{"id":1076,"date":"2024-07-16T15:13:55","date_gmt":"2024-07-16T07:13:55","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=1076"},"modified":"2024-07-16T15:13:55","modified_gmt":"2024-07-16T07:13:55","slug":"summary-of-key-points-in-preparing-nmpa-registration-documents-for-medical-device-software","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/ja\/summary-of-key-points-in-preparing-nmpa-registration-documents-for-medical-device-software\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306eNMPA\u767b\u9332\u66f8\u985e\u4f5c\u6210\u306e\u30dd\u30a4\u30f3\u30c8\u307e\u3068\u3081"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u4e2d\u56fd\u306e5G\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306e\u767a\u5c55\u306b\u4f34\u3044\u3001\u30b9\u30de\u30fc\u30c8\u533b\u7642\u7523\u696d\u3082\u3055\u3089\u306b\u9032\u6b69\u30fb\u767a\u5c55\u3057\u3066\u304a\u308a\u3001\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30c8\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u9700\u8981\u3082\u5897\u52a0\u306e\u4e00\u9014\u3092\u305f\u3069\u3063\u3066\u3044\u308b\u3002\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30c8\u30fb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u533b\u7642\u6a5f\u5668\u53ca\u3073AI\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306f\u3001\u533b\u7642\u6a5f\u5668\u5358\u72ec\u767b\u9332\u8a3c\u306e\u7533\u8acb\u66f8\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002 <a href=\"https:\/\/www.nmpa.gov.cn\/\" rel=\"nofollow noopener\" target=\"_blank\">\u533b\u85ac\u54c1\u7ba1\u7406\u5c40<\/a> \uff08NMPA\u307e\u305f\u306fProvincial MPA\uff09\u3092\u53d7\u3051\u306a\u3051\u308c\u3070\u8ca9\u58f2\u3067\u304d\u306a\u3044\u3002\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30c8\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u533b\u7642\u6a5f\u5668\u306f\u533b\u7642\u6a5f\u5668\u306e\u4e00\u90e8\u3067\u3059\u304c\u3001\u4e00\u90e8\u306e\u898f\u5236\u306f\u7570\u306a\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u5358\u4f53\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u767b\u9332\u7533\u8acb\u306f\u3069\u306e\u3088\u3046\u306b\u6a5f\u80fd\u3059\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u3069\u306e\u3088\u3046\u306a\u554f\u984c\u304c\u767a\u751f\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u304b\uff1f\u8a73\u7d30\u60c5\u5831 <a href=\"https:\/\/www.consulting-hmk.com\/ja\/%e3%82%b3%e3%83%b3%e3%82%bf%e3%82%af%e3%83%88\/\">\u3054\u9023\u7d61\u304f\u3060\u3055\u3044<\/a>.<\/span><\/p>\n<h1><a href=\"https:\/\/www.consulting-hmk.com\/ja\/products-category\/nmpa-medical-device-and-ivd-registration-filing\/\"><span style=\"font-size: 18pt;\"><strong><span style=\"font-family: arial, helvetica, sans-serif;\">\u65b0\u898f\u767b\u9332<\/span><\/strong><\/span><\/a><\/h1>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">1.\u7533\u8fbc\u66f8<\/span><\/h2>\n<h3><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">(1) \u72ec\u7acb\u7cfb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/span><\/h3>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u88fd\u54c1\u540d\u306f\u3001\u72ec\u7acb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4e00\u822c\u7684\u306a\u540d\u79f0\u547d\u540d\u4ed5\u69d8\u306e\u8981\u4ef6\u306b\u6e96\u62e0\u3059\u308b\u3082\u306e\u3068\u3057\u3001\u901a\u5e38\u3001\u5165\u529b\u30c7\u30fc\u30bf\u3001\u30b3\u30a2\u6a5f\u80fd\u3001\u4f7f\u7528\u76ee\u7684\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u7279\u5fb4\u7684\u306a\u5358\u8a9e\u3092\u53cd\u6620\u3059\u308b\u3082\u306e\u3068\u3059\u308b\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u30e2\u30c7\u30eb\u4ed5\u69d8\u3067\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30ea\u30ea\u30fc\u30b9\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u82f1\u8a9e\u7565\u8a9eV\u3092\u53cd\u6620\u3055\u305b\u305a\u306b\u793a\u3057\u3066\u3044\u308b\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u69cb\u9020\u69cb\u6210\u306f\u3001\u914d\u4fe1\u30b3\u30f3\u30c6\u30f3\u30c4\u3068\u6a5f\u80fd\u30e2\u30b8\u30e5\u30fc\u30eb\u3092\u6307\u5b9a\u3057\u3001\u914d\u4fe1\u30b3\u30f3\u30c6\u30f3\u30c4\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30a4\u30f3\u30b9\u30c8\u30fc\u30eb\u30d7\u30ed\u30b0\u30e9\u30e0\u3001\u8a8d\u8a3c\u30d5\u30a1\u30a4\u30eb\u3001\u5916\u90e8\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u74b0\u5883\u30a4\u30f3\u30b9\u30c8\u30fc\u30eb\u30d7\u30ed\u30b0\u30e9\u30e0\u306a\u3069\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d7\u30ed\u30b0\u30e9\u30e0\u30d5\u30a1\u30a4\u30eb\u3092\u542b\u3080\u3002\u6a5f\u80fd\u30e2\u30b8\u30e5\u30fc\u30eb\u