{"id":475817,"date":"2024-03-21T13:20:58","date_gmt":"2024-03-21T05:20:58","guid":{"rendered":"https:\/\/beta3.law.asia\/?p=475817"},"modified":"2024-03-21T13:20:58","modified_gmt":"2024-03-21T05:20:58","slug":"healthtech-regulatory-issues-japan","status":"publish","type":"post","link":"https:\/\/beta3.law.asia\/zh-hans\/healthtech-regulatory-issues-japan\/","title":{"rendered":"\u5317\u4e9a\u5404\u56fd\/\u5730\u533a\u533b\u7597\u79d1\u6280\u884c\u4e1a\u76d1\u7ba1\u73b0\u72b6\u4e4b\u65e5\u672c"},"content":{"rendered":"<table style=\"margin-top: 0px; height: 12px;\" width=\"700\">\n<tbody style=\"border: 1px solid transparent; width: 100%; background-color: #f79433;\">\n<tr style=\"border: 1px solid transparent;\">\n<td style=\"width: 25%; margin: 0px; padding-top: 5px; padding-bottom: 5px; border-right: 2px solid #ffffff;\" valign=\"middle\">\n<p style=\"margin-bottom: 0px; text-align: center;\"><span style=\"color: #000000;\"><b>\u65e5\u672c<\/b><\/span><\/p>\n<\/td>\n<td style=\"width: 25%; margin: 0px; padding-top: 5px; padding-bottom: 5px; border-right: 2px solid #ffffff;\" valign=\"middle\">\n<p style=\"margin-bottom: 0px; text-align: center;\"><a href=\"https:\/\/beta3.law.asia\/zh-hans\/healthtech-regulatory-issues-korea\/\"><span style=\"color: #ffffff;\"><b> \u97e9\u56fd<\/b><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\">\u533b\u7597\u79d1\u6280\u5728\u65e5\u672c\u5907\u53d7\u5173\u6ce8\uff0c\u9884\u8ba1\u65e5\u672c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u5e02\u573a\u89c4\u6a21\u5c06\u5ef6\u7eed\u589e\u957f\u6001\u52bf\u3002\u65e5\u672c\u7ecf\u6d4e\u4ea7\u4e1a\u7701\u53d1\u5e03\u7684\u4e00\u4efd\u62a5\u544a\u663e\u793a\uff0c\u52302025\u5e74\uff0c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u4ef7\u503c\u9884\u8ba1\u5c06\u8fbe\u523033\u4e07\u4ebf\u65e5\u5143(\u6298\u54082,300\u4ebf\u7f8e\u5143)\u3002\u6b64\u5916\uff0c\u533b\u7597\u79d1\u6280\u9886\u57df\u7684\u4e13\u5229\u7533\u8bf7\u6570\u76ee\u4e5f\u6b63\u5728\u7a33\u6b65\u4e0a\u5347\uff1b\u65e5\u672c\u4e13\u5229\u5c40\u7684\u6570\u636e\u663e\u793a\uff0c2013\u5e74\u81f32019\u5e74\uff0c\u5168\u7403\u8303\u56f4\u7684\u533b\u7597\u6280\u672f\u4e13\u5229\u7533\u8bf7\u6570\u7ffb\u4e86\u4e00\u756a\u3002\u65e5\u672c\u653f\u5e9c\u4e00\u76f4\u5728\u5927\u529b\u63a8\u52a8\u533b\u7597\u79d1\u6280\u7684\u53d1\u5c55\u53ca\u533b\u7597\u6570\u5b57\