{"id":67686,"date":"2024-04-10T16:02:44","date_gmt":"2024-04-10T07:02:44","guid":{"rendered":"https:\/\/monolith.law\/zh-tw\/?p=67686"},"modified":"2024-05-25T11:26:36","modified_gmt":"2024-05-25T02:26:36","slug":"medical-equipment-regulation","status":"publish","type":"post","link":"https:\/\/monolith.law\/zh-tw\/general-corporate\/medical-equipment-regulation","title":{"rendered":"\u91dd\u5c0d\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u520a\u767b\u7684\u898f\u7bc4\u2014\u2014\u4f55\u8b02\u300c\u65e5\u672c\u85e5\u6a5f\u6cd5\u300d"},"content":{"rendered":"\n<p>\u91ab\u7642\u5668\u68b0\u6709\u8a31\u591a\u7a2e\u985e\u3002\u5176\u4e2d\uff0c\u6709\u4e9b\u91ab\u7642\u5668\u68b0\u5c0d\u672c\u6240\u7684\u8eab\u9ad4\u548c\u5065\u5eb7\u6709\u91cd\u5927\u5f71\u97ff\u3002<\/p>\n\n\n\n<p>\u5982\u679c\u5c0d\u9019\u985e\u91ab\u7642\u5668\u68b0\u9032\u884c\u4e0d\u9069\u7576\u7684\u5ee3\u544a\uff0c\u90a3\u9ebc\u76f8\u4fe1\u9019\u4e9b\u4e0d\u9069\u7576\u5ee3\u544a\u5167\u5bb9\u7684\u4eba\u53ef\u80fd\u6703\u8cfc\u8cb7\u4e26\u4f7f\u7528\u9019\u4e9b\u91ab\u7642\u5668\u68b0\uff0c\u7d50\u679c\u53ef\u80fd\u5c0e\u81f4\u56b4\u91cd\u7684\u5065\u5eb7\u640d\u5bb3\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u5c0d\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\uff0c\u65e5\u672c\u7684\u300c\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u7b49\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u78ba\u4fdd\u7b49\u76f8\u95dc\u6cd5\u5f8b\u300d\uff08\u4ee5\u4e0b\u7c21\u7a31\u300c\u85e5\u6a5f\u6cd5\u300d\uff09\u9032\u884c\u4e86\u898f\u7bc4\u3002<\/p>\n\n\n\n<p>\u672c\u6587\u5c07\u91dd\u5c0d\u8003\u616e\u6295\u653e\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u7684\u696d\u8005\uff0c\u4ecb\u7d39\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u7684\u6cd5\u5f8b\u898f\u5b9a\u3002<\/p>\n\n\n\n<p><a href=\"https:\/\/monolith-law.jp\/corporate\/medical-supplies-law\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith-law.jp\/corporate\/medical-supplies-law[ja]<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/monolith-law.jp\/corporate\/cbd-ad-pmd-restriction\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith-law.jp\/corporate\/cbd-ad-pmd-restriction[ja]<\/a><\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_53 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/medical-equipment-regulation\/#%E8%97%A5%E6%A9%9F%E6%B3%95%E5%B0%8D%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E5%BB%A3%E5%91%8A%E8%A6%8F%E7%AF%84%E7%9A%84%E8%A6%8F%E5%AE%9A%E6%98%AF%E4%BB%80%E9%BA%BC\" title=\"\u85e5\u6a5f\u6cd5\u5c0d\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u898f\u7bc4\u7684\u898f\u5b9a\u662f\u4ec0\u9ebc\">\u85e5\u6a5f\u6cd5\u5c0d\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u898f\u7bc4\u7684\u898f\u5b9a\u662f\u4ec0\u9ebc<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/medical-equipment-regulation\/#%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E7%9A%84%E6%B3%95%E5%BE%8B%E5%AE%9A%E7%BE%A9\" title=\"\u91ab\u7642\u5668\u68b0\u7684\u6cd5\u5f8b\u5b9a\u7fa9\">\u91ab\u7642\u5668\u68b0\u7684\u6cd5\u5f8b\u5b9a\u7fa9<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" 