306b\u306f\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u30b5\u30a4\u30c9\u3001\u30b5\u30fc\u30d0\u30fc\u30b5\u30a4\u30c9\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3001\u30af\u30e9\u30a6\u30c9\u30b5\u30a4\u30c9\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u304c\u542b\u307e\u308c\u3001\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u30aa\u30d7\u30b7\u30e7\u30f3\u3068\u30e2\u30b8\u30e5\u30fc\u30eb\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u6307\u5b9a\u3059\u308b\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u9069\u7528\u7bc4\u56f2\u306f\u901a\u5e38\u3001\u4f7f\u7528\u76ee\u7684\u3001\u4f7f\u7528\u30b7\u30ca\u30ea\u30aa\u3001\u30b3\u30a2\u6a5f\u80fd\u306b\u57fa\u3065\u3044\u3066\u6a19\u6e96\u5316\u3055\u308c\u3001\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u5404\u6a5f\u80fd\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u9069\u7528\u7bc4\u56f2\u304c\u8a18\u8ff0\u3055\u308c\u308b\u3002\u540c\u6642\u306b\u7528\u8a9e\u306e\u6a19\u6e96\u5316\u3092\u78ba\u5b9f\u306b\u3059\u308b\u305f\u3081\u3001\"\u5206\u6790 \"\u3068 \"\u6e2c\u5b9a\"\u3001\"\u624b\u8853\u30b7\u30df\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3 \"\u3068 \"\u624b\u8853\u8a08\u753b \"\u3092\u533a\u5225\u3057\u3001\"\u5206\u6790 \"\u3068 \"\u6e2c\u5b9a \"\u3092\u4f7f\u7528\u3059\u308b\u3002\"\u30d6\u30e9\u30a6\u30ba \"\u3068 \"\u30ad\u30e3\u30d7\u30c1\u30e3 \"\u306e\u4ee3\u308f\u308a\u306b \"\u8868\u793a \"\u3068 \"\u53d7\u4fe1 \"\u3068\u3044\u3046\u7528\u8a9e\u3092\u4f7f\u7528\u3059\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">(2) \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8<\/span><\/h3>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306f\u901a\u5e38\u3001\u767b\u9332\u8a3c\u306b\u542b\u307e\u308c\u308b\u60c5\u5831\u306b\u53cd\u6620\u3055\u305b\u308b\u5fc5\u8981\u306f\u306a\u3044\u3002\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u6a5f\u80fd\u306e\u540d\u79f0\u306f\u3001\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30c8\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8981\u4ef6\u3092\u53c2\u7167\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u69cb\u9020\u90e8\u54c1\u306f\u3001\u7528\u8a9e\u306e\u6a19\u6e96\u5316\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3001\"\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\"\u3001\"\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\"\u3001\"\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf \"\u3067\u306f\u306a\u304f\u3001\"\u30db\u30b9\u30c8\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\"\u3001\"\u30ef\u30fc\u30af\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3 \"\u306e\u4f7f\u7528\u3002\".\u610f\u601d\u6c7a\u5b9a\u3092\u652f\u63f4\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u6a5f\u80fd\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u69cb\u9020\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3068\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u7bc4\u56f2\u3092\u53cd\u6620\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u5c02\u7528\u77e5\u80fd\u5316\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u90e8\u54c1\u3068\u898b\u306a\u3059\u5834\u5408\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u540d\u79f0\u306f\u77e5\u80fd\u5316\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3068\u540c\u4e00\u3068\u3057\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u69cb\u9020\u69cb\u6210\u306b\u306f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u540d\u79f0\u3001\u30e2\u30c7\u30eb\u4ed5\u69d8\u3001\u30ea\u30ea\u30fc\u30b9\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u660e\u8a18\u3057\u3001\u9069\u7528\u7bc4\u56f2\u306b\u306f\u610f\u601d\u6c7a\u5b9a\u652f\u63f4\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u6a5f\u80fd\u3092\u53cd\u6620\u3055\u305b\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">2.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u7814\u7a76\u60c5\u5831<\/span><\/h2>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u81ea\u5df1\u7814\u7a76\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8abf\u67fb\u5831\u544a\u66f8\u3001\u5916\u90e8\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u74b0\u5883\u8a55\u4fa1\u5831\u544a\u66f8\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3001GB\/T 25000.51\u81ea\u5df1\u30c6\u30b9\u30c8\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u65e2\u88fd\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u306f\u3001\u305d\u306e\u4f7f\u7528\u65b9\u6cd5\u306b\u5fdc\u3058\u3066\u9069\u5207\u306a\u8a66\u9a13\u60c5\u5831\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u307e\u305f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306e\u8ca9\u58f2\u8cc7\u6599\u3092\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ea\u30b5\u30fc\u30c1\u30c7\u30fc\u30bf\u3067\u63d0\u51fa\u3059\u308b\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u308b\u3002\u3053\u306e\u8cc7\u6599\u306f\u3001\u88fd\u54c1\u60c5\u5831\u3092\u88dc\u8db3\u3059\u308b\u5be9\u67fb\u53c2\u8003\u8cc7\u6599\u3068\u3057\u3066\u306e\u307f\u4f7f\u7528\u3055\u308c\u3001\u5be9\u67fb\u306e\u5bfe\u8c61\u3084\u5be9\u67fb\u5224\u65ad\u306e\u6839\u62e0\u3068\u306a\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">3.