u5316\u8f6c\u578b\u30022022\u5e74\uff0c\u65e5\u672c\u4e8e\u5185\u9601\u5e9c\u4e0b\u8bbe\u7acb\u4e86\u533b\u7597\u6570\u5b57\u5316\u8f6c\u578b\u63a8\u8fdb\u672c\u90e8\uff0c\u65e8\u5728\u5171\u4eab\u5e76\u9a8c\u8bc1\u6570\u5b57\u5316\u8f6c\u578b\u7684\u8fdb\u5c55\u3002\u5176\u4e3b\u8981\u4efb\u52a1\u662f\u4fc3\u8fdb\u4e2a\u4eba\u5065\u5eb7\u8bb0\u5f55(PHR)\u7684\u4f7f\u7528\uff0c\u9884\u8ba1\u65e5\u672c\u5c06\u63a8\u51fa\u56fd\u6c11\u8eab\u4efd\u8bc1\u4f5c\u4e3a\u4e2a\u4eba\u5065\u5eb7\u8bb0\u5f55\u7684\u95e8\u6237\u3002\u65e0\u8bba\u672a\u6765\u53d1\u5c55\u65b9\u5411\u5982\u4f55\uff0c\u4e2a\u4eba\u4fe1\u606f\u4fdd\u62a4\u95ee\u9898\u90fd\u662f\u533b\u7597\u79d1\u6280\u9886\u57df(\u5305\u62ec\u533b\u7597\u6570\u5b57\u5316\u8f6c\u578b)\u65e0\u6cd5\u7ed5\u5f00\u7684\u4e00\u9879\u91cd\u8981\u6cd5\u5f8b\u95ee\u9898\u3002<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong>\u4fe1\u606f\u5171\u4eab\u95ee\u9898<\/strong><\/span><\/h2>\n<figure id=\"attachment_469490\" aria-describedby=\"caption-attachment-469490\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-469491 size-full\" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/Koji-Sugimura.jpg\" alt=\"Koji Sugimura\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-469490\" class=\"wp-caption-text\"><b> \u6749\u6751\u5149\u55e3<\/b><br \/>\u7ba1\u7406\u5408\u4f19\u4eba\u3001\u5f8b\u5e08\u6cd5\u5f8b\/\u4e13\u5229\u5f8b\u5e08<br \/>\u6749\u6751\u4e07\u56fd\u7279\u8bb8\u6cd5\u5f8b\u4e8b\u52a1\u6240(SUGIMURA &amp; Partners)<br \/>\u4e1c\u4eac<br \/>\u7535\u90ae\uff1a<a href=\"mailto:kjs@sugimura.partners\">kjs@sugimura.partners<\/a><\/figcaption><\/figure>\n<p style=\"text-align: justify;\">\u5728\u533b\u7597\u6570\u5b57\u5316\u8f6c\u578b\u8fc7\u7a0b\u4e2d\uff0c\u6d77\u91cf\u533b\u7597\u4fe1\u606f\u7684\u5206\u4eab\u662f\u5fc5\u7136\uff0c\u4f46\u540c\u65f6\u4e2a\u4eba\u4fe1\u606f\u4e5f\u8981\u5f97\u5230\u9002\u5f53\u4fdd\u62a4\uff0c\u4e24\u8005\u95f4\u7684\u5e73\u8861\u662f\u4e00\u5927\u96be\u9898\u3002<\/p>\n<p style=\"text-align: justify;\">\u533b\u7597\u4fe1\u606f\u5c5e\u201c\u4e2a\u4eba\u4fe1\u606f\u201d\uff0c\u7406\u6240\u5f53\u7136\u53d7\u65e5\u672c\u300a\u4e2a\u4eba\u4fe1\u606f\u4fdd\u62a4\u6cd5\u300b(APPI)\u7684\u4fdd\u62a4\u3002\u540c\u65f6\uff0c\u533b\u7597\u4fe1\u606f\u4f5c\u4e3a\u201c\u654f\u611f\u4e2a\u4eba\u4fe1\u606f\u201d\u8fd8\u53d7\u5230\u66f4\u5927\u529b\u5ea6\u7684\u4fdd\u62a4\u3002<\/p>\n<p