{"id":6644,"date":"2026-05-27T10:00:00","date_gmt":"2026-05-27T02:00:00","guid":{"rendered":"https:\/\/aseanmedipass.com\/?p=6644"},"modified":"2026-10-30T00:28:00","modified_gmt":"2026-10-29T16:28:00","slug":"thailand-ivd-combination-panels-models-grouping","status":"publish","type":"post","link":"https:\/\/aseanmedipass.com\/zh-hans\/thailand-ivd-combination-panels-models-grouping\/","title":{"rendered":"\u6cf0\u56fd IVD \u8054\u68c0\u7ec4\u5408\u4e0e\u578b\u53f7\u53d8\u5316\uff1a\u4f55\u65f6\u9700\u8981\u62c6\u5206\u7533\u8bf7"},"content":{"rendered":"\n<style>.postid-6644 .entry-header{display:none}.postid-6644 #primary{width:100%;margin:0}.postid-6644 #secondary{display:none}.postid-6644 #content .ast-container{max-width:844px!important;width:100%;padding:0!important}.postid-6644 .ast-article-single{padding:50px 22px!important}.mp-editorial{width:100%;max-width:800px!important;margin:auto;font:16px\/1.75 Arial,Helvetica,sans-serif;color:#556b7d}.mp-editorial h1,.mp-editorial h2,.mp-editorial h3{font-family:Georgia,'Times New Roman',serif;font-weight:400;color:#183b5b;line-height:1.22}.mp-editorial h1{font-size:43px;margin:16px 0 22px}.mp-editorial h2{font-size:29px;margin:44px 0 20px}.mp-editorial h3{font-size:27px;margin:0 0 18px}.mp-editorial p{margin:0 0 20px}.mp-editorial .eyebrow{font:700 12px\/1.5 Arial,sans-serif;letter-spacing:1.6px;color:#008a8a}.mp-editorial .byline{font-size:14px;color:#6b7e8f;margin-bottom:32px}.mp-editorial .summary,.mp-editorial .article-cta{background:#edf4f8;border-left:3px solid #008a8a;padding:28px 30px;margin:32px 0}.mp-editorial .summary dl{margin:0;display:grid;grid-template-columns:145px 1fr;gap:10px 20px;font-size:15px}.mp-editorial dt{font-weight:600;color:#183b5b}.mp-editorial dd{margin:0}.mp-editorial a{color:#003a73}.mp-editorial .button{display:inline-block;background:#003a73;color:white!important;text-decoration:none!important;padding:14px 22px;border-radius:3px;font-size:15px;font-weight:600}.mp-editorial .references{border-top:1px solid #d9e4ec;margin-top:44px;font-size:14px;overflow-wrap:anywhere}.mp-editorial .references li{margin-bottom:18px}.mp-editorial .references ol{padding-left:22px}.mp-editorial ul{padding-left:22px;margin:0 0 20px}.mp-editorial ul li{margin-bottom:8px}.mp-editorial .faq p strong{color:#183b5b}.mp-editorial .related ul{list-style:none;padding:0}.mp-editorial .related li{border-bottom:1px solid #d9e4ec;padding:10px 0;margin:0}.mp-editorial .references .note{color:#6b7e8f}.mp-editorial .src{font-size:14px;color:#6b7e8f}.mp-editorial .related li a{display:block;text-decoration:none}.mp-editorial .related li a strong{display:block;font-weight:600;color:#183b5b}.mp-editorial .related li a span{display:block;font-size:14px;color:#6b7e8f;margin-top:4px}.mp-editorial .table-wrap{overflow-x:auto;margin:24px 0}.mp-editorial .table-wrap table{margin:0}@media(max-width:767px){.mp-editorial h1{font-size:32px}.mp-editorial h2{font-size:26px}.mp-editorial .summary,.mp-editorial .article-cta{padding:24px 22px}.mp-editorial .summary dl{grid-template-columns:1fr;gap:4px}.mp-editorial dd{margin-bottom:12px}.mp-editorial .button{width:100%;text-align:center}.postid-6644 .ast-article-single{padding:32px 22px!important}}.postid-6644 nav.post-navigation{display:none!important}.mp-editorial table{width:100%;border-collapse:collapse;margin:24px 0;font-size:15px;line-height:1.6;color:#183b5b;table-layout:fixed}.mp-editorial th,.mp-editorial td{border:1px solid #d9e4ec;padding:14px 16px;text-align:left;vertical-align:top;overflow-wrap:anywhere}.mp-editorial th{background:#edf4f8;font-weight:600}.mp-editorial tbody tr:nth-child(even){background:#f6f8fa}@media(max-width:767px){.mp-editorial th,.mp-editorial td{padding:12px 10px;font-size:14px}}<\/style>\n<article class=\"mp-editorial\">\n<p class=\"eyebrow\">\u6cf0\u56fd \u00b7 IVD<\/p>\n<h1>\u6cf0\u56fd IVD \u8054\u68c0\u7ec4\u5408\u4e0e\u578b\u53f7\u53d8\u5316\uff1a\u4f55\u65f6\u9700\u8981\u62c6\u5206\u7533\u8bf7<\/h1>\n<div class=\"byline\">\n<div style=\"font-size:14px;margin-top:0;margin-bottom:0\" class=\"mp-published-date wp-block-post-date\"><time datetime=\"2026-05-27T10:00:00+08:00\">2026\u5e745\u670827\u65e5<\/time><\/div>\n<span> \u00b7 <a href=\"https:\/\/aseanmedipass.com\/zh-hans\/%e5%85%b3%e4%ba%8e%e6%88%91%e4%bb%ac\/\" rel=\"author\">MediPass \u6cd5\u89c4\u56e2\u961f<\/a><\/span><\/div><style>.mp-editorial .mp-published-date{display:inline;color:inherit;font:inherit}.mp-editorial .mp-published-date time{font:inherit;color:inherit}<\/style>\n<p>\u51c6\u5907\u6cf0\u56fd IVD \u6ce8\u518c\u65f6\uff0c\u68c0\u6d4b\u9879\u76ee\u6570\u3001\u62df\u552e\u8d27\u53f7\u6570\u548c\u7533\u8bf7\u6570\u662f\u4e09\u4e2a\u4e0d\u540c\u7684\u6570\u5b57\u3002\u540c\u4e00\u68c0\u6d4b\u5e73\u53f0\u53ef\u4ee5\u884d\u751f\u591a\u4e2a\u5206\u522b\u9500\u552e\u7684\u8054\u68c0\u7ec4\u5408\uff1b\u4e00\u4efd\u7533\u8bf7\u4e5f\u53ef\u4ee5\u5728\u6ee1\u8db3\u5206\u7ec4\u6761\u4ef6\u65f6\u8986\u76d6\u591a\u4e2a\u9879\u76ee\u3002\u5224\u65ad\u7684\u8d77\u70b9\u662f\u6bcf\u4e2a\u62df\u552e\u8d27\u53f7\u7684\u5b8c\u6574\u7528\u9014\u4e0e\u914d\u7f6e\uff0c\u800c\u4e0d\u662f\u5e73\u53f0\u6216\u4ea7\u54c1\u76ee\u5f55\u7684\u6807\u9898\u3002<\/p>\n<p>Thai FDA 2026 \u5e74 5 \u6708\u4fee\u8ba2\u7684 IVD \u6ce8\u518c\u68c0\u67e5\u8868\u8981\u6c42\u5728\u7533\u8bf7\u9875\u586b\u5199\u5206\u7ec4\u5f62\u5f0f\uff08Grouping\uff09\u3001\u98ce\u9669\u5206\u7c7b\u548c\u4f7f\u7528\u8005\u7fa4\u4f53\uff0c\u5e76\u89c4\u5b9a\u4e00\u4efd\u7533\u8bf7\u542b\u591a\u4e2a\u9879\u76ee\u65f6\uff0c\u8d44\u6599\u548c\u6570\u636e\u987b\u8986\u76d6\u6bcf\u4e00\u9879\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/06\/pwsETXUtwPxhT8wSpPJ5LDsc.pdf\" target=\"_blank\" rel=\"noopener\">Thai FDA IVD Full-CSDT \u68c0\u67e5\u8868<\/a>\uff0c\u7b2c 1\u20133 \u9875\uff09<\/span>\u5404\u5206\u7ec4\u5f62\u5f0f\u7684\u5b9a\u4e49\u53ef\u53c2\u9605 <a href=\"https:\/\/aseanmedipass.com\/zh-hans\/thailand-medical-device-registration\/\">MediPass \u6cf0\u56fd\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1<\/a>\uff1b\u672c\u6587\u53ea\u8ba8\u8bba\u8054\u68c0\u7ec4\u5408\u3001panel \u5220\u51cf\u548c\u4e13\u4e1a\uff0f\u81ea\u6d4b\u7248\u672c\u5e26\u6765\u7684\u5177\u4f53\u5224\u65ad\u3002<\/p>\n\n<aside class=\"summary\">\n<p class=\"eyebrow\">\u8981\u70b9\u901f\u89c8<\/p>\n<dl>\n<dt>\u5224\u65ad\u5355\u4f4d<\/dt><dd>\u6bcf\u4e2a\u62df\u552e\u8d27\u53f7\uff08REF\u3001\u578b\u53f7\u6216\u4ea7\u54c1\u4ee3\u7801\uff09\u53ca\u5176\u9776\u6807\u3001\u6837\u672c\u3001\u4f7f\u7528\u8005\u548c\u7528\u9014\uff1b\u76ee\u5f55\u6807\u9898\u3001\u5916\u58f3\u6216\u5171\u7528\u5e73\u53f0\u4e0d\u51b3\u5b9a\u7533\u8bf7\u8fb9\u754c\u3002<\/dd>\n<dt>\u53ef\u8003\u8651\u7684\u5206\u7ec4<\/dt><dd>Family \u7684\u578b\u53f7\u5dee\u5f02\u987b\u843d\u5728\u5206\u7ec4\u51c6\u5219\u9644\u4ef6 3 \u7684\u5141\u8bb8\u53d8\u4f53\u4e4b\u5185\uff1bIVD Cluster \u9650\u540c\u4e00\u5236\u9020\u5546\u3001Class 1 \u6216 2\u3001\u540c\u4e00\u68c0\u6d4b\u65b9\u6cd5\uff0c\u4e14\u5168\u90e8\u9879\u76ee\u5c5e\u4e8e\u540c\u4e00 cluster category\u3002<\/dd>\n<dt>\u5408\u5e76\u7684\u4ee3\u4ef7<\/dt><dd>\u4e00\u4efd\u7533\u8bf7\u542b\u591a\u4e2a\u9879\u76ee\u65f6\uff0c\u8d44\u6599\u987b\u8986\u76d6\u6bcf\u4e00\u9879\uff1b\u540c\u4e00\u68c0\u6d4b\u6709\u591a\u79cd\u7528\u9014\u6216\u7ed3\u679c\u89e3\u91ca\u65f6\uff0c\u7814\u7a76\u4e5f\u53ef\u80fd\u9700\u8981\u9010\u4e00\u8986\u76d6\u3002<\/dd>\n<dt>\u4e13\u4e1a\u4e0e\u81ea\u6d4b<\/dt><dd>\u4f7f\u7528\u8005\u7fa4\u4f53\u987b\u4e0e\u6807\u7b7e\u3001IFU \u4e00\u81f4\uff1bHome use \u53e6\u9700\u6cf0\u6587\u6807\u7b7e\u548c IFU\u3001\u81ea\u6d4b\u7ea2\u8272\u8b66\u793a\u53ca\u53ef\u7528\u6027\u6d4b\u8bd5\u62a5\u544a\u3002<\/dd>\n<dt>\u83b7\u6279\u540e\u589e\u9879<\/dt><dd>\u987b\u53e6\u884c\u63d0\u4ea4\u53d8\u66f4\u7533\u8bf7\uff1b\u65b0\u578b\u53f7\u662f\u5426\u4ecd\u7b26\u5408\u539f\u5206\u7ec4\uff0c\u9700\u8981\u5355\u72ec\u5224\u65ad\u3002<\/dd>\n<\/dl>\n<\/aside>\n\n<h2>\u68c0\u6d4b\u9879\u76ee\u3001\u9500\u552e\u5355\u5143\u4e0e\u7533\u8bf7\uff0c\u5148\u5206\u5f00\u7edf\u8ba1<\/h2>\n<p>\u4e00\u4e2a\u76d2\u5185\u7684\u6d4b\u8bd5\u5361\u3001\u7f13\u51b2\u6db2\u548c\u91c7\u6837\u62ed\u5b50\uff0c\u901a\u5e38\u5171\u540c\u6784\u6210\u4e00\u4e2a\u62df\u552e\u4ea7\u54c1\uff1b\u540c\u4e00\u5382\u5546\u76ee\u5f55\u91cc\u7684\u56db\u6b3e\u8054\u68c0\u7ec4\u5408\uff0c\u5219\u53ef\u80fd\u662f\u56db\u4e2a\u5206\u522b\u9500\u552e\u7684\u4ea7\u54c1\u3002\u540e\u8005\u8981\u653e\u8fdb\u540c\u4e00\u4efd\u7533\u8bf7\uff0c\u9700\u8981\u8bf4\u660e\u5b83\u4eec\u4e3a\u4f55\u7b26\u5408\u67d0\u4e00\u5206\u7ec4\u5f62\u5f0f\u7684\u5168\u90e8\u6761\u4ef6\uff0c\u800c\u4e0d\u662f\u56e0\u4e3a\u54c1\u724c\u3001\u5916\u58f3\u6216\u5e73\u53f0\u76f8\u540c\u3002<\/p>\n<p>\u68c0\u67e5\u8868\u8981\u6c42\u5728\u9879\u76ee\u6e05\u5355\uff08Items\uff09\u4e2d\u9010\u9879\u586b\u5199\u4ea7\u54c1\u540d\u79f0\uff08\u987b\u4e0e\u6807\u7b7e\u4e00\u81f4\uff09\u3001\u5883\u5916\u5236\u9020\u5546\u53ca\u573a\u6240\u3001\u6807\u7b7e\u4e0a\u7684\u6807\u8bc6\u53f7\uff08REF\u3001\u578b\u53f7\u6216\u4ea7\u54c1\u4ee3\u7801\uff09\uff0c\u5e76\u5efa\u8bae\u5728\u9644\u52a0\u8bf4\u660e\u4e2d\u6ce8\u660e\u5305\u88c5\u89c4\u683c\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aFull-CSDT \u68c0\u67e5\u8868\uff0c\u7b2c 2 \u9875 Items \u680f\u7b2c 1\u20136 \u9879\uff09<\/span>\u56e0\u6b64\u5728\u8ba8\u8bba\u5206\u7ec4\u4e4b\u524d\uff0c\u5148\u6309\u8d27\u53f7\u5efa\u7acb\u578b\u53f7\u77e9\u9635\u3002\u5efa\u8bae\u81f3\u5c11\u5305\u62ec\u4ee5\u4e0b\u5404\u5217\uff1a<\/p>\n<ul>\n<li>\u8d27\u53f7\u4e0e\u4ea7\u54c1\u540d\u79f0\uff08\u4e0e\u6807\u7b7e\u4e00\u81f4\uff09<\/li>\n<li>\u68c0\u6d4b\u9776\u6807\u53ca\u5176\u7ec4\u5408\u3001\u68c0\u6d4b\u65b9\u6cd5\u4e0e\u5224\u8bfb\u65b9\u5f0f<\/li>\n<li>\u6837\u672c\u7c7b\u578b\u53ca\u91c7\u96c6\u65b9\u5f0f<\/li>\n<li>\u4f7f\u7528\u8005\uff08\u4e13\u4e1a\uff0f\u81ea\u6d4b\uff09\u3001\u9884\u671f\u7528\u9014\u53ca\u7ed3\u679c\u89e3\u91ca<\/li>\n<li>\u76d2\u5185\u7ec4\u6210\u4e0e\u5305\u88c5\u89c4\u683c<\/li>\n<li>\u6cf0\u56fd\u98ce\u9669\u5206\u7c7b\u53ca\u4f9d\u636e<\/li>\n<li>\u73b0\u6709\u6027\u80fd\u7814\u7a76\u5b9e\u9645\u8986\u76d6\u7684\u914d\u7f6e<\/li>\n<\/ul>\n<p>\u8fd9\u4e00\u77e9\u9635\u662f MediPass \u5efa\u8bae\u7684\u9879\u76ee\u5de5\u5177\uff0c\u5e76\u975e\u5b98\u65b9\u8868\u683c\u3002\u5b83\u7684\u4f5c\u7528\u662f\u8ba9\u6bcf\u4e00\u5904\u578b\u53f7\u5dee\u5f02\u90fd\u80fd\u5bf9\u5e94\u5230\u9700\u8981\u6838\u5bf9\u7684\u5206\u7ec4\u6761\u4ef6\u548c\u8bc1\u636e\u3002<\/p>\n\n<h2>\u56db\u79cd\u5408\u5e76\u5f62\u5f0f\uff0c\u5206\u522b\u8981\u56de\u7b54\u4ec0\u4e48\u95ee\u9898\uff1f<\/h2>\n<p>\u68c0\u67e5\u8868\u628a\u8be6\u7ec6\u6761\u4ef6\u6307\u5411 Thai FDA\u300a\u533b\u7597\u5668\u68b0\u5206\u7ec4\u51c6\u5219\u300b\uff08\u0e2b\u0e25\u0e31\u0e01\u0e40\u0e01\u0e13\u0e11\u0e4c\u0e43\u0e19\u0e01\u0e32\u0e23\u0e08\u0e31\u0e14\u0e01\u0e25\u0e38\u0e48\u0e21\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c \u0e1e.\u0e28. 2561\uff0c2018 \u5e74 10 \u6708 26 \u65e5\u516c\u544a\uff09\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/06\/pwsETXUtwPxhT8wSpPJ5LDsc.pdf\" target=\"_blank\" rel=\"noopener\">Full-CSDT \u68c0\u67e5\u8868<\/a>\u53ca <a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/07\/1KJ3JNOzAR9k2O7OLF9yTvh5.pdf\" target=\"_blank\" rel=\"noopener\">Abridged \u68c0\u67e5\u8868<\/a>\uff0cItems \u680f\u7b2c 4\u30015 \u9879\uff09<\/span>\u51c6\u5219\u5171\u8bbe\u516d\u79cd\u5f62\u5f0f\uff1aSingle\u3001System\u3001Family\u3001Set\u3001IVD Test Kit \u548c IVD Cluster\uff1bFamily \u6761\u4ef6\u89c1\u7b2c 5.3 \u8282\uff0cIVD Test Kit \u89c1\u7b2c 5.5 \u8282\uff0cIVD Cluster \u89c1\u7b2c 5.6 \u8282\uff0c\u5141\u8bb8\u53d8\u4f53\u89c1\u9644\u4ef6 3\uff0cIVD Cluster \u7c7b\u522b\u89c1\u9644\u4ef6 7\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/medical.fda.moph.go.th\/media.php?id=479191681393106944&amp;name=9.%E0%B8%AB%E0%B8%A5%E0%B8%B1%E0%B8%81%E0%B9%80%E0%B8%81%E0%B8%93%E0%B8%91%E0%B9%8C%E0%B9%83%E0%B8%99%E0%B8%81%E0%B8%B2%E0%B8%A3%E0%B8%88%E0%B8%B1%E0%B8%94%E0%B8%81%E0%B8%A5%E0%B8%B8%E0%B9%88%E0%B8%A1%E0%B9%80%E0%B8%84%E0%B8%A3%E0%B8%B7%E0%B9%88%E0%B8%AD%E0%B8%87%E0%B8%A1%E0%B8%B7%E0%B8%AD%E0%B9%81%E0%B8%9E%E0%B8%97%E0%B8%A2%E0%B9%8C+%E0%B8%9E.%E0%B8%A8.+2561.pdf\" target=\"_blank\" rel=\"noopener\">Thai FDA \u533b\u7597\u5668\u68b0\u5206\u7ec4\u51c6\u5219<\/a>\uff09<\/span>\u5bf9\u8054\u68c0\u548c\u591a\u578b\u53f7\u4ea7\u54c1\uff0c\u5404\u5f62\u5f0f\u7684\u5173\u952e\u95ee\u9898\u5982\u4e0b\uff1a<\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u5206\u7ec4\u5f62\u5f0f<\/th><th>\u5bf9\u8054\u68c0\uff0f\u591a\u578b\u53f7\u7684\u5173\u952e\u95ee\u9898<\/th><th>2026 \u5e74\u68c0\u67e5\u8868\u7684\u586b\u5199\u8981\u6c42<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>Family<\/td><td>\u662f\u5426\u540c\u4e00\u4ea7\u54c1\u6240\u6709\u8005\uff08\u53ef\u7531\u4e00\u4e2a\u6216\u591a\u4e2a\u573a\u6240\u751f\u4ea7\uff09\u3001\u540c\u4e00\u98ce\u9669\u7b49\u7ea7\u3001\u540c\u4e00\u4ea7\u54c1\u540d\u6216\u54c1\u724c\u540d\u3001\u540c\u4e00\u9884\u671f\u7528\u9014\uff0c\u7269\u7406\u8bbe\u8ba1\u3001\u7ed3\u6784\u548c\u751f\u4ea7\u5de5\u827a\u76f8\u540c\u6216\u9ad8\u5ea6\u76f8\u4f3c\uff1b\u5404\u578b\u53f7\u5dee\u5f02\u662f\u5426\u90fd\u843d\u5728\u5141\u8bb8\u53d8\u4f53\u4e4b\u5185\uff08\u7b2c 5.3.1 \u8282\uff09\u3002<\/td><td>\u201cPermissible