<a href=\"https:\/\/www.consulting-hmk.com\/ja\/products-category\/nmpa-product-technical-requirements-support\/\">\u88fd\u54c1\u6280\u8853\u8981\u6c42<\/a>(PTR\uff09<\/span><\/h2>\n<h3><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">(1) \u72ec\u7acb\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/span><\/h3>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30c8\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u88fd\u54c1\u306e\u6280\u8853\u8981\u4ef6 \"\u88fd\u54c1\u30e2\u30c7\u30eb\/\u4ed5\u69d8\u3068\u305d\u306e\u90e8\u9580\u306e\u8aac\u660e \"\u3092\u660e\u78ba\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u540d\u524d\u3001\u30e2\u30c7\u30eb\u306e\u4ed5\u69d8\u3001\u30ea\u30ea\u30fc\u30b9\u30d0\u30fc\u30b8\u30e7\u30f3\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u547d\u540d\u898f\u5247\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30e2\u30b8\u30e5\u30fc\u30eb\uff08\u533b\u7642\u7528\u30df\u30c9\u30eb\u30a6\u30a7\u30a2\u3092\u542b\u3080\uff09\u3001\u5225\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u547d\u540d\u898f\u5247\u3092\u8aac\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\"\u6027\u80fd\u6307\u6a19 \"\u306b\u306f\u3001\u4e00\u822c\u8981\u6c42\u4e8b\u9805\u3001\u7279\u5225\u8981\u6c42\u4e8b\u9805\u3001\u5b89\u5168\u8981\u6c42\u4e8b\u9805\u304c\u542b\u307e\u308c\u3001\u305d\u306e\u3046\u3061\u3001\u4e00\u822c\u8981\u6c42\u4e8b\u9805\u306f\u3001\u4ed5\u69d8\u66f8\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u88fd\u54c1\u306e\u7279\u6027\u3001\u88fd\u54c1\u306e\u6280\u8853\u7684\u8981\u6c42\u4e8b\u9805\u306e\u7ae0\u3067\u8aac\u660e\u3055\u308c\u308b\u975e\u81e8\u5e8a\u60c5\u5831\u306e\u4e2d\u3067\u9069\u7528\u3067\u304d\u306a\u3044\u5185\u5bb9\u3001\u7279\u5225\u8981\u6c42\u4e8b\u9805\u306f\u3001\u95a2\u9023\u3059\u308b\u88fd\u54c1\u898f\u683c\uff08\u653e\u5c04\u7dda\u6cbb\u7642\u8a08\u753b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306a\u3069\uff09\u306e\u8981\u6c42\u4e8b\u9805\u306b\u6cbf\u3063\u305f\u3082\u306e\u3001\u5b89\u5168\u8981\u6c42\u4e8b\u9805\u306f\u3001\u95a2\u9023\u3059\u308b\u5b89\u5168\u898f\u683c\uff08\u30a2\u30e9\u30fc\u30e0\u3001\u653e\u5c04\u7dda\u6cbb\u7642\u306a\u3069\uff09\u306e\u8981\u6c42\u4e8b\u9805\u306b\u6cbf\u3063\u305f\u3082\u306e\u3067\u3042\u308b\u3002\u5b89\u5168\u8981\u4ef6\u306f\u3001\u95a2\u9023\u3059\u308b\u5b89\u5168\u898f\u683c\uff08\u30a2\u30e9\u30fc\u30e0\u3001\u653e\u5c04\u7dda\u6cbb\u7642\u306a\u3069\uff09\u306b\u6cbf\u3063\u305f\u3082\u306e\u3067\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u4ed8\u9332\u300d\u306b\u306f\u3001\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u56f3\u3001\u30e6\u30fc\u30b6\u30fc\u30fb\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u95a2\u4fc2\u56f3\u3001\u30e1\u30a4\u30f3\u30fb\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u56f3\u3001\u7269\u7406\u30c8\u30dd\u30ed\u30b8\u30fc\u56f3\u3001\u304a\u3088\u3073\u5fc5\u8981\u306a\u30b3\u30e1\u30f3\u30c8\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">(2) \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8<\/span><\/h3>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u540d\u524d\u3092\u660e\u78ba\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u305d\u306e\u3046\u3061\u306e \"\u88fd\u54c1\u30e2\u30c7\u30eb\/\u4ed5\u69d8\u304a\u3088\u3073\u547d\u4ee4\u306e\u305d\u306e\u5206\u5272 \"\u533b\u7642\u6a5f\u5668\u306e\u88fd\u54c1\u306e\u6280\u8853\u8981\u4ef6\u306b\u6a19\u6e96\u5316\u3055\u308c\u3066\u3044\u308b\u3001\u30e2\u30c7\u30eb\u306e\u4ed5\u69d8\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3001\u30ea\u30ea\u30fc\u30b9\u30d0\u30fc\u30b8\u30e7\u30f3\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u547d\u540d\u898f\u5247\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30e2\u30b8\u30e5\u30fc\u30eb\uff08\u533b\u7642\u7528\u30df\u30c9\u30eb\u30a6\u30a7\u30a2\u3092\u542b\u3080\uff09\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u5225\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u547d\u540d\u898f\u5247\u3092\u8aac\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; 