style=\"text-align: justify;\">\u539f\u5219\u4e0a\uff0cAPPI\u8981\u6c42\u5728\u5c06\u654f\u611f\u4e2a\u4eba\u4fe1\u606f\u63d0\u4f9b\u7ed9\u7b2c\u4e09\u65b9\u65f6\u5fc5\u987b\u83b7\u5f97\u6570\u636e\u4e3b\u4f53\u7684\u540c\u610f\u3002\u4f46\u662f\uff0c\u5bf9\u4e8e\u9700\u8981\u6536\u96c6\u548c\u5206\u6790\u6d77\u91cf\u533b\u7597\u4fe1\u606f\u7528\u4f5c\u7814\u7a76\u7b49\u7528\u9014\u7684\u533b\u7597\u673a\u6784\u800c\u8a00\uff0c\u8ba9\u6bcf\u4e2a\u6570\u636e\u4e3b\u4f53\u90fd\u52fe\u9009\u540c\u610f\u5728\u5b9e\u8df5\u5c42\u9762\u9887\u6709\u96be\u5ea6\u3002<\/p>\n<p style=\"text-align: justify;\">\u4e3a\u6b64\uff0cAPPI\u63d0\u4f9b\u4e86\u4e00\u79cd\u66ff\u4ee3\u65b9\u6848\uff1a\u5bf9\u654f\u611f\u4e2a\u4eba\u4fe1\u606f\uff08\u5305\u62ec\u533b\u7597\u4fe1\u606f\uff09\u4f5c\u533f\u540d\u5904\u7406\u3001\u9690\u53bb\u4e2a\u4eba\u8eab\u4efd\u7684\uff0c\u53ef\u4ee5\u5728\u672a\u7ecf\u6570\u636e\u4e3b\u4f53\u540c\u610f\u7684\u60c5\u51b5\u4e0b\u63d0\u4f9b\u7ed9\u7b2c\u4e09\u65b9\u3002\u4f46\u5728\u6b64\u65b9\u6848\u4e0b\uff0c\u7531\u5404\u5bb6\u533b\u7597\u673a\u6784\u8d1f\u8d23\u6570\u636e\u533f\u540d\u5904\u7406\u3002\u8fd9\u4e2a\u65b9\u6848\u8fd8\u6709\u4e00\u4e2a\u5f0a\u7aef\uff0c\u7531\u4e8e\u533f\u540d\u533b\u7597\u6570\u636e\u7f3a\u4e4f\u4ea4\u53c9\u53c2\u8003\u4fe1\u606f\uff0c\u63a5\u6536\u533f\u540d\u533b\u7597\u6570\u636e\u7684\u7814\u7a76\u673a\u6784\u65e0\u6cd5\u8fdb\u884c\u8de8\u673a\u6784\u5206\u6790\u3002<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong>\u6b21\u4e16\u4ee3\u6cd5\u5f8b<\/strong><\/span><\/h2>\n<p style=\"text-align: justify;\">\u4e3a\u89e3\u51b3\u4e0a\u8ff0\u95ee\u9898\uff0c\u65e5\u672c\u4e8e2018\u5e745\u670811\u65e5\u9881\u5e03\u300a\u6b21\u4e16\u4ee3\u533b\u7597\u57fa\u672c\u6cd5\u300b\uff08\u7b80\u79f0NGMIL\uff0c\u6b63\u5f0f\u540d\u4e3a\u300a\u5173\u4e8e\u4e3a\u63a8\u52a8\u533b\u7597\u9886\u57df\u7684\u7814\u7a76\u5f00\u53d1\u800c\u533f\u540d\u52a0\u5de5\u533b\u7597\u4fe1\u606f\u7684\u6cd5\u5f8b\u300b)\u3002<\/p>\n<p style=\"text-align: justify;\">\u8be5\u6cd5\u5f8b\u65e8\u5728\u63a8\u52a8\u533f\u540d\u4e2a\u4eba\u533b\u7597\u4fe1\u606f\uff08\u5982\u4f53\u68c0\u7ed3\u679c\u548c\u533b\u7597\u8bb0\u5f55\uff09\u5728\u533b\u7597\u9886\u57df\u7814\u53d1\u7528\u9014\u7684\u4f7f\u7528\u3002\u8be5\u6cd5\u8fd8\u89c4\u5b9a\u4e86\u4e00\u4e2a\u8ba4\u8bc1\u7a0b\u5e8f\uff0c\u7531\u653f\u5e9c\u5ba1\u6838\u533f\u540d\u52a0\u5de5\u4fe1\u606f\u5236\u4f5c\u7533\u8bf7\u4eba\u662f\u5426\u7b26\u5408\u6280\u672f\u6807\u51c6(\u4f8b\u5982\uff0c\u5ba1\u6838\u5236\u4f5c\u7533\u8bf7\u4eba\u662f\u5426\u80fd\u591f\u786e\u4fdd\u9ad8\u5ea6\u7684\u4fe1\u606f\u5b89\u5168\u5e76\u62e5\u6709\u5145\u5206\u6709\u6548\u7684\u533f\u540d\u6280\u672f)\uff0c\u4ee5\u53ca\u5236\u4f5c\u7533\u8bf7\u4eba\u662f\u5426\u6709\u9002\u5f53\u53ef\u9760\u7684\u624b\u6bb5\u5bf9\u533b\u7597\u4fe1\u606f\u5b9e\u65bd\u533f\u540d\u5316\u7ba1\u7406\u548c\u4f7f\u7528\u3002<\/p>\n<p style=\"text-align: justify;\">\u533b\u7597\u673a\u6784\u53ef\u4ee5\u5411\u7ecf\u8ba4\u8bc1\u7684\u4fe1\u606f\u5236\u4f5c\u8005\u63d0\u4f9b\u533b\u7597\u4fe1\u606f\uff0c\u76f4\u5230\u6570\u636e\u4e3b\u4f53\u62d2\u7edd(\u9009\u62e9\u9000\u51fa)\u63d0\u4f9b\u6b64\u7c7b\u4fe1\u606f\u3002\u7ecf\u8fc7\u8ba4\u8bc1\u7684\u5236\u4f5c\u8005\u53ef\u4ee5\u533f\u540d\u5904\u7406\u4fe1\u606f\uff0c\u5e76\u5c06\u533f\u540d\u5904\u7406\u540e\u7684\u533b\u7597\u6570\u636e\u63d0\u4f9b\u7ed9\u7814\u7a76\u673a\u6784\u7528\u4f5c\u533b\u7597\u7814\u53d1\u3002<\/p>\n<p style=\"text-align: justify;\">\u7b80\u800c\u8a00\u4e4b\uff0c\u300a\u6b21\u4e16\u4ee3\u533b\u7597\u57fa\u672c\u6cd5\u300b\u7684\u5b97\u65e8\u662f\u63a8\u52a8\u533b\u7597\u4fe1\u606f\u7684\u4f7f\u7528\uff0c\u5b83\u89c4\u5b9a\uff0c\u533b\u7597\u4fe1\u606f\u53ea\u80fd\u63d0\u4f9b\u7ed9\u7ecf\u8fc7\u8ba4\u8bc1\u7684\u4fe1\u606f\u5236\u4f5c\u8005\uff0c\u9664\u975e\u6570\u636e\u4e3b\u4f53\u660e\u786e\u62d2\u7edd\u63d0\u4f9b\u6b64\u7c7b\u4fe1\u606f\uff0c\u540c\u65f6\u786e\u4fdd\u4e2a\u4eba\u6743\u76ca\u5f97\u5230\u4fdd\u969c\u3002<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong>\u300a\u6b21\u4e16\u4ee3\u533b\u7597\u57fa\u672c\u6cd5\u300b\u4fee\u8ba2<\/strong><\/span><\/h2>\n<figure id=\"attachment_469494\" aria-describedby=\"caption-attachment-469494\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-469495 size-full\" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/Mitsukuni-Terada.jpg\" alt=\"Mitsukuni Terada\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-469494\" class=\"wp-caption-text\"><b> \u5bfa\u7530\u5149\u90a6<\/b><br \/>\u6cd5\u5f8b\u90e8\u7ecf\u7406\uff0c\u5f8b\u5e08<br \/>\u6cd5\u5f8b\/\u4e13\u5229\u5f8b\u5e08<br \/>\u6749\u6751\u4e07\u56fd\u7279\u8bb8\u6cd5\u5f8b\u4e8b\u52a1\u6240(SUGIMURA &amp; Partners)<br \/>\u4e1c\u4eac<br \/>\u7535\u90ae\uff1a<a href=\"mailto:m.terada@sugimura.partners\">m.terada@sugimura.partners<\/a><\/figcaption><\/figure>\n<p style=\"text-align: justify;\">\u4f46\u95ee\u9898\u4ecd\u6ca1\u6709\u5f97\u5230\u5168\u9762\u89e3\u51b3\u3002\u7ecf\u8ba4\u8bc1\u7684\u4fe1\u606f\u5236\u4f5c\u8005\u53ea\u80fd\u4ee5\u533f\u540d\u533b\u7597\u6570\u636e\u7684\u5f62\u5f0f\u5411\u7814\u7a76\u673a\u6784\u63d0\u4f9b\u6570\u636e\u3002\u8fd9\u610f\u5473\u7740\uff1a<\/p>\n<p style=\"text-align: justify;\">(1)\u5373\u4f7f\u7814\u7a76\u673a\u6784\u5e0c\u671b\u6570\u636e\u4e2d\u5305\u542b\u5c11\u91cf\u533b\u7597\u75c5\u4f8b\u548c\u72ec\u7279\u6570\u636e\uff0c\u8fd9\u90e8\u5206\u6570\u636e\u5b9e\u9645\u4e0a\u5e76\u4e0d\u53ef\u7528\uff0c\u56e0\u4e3a\u5f53\u8fd9\u4e9b\u6570\u636e\u4e0e\u5176\u4ed6\u6570\u636e\u76f8\u7ed3\u5408\u65f6\uff0c\u53ef\u80fd\u4f1a\u8bc6\u522b\u51fa\u7279\u5b9a\u7684\u4e2a\u4eba\u3002<\/p>\n<p style=\"text-align: justify;\">(2) \u6839\u636e\u9884\u5148\u4fee\u8ba2\u7684\u300a\u6b21\u4e16\u4ee3\u533b\u7597\u57fa\u672c\u6cd5\u300b\u7684\u76f8\u5173\u89c4\u5b9a\uff0c\u51e0\u4e4e\u4e0d\u53ef\u80fd\u6301\u7eed\u63d0\u4f9b\u60a3\u8005\u7684\u533b\u7597\u6570\u636e\u6765\u8ddf\u8e2a\u5176\u75c5\u60c5\u7684\u6f14\u53d8\u8fc7\u7a0b\u3002<\/p>\n<p style=\"text-align: justify;\">(3) 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justify;\">\u4e3a\u4e86\u89e3\u51b3\u8fd9\u4e9b\u95ee\u9898\uff0c\u300a\u6b21\u4e16\u4ee3\u533b\u7597\u57fa\u672c\u6cd5\u300b\u4e8e2023\u5e745\u6708\u8fdb\u884c\u4e86\u4fee\u8ba2\uff0c\u7eb3\u5165\u4e86\u4e00\u4e2a\u65b0\u7684\u6570\u636e\u7c7b\u522b\uff0c\u5176\u540e\u88ab\u547d\u540d\u4e3a\u201c\u5316\u540d\u533b\u7597\u6570\u636e\u201d\u3002\u4fee\u8ba2\u540e\u7684\u6cd5\u5f8b\u5c06\u81ea2024\u5e745\u6708\u8d77\uff0c\u4e5f\u5c31\u662f\u9881\u5e03\u540e\u4e00\u5e74\u5185\u751f\u6548\u3002<\/p>\n<p style=\"text-align: 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justify;\">\u300a\u6b21\u4e16\u4ee3\u533b\u7597\u57fa\u672c\u6cd5\u300b\u53ca\u5176\u4fee\u6b63\u6848\u65e8\u5728\u4fc3\u8fdb\u533b\u7597\u4fe1\u606f\u7684\u4f7f\u7528\uff0c\u8fd9\u65e0\u7591\u89e3\u51b3\u4e86\u4e00\u4e9b\u5b9e\u9645\u95ee\u9898\u3002\u7136\u800c\uff0c\u7531\u4e8e\u79cd\u79cd\u539f\u56e0\uff0c\u5305\u62ec\u516c\u4f17\u7f3a\u4e4f\u5bf9\u5236\u5ea6\u672c\u8eab\u7684\u8ba4\u8bc6\uff0c\u6cd5\u6848\u8fd8\u672a\u80fd\u5145\u5206\u53d1\u6325\u6548\u529b\u3002<\/p>\n<p