variants\u201d\u680f\u987b\u6309\u4ea7\u54c1\u5b9e\u9645\u60c5\u51b5\u586b\u5199\u6bcf\u4e2a\u9879\u76ee\u7684\u53d8\u4f53\u3002<\/td><\/tr>\n<tr><td>IVD Test Kit<\/td><td>\u540c\u4e00\u4ea7\u54c1\u6240\u6709\u8005\u3001\u4ee5\u540c\u4e00 Kit \u540d\u79f0\u9500\u552e\u3001\u7ec4\u5408\u4f7f\u7528\u4ee5\u5b9e\u73b0\u540c\u4e00\u7528\u9014\u7684\u8bd5\u5242\u548c\u7269\u54c1\uff1b\u5b83\u754c\u5b9a\u7684\u662f\u4e00\u4e2a\u76d2\u5185\u7684\u7ec4\u6210\u3002Test Kit \u7533\u8bf7\u4e0d\u5305\u62ec\u914d\u5408\u4f7f\u7528\u7684\u5206\u6790\u4eea\uff08\u7b2c 5.5.2 \u8282\uff09\u3002<\/td><td>\u65e0\u4e13\u95e8\u680f\u4f4d\uff1b\u5206\u522b\u9500\u552e\u7684\u591a\u4e2a panel \u4e0d\u4f1a\u56e0\u6b64\u6210\u4e3a\u4e00\u4e2a Kit\u3002<\/td><\/tr>\n<tr><td>System\uff0fFamily of systems<\/td><td>\u90e8\u4ef6\u662f\u5426\u6309\u6807\u8bc6\u5171\u540c\u4f7f\u7528\u5e76\u5b9e\u73b0\u540c\u4e00\u76ee\u7684\u3002\u51c6\u5219\u793a\u4f8b\uff1aIVD System \u53ef\u7531\u8bd5\u5242\u76d2\u548c\u4e13\u4e3a\u5176\u8bbe\u8ba1\u7684\u5206\u6790\u4eea\u7ec4\u6210\uff08\u7b2c 5.2 \u8282\uff09\u3002<\/td><td>\u5668\u68b0\u63cf\u8ff0\u680f\u586b\u5199\u4e3b\u5668\u68b0\uff08Main device\uff09\u7684\u7528\u9014\u3002<\/td><\/tr>\n<tr><td>IVD Cluster<\/td><td>\u662f\u5426\u540c\u4e00\u5236\u9020\u5546\u3001\u5168\u90e8\u4e3a Class 1 \u6216 2\u3001\u4f7f\u7528\u540c\u4e00\u68c0\u6d4b\u65b9\u6cd5\uff08methodology\uff09\uff0c\u5e76\u5c5e\u4e8e\u540c\u4e00 cluster category\uff1b\u53ef\u5305\u62ec\u4e13\u4e3a\u8be5\u7ec4\u8bd5\u5242\u8bbe\u8ba1\u7684\u5206\u6790\u4eea\uff08\u7b2c 5.6 \u8282\uff09\u3002<\/td><td>\u4ece\u5c01\u95ed\u6e05\u5355\u590d\u5236\u7c7b\u522b\u540d\u79f0\uff1b\u5168\u90e8\u9879\u76ee\u987b\u5c5e\u4e8e\u540c\u4e00\u7c7b\u522b\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u4e00\u4e2a\u5feb\u901f\u68c0\u6d4b\u76d2\u4e0d\u4f1a\u56e0\u4e3a\u542b\u591a\u4e2a\u6d4b\u8bd5\u6761\u5c31\u6210\u4e3a System\uff1b\u51e0\u6b3e\u68c0\u6d4b\u4e5f\u4e0d\u4f1a\u56e0\u4e3a\u540c\u5c5e\u547c\u5438\u9053\u9886\u57df\u5c31\u6210\u4e3a Cluster\u3002\u547c\u5438\u9053\u8054\u68c0\u5f80\u5f80\u5148\u53d7\u98ce\u9669\u5206\u7c7b\u9650\u5236\uff1a\u53ea\u8981\u5176\u4e2d\u4efb\u4f55\u4e00\u6b3e\u6309\u6cf0\u56fd\u89c4\u5219\u5c5e\u4e8e Class 3 \u6216 4\uff0c\u5c31\u4e0d\u80fd\u91c7\u7528 IVD Cluster\uff0c\u9700\u8981\u6539\u4e3a\u8bc4\u4f30 Family \u6216\u5206\u522b\u7533\u8bf7\u3002\u5176\u4ed6\u5e02\u573a\u7684 Cluster \u5b89\u6392\u5df2\u6709\u8c03\u6574\uff08\u4f8b\u5982<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/singapore-covid-19-ivd-class-c-ivd-cluster-2026\/\">\u65b0\u52a0\u5761<\/a>\uff09\uff0c\u6cf0\u56fd 2026 \u5e74\u7248\u68c0\u67e5\u8868\u5219\u4ecd\u4fdd\u7559 IVD Cluster\uff0c\u4e24\u5730\u5224\u65ad\u4e0d\u80fd\u4e92\u76f8\u66ff\u4ee3\u3002<\/p>\n\n<h2>panel \u5220\u51cf\u3001\u6837\u672c\u548c\u4f7f\u7528\u8005\u53d8\u5316\uff0c\u9010\u9879\u5bf9\u5e94\u8bc1\u636e<\/h2>\n<p>\u5141\u8bb8\u53d8\u4f53\u8868\u5217\u7684\u662f\u5177\u4f53\u53ef\u53d8\u9879\u3002\u9644\u4ef6 3 \u5bf9 IVD \u53ea\u5217\u51fa\u5c11\u6570\u51e0\u9879\uff1a\u5feb\u901f\u68c0\u6d4b\u7684\u7ec4\u88c5\u5f62\u5f0f\uff08cassette\u3001midstream\u3001strip\uff09\u3001\u5c3f\u6db2\u5206\u6790\u8bd5\u7eb8\u7684\u4e0d\u540c\u68c0\u6d4b\u7ec4\u5408\u914d\u7f6e\uff0c\u4ee5\u53ca\u6297\u751f\u7d20\u68c0\u6d4b\uff08IVD\uff09\u7684\u6d53\u5ea6\u3002\u9776\u6807\u7ec4\u5408\u53d8\u5316\u53ea\u5bf9\u5c3f\u6db2\u5206\u6790\u8bd5\u7eb8\u5217\u4e3a\u5141\u8bb8\u53d8\u4f53\uff1b\u5176\u4ed6\u591a\u91cd panel \u7684\u9776\u6807\u4ece\u4e03\u9879\u51cf\u4e3a\u4e94\u9879\uff0c\u5e76\u4e0d\u5728\u6240\u5217\u9879\u76ee\u4e4b\u4e2d\uff0c\u4e0d\u80fd\u7531\u6b64\u7c7b\u63a8\u3002\u68c0\u67e5\u8868\u540c\u65f6\u63d0\u793a\uff0c\u4e00\u4e2a\u68c0\u6d4b\u53ef\u80fd\u6709\u591a\u79cd\u7528\u9014\u6216\u7ed3\u679c\u89e3\u91ca\uff0c\u7814\u7a76\u7ed3\u679c\u53ef\u80fd\u9700\u8981\u6309\u5404\u68c0\u6d4b\u7684\u60c5\u51b5\u9010\u4e00\u8986\u76d6\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aFull-CSDT \u68c0\u67e5\u8868\uff0c\u6027\u80fd\u8bc4\u4ef7\u90e8\u5206\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u578b\u53f7\u95f4\u5dee\u5f02<\/th><th>\u5148\u6838\u5bf9<\/th><th>\u901a\u5e38\u9700\u8981\u51c6\u5907\u7684\u652f\u6301<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u5220\u51cf\u6216\u589e\u52a0\u68c0\u6d4b\u9776\u6807<\/td><td>\u7528\u9014\u548c\u7ed3\u679c\u89e3\u91ca\u662f\u5426\u6539\u53d8\uff1b\u5404\u9776\u6807\u6027\u80fd\u5728\u8be5\u7ec4\u5408\u914d\u7f6e\u4e0b\u662f\u5426\u4ecd\u6210\u7acb\u3002<\/td><td>\u8bf4\u660e\u73b0\u6709\u6027\u80fd\u6570\u636e\u8986\u76d6\u54ea\u4e9b\u914d\u7f6e\uff1b\u4e0d\u80fd\u8986\u76d6\u7684\uff0c\u8865\u5145\u9488\u5bf9\u8be5\u914d\u7f6e\u7684\u6570\u636e\u3002<\/td><\/tr>\n<tr><td>\u6837\u672c\u7c7b\u578b\u4e0d\u540c<\/td><td>\u662f\u5426\u65b0\u589e\u6216\u6539\u53d8\u91c7\u6837\u4e0e\u524d\u5904\u7406\u6d41\u7a0b\u3002<\/td><td>\u6837\u672c\u7c7b\u578b\u7b49\u6548\u6027\u6216\u9002\u7528\u6027\u8bc4\u4f30\uff08\u68c0\u67e5\u8868\u6240\u5217\u7814\u7a76\u4e4b\u4e00\uff09\u3002<\/td><\/tr>\n<tr><td>\u4e13\u4e1a\u7248\u8f6c\u81ea\u6d4b<\/td><td>\u4f7f\u7528\u8005\u3001\u64cd\u4f5c\u6b65\u9aa4\u548c\u7ed3\u679c\u5224\u8bfb\u8bf4\u660e\u3002<\/td><td>\u4e0e\u7528\u9014\u4e00\u81f4\u7684\u4f7f\u7528\u8005\u680f\u3001\u6cf0\u6587\u6807\u7b7e\u548c IFU\u3001\u7ea2\u8272\u8b66\u793a\u3001\u53ef\u7528\u6027\u6d4b\u8bd5\u62a5\u544a\u3002<\/td><\/tr>\n<tr><td>\u5916\u89c2\u6216\u7ec4\u88c5\u5f62\u5f0f\u4e0d\u540c<\/td><td>\u5feb\u901f\u68c0\u6d4b\u7684 cassette\u3001midstream\u3001strip \u5f62\u5f0f\u5c5e\u4e8e\u9644\u4ef6 3 \u6240\u5217\u53d8\u4f53\uff1b\u5176\u4ed6\u5f62\u5f0f\u5dee\u5f02\u9700\u9010\u9879\u6838\u5bf9\u3002<\/td><td>\u53d8\u4f53\u8bf4\u660e\u53ca\u5bf9\u5e94\u7684\u51c6\u5219\u6761\u76ee\u3002<\/td><\/tr>\n<tr><td>\u5305\u88c5\u89c4\u683c\u4e0d\u540c<\/td><td>\u662f\u5426\u53ea\u6539\u53d8\u6570\u91cf\u6216\u5305\u88c5\u5f62\u5f0f\u3002<\/td><td>\u5728\u9879\u76ee\u9644\u52a0\u8bf4\u660e\u4e2d\u6ce8\u660e\u5305\u88c5\u89c4\u683c\uff1b\u786e\u8ba4\u7ec4\u6210\u548c\u6027\u80fd\u58f0\u660e\u672a\u53d8\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u4e13\u4e1a\u7248\u4e0e\u81ea\u6d4b\u7248\u9700\u8981\u7279\u522b\u5904\u7406\u3002\u68c0\u67e5\u8868\u8981\u6c42\u4f7f\u7528\u8005\u7fa4\u4f53\uff08Home use \u6216 Professional use\uff09\u53ea\u6309\u6807\u7b7e\u6216 IFU \u6240\u793a\u7528\u9014\u586b\u5199\uff1bHome use \u4ea7\u54c1\u987b\u9644\u7b26\u5408\u76f8\u5173\u516c\u544a\u7684\u6cf0\u6587\u6807\u7b7e\u548c\u6cf0\u6587 IFU\uff0c\u81ea\u6d4b\u68c0\u6d4b\u987b\u5728\u6807\u7b7e\u4e0a\u4ee5\u7ea2\u8272\u5b57\u4f53\u663e\u793a\u8b66\u793a\uff0c\u5e76\u63d0\u4ea4\u53ef\u7528\u6027\u6d4b\u8bd5\u62a5\u544a\u3002\u540c\u4e00\u68c0\u6d4b\u65e2\u4f9b\u5bb6\u5ead\u4e5f\u4f9b\u4e13\u4e1a\u4f7f\u7528\uff0c\u800c\u6837\u672c\u4e0d\u5c5e\u4e8e\u6307\u5c16\u8840\u3001\u9f3b\u62ed\u5b50\u3001\u5c3f\u6db2\u3001\u7caa\u4fbf\u6216\u553e\u6db2\uff0c\u6216\u91c7\u6837\u65b9\u6cd5\u987b\u7531\u533b\u52a1\u4eba\u5458\u8fdb\u884c\u65f6\uff0c\u8fd8\u987b\u6807\u793a\u54ea\u4e9b\u91c7\u6837\u53ea\u80fd\u7531\u533b\u52a1\u4eba\u5458\u8fdb\u884c\u3001\u54ea\u4e9b\u53ef\u7531\u4e00\u822c\u4f7f\u7528\u8005\u8fdb\u884c\uff0c\u4f8b\u5982\u4e00\u822c\u4f7f\u7528\u8005\u53ea\u91c7\u6307\u5c16\u8840\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aFull-CSDT \u68c0\u67e5\u8868\uff0c\u7533\u8bf7\u9875\u7b2c 8 \u9879\u3001\u7b2c 9 \u9875 IFU \u90e8\u5206\u53ca\u6807\u7b7e\u3001\u6027\u80fd\u90e8\u5206\uff09<\/span>\u4e24\u7248\u5373\u4f7f\u5171\u7528\u5206\u6790\u6027\u80fd\u62a5\u544a\uff0c\u4e5f\u5e94\u5217\u660e\u5171\u7528\u8303\u56f4\u548c\u5dee\u5f02\uff1b\u80fd\u5426\u653e\u5728\u540c\u4e00\u7533\u8bf7\u4e2d\uff0c\u5e94\u7ed3\u5408\u5b8c\u6574\u8d44\u6599\u5411 Thai FDA \u786e\u8ba4\u3002<\/p>\n\n<h2>\u8bf4\u660e\u6027\u793a\u4f8b\uff1a\u56db\u6b3e\u547c\u5438\u9053\u6297\u539f\u7ec4\u5408\u600e\u6837\u62c6\u5206\u8ba8\u8bba<\/h2>\n<p>\u4ee5\u4e0b\u4e3a\u5047\u8bbe\u60c5\u666f\uff0c\u4ec5\u7528\u4e8e\u5c55\u793a\u5224\u65ad\u65b9\u6cd5\uff0c\u4e0d\u4ee3\u8868\u4efb\u4f55\u4ea7\u54c1\u7684\u5206\u7c7b\u6216\u5206\u7ec4\u7ed3\u8bba\u3002\u67d0\u5382\u5546\u8ba1\u5212\u5728\u6cf0\u56fd\u9500\u552e\u56db\u6b3e\u6297\u539f\u8054\u68c0\uff1aA \u542b\u4e09\u4e2a\u9776\u6807\uff0cB \u548c C \u5404\u5220\u53bb\u5176\u4e2d\u4e00\u4e2a\uff0cD \u53ea\u4fdd\u7559\u4e24\u4e2a\u975e\u65b0\u51a0\u9776\u6807\u3002\u56db\u6b3e\u540c\u4e00\u54c1\u724c\u3001\u5404\u6709\u72ec\u7acb\u8d27\u53f7\uff0c\u5e76\u5206\u522b\u6709\u4e13\u4e1a\u7248\u548c\u81ea\u6d4b\u7248\uff0c\u5171\u516b\u4e2a\u8d27\u53f7\u3002<\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u6b65\u9aa4<\/th><th>\u5bf9\u516b\u4e2a\u8d27\u53f7\u505a\u4ec0\u4e48<\/th><th>\u53ef\u80fd\u5f71\u54cd\u7533\u8bf7\u8fb9\u754c\u7684\u7ed3\u679c<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>1. \u98ce\u9669\u5206\u7c7b<\/td><td>\u6309\u6cf0\u56fd\u89c4\u5219\u9010\u6b3e\u786e\u5b9a\u7b49\u7ea7\u3002<\/td><td>\u4efb\u4f55\u4e00\u6b3e\u4e3a