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font-size: 14pt;\">\u7279\u5316\u578b\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30c8\u30fb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3068\u307f\u306a\u3055\u308c\u308b\u305f\u3081\u306b\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306b\u95a2\u3059\u308b\u4e0a\u8a18\u306e\u8981\u4ef6\u306b\u52a0\u3048\u3066\u3001\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u56f3\u3001\u30e6\u30fc\u30b6\u30fc\u30fb\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u95a2\u4fc2\u56f3\u304a\u3088\u3073\u30e1\u30a4\u30f3\u30fb\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u56f3\u3001\u7269\u7406\u7684\u30c8\u30dd\u30ed\u30b8\u30fc\u56f3\u3001\u304a\u3088\u3073\u5fc5\u8981\u306a\u6ce8\u91c8\u3082\u300c\u4ed8\u9332\u300d\u306b\u8a18\u8f09\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">4.\u4f7f\u7528\u8aac\u660e\u66f8(IFU)<\/span><\/h2>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">IFU\u306f\u3001\u95a2\u9023\u6cd5\u898f\u3001\u898f\u7bc4\u6587\u66f8\u3001\u56fd\u5bb6\u898f\u683c\u3001\u696d\u754c\u898f\u683c\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">IFU\u306b\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u6a5f\u80fd\u3001\u4f7f\u7528\u5236\u9650\u3001\u5165\u51fa\u529b\u30c7\u30fc\u30bf\u306e\u7a2e\u985e\u3001\u5fc5\u8981\u306a\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u3068\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u6700\u5927\u540c\u6642\u5b9f\u884c\u6570\u3001\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u3001\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u52d5\u4f5c\u74b0\u5883\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3001\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3068\u52b9\u7387\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3001\u305d\u306e\u4ed6\u306e\u60c5\u5831\u3001\u660e\u78ba\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30ea\u30ea\u30fc\u30b9\u30d0\u30fc\u30b8\u30e7\u30f3\u304c\u53cd\u6620\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u305d\u306e\u4e2d\u3067\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u6a5f\u80fd\u306f\u3001\u3059\u3079\u3066\u306e\u30b3\u30a2\u6a5f\u80fd\uff08\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u6a5f\u80fd\u3092\u542b\u3080\uff09\u3001\u30aa\u30d7\u30b7\u30e7\u30f3\u3001\u81ea\u52d5\u6a5f\u80fd\u3092\u793a\u3057\u3001\u6e2c\u5b9a\u6a5f\u80fd\u306f\u3001\u6e2c\u5b9a\u7cbe\u5ea6\u306e\u6307\u6a19\u3092\u6307\u5b9a\u3057\u3001\u30b0\u30e9\u30d5\u30a3\u30ab\u30eb\u306a\u6e2c\u5b9a\u6a5f\u80fd\u306f\u3001\u6e2c\u5b9a\u306e\u7cbe\u5ea6\u306b\u95a2\u3059\u308b\u8b66\u544a\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3082\u5fc5\u8981\u3067\u3042\u308a\u3001\u30c7\u30fc\u30bf\u30ea\u30bd\u30fc\u30b9\u306f\u3001\u30c7\u30fc\u30bf\u306e\u7a2e\u985e\u3068\u30c7\u30fc\u30bf\u306e\u5404\u30bf\u30a4\u30d7\u306e\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u3092\u6307\u5b9a\u3057\u307e\u3059\u3002\u5404\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30a4\u30b9\u306e\u9805\u76ee\u3054\u3068\u306e\u8aac\u660e\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u304c\u60f3\u5b9a\u3055\u308c\u308b\u30e6\u30fc\u30b6\u30fc\u3001\u30b7\u30fc\u30f3\u306e\u4f7f\u7528\u3001\u60f3\u5b9a\u3055\u308c\u308b\u4f7f\u7528\u3001\u6280\u8853\u7684\u7279\u6027\u3001\u4f7f\u7528\u5236\u9650\u3001\u969c\u5bb3\u5bfe\u7b56\u3092\u547c\u3073\u51fa\u3057\u307e\u3059\u3002\u52d5\u4f5c\u74b0\u5883\uff08\u30af\u30e9\u30a6\u30c9\u30b3\u30f3\u30d4\u30e5\u30fc\u30c6\u30a3\u30f3\u30b0\u3092\u542b\u3080\uff09\u3001\u6027\u80fd\u52b9\u7387\u306f\u3001\u72ec\u7acb\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u5916\u90e8\u5236\u5fa1\u578b\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306b\u9069\u7528\u3055\u308c\u3001\u5c02\u7528\u306e\u72ec\u7acb\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3068\u307f\u306a\u3055\u308c\u3001\u5177\u4f53\u7684\u306a\u8981\u4ef6\u306f\u3001\u524d\u9805\u306e\u8a73\u7d30\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u6c4e\u7528\u30b3\u30f3\u30d4\u30e5\u30fc\u30c6\u30a3\u30f3\u30b0\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u304c\u60c5\u5831\u6280\u8853\u6a5f\u5668\u306e\u5b89\u5168\u8981\u4ef6\uff08\u96fb\u78c1\u4e21\u7acb\u6027\u3092\u542b\u3080\uff09\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u30e6\u30fc\u30b6\u30fc\u306b\u901a\u77e5\u3057\u3001\u8a72\u5f53\u3059\u308b\u898f\u683c\u3092\u8a18\u8f09\u3059\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">5.