style=\"text-align: justify;\">\u4f46\u8fd9\u5e76\u4e0d\u610f\u5473\u7740\u6cd5\u6848\u5728\u672a\u6765\u7684\u4f7f\u7528\u4e5f\u4f1a\u53d7\u9650\u3002\u4f5c\u8005\u8ba4\u4e3a\uff0c\u533b\u7597\u6570\u5b57\u5316\u8f6c\u578b\u7684\u52bf\u5934\u4e0d\u4f1a\u51cf\u5f31\u3002\u968f\u7740\u6570\u636e\u5e93\u548c\u5176\u4ed6\u5e73\u53f0\u5efa\u7acb\uff0c\u52a0\u4e4b\u533b\u7597\u4fe1\u606f\u7684\u4f7f\u7528\u8d8a\u53d1\u6d3b\u8dc3\uff0c\u672a\u6765\u5e02\u573a\u5bf9\u719f\u6089\u533b\u7597\u9886\u57df\u4e2a\u4eba\u4fe1\u606f\u4fdd\u62a4\u6cd5\u7684\u4e13\u4e1a\u4eba\u624d\u4f1a\u6709\u66f4\u5927\u9700\u6c42\u3002<\/p>\n<div id=\"_idContainer041\" class=\"Basic-Text-Frame\" style=\"text-align: justify;\">\n<section class=\"format-info\">\n<p class=\"Normal ParaOverride-8\" style=\"text-align: justify;\"><strong><img class=\"aligncenter wp-image-469474\" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1024x336.jpg\" alt=\"\" width=\"500\" height=\"164\" srcset=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1024x336.jpg 1024w, https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-300x99.jpg 300w, https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-768x252.jpg 768w, https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1536x504.jpg 1536w, https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-2048x673.jpg 2048w, https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-696x229.jpg 696w, https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1068x351.jpg 1068w, https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1279x420.jpg 1279w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>SUGIMURA &amp; PARTNERS<\/strong><br \/>\n36F, Common Gate West Tower<br \/>\n3-2-1 Kasumigaseki, Chiyoda-ku<br \/>\nTokyo 100-0013 JAPAN<\/p>\n<p style=\"text-align: justify;\">\u7535\u8bdd\uff1a +81 3 3581 2241<\/p>\n<p style=\"text-align: justify;\">\u7535\u90ae\uff1a<a href=\"mailto:legal@sugimura.partners\">legal@sugimura.partners<\/a><\/p>\n<p style=\"text-align: justify;\">\u7535\u90ae\uff1a <a href=\"mailto:jpatent@sugimura.partners\">jpatent@sugimura.partners<\/a><\/p>\n<\/section>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u65e5\u672c \u97e9\u56fd &nbsp; 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