Class 3 \u6216 4\uff0c\u5373\u6392\u9664 IVD Cluster\u3002<\/td><\/tr>\n<tr><td>2. Family \u5bf9\u7167<\/td><td>\u9010\u5217\u6bd4\u8f83\u9776\u6807\u3001\u6837\u672c\u548c\u7528\u9014\u5dee\u5f02\uff0c\u5bf9\u7167\u5141\u8bb8\u53d8\u4f53\u8868\u3002<\/td><td>\u9776\u6807\u5220\u51cf\u82e5\u4e0d\u5728\u5141\u8bb8\u53d8\u4f53\u4e4b\u5185\uff0cA\u2013D \u96be\u4ee5\u51ed Family \u5408\u5e76\u3002<\/td><\/tr>\n<tr><td>3. \u4f7f\u7528\u8005<\/td><td>\u4e13\u4e1a\u7248\u4e0e\u81ea\u6d4b\u7248\u5206\u522b\u6838\u5bf9\u6807\u7b7e\u3001IFU\u3001\u8b66\u793a\u548c\u53ef\u7528\u6027\u8bc1\u636e\u3002<\/td><td>\u81ea\u6d4b\u7248\u8d44\u6599\u7684\u6210\u719f\u5ea6\uff0c\u53ef\u80fd\u51b3\u5b9a\u662f\u5426\u4e0e\u4e13\u4e1a\u7248\u540c\u6279\u7533\u62a5\u3002<\/td><\/tr>\n<tr><td>4. \u8bc1\u636e\u8986\u76d6<\/td><td>\u6807\u51fa\u6bcf\u4e2a\u8d27\u53f7\u53ef\u5171\u7528\u7684\u6027\u80fd\u6570\u636e\u548c\u72ec\u6709\u6570\u636e\u3002<\/td><td>\u8bc1\u636e\u4e0d\u8db3\u7684\u8d27\u53f7\u53ef\u5148\u63a8\u8fdf\uff0c\u8865\u8db3\u8bc1\u636e\u540e\u518d\u53e6\u884c\u7533\u62a5\u3002<\/td><\/tr>\n<tr><td>5. \u786e\u8ba4\u95ee\u9898<\/td><td>\u628a\u65e0\u6cd5\u4ece\u89c4\u5219\u76f4\u63a5\u5f97\u51fa\u7ed3\u8bba\u7684\u90e8\u5206\u5199\u6210\u5177\u4f53\u95ee\u9898\u3002<\/td><td>\u9644 IFU\u3001\u6784\u6210\u56fe\u548c\u6bd4\u8f83\u8868\uff0c\u5411 Thai FDA \u786e\u8ba4\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u5728\u8fd9\u4e00\u5047\u8bbe\u4e0b\uff0c\u7533\u8bf7\u6570\u91cf\u53ef\u80fd\u4ece\u201c\u4e00\u4efd\u8986\u76d6\u591a\u4e2a\u8d27\u53f7\u201d\u5230\u201c\u6309\u7ec4\u5408\u6216\u4f7f\u7528\u8005\u62c6\u6210\u591a\u4efd\u201d\u4e0d\u7b49\u3002\u5e94\u5728\u4e0a\u8ff0\u6761\u4ef6\u660e\u786e\u540e\u518d\u4f30\u7b97\u7533\u8bf7\u6570\u91cf\u548c\u8d39\u7528\uff0c\u4e0d\u5b9c\u5728\u6536\u5230\u4ea7\u54c1\u76ee\u5f55\u5f53\u5929\u7ed9\u51fa\u56fa\u5b9a\u7ed3\u8bba\u3002<\/p>\n\n<h2>\u5df2\u83b7\u6279\u4ea7\u54c1\u65b0\u589e\u578b\u53f7\uff0c\u53e6\u505a\u53d8\u66f4\u5224\u65ad<\/h2>\n<p>\u68c0\u67e5\u8868\u9996\u9875\u63d0\u793a\uff1a\u7533\u8bf7\u83b7\u6279\u540e\uff0c\u5982\u9700\u589e\u52a0\u4ea7\u54c1\u9879\u76ee\u6216\u6587\u4ef6\uff0c\u5e94\u5728\u4e4b\u540e\u53e6\u884c\u63d0\u4ea4\u53d8\u66f4\u7533\u8bf7\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aFull-CSDT \u68c0\u67e5\u8868\uff0c\u7b2c 1 \u9875\uff09<\/span>\u8fd9\u5e76\u4e0d\u8868\u793a\u4efb\u4f55\u65b0\u578b\u53f7\u90fd\u80fd\u4ee5\u53d8\u66f4\u65b9\u5f0f\u52a0\u5165\u3002\u5148\u6bd4\u8f83\u65b0\u578b\u53f7\u4e0e\u5df2\u6279\u51c6\u8303\u56f4\uff0c\u8bb0\u5f55\u7528\u9014\u3001\u9776\u6807\u3001\u6837\u672c\u548c\u914d\u7f6e\u5dee\u5f02\uff0c\u518d\u6309\u73b0\u884c\u53d8\u66f4\u89c4\u5219\u5224\u65ad\uff1b\u65b0\u578b\u53f7\u82e5\u5df2\u8d85\u51fa\u539f\u5206\u7ec4\u6761\u4ef6\uff0c\u5219\u9700\u8bc4\u4f30\u65b0\u7533\u8bf7\u3002\u6cf0\u56fd 2026 \u5e74\u53d8\u66f4\u89c4\u5219\u7684\u7c7b\u522b\u548c\u8d39\u7528\uff0c\u89c1<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/thailand-medical-device-amendment-change-2026\/\">\u6cf0\u56fd\u533b\u7597\u5668\u68b0\u53d8\u66f4\u7533\u62a5\u8bf4\u660e<\/a>\u3002<\/p>\n\n<h2>\u786e\u8ba4\u5206\u7ec4\u524d\uff0c\u51c6\u5907\u8fd9\u4e9b\u8d44\u6599<\/h2>\n<p>MediPass \u5efa\u8bae\u6574\u7406\u4e00\u4efd\u53ef\u9010\u6b3e\u6838\u5bf9\u7684\u578b\u53f7\u77e9\u9635\uff0c\u5e76\u9644\u6bcf\u6b3e\u62df\u552e\u6807\u7b7e\u4e0e IFU\u3001\u6a21\u5757\u53ca\u90e8\u4ef6\u6784\u6210\u56fe\u3001\u98ce\u9669\u5206\u7c7b\u4f9d\u636e\u3001\u5236\u9020\u5546\u4e0e\u4ea7\u54c1\u6240\u6709\u8005\u5173\u7cfb\uff0c\u4ee5\u53ca\u6027\u80fd\u62a5\u544a\u8986\u76d6\u8868\u3002\u62df\u5171\u7528\u6587\u4ef6\u7684\u5730\u65b9\u5199\u660e\u7406\u7531\uff1b\u62df\u62c6\u5206\u7533\u8bf7\u7684\u8fb9\u754c\uff0c\u4e5f\u5e94\u4e0e\u4e0a\u5e02\u8ba1\u5212\u5bf9\u5e94\u3002<\/p>\n<p>\u82e5\u5df2\u6709\u5883\u5916\u6279\u51c6\uff0c\u518d\u52a0\u5165\u6279\u51c6\u8303\u56f4\u4e0e\u6cf0\u56fd\u62df\u552e\u8d27\u53f7\u7684\u5dee\u5f02\u8868\u3002\u5883\u5916\u5206\u7ec4\u7ed3\u679c\u53ef\u4ee5\u5e2e\u52a9\u89e3\u91ca\u4ea7\u54c1\u7ed3\u6784\uff0c\u4f46\u6cf0\u56fd\u662f\u5426\u63a5\u53d7\uff0c\u4ecd\u987b\u6309\u6cf0\u56fd\u89c4\u5219\u5224\u65ad\u3002\u5411\u4e3b\u7ba1\u673a\u5173\u8be2\u95ee\u65f6\uff0c\u628a\u95ee\u9898\u6536\u655b\u5230\u5177\u4f53\u914d\u7f6e\uff0c\u4f8b\u5982\u201cB\u3001C \u4e24\u4e2a\u9776\u6807\u7ec4\u5408\u80fd\u5426\u5728\u62df\u5b9a