\u30b5\u30f3\u30d7\u30eb\u30e9\u30d9\u30ea\u30f3\u30b0\uff08\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30c8\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u7528\uff09<\/span><\/h2>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u7269\u7406\u7684\u914d\u9001\u306e\u5834\u5408\u3001\u88fd\u54c1\u30e9\u30d9\u30eb\u306f\u8a72\u5f53\u3059\u308b\u898f\u5236\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u3002\u30a6\u30a7\u30d6\u914d\u4fe1\u306e\u5834\u5408\u306f\u3001\u88fd\u54c1\u306e\u30a6\u30a7\u30d6\u914d\u4fe1\u30da\u30fc\u30b8\u306e\u5199\u771f\u3092\u63d0\u51fa\u3057\u3001\u88fd\u54c1\u767b\u9332\u60c5\u5831\u304c\u8a72\u5f53\u3059\u308b\u898f\u5236\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u307e\u305f\u3001\u300c\u30d0\u30fc\u30b8\u30e7\u30f3\u60c5\u5831\u300d\u3084\u300c\u30d8\u30eb\u30d7\u300d\u306a\u3069\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30e6\u30fc\u30b6\u30fc\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306b\u88fd\u54c1\u767b\u9332\u60c5\u5831\u3092\u53cd\u6620\u3055\u305b\u308b\u3053\u3068\u3092\u63a8\u5968\u3057\u307e\u3059\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h1><a href=\"https:\/\/www.consulting-hmk.com\/ja\/products-category\/nmpa-medical-device-and-ivd-registration-filing\/\"><span style=\"font-size: 18pt;\"><strong><span style=\"font-family: arial, helvetica, sans-serif;\">\u5909\u66f4\u767b\u9332<\/span><\/strong><\/span><\/a><\/h1>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">1.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u7814\u7a76\u60c5\u5831<\/span><\/h2>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u533b\u7642\u6a5f\u5668\u306e\u5909\u66f4\u767b\u9332\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u66f4\u65b0\u306b\u57fa\u3065\u3044\u3066\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u7814\u7a76\u60c5\u5831\u306e\u5f71\u97ff\u306e\u6709\u52b9\u6027\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5909\u66f4\u306e\u4e00\u90e8\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1a<\/span><\/p>\n<p style=\"padding-left: 40px;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">(1\uff09\u5b8c\u5168\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u66f4\u65b0\u306b\u95a2\u4e0e\uff1a\u81ea\u5df1\u958b\u767a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u9069\u7528\u3055\u308c\u308b\u5b8c\u5168\u306a\u66f4\u65b0\u3001\u307e\u305f\u306f\u8907\u5408\u9069\u5fdc\u66f4\u65b0\u3001\u662f\u6b63\u66f4\u65b0\u3001\u3053\u306e\u6642\u9593\u3092\u63d0\u51fa\u3059\u308b\u5b8c\u5168\u306a\u7814\u7a76\u5831\u544a\u66f8\uff08\u307e\u305f\u306f\u81ea\u5df1\u7814\u7a76\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u7814\u7a76\u5831\u544a\u66f8\uff09\u3001\u5916\u90e8\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u74b0\u5883\u8a55\u4fa1\u5831\u544a\u66f8\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3001\u304a\u3088\u3073GB \/ T 25000.51\u30bb\u30eb\u30d5\u30c6\u30b9\u30c8\u5831\u544a\u66f8\u3092\u66f4\u65b0\u3059\u308b\u305f\u3081\u306b\u767a\u751f\u3059\u308b\uff1b<\/span><\/p>\n<p style=\"padding-left: 40px;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">(2) \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u9069\u5fdc\u7684\u66f4\u65b0\u3092\u4f34\u3046\u3082\u306e\uff1a\u81ea\u5df1\u7814\u7a76\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u9069\u5fdc\u7684\u306a\u66f4\u65b0\u3001\u307e\u305f\u306f\u8907\u5408\u7684\u306a\u4fee\u6b63\u66f4\u65b0\u306b\u9069\u7528\u3055\u308c\u308b\u304c\u3001\u5b8c\u5168\u306a\u66f4\u65b0\u306e\u5834\u5408\u306f\u9069\u7528\u3055\u308c\u306a\u3044\u5834\u5408\u306f\u3001\u81ea\u5df1\u7814\u7a76\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u9069\u5fdc\u7684\u66f4\u65b0\u7814\u7a76\u5831\u544a\u66f8\uff08\u307e\u305f\u306f\u81ea\u5df1\u7814\u7a76\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u7814\u7a76\u5831\u544a\u66f8\uff09\u3092\u63d0\u51fa\u3059\u308b\uff1b<\/span><\/p>\n<p style=\"padding-left: 40px;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">(3) \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4fee\u6b63\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u307f\uff1a\u81ea\u5df1\u7814\u7a76\u7528\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4fee\u6b63\u66f4\u65b0\u306e\u307f\u306e\u5834\u5408\u306f\u3001\u81ea\u5df1\u7814\u7a76\u7528\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4fee\u6b63\u66f4\u65b0\u306b\u95a2\u3059\u308b\u8abf\u67fb\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3059\u308b\uff1b<\/span><\/p>\n<p style=\"padding-left: 