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href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/medical-equipment-regulation\/#%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E5%BB%A3%E5%91%8A%E8%A6%8F%E7%AF%84%E7%9A%84%E4%B8%BB%E9%AB%94\" title=\"\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u898f\u7bc4\u7684\u4e3b\u9ad4\">\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u898f\u7bc4\u7684\u4e3b\u9ad4<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/medical-equipment-regulation\/#%E5%93%AA%E4%BA%9B%E8%A1%A8%E7%8F%BE%E6%9C%83%E6%88%90%E7%82%BA%E8%A6%8F%E7%AF%84%E7%9A%84%E5%B0%8D%E8%B1%A1\" title=\"\u54ea\u4e9b\u8868\u73fe\u6703\u6210\u70ba\u898f\u7bc4\u7684\u5c0d\u8c61\">\u54ea\u4e9b\u8868\u73fe\u6703\u6210\u70ba\u898f\u7bc4\u7684\u5c0d\u8c61<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/medical-equipment-regulation\/#%E9%97%9C%E6%96%BC%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E8%AA%87%E5%A4%A7%E5%BB%A3%E5%91%8A%E7%AD%89%E7%9A%84%E7%A6%81%E6%AD%A2%EF%BC%88%E7%AC%AC66%E6%A2%9D%EF%BC%89\" title=\"\u95dc\u65bc\u91ab\u7642\u5668\u68b0\u8a87\u5927\u5ee3\u544a\u7b49\u7684\u7981\u6b62\uff08\u7b2c66\u689d\uff09\">\u95dc\u65bc\u91ab\u7642\u5668\u68b0\u8a87\u5927\u5ee3\u544a\u7b49\u7684\u7981\u6b62\uff08\u7b2c66\u689d\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/medical-equipment-regulation\/#%E9%97%9C%E6%96%BC%E6%9C%AA%E7%8D%B2%E6%89%B9%E5%87%86%E7%9A%84%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E7%9A%84%E5%BB%A3%E5%91%8A%E7%A6%81%E6%AD%A2%EF%BC%88%E7%AC%AC68%E6%A2%9D%EF%BC%89\" title=\"\u95dc\u65bc\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u7981\u6b62\uff08\u7b2c68\u689d\uff09\">\u95dc\u65bc\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u7981\u6b62\uff08\u7b2c68\u689d\uff09<\/a><\/li><\/ul><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/medical-equipment-regulation\/#%E7%B8%BD%E7%B5%90\" title=\"\u7e3d\u7d50\">\u7e3d\u7d50<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/medical-equipment-regulation\/#%E6%9C%AC%E6%89%80%E4%BA%8B%E5%8B%99%E6%89%80%E7%9A%84%E5%B0%8D%E7%AD%96%E4%BB%8B%E7%B4%B9\" title=\"\u672c\u6240\u4e8b\u52d9\u6240\u7684\u5c0d\u7b56\u4ecb\u7d39\">\u672c\u6240\u4e8b\u52d9\u6240\u7684\u5c0d\u7b56\u4ecb\u7d39<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%97%A5%E6%A9%9F%E6%B3%95%E5%B0%8D%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E5%BB%A3%E5%91%8A%E8%A6%8F%E7%AF%84%E7%9A%84%E8%A6%8F%E5%AE%9A%E6%98%AF%E4%BB%80%E9%BA%BC\"><\/span>\u85e5\u6a5f\u6cd5\u5c0d\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u898f\u7bc4\u7684\u898f\u5b9a\u662f\u4ec0\u9ebc<