63d0\u4f9b\u3055\u308c\u305f\u30c7\u30fc\u30bf\u306b\u66d6\u6627\u3055\u304c\u3042\u308b\u5834\u5408\u3001\u3053\u308c\u304c\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u30d7\u30ed\u30bb\u30b9\u306e\u53cd\u5fa9\u7684\u306a\u6027\u8cea\u306b\u3088\u308a\u3001\u767b\u9332\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u304c\u9045\u5ef6\u3057\u3001\u5e02\u5834\u3067\u306e\u6a5f\u5668\u306e\u5165\u624b\u53ef\u80fd\u6027\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u898f\u5236\u67a0\u7d44\u307f\u306f\u52d5\u7684\u3067\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u30cf\u30e9\u30fc\u30eb\u8a8d\u8a3c\u8981\u4ef6\u306e\u5c0e\u5165\u306a\u3069\u3001\u7d99\u7d9a\u7684\u306b\u66f4\u65b0\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u88fd\u9020\u696d\u8005\u306f\u3001\u88fd\u54c1\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3001\u898f\u5236\u72b6\u6cc1\u306e\u3042\u3089\u3086\u308b\u5909\u66f4\u306b\u3064\u3044\u3066\u5e38\u306b\u6ce8\u610f\u3092\u6255\u3044\u3001\u60c5\u5831\u3092\u5165\u624b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u6700\u65b0\u60c5\u5831\u3092\u628a\u63e1\u3059\u308b\u306b\u306f\u3001\u4fdd\u5065\u7701\u3068\u306e\u7a4d\u6975\u7684\u306a\u9023\u643a\u3068\u898f\u5236\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306e\u7a4d\u6975\u7684\u306a\u7ba1\u7406\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u304c\u3001\u7279\u306b\u73fe\u5730\u306e\u898f\u5236\u74b0\u5883\u306b\u4e0d\u6163\u308c\u306a\u5916\u8cc7\u7cfb\u4f01\u696d\u306b\u3068\u3063\u3066\u306f\u3001\u591a\u304f\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u8cbb\u3084\u3059\u3053\u3068\u306b\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><\/p>\n<h4 class=\"wp-block-heading\">\u7d50\u8ad6<\/h4>\n<p><\/p>\n<p>\u7d50\u8ad6\u3068\u3057\u3066\u3001 <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668<\/a> \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332\u5236\u5ea6\u306f\u3001\u4e16\u754c\u57fa\u6e96\u3001\u7279\u306bGHTF\uff08\u533b\u7642\u6a5f\u5668\u898f\u5236\u56fd\u969b\u8abf\u548c\u30bf\u30b9\u30af\u30d5\u30a9\u30fc\u30b9\uff09\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3057\u3001ASEAN\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08AMDD\uff09\u3068\u8abf\u548c\u3057\u305f\u69cb\u9020\u5316\u3055\u308c\u305f\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u5f93\u3063\u3066\u3044\u307e\u3059\u3002\u30af\u30e9\u30b9I\u3001II\u3001III\u306e\u5206\u985e\u306f\u3001\u6a5f\u5668\u304c\u60a3\u8005\u3068\u30e6\u30fc\u30b6\u30fc\u306b\u3082\u305f\u3089\u3059\u30ea\u30b9\u30af\u306e\u30ec\u30d9\u30eb\u3092\u6c7a\u5b9a\u3057\u3001\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u3001\u898f\u5236\u8abf\u67fb\u3001\u95a2\u9023\u30b3\u30b9\u30c8\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002\u5404\u30af\u30e9\u30b9\u306b\u306f\u3001\u30af\u30e9\u30b9I\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u6700\u5c0f\u9650\u306e\u6587\u66f8\u5316\u304b\u3089\u3001\u81e8\u5e8a\u8a66\u9a13\u3084\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u3092\u542b\u3080\u30af\u30e9\u30b9III\u6a5f\u5668\u306e\u5305\u62ec\u7684\u306a\u8a55\u4fa1\u307e\u3067\u3001\u72ec\u81ea\u306e\u57fa\u6e96\u3068\u898f\u5236\u8981\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u306e\u5c0e\u5165\u306b\u3088\u308a\u3001\u8abf\u9054\u304c\u3055\u3089\u306b\u5408\u7406\u5316\u3055\u308c\u3001\u900f\u660e\u6027\u3068\u52b9\u7387\u6027\u304c\u5411\u4e0a\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u5206\u985e\u3068\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u3092\u9032\u3081\u308b\u306b\u306f\u3001\u898f\u5236\u74b0\u5883\u3068\u96fb\u5b50\u30ab\u30bf\u30ed\u30b0\u30b7\u30b9\u30c6\u30e0\u306e\u7279\u5b9a\u306e\u8981\u6c42\u306e\u4e21\u65b9\u3092\u5b8c\u5168\u306b\u7406\u89e3\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u3053\u308c\u306f\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u3067\u306e\u6210\u529f\u3092\u76ee\u6307\u3059\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002<\/p>\n<p><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Medical devices play an essential role in healthcare by providing diagnostic, preventive, therapeutic, monitoring, or rehabilitative functions. In Indonesia, medical devices are regulated by the Ministry of Health (MoH), which ensures their safety, efficacy, and quality. The regulatory framework categorizes medical devices into different classes based on risk, which dictates the regulatory process, registration requirements, and oversight. This article provides an in-depth look at these classifications, the criteria for each, and the associated registration process in Indonesia. Classification of Medical Devices in Indonesia Medical device classification in Indonesia is crucial in defining the regulatory framework for various devices based on their associated risks. The system aligns with international guidelines, including [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":5349,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-1375","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-articles"],"acf":[],"_links":{"self":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/1375","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=1375"}],"version-history":[{"count":13,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/1375\/revisions"}],"predecessor-version":[{"id":5350,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/1375\/revisions\/5350"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/5349"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=1375"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=1375"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=1375"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=1375"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}