40px;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">(4)\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u304c\u884c\u308f\u308c\u3066\u3044\u306a\u3044\uff1a\u6cd5\u7684\u8cac\u4efb\u3092\u660e\u78ba\u306b\u60f3\u5b9a\u3057\u305f\u771f\u6b63\u6027\u306e\u58f0\u660e\u304c\u767a\u884c\u3055\u308c\u3066\u3044\u308b\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u65e2\u88fd\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u90e8\u54c1\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u306f\u3001\u305d\u306e\u4f7f\u7528\u65b9\u6cd5\u306b\u5fdc\u3058\u305f\u7814\u7a76\u60c5\u5831\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3002\u8a72\u5f53\u3059\u308b\u7814\u7a76\u8cc7\u6599\u306e\u8981\u4ef6\u306b\u3064\u3044\u3066\u306f\u3001\u7b2c8\u7ae0\u3092\u53c2\u7167\u306e\u3053\u3068\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b9\u30bf\u30c7\u30a3\u30c7\u30fc\u30bf\u306b\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306e\u8ca9\u58f2\u8cc7\u6599\u3092\u6dfb\u4ed8\u3057\u3066\u63d0\u51fa\u3059\u308b\u3053\u3068 \u304c\u63a8\u5968\u3055\u308c\u308b\u3002\u3053\u306e\u8cc7\u6599\u306f\u3001\u88fd\u54c1\u60c5\u5831\u3092\u88dc\u8db3\u3059\u308b\u53c2\u8003\u8cc7\u6599\u3068\u3057\u3066\u306e\u307f\u4f7f\u7528\u3055\u308c\u3001\u5be9\u67fb\u306e\u5bfe\u8c61\u3068\u3057\u3066\u3067\u306f\u306a\u304f\u3001\u5be9\u67fb\u5224\u65ad\u306e\u6839\u62e0\u3068\u3057\u3066\u4f7f\u7528\u3055\u308c\u308b\u3082\u306e\u3067\u3082\u3042\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">2.\u88fd\u54c1\u6280\u8853\u8981\u4ef6<\/span><\/h2>\n<h3><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">(1) \u72ec\u7acb\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/span><\/h3>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u72ec\u7acb\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u88fd\u54c1\u306e\u6280\u8853\u8981\u4ef6\u306f\u3001\"\u88fd\u54c1\u30e2\u30c7\u30eb\/\u4ed5\u69d8\u3068\u305d\u306e\u8aac\u660e\u306e\u5206\u5272\"\u3001\"\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u6307\u6a19\"\u3001\"\u4ed8\u9332 \"\u3092\u542b\u3080\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u66f4\u65b0\u3092\u53cd\u6620\u3057\u307e\u3059\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">(2) \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8<\/span><\/h3>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u60c5\u5831\u306e \"\u88fd\u54c1\u30e2\u30c7\u30eb\/\u4ed5\u69d8\u3068\u305d\u306e\u5206\u5272\"\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8981\u4ef6\u306e \"\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u6307\u6a19 \"\u3092\u542b\u3080\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u66f4\u65b0\u306e\u6280\u8853\u8981\u4ef6\u306b\u5c5e\u3059\u308b\u533b\u7642\u6a5f\u5668\u306e\u88fd\u54c1\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u72ec\u7acb\u3057\u305f\u7279\u6b8a\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u540c\u3058\u8981\u4ef6\u3068\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3068\u307f\u306a\u3055\u308c\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">3.\u4f7f\u7528\u8aac\u660e\u66f8<\/span><\/h2>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001IFU\u306e\u5909\u66f4\u5185\u5bb9\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">4.\u88fd\u54c1\u30e9\u30d9\u30ea\u30f3\u30b0\u30b5\u30f3\u30d7\u30eb\uff08\u72ec\u7acb\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff09<\/span><\/h2>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u7533\u544a\u88fd\u54c1\u304a\u3088\u3073\u305d\u306e\u5909\u66f4\u306b\u95a2\u3059\u308b\u88fd\u54c1\u30e9\u30d9\u30eb\u306e\u30b5\u30f3\u30d7\u30eb\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h1><a href=\"https:\/\/www.consulting-hmk.com\/ja\/products-category\/nmpa-medical-device-and-ivd-registration-filing\/\"><span style=\"font-size: 18pt;\"><strong><span style=\"font-family: arial, helvetica, sans-serif;\">\u66f4\u65b0\u767b\u9332<\/span><\/strong><\/span><\/a><\/h1>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u66f4\u65b0\u767b\u9332\u3067\u306f\u901a\u5e38\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u95a2\u9023\u306e\u7814\u7a76\u30c7\u30fc\u30bf\u306e\u63d0\u51fa\u306f\u5fc5\u8981\u3042\u308a\u307e\u305b\u3093\u3002\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u767b\u9332\u8a3c\u306e\u300c\u5099\u8003\u300d\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u8981\u4ef6\u306b\u5f93\u3044\u3001\u8a72\u5f53\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u7814\u7a76\u30c7\u30fc\u30bf\u3092\u63d0\u51fa\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u88fd\u54c1\u306e\u6280\u8853\u8981\u4ef6 \"\u88fd\u54c1\u30e2\u30c7\u30eb\/\u4ed5\u69d8\u3068\u305d\u306e\u90e8\u9580\u306e\u8aac\u660e \"\u660e\u78ba\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u540d\u3001\u30e2\u30c7\u30eb\u4ed5\u69d8\u3001\u30ea\u30ea\u30fc\u30b9\u30d0\u30fc\u30b8\u30e7\u30f3\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u547d\u540d\u898f\u5247\u306f\u3001\u5143\u306e\u767b\u9332\u88fd\u54c1\u306e\u898f\u683c\uff08\u307e\u305f\u306f\u5143\u306e\u88fd\u54c1\u306e\u6280\u8853\u8981\u4ef6\uff09\u3068\u6bd4\u8f03\u8868\u306e\u305d\u306e\u5909\u66f4\u306f\u3001\u4e0a\u8a18\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u60c5\u5831\u3092\u53cd\u6620\u3057\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u3001\u9069\u5408\u5ba3\u8a00\u3067\u660e\u3089\u304b\u306b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u72ec\u7acb\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u88fd\u54c1\u306e\u6280\u8853\u7684\u8981\u6c42\u4e8b\u9805 \"\u6027\u80fd\u6307\u6a19\"\u3001\"\u8a66\u9a13\u65b9\u6cd5 \"\u306f\u3001\u672c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u4ed8\u9332\u306e\u8981\u4ef6\u306b\u5f93\u3063\u3066\u5909\u66f4\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3001\u5143\u306e\u767b\u9332\u88fd\u54c1\u306e\u898f\u683c\uff08\u307e\u305f\u306f\u5143\u306e\u88fd\u54c1\u306e\u6280\u8853\u7684\u8981\u6c42\u4e8b\u9805\uff09\u3068\u6bd4\u8f03\u8868\u3067\u3001\u305d\u306e\u5909\u66f4\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059 \"\u6027\u80fd\u6307\u6a19\"\u3002\u6027\u80fd\u6307\u6a19\u300d\u306e\u95a2\u9023\u6761\u9805\u306f\u3001\u767b\u9332\u8a3c\u306b\u65e2\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u60c5\u5831\u304b\u3089\u524a\u9664\u3059\u308b\u3053\u3068\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h1><strong><span style=\"font-family: arial, helvetica, sans-serif; font-size: 18pt;\">\u533b\u7642\u6a5f\u5668\u72ec\u7acb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u767b\u9332\u306b\u95a2\u9023\u3059\u308b\u6cd5\u5f8b\u3068\u898f\u5236<\/span><\/strong><\/h1>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u533b\u7642\u6a5f\u5668\u72ec\u7acb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u767b\u9332\u3092\u7533\u8acb\u3059\u308b\u969b\u306b\u306f\u3001\u4ee5\u4e0b\u3092\u542b\u3080\u304c\u3053\u308c\u306b\u9650\u5b9a\u3055\u308c\u306a\u3044\u4e00\u9023\u306e\u6cd5\u898f\u5236\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308b\u3002<\/span><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><a href=\"https:\/\/www.nmpa.gov.cn\/ylqx\/ylqxjgdt\/20150807150501210.html\" rel=\"nofollow noopener\" target=\"_blank\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u767b\u9332\u306e\u6280\u8853\u7684\u5be9\u67fb\u306b\u95a2\u3059\u308b\u6307\u91dd<\/span><\/a><\/li>\n<li><a href=\"https:\/\/www.consulting-hmk.com\/ja\/products-category\/nmpa-medical-device-classification-consulting\/\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u533b\u7642\u6a5f\u5668\u5206\u985e\u30ab\u30bf\u30ed\u30b0<\/span><\/a><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u30b7\u30b9\u30c6\u30e0\u304a\u3088\u3073\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u5de5\u5b66 \u30b7\u30b9\u30c6\u30e0\u304a\u3088\u3073\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u54c1\u8cea\u8981\u4ef6\u3068\u8a55\u4fa1 \u7b2c 51 \u90e8\uff1a\u3059\u3050\u306b\u4f7f\u3048\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u88fd\u54c1\u306e\u54c1\u8cea\u8981\u4ef6\u3068\u30c6\u30b9\u30c8\u898f\u5247<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u533b\u7642\u6a5f\u5668\u767b\u9332\u7533\u8acb\u306e\u8981\u4ef6\u3068\u6307\u793a<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2 \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u751f\u5b58\u30b5\u30a4\u30af\u30eb\u30d7\u30ed\u30bb\u30b9<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8981\u6c42\u4ed5\u69d8\u306b\u95a2\u3059\u308b\u4ed5\u69d8\u66f8<\/span><\/li>\n<li><a href=\"https:\/\/www.nmpa.gov.cn\/xxgk\/ggtg\/ylqxggtg\/ylqxqtggtg\/20210928170338138.html\" rel=\"nofollow noopener\" target=\"_blank\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u6280\u8853\u6307\u91dd<\/span><\/a><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u533b\u7642\u6a5f\u5668\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u533b\u7642\u6a5f\u5668\u3078\u306e\u5fdc\u7528<\/span><\/li>\n<li><a href=\"https:\/\/www.samr.gov.cn\/zw\/zfxxgk\/fdzdgknr\/bgt\/art\/2023\/art_0b21c1f7edae42d1a1653a98d28ea99b.html\" rel=\"nofollow noopener\" target=\"_blank\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u533b\u7642\u6a5f\u5668\u306e\u4ed5\u69d8\u304a\u3088\u3073\u8868\u793a\u306b\u95a2\u3059\u308b\u7ba1\u7406\u898f\u5247<\/span><\/a><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u533b\u7642\u6a5f\u5668\u88fd\u9020\u54c1\u8cea\u7ba1\u7406\u30b3\u30fc\u30c9 \u4ed8\u9332 \u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30c8\u30fb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\"><a href=\"https:\/\/www.nmpa.gov.cn\/xxgk\/ggtg\/ylqxggtg\/ylqxqtggtg\/20170124161801818.html\" rel=\"nofollow noopener\" target=\"_blank\">\u533b\u7642\u6a5f\u5668\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u767b\u9332\u306e\u6280\u8853\u7684\u5be9\u67fb\u306e\u305f\u3081\u306e\u6307\u91dd<\/a>\u7b49\u3005\u3002<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u767b\u9332\u7533\u8acb\u306e\u969b\u306b\u306f\u3001\u6700\u65b0\u306e\u898f\u5236\u52d5\u5411\u306b\u6ce8\u610f\u3092\u6255\u3046\u5fc5\u8981\u304c\u3042\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h1><span style=\"font-size: 18pt;\"><strong><span style=\"font-family: arial, helvetica, sans-serif;\">\u533b\u7642\u6a5f\u5668\u72ec\u7acb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u767b\u9332\u306b\u95a2\u3059\u308b\u3088\u304f\u3042\u308b\u8cea\u554f<\/span><\/strong><\/span><\/h1>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u533b\u7642\u6a5f\u5668\u72ec\u7acb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u767b\u9332\u7533\u8acb\u306e\u904e\u7a0b\u3067\u3001\u3044\u304f\u3064\u304b\u306e\u554f\u984c\u306b\u906d\u9047\u3059\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u4ee5\u4e0b\u306f\u3088\u304f\u3042\u308b\u8cea\u554f\u306b\u5bfe\u3059\u308b\u56de\u7b54\u3067\u3059\uff1a<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">Q1:\u3069\u306e\u3088\u3046\u306b\u958b\u767a\u3059\u308b\u304b<a href=\"https:\/\/www.consulting-hmk.com\/ja\/products-category\/nmpa-product-technical-requirements-support\/\"> \u72ec\u7acb\u7cfb\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u6307\u6a19<\/a>\u307e\u305f\u3001\u691c\u67fb\u5831\u544a\u66f8\u306b\u306f\u4f55\u3092\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u306e\u304b\uff1f<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">A:\u72ec\u7acb\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u88fd\u54c1\u306e\u6280\u8853\u7684\u8981\u6c42\u4e8b\u9805\u306e\u4f5c\u6210\u306e\u305f\u3081\u306b\u3001\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u767b\u9332\u306e\u6280\u8853\u7684\u5be9\u67fb\u306e\u305f\u3081\u306e\u6307\u91dd\u306e\u4ed8\u9332\u2160\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u76f4\u63a5\u53c2\u7167\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u307e\u305f\u3001\u533b\u7528\u753b\u50cf\u4fdd\u7ba1\u30fb\u4f1d\u9001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff08PACS\uff09\u306b\u3064\u3044\u3066\u306f\u3001\u753b\u50cf\u4f1d\u9001\u5f8c\u306e\u753b\u50cf\u30c7\u30fc \u30bf\u306e\u6574\u5408\u6027\u30fb\u5b8c\u5168\u6027\u3001\u6307\u5b9a\u3055\u308c\u305f\u8a66\u9a13\u6761\u4ef6\u4e0b\u3067\u306e\u753b\u50cf\u30aa\u30fc\u30d7\u30f3\u6642\u9593\uff08\u753b\u50cf\u4f1d\u9001\u30fb\u8868\u793a\u6642\u9593\u3092\u542b \u3080\uff09\u3001\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u74b0\u5883\u304c\u30b9\u30bf\u30f3\u30c9\u30a2\u30ed\u30f3\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u304b\u3001\u30ed\u30fc\u30ab\u30eb\u30a8\u30ea\u30a2\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\uff08LAN\uff09 \u304b\u3001\u30ef\u30a4\u30c9\u30a8\u30ea\u30a2\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\uff08WAN\uff09\u304b\u3092\u8a66\u9a13\u6761\u4ef6\u3068\u3057\u3066\u898f\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u30e2\u30d0\u30a4\u30eb\u753b\u50cf\u51e6\u7406\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8a3a\u65ad\u306b\u4f7f\u7528\u3055\u308c\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u3001\"\u30e2\u30d0\u30a4\u30eb\u533b\u7642\u6a5f\u5668\u767b\u9332\u306e\u6280\u8853\u7684\u30ec\u30d3\u30e5\u30fc\u306e\u305f\u3081\u306e\u6307\u5c0e\u539f\u5247 \"\u306b\u3088\u308b\u3068\u3001\u88fd\u54c1\u306e\u6280\u8853\u7684\u8981\u4ef6\u306f\u3001\u30c7\u30fc\u30bf\u304c\u5229\u7528\u3067\u304d\u306a\u3044\u6a5f\u80fd\u3092\u958b\u767a\u3059\u308b\u305f\u3081\u306b\u3001\u88fd\u54c1\u767b\u9332\u60c5\u5831\u306e\u30e6\u30fc\u30b6\u30fc\u78ba\u8a8d\u6a5f\u80fd\u3001\u52d5\u4f5c\u74b0\u5883\u96fb\u6e90\u30aa\u30f3\u30bb\u30eb\u30d5\u30c6\u30b9\u30c8\u6a5f\u80fd\u3001\u5468\u56f2\u5149\u691c\u51fa\u6a5f\u80fd\u3001\u30c7\u30a3\u30b9\u30d7\u30ec\u30a4\u306e\u660e\u308b\u3055\u88dc\u6b63\u6a5f\u80fd\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u6027\u80fd\u6307\u6a19\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; 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