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u5728\u85e5\u6a5f\u6cd5\u4e2d\uff0c\u70ba\u4e86\u78ba\u4fdd\u91ab\u7642\u5668\u68b0\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\uff0c\u4ee5\u53ca\u9632\u6b62\u91ab\u7642\u5668\u68b0\u4f7f\u7528\u5c0e\u81f4\u7684\u516c\u5171\u885b\u751f\u5371\u5bb3\u7684\u7522\u751f\u548c\u64f4\u5927\uff0c\u5c0d\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u520a\u767b\u9032\u884c\u4e86\u4ee5\u4e0b\u7684\u898f\u7bc4\u3002<\/p>\n\n\n\n<ul>\n<li>\u7981\u6b62\u8a87\u5927\u5ee3\u544a\u7b49\uff08\u7b2c66\u689d\uff09<\/li>\n\n\n\n<li>\u7981\u6b62\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\uff08\u7b2c68\u689d\uff09<\/li>\n<\/ul>\n\n\n\n<p>\u4ee5\u4e0b\u5c07\u8a73\u7d30\u89e3\u91cb\u85e5\u6a5f\u6cd5\u5c0d\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u898f\u7bc4\u7684\u898f\u5b9a\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E7%9A%84%E6%B3%95%E5%BE%8B%E5%AE%9A%E7%BE%A9\"><\/span>\u91ab\u7642\u5668\u68b0\u7684\u6cd5\u5f8b\u5b9a\u7fa9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/monolith-law.jp\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation4.jpg\" alt=\"\" class=\"wp-image-45031\" \/><\/figure><\/div>\n\n\n<p>\u300c\u91ab\u7642\u5668\u68b0\u300d\u7684\u5b9a\u7fa9\uff0c\u6839\u64da\u4ee5\u4e0b\u7684\u65e5\u672c\u300a\u85e5\u6a5f\u6cd5\u300b\uff08Pharmaceuticals and Medical Devices Act\uff09\u7b2c2\u689d\u7b2c4\u9805\u9032\u884c\u898f\u5b9a\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\uff08\u5b9a\u7fa9\uff09<br>\u5728\u672c\u6cd5\u4e2d\uff0c\u300c\u91ab\u7642\u5668\u68b0\u300d\u6307\u7684\u662f\u7528\u65bc\u4eba\u6216\u52d5\u7269\u7684\u75be\u75c5\u8a3a\u65b7\u3001\u6cbb\u7642\u6216\u9810\u9632\uff0c\u6216\u8005\u5f71\u97ff\u4eba\u6216\u52d5\u7269\u7684\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd\u7684\u6a5f\u68b0\u5668\u5177\u7b49\uff08\u4e0d\u5305\u62ec\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\uff09\uff0c\u7531\u653f\u4ee4\u898f\u5b9a\u3002<\/p>\n<\/blockquote>\n\n\n\n<p>\u6839\u64da\u4e0a\u8ff0\u5b9a\u7fa9\uff0c\u8981\u88ab\u8a8d\u5b9a\u70ba\u300c\u91ab\u7642\u5668\u68b0\u300d\uff0c\u5fc5\u9808\u7b26\u5408\u4ee5\u4e0b\u4efb\u4e00\u689d\u4ef6\uff1a<\/p>\n\n\n\n<ul>\n<li>\u7528\u65bc\u4eba\u6216\u52d5\u7269\u7684\u75be\u75c5\u8a3a\u65b7\u3001\u6cbb\u7642\u6216\u9810\u9632<\/li>\n\n\n\n<li>\u5f71\u97ff\u4eba\u6216\u52d5\u7269\u7684\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd\u70ba\u76ee\u7684<\/li>\n<\/ul>\n\n\n\n<p>\u53e6\u5916\uff0c\u5f9e\u300c\u91ab\u7642\u5668\u68b0\u300d\u7684\u5b9a\u7fa9\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u88ab\u6392\u9664\u5728\u5916\uff0c\u56e0\u6b64\uff0c\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u4e26\u4e0d\u5c6c\u65bc\u91ab\u7642\u5668\u68b0\u3002<\/p>\n\n\n\n<p>\u5728\u672c\u6240\u65e5\u5e38\u751f\u6d3b\u4e2d\uff0c\u91ab\u7642\u5668\u68b0\u7684\u5177\u9ad4\u4f8b\u5b50