Family \u4e0b\u4e0e A \u5408\u5e76\u201d\uff0c\u5e76\u9644\u7406\u7531\u548c\u8bc1\u636e\uff0c\u907f\u514d\u53ea\u95ee\u201c\u80fd\u5426\u4e00\u8bc1\u591a\u578b\u53f7\u201d\u3002<\/p>\n\n<section class=\"faq\">\n<h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n<p><strong>\u5305\u88c5\u89c4\u683c\u4e0d\u540c\uff0c\u662f\u5426\u4e00\u5b9a\u8981\u5206\u5f00\u7533\u8bf7\uff1f<\/strong><br\/>\u4e0d\u4e00\u5b9a\u3002\u68c0\u67e5\u8868\u5efa\u8bae\u5728\u6bcf\u4e2a\u9879\u76ee\u7684\u9644\u52a0\u8bf4\u660e\u4e2d\u6ce8\u660e\u5305\u88c5\u89c4\u683c\uff0c\u4fbf\u4e8e\u533a\u5206\u9879\u76ee\u3002\u5173\u952e\u662f\u786e\u8ba4\u53d8\u5316\u53ea\u6d89\u53ca\u6570\u91cf\u6216\u5305\u88c5\u5f62\u5f0f\uff0c\u6ca1\u6709\u540c\u65f6\u6539\u53d8\u7ec4\u6210\u3001\u7528\u9014\u6216\u6027\u80fd\u58f0\u660e\u3002<\/p>\n<p><strong>\u9776\u6807\u76f8\u540c\u4f46\u6837\u672c\u7c7b\u578b\u4e0d\u540c\uff0c\u53ef\u4ee5\u5408\u5e76\u5417\uff1f<\/strong><br\/>\u9700\u8981\u5bf9\u7167\u62df\u7528\u5206\u7ec4\u7684\u6761\u4ef6\uff0c\u5e76\u63d0\u4f9b\u5404\u6837\u672c\u7c7b\u578b\u7684\u652f\u6301\u8bc1\u636e\uff1b\u68c0\u67e5\u8868\u628a\u6837\u672c\u7c7b\u578b\u7b49\u6548\u6027\u6216\u9002\u7528\u6027\u8bc4\u4f30\u5217\u4e3a\u53ef\u63d0\u4ea4\u7684\u7814\u7a76\u3002\u4e0d\u80fd\u4ec5\u51ed\u9776\u6807\u76f8\u540c\u4e0b\u7ed3\u8bba\u3002<\/p>\n<p><strong>\u6cf0\u56fd\u73b0\u5728\u8fd8\u80fd\u7528 IVD Cluster \u5417\uff1f<\/strong><br\/>\u53ef\u4ee5\u30022026 \u5e74 5 \u6708\u7248 Full-CSDT \u548c Abridged \u68c0\u67e5\u8868\u90fd\u4fdd\u7559 IVD Cluster \u7684\u586b\u5199\u8981\u6c42\uff1a\u4ece\u5c01\u95ed\u6e05\u5355\u9009\u62e9\u7c7b\u522b\uff0c\u5168\u90e8\u9879\u76ee\u5c5e\u4e8e\u540c\u4e00\u7c7b\u522b\u3002\u524d\u63d0\u662f\u540c\u4e00\u5236\u9020\u5546\u3001Class 1 \u6216 2\u3001\u540c\u4e00\u68c0\u6d4b\u65b9\u6cd5\uff1b\u5176\u4ed6\u5e02\u573a\u7684\u8c03\u6574\u4e0d\u80fd\u76f4\u63a5\u5957\u7528\u3002<\/p>\n<p><strong>\u5148\u5c11\u62a5\u51e0\u4e2a\u578b\u53f7\u3001\u4ee5\u540e\u518d\u52a0\uff0c\u662f\u5426\u66f4\u7701\u4e8b\uff1f<\/strong><br\/>\u4e0d\u4e00\u5b9a\u3002\u83b7\u6279\u540e\u589e\u9879\u987b\u63d0\u4ea4\u53d8\u66f4\u7533\u8bf7\uff0c\u65b0\u578b\u53f7\u8fd8\u8981\u7b26\u5408\u539f\u5206\u7ec4\uff0c\u8d85\u51fa\u65f6\u9700\u53e6\u884c\u7533\u8bf7\u3002\u5e94\u7ed3\u5408\u9996\u6279\u4e0a\u5e02\u8ba1\u5212\u3001\u8bc1\u636e\u6210\u719f\u5ea6\u548c\u540e\u7eed\u53d8\u66f4\u53ef\u884c\u6027\u4e00\u5e76\u5224\u65ad\u3002<\/p>\n<\/section>\n\n<aside class=\"article-cta\"><p class=\"eyebrow\">\u6cf0\u56fd IVD \u5206\u7ec4\u8bc4\u4f30<\/p><h3>\u8054\u68c0\u7ec4\u5408\u600e\u6837\u7533\u62a5\uff1f\u5148\u544a\u8bc9\u6211\u4eec\u7ec4\u5408\u548c\u7528\u9014<\/h3><p>\u5148\u544a\u8bc9\u6211\u4eec <strong>\u5404\u68c0\u6d4b\u7ec4\u5408\u7684\u540d\u79f0\u6216\u8d27\u53f7\u3001\u9776\u6807\uff0c\u4ee5\u53ca\u4e13\u4e1a\u7528\u6216\u81ea\u6d4b\u7528\u9014<\/strong> \u5373\u53ef\uff0c\u6807\u7b7e\u3001IFU \u548c\u6027\u80fd\u8d44\u6599\u53ef\u5728\u9879\u76ee\u542f\u52a8\u540e\u518d\u6574\u7406\u3002MediPass \u53ef\u636e\u6b64\u521d\u6b65\u5224\u65ad\u5206\u7ec4\u601d\u8def\u548c\u5927\u81f4\u7533\u8bf7\u6570\u91cf\uff0c\u5e76\u7ed9\u51fa\u62a5\u4ef7\uff1b\u53ef\u5171\u7528\u8d44\u6599\u4e0e\u9700\u8865\u5145\u8d44\u6599\u7684\u9010\u9879\u6bd4\u5bf9\u5728\u9879\u76ee\u542f\u52a8\u540e\u8fdb\u884c\u3002<\/p><a class=\"button\" href=\"https:\/\/aseanmedipass.com\/zh-hans\/%e8%81%94%e7%b3%bb%e6%96%b9%e5%bc%8f\/\">\u8ba8\u8bba\u6cf0\u56fd IVD \u7533\u8bf7\u8303\u56f4<\/a><\/aside>\n\n<section class=\"related\"><h2>\u5ef6\u4f38\u9605\u8bfb<\/h2><ul>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/thailand-medical-device-registration\/\"><strong>\u6cf0\u56fd\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4e0e Thai FDA \u6cd5\u89c4\u670d\u52a1<\/strong><span>\u98ce\u9669\u5206\u7c7b\u3001\u5206\u7ec4\u5f62\u5f0f\u5b9a\u4e49\u3001\u6ce8\u518c\u8def\u5f84\u4e0e\u5b98\u65b9\u8d39\u7528\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/thailand-medical-device-amendment-change-2026\/\"><strong>\u6cf0\u56fd\u533b\u7597\u5668\u68b0\u53d8\u66f4\u7533\u62a5 2026<\/strong><span>\u83b7\u6279\u540e\u589e\u51cf\u578b\u53f7\u3001\u53d8\u66f4\u7c7b\u522b\u4e0e\u8d39\u7528\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/singapore-covid-19-ivd-class-c-ivd-cluster-2026\/\"><strong>\u65b0\u52a0\u5761\u65b0\u51a0 IVD \u964d\u4e3a Class C\uff0cIVD Cluster \u505c\u7528<\/strong><span>\u5bf9\u6bd4\u65b0\u52a0\u5761\u7684 IVD \u5206\u7ec4\u8c03\u6574\u3002<\/span><\/a><\/li>\n<\/ul><\/section>\n\n<section class=\"references\"><h2>\u5b98\u65b9\u53c2\u8003\u8d44\u6599<\/h2><ol>\n<li>Thai FDA \u533b\u7597\u5668\u68b0\u7ba1\u5236\u53f8\uff0cChecklist \u0e41\u0e19\u0e27\u0e17\u0e32\u0e07\u0e01\u0e32\u0e23\u0e1e\u0e34\u0e08\u0e32\u0e23\u0e13\u0e32\u0e40\u0e2d\u0e01\u0e2a\u0e32\u0e23\u0e04\u0e33\u0e02\u0e2d\u0e02\u0e36\u0e49\u0e19\u0e17\u0e30\u0e40\u0e1a\u0e35\u0e22\u0e19\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c (Full-CSDT) \u0e1b\u0e23\u0e30\u0e40\u0e20\u0e17 IVD Class 2-4\uff08IVD Class 2\u20134 \u5b8c\u6574 CSDT \u6ce8\u518c\u7533\u8bf7\u8d44\u6599\u5ba1\u67e5\u68c0\u67e5\u8868\uff09\uff0cIVD_MDCD_CL_FU Rev.01\uff0c\u7b2c 1 \u9875\uff1a\u83b7\u6279\u540e\u589e\u9879\uff1b\u7b2c 2\u20133 \u9875\uff1a\u7533\u8bf7\u9875\u7b2c 8\u201310 \u9879\u3001Items \u680f\u7b2c 1\u20136 \u9879\uff1b\u6807\u7b7e\u3001IFU \u53ca\u6027\u80fd\u8bc4\u4ef7\u90e8\u5206\uff0c2026-05-25\uff08\u4f5b\u5386 2569 \u5e74\uff09\uff0c<a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/06\/pwsETXUtwPxhT8wSpPJ5LDsc.pdf\" target=\"_blank\" rel=\"noopener\">cms-media.fda.moph.go.th\uff08PDF\uff09<\/a><\/li>\n<li>Thai FDA \u533b\u7597\u5668\u68b0\u7ba1\u5236\u53f8\uff0cChecklist \u0e41\u0e19\u0e27\u0e17\u0e32\u0e07\u0e01\u0e32\u0e23\u0e1e\u0e34\u0e08\u0e32\u0e23\u0e13\u0e32\u0e40\u0e2d\u0e01\u0e2a\u0e32\u0e23\u0e04\u0e33\u0e02\u0e2d\u0e02\u0e36\u0e49\u0e19\u0e17\u0e30\u0e40\u0e1a\u0e35\u0e22\u0e19\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c (Abridged) \u0e1b\u0e23\u0e30\u0e40\u0e20\u0e17 IVD Class 2-4\uff08IVD Class 2\u20134 \u7b80\u5316\u8def\u5f84\u6ce8\u518c\u7533\u8bf7\u8d44\u6599\u5ba1\u67e5\u68c0\u67e5\u8868\uff09\uff0cIVD_MDCD_CL_AB Rev.1\uff0c\u7b2c 2\u20133 \u9875\uff1a\u5206\u7ec4\u76f8\u5173\u586b\u5199\u8981\u6c42\uff0c2026-05-25\uff08\u4f5b\u5386 2569 \u5e74\uff09\uff0c<a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/07\/1KJ3JNOzAR9k2O7OLF9yTvh5.pdf\" target=\"_blank\" rel=\"noopener\">cms-media.fda.moph.go.th\uff08PDF\uff09<\/a><\/li>\n<li>Thai FDA\uff0c\u0e2b\u0e25\u0e31\u0e01\u0e40\u0e01\u0e13\u0e11\u0e4c\u0e43\u0e19\u0e01\u0e32\u0e23\u0e08\u0e31\u0e14\u0e01\u0e25\u0e38\u0e48\u0e21\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c \u0e1e.\u0e28. 2561\uff08\u533b\u7597\u5668\u68b0\u5206\u7ec4\u51c6\u5219\uff09\uff0c\u7b2c 1 \u6761\uff1a\u516d\u79cd\u5206\u7ec4\u5f62\u5f0f\uff1b\u9644\u4ef6\u7b2c 5.2\u30015.3\u30015.5\u30015.6 \u8282\uff1b\u9644\u4ef6 3\uff1aFamily \u5141\u8bb8\u53d8\u4f53\uff08\u542b IVD rapid tests\u3001IVD urinalysis strips\uff09\uff1b\u9644\u4ef6 7\uff1aIVD Cluster \u5206\u7c7b\uff0c2018-10-26\uff08\u4f5b\u5386 2561 \u5e74 10 \u6708 26 \u65e5\uff09\uff0c<a href=\"https:\/\/medical.fda.moph.go.th\/media.php?id=479191681393106944&amp;name=9.%E0%B8%AB%E0%B8%A5%E0%B8%B1%E0%B8%81%E0%B9%80%E0%B8%81%E0%B8%93%E0%B8%91%E0%B9%8C%E0%B9%83%E0%B8%99%E0%B8%81%E0%B8%B2%E0%B8%A3%E0%B8%88%E0%B8%B1%E0%B8%94%E0%B8%81%E0%B8%A5%E0%B8%B8%E0%B9%88%E0%B8%A1%E0%B9%80%E0%B8%84%E0%B8%A3%E0%B8%B7%E0%B9%88%E0%B8%AD%E0%B8%87%E0%B8%A1%E0%B8%B7%E0%B8%AD%E0%B9%81%E0%B8%9E%E0%B8%97%E0%B8%A2%E0%B9%8C+%E0%B8%9E.%E0%B8%A8.+2561.pdf\" target=\"_blank\" rel=\"noopener\">medical.fda.moph.go.th\uff08PDF\uff09<\/a><\/li>\n<\/ol><p class=\"note\">\u672c\u6587\u4f9d\u636e\u622a\u81f3 2026 \u5e74 5 \u6708 27 \u65e5\u53ef\u6838\u5b9e\u7684\u5b98\u65b9\u8d44\u6599\u7f16\u5199\uff0c\u7528\u4e8e\u5382\u5546\u9879\u76ee\u51c6\u5907\uff1b\u5177\u4f53\u4ea7\u54c1\u7684\u98ce\u9669\u5206\u7c7b\u3001\u5206\u7ec4\u548c\u7533\u8bf7\u8303\u56f4\uff0c\u5e94\u7ed3\u5408\u5b8c\u6574\u4ea7\u54c1\u8d44\u6599\u53ca Thai FDA \u7684\u610f\u89c1\u786e\u8ba4\u3002<\/p><\/section>\n<\/article>\n\n","protected":false},"excerpt":{"rendered":"<p>\u5148\u8bc6\u522b\u6bcf\u4e2a\u62df\u552e\u8d27\u53f7\u53ca\u5176\u7528\u9014\uff0c\u518d\u5bf9\u7167\u6cf0\u56fd\u5206\u7ec4\u6761\u4ef6\u548c 2026 \u5e74 IVD \u68c0\u67e5\u8868\u3002\u8054\u68c0\u9879\u76ee\u76f8\u8fd1\u3001\u5916\u58f3\u76f8\u540c\u6216\u5171\u7528\u5e73\u53f0\uff0c\u90fd\u4e0d\u80fd\u5355\u72ec\u51b3\u5b9a\u7533\u8bf7\u6570\u91cf\u3002<\/p>\n","protected":false},"author":2,"featured_media":4098,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"disabled","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"disabled","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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