\u5305\u62ec\u9ad4\u6eab\u8a08\u3001\u8840\u58d3\u8a08\u3001\u96b1\u5f62\u773c\u93e1\u7b49\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0cAED\uff08\u81ea\u52d5\u9ad4\u5916\u5fc3\u81df\u53bb\u986b\u5668\uff09\u4e5f\u88ab\u5305\u542b\u5728\u91ab\u7642\u5668\u68b0\u4e4b\u4e2d\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E7%9A%84%E5%BB%A3%E5%91%8A%E8%A1%A8%E7%8F%BE%E8%A6%8F%E7%AF%84\"><\/span>\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u8868\u73fe\u898f\u7bc4<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/monolith-law.jp\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation2.jpg\" alt=\"\" class=\"wp-image-45028\" \/><\/figure><\/div>\n\n\n<p>\u95dc\u65bc\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u8868\u73fe\u898f\u7bc4\uff0c\u5982\u524d\u6240\u8ff0\uff0c\u4e3b\u8981\u91dd\u5c0d\u8a87\u5927\u5ee3\u544a\u4ee5\u53ca\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E3%80%8C%E5%BB%A3%E5%91%8A%E3%80%8D%E7%9A%84%E9%81%A9%E7%94%A8%E6%80%A7\"><\/span>\u300c\u5ee3\u544a\u300d\u7684\u9069\u7528\u6027<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u5728\u85e5\u6a5f\u6cd5\u4e2d\uff0c\u4e26\u672a\u5c0d\u300c\u91ab\u7642\u5668\u68b0\u300d\u7684\u300c\u5ee3\u544a\u300d\u9032\u884c\u660e\u78ba\u7684\u5b9a\u7fa9\u898f\u5b9a\u3002<\/p>\n\n\n\n<p>\u7136\u800c\uff0c\u5728\u85e5\u6a5f\u6cd5\u7684\u898f\u5b9a\u4e2d\uff0c\u4f7f\u7528\u4e86\u300c\u5ee3\u544a\u300d\u9019\u500b\u8a5e\u8a9e\uff0c\u5982\u679c\u4e0d\u6e05\u695a\u4ec0\u9ebc\u662f\u300c\u5ee3\u544a\u300d\uff0c\u5c31\u7121\u6cd5\u5224\u65b7\u85e5\u6a5f\u6cd5\u662f\u5426\u9069\u7528\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u672c\u6240\u9700\u8981\u8003\u616e\u300c\u5ee3\u544a\u300d\u7684\u610f\u7fa9\u3002<\/p>\n\n\n\n<p>\u95dc\u65bc\u85e5\u6a5f\u6cd5\u4e2d\u7684\u300c\u5ee3\u544a\u300d\uff0c\u5728\u4ee5\u4e0b\u7684\u300c\u85e5\u4e8b\u6cd5\u4e2d\u7684\u91ab\u85e5\u54c1\u7b49\u5ee3\u544a\u7684\u9069\u7528\u6027\u300d\uff08\u5e73\u621010\u5e74\uff081998\u5e74\uff099\u670829\u65e5\u91ab\u85e5\u76e3\u7b2c148\u865f\u90fd\u9053\u5e9c\u7e23\u885b\u751f\u4e3b\u7ba1\u90e8\uff08\u5c40\uff09\u9577\u81f4\u65e5\u672c\u539a\u751f\u7701\u91ab\u85e5\u5b89\u5168\u5c40\u76e3\u8996\u6307\u5c0e\u8ab2\u9577\u901a\u77e5\uff09\u4e2d\uff0c\u516c\u5e03\u4e86\u8981\u4ef6\u3002<\/p>\n\n\n\n<p>\u5177\u9ad4\u4f86\u8aaa\uff0c\u5982\u679c\u7b26\u5408\u4ee5\u4e0b\u4e09\u500b\u8981\u4ef6\uff0c\u5247\u6703\u88ab\u8a8d\u5b9a\u70ba\u300c\u5ee3\u544a\u300d\uff1a<\/p>\n\n\n\n<ul>\n<li>\u660e\u78ba\u6709\u5438\u5f15\u5ba2\u6236\uff08\u63d0\u9ad8\u5ba2\u6236\u7684\u8cfc\u8cb7\u610f\u9858\uff09\u7684\u610f\u5716<\/li>\n\n\n\n<li>\u91ab\u7642\u5668\u68b0\u7684\u5546\u54c1\u540d\u5df2\u660e\u78ba\u516c\u958b<\/li>\n\n\n\n<li>\u4e00\u822c\u4eba\u80fd\u5920\u8a8d\u77e5\u7684\u72c0\u614b<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E5%BB%A3%E5%91%8A%E8%A6%8F%E7%AF%84%E7%9A%84%E4%B8%BB%E9%AB%94\"><\/span>\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u898f\u7bc4\u7684\u4e3b\u9ad4<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u91ab\u7642\u5668\u68b0\u5ee3\u544a\u898f\u7bc4\u7684\u4e3b\u9ad4\u4e26\u7121\u9650\u5236\uff0c\u4efb\u4f55\u4eba\u90fd\u53ef\u80fd\u6210\u70ba\u898f\u7bc4\u7684\u5c0d\u8c61\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u5373\u4f7f\u4e0d\u662f\u92b7\u552e\u91ab\u7642\u5668\u68b0\u7684\u696d\u8005\uff0c\u53ea\u8981\u9032\u884c\u4e86\u95dc\u65bc\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\uff0c\u5c31\u6703\u53d7\u5230\u85e5\u6a5f\u6cd5\u7684\u898f\u7bc4\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%93%AA%E4%BA%9B%E8%A1%A8%E7%8F%BE%E6%9C%83%E6%88%90%E7%82%BA%E8%A6%8F%E7%AF%84%E7%9A%84%E5%B0%8D%E8%B1%A1\"><\/span>\u54ea\u4e9b\u8868\u73fe\u6703\u6210\u70ba\u898f\u7bc4\u7684\u5c0d\u8c61<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u5982\u524d\u6240\u8ff0\uff0c\u85e5\u6a5f\u6cd5\u898f\u7bc4\u7684\u5c0d\u8c61\u662f\u8a87\u5927\u5ee3\u544a\u7b49\u7684\u7981\u6b62\uff08\u7b2c66\u689d\uff09\u4ee5\u53ca\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u7684\u7981\u6b62\uff08\u7b2c68\u689d\uff09\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u4ee5\u4e0b\u5c07\u8a73\u7d30\u89e3\u91cb\u9019\u5169\u7a2e\u5ee3\u544a\u898f\u7bc4\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%97%9C%E6%96%BC%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E8%AA%87%E5%A4%A7%E5%BB%A3%E5%91%8A%E7%AD%89%E7%9A%84%E7%A6%81%E6%AD%A2%EF%BC%88%E7%AC%AC66%E6%A2%9D%EF%BC%89\"><\/span>\u95dc\u65bc\u91ab\u7642\u5668\u68b0\u8a87\u5927\u5ee3\u544a\u7b49\u7684\u7981\u6b62\uff08\u7b2c66\u689d\uff09<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u85e5\u6a5f\u6cd5\u7b2c66\u689d\u898f\u5b9a\u4e86\u95dc\u65bc\u91ab\u7642\u5668\u68b0\u8a87\u5927\u5ee3\u544a\u7b49\u7684\u7981\u6b62\uff0c\u5177\u9ad4\u5167\u5bb9\u5982\u4e0b\uff1a<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\uff08\u8a87\u5927\u5ee3\u544a\u7b49\uff09<br>\u7b2c\u516d\u5341\u516d\u689d\u3000\u4efb\u4f55\u4eba\u4e0d\u5f97\u5c0d\u91ab\u85e5\u54c1\u3001\u91ab\u85e5\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u68b0\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u540d\u7a31\u3001\u88fd\u9020\u65b9\u6cd5\u3001\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\u9032\u884c\u660e\u793a\u6216\u6697\u793a\u7684\u865b\u5047\u6216\u8a87\u5927\u7684\u6587\u7ae0\u5ee3\u544a\u3001\u63cf\u8ff0\u6216\u6563\u64ad\u3002<br>2\u3000\u5c0d\u65bc\u91ab\u85e5\u54c1\u3001\u91ab\u85e5\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u68b0\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\uff0c\u5982\u679c\u6709\u53ef\u80fd\u8aa4\u89e3\u70ba\u91ab\u751f\u7b49\u4eba\u4fdd\u8b49\u7684\u6587\u7ae0\u7684\u5ee3\u544a\u3001\u63cf\u8ff0\u6216\u6563\u64ad\uff0c\u61c9\u8996\u70ba\u9055\u53cd\u524d\u9805\u3002<br>3\u3000\u4efb\u4f55\u4eba\u4e0d\u5f97\u4f7f\u7528\u6697\u793a\u58ae\u80ce\u6216\u6deb\u7a62\u7684\u6587\u4ef6\u6216\u5716\u756b\u8207\u91ab\u85e5\u54c1\u3001\u91ab\u85e5\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u68b0\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u6709\u95dc\u3002<\/p>\n<\/blockquote>\n\n\n\n<p>\u95dc\u65bc\u91ab\u7642\u5668\u68b0\u8a87\u5927\u5ee3\u544a\u7b49\u7684\u7981\u6b62\u7684\u5167\u5bb9\u53ef\u4ee5\u7e3d\u7d50\u5982\u4e0b\uff1a<\/p>\n\n\n\n<ul>\n<li>\u7981\u6b62\u5c0d\u91ab\u7642\u5668\u68b0\u7684\u540d\u7a31\u3001\u88fd\u9020\u65b9\u6cd5\u3001\u529f\u6548\u30fb\u6548\u679c\u3001\u6027\u80fd\u9032\u884c\u865b\u5047\u30fb\u8a87\u5927\u7684\u6587\u7ae0\u7684\u5ee3\u544a\u3001\u63cf\u8ff0\u3001\u6563\u64ad<\/li>\n\n\n\n<li>\u7981\u6b62\u5c0d\u91ab\u7642\u5668\u68b0\u7684\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\u9032\u884c\u53ef\u80fd\u8aa4\u5c0e\u70ba\u91ab\u751f\u7b49\u4eba\u4fdd\u8b49\u7684\u6587\u7ae0\u7684\u5ee3\u544a\u3001\u63cf\u8ff0\u3001\u6563\u64ad<\/li>\n\n\n\n<li>\u7981\u6b62\u4f7f\u7528\u8207\u91ab\u7642\u5668\u68b0\u76f8\u95dc\u7684\u6697\u793a\u58ae\u80ce\u6216\u6deb\u7a62\u7684\u6587\u4ef6\u6216\u5716\u756b<\/li>\n<\/ul>\n\n\n\n<p>\u91ab\u7642\u5668\u68b0\u8a87\u5927\u5ee3\u544a\u7b49\u7684\u5178\u578b\u4f8b\u5b50\u662f\uff0c\u5118\u7ba1\u91ab\u7642\u5668\u68b0\u6c92\u6709\u4efb\u4f55\u6548\u679c\uff0c\u6216\u8005\u6548\u679c\u5e7e\u4e4e\u6c92\u6709\uff0c\u4f46\u4ecd\u9032\u884c\u5927\u5927\u7684\u6548\u679c\u7684\u5ee3\u544a\u3002\u53e6\u5916\uff0c\u5373\u4f7f\u5c55\u793a\u4e86\u5177\u9ad4\u7684\u6578\u64da\u4e26\u9032\u884c\u4e86\u6709\u95dc\u91ab\u7642\u5668\u68b0\u6548\u679c\u7684\u5ee3\u544a\uff0c\u4f46\u5982\u679c\u5177\u9ad4\u7684\u6578\u64da\u662f\u88ab\u7be1\u6539\u7684\u865b\u5047\u6578\u64da\uff0c\u4e5f\u6703\u88ab\u8996\u70ba\u9055\u898f\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%97%9C%E6%96%BC%E6%9C%AA%E7%8D%B2%E6%89%B9%E5%87%86%E7%9A%84%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0%E7%9A%84%E5%BB%A3%E5%91%8A%E7%A6%81%E6%AD%A2%EF%BC%88%E7%AC%AC68%E6%A2%9D%EF%BC%89\"><\/span>\u95dc\u65bc\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u7981\u6b62\uff08\u7b2c68\u689d\uff09<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u85e5\u6a5f\u6cd5\u7b2c68\u689d\u898f\u5b9a\u4e86\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u7981\u6b62\uff0c\u5177\u9ad4\u5167\u5bb9\u5982\u4e0b\uff1a<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\uff08\u672a\u7372\u6279\u51c6\u7684\u91ab\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u53ca\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u5ee3\u544a\u7981\u6b62\uff09<br>\u7b2c\u516d\u5341\u516b\u689d\u3000\u4efb\u4f55\u4eba\u4e0d\u5f97\u5c0d\u7b2c\u5341\u56db\u689d\u7b2c\u4e00\u9805\u3001\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u4e94\u7b2c\u4e00\u9805\u6216\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u4e8c\u5341\u4e09\u7b2c\u4e00\u9805\u898f\u5b9a\u7684\u91ab\u85e5\u54c1\u6216\u91ab\u7642\u5668\u68b0\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\uff0c\u5982\u679c\u5c1a\u672a\u7372\u5f97\u7b2c\u5341\u56db\u689d\u7b2c\u4e00\u9805\u3001\u7b2c\u5341\u4e5d\u689d\u7684\u4e8c\u7b2c\u4e00\u9805\u3001\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u4e94\u7b2c\u4e00\u9805\u3001\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u5341\u4e03\u7b2c\u4e00\u9805\u3001\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u5341\u4e94\u7b2c\u4e00\u9805\u6216\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e09\u5341\u4e03\u7b2c\u4e00\u9805\u7684\u6279\u51c6\u6216\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u4e8c\u5341\u4e09\u7b2c\u4e00\u9805\u7684\u8a8d\u8b49\uff0c\u9032\u884c\u5176\u540d\u7a31\u3001\u88fd\u9020\u65b9\u6cd5\u3001\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\u7684\u5ee3\u544a\u3002<\/p>\n<\/blockquote>\n\n\n\n<p>\u5c0d\u65bc\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u7981\u6b62\uff0c\u5c0d\u65bc\u672a\u7372\u5f97\u6279\u51c6\uff08\u6216\u8a8d\u8b49\uff09\u7684\u91ab\u7642\u5668\u68b0\uff0c\u5176\u540d\u7a31\u3001\u88fd\u9020\u65b9\u6cd5\u3001\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\u7684\u5ee3\u544a\u5c07\u6210\u70ba\u7981\u6b62\u7684\u5c0d\u8c61\u3002<\/p>\n\n\n\n<p>\u5c0d\u65bc\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u7981\u6b62\uff0c\u5373\u4f7f\u5728\u5916\u570b\u5df2\u7d93\u7372\u5f97\u6279\u51c6\uff0c\u4f46\u5982\u679c\u5728\u65e5\u672c\u5c1a\u672a\u7372\u5f97\u6279\u51c6\uff0c\u5247\u9032\u884c\u5ee3\u544a\u5c07\u9055\u53cd\u672a\u7372\u6279\u51c6\u7684\u91ab\u7642\u5668\u68b0\u7684\u5ee3\u544a\u7981\u6b62\uff0c\u56e0\u6b64\u9700\u8981\u6ce8\u610f\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E7%B8%BD%E7%B5%90\"><\/span>\u7e3d\u7d50<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/monolith-law.jp\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation3.jpg\" alt=\"\" class=\"wp-image-45030\" 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href=\"https:\/\/monolith.law\/operationofmedia\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/operationofmedia[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u91ab\u7642\u5668\u68b0\u6709\u8a31\u591a\u7a2e\u985e\u3002\u5176\u4e2d\uff0c\u6709\u4e9b\u91ab\u7642\u5668\u68b0\u5c0d\u672c\u6240\u7684\u8eab\u9ad4\u548c\u5065\u5eb7\u6709\u91cd\u5927\u5f71\u97ff\u3002 \u5982\u679c\u5c0d\u9019\u985e\u91ab\u7642\u5668\u68b0\u9032\u884c\u4e0d\u9069\u7576\u7684\u5ee3\u544a\uff0c\u90a3\u9ebc\u76f8\u4fe1\u9019\u4e9b\u4e0d\u9069\u7576\u5ee3\u544a\u5167\u5bb9\u7684\u4eba\u53ef\u80fd\u6703\u8cfc\u8cb7\u4e26\u4f7f\u7528\u9019\u4e9b\u91ab\u7642\u5668\u68b0\uff0c\u7d50\u679c\u53ef\u80fd\u5c0e\u81f4\u56b4\u91cd\u7684\u5065\u5eb7\u640d\u5bb3\u3002 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