{"id":6639,"date":"2026-07-03T10:00:00","date_gmt":"2026-07-03T02:00:00","guid":{"rendered":"https:\/\/aseanmedipass.com\/?p=6639"},"modified":"2026-10-30T00:27:56","modified_gmt":"2026-10-29T16:27:56","slug":"thailand-medical-device-registration-types-csdt-documents","status":"publish","type":"post","link":"https:\/\/aseanmedipass.com\/zh-hans\/thailand-medical-device-registration-types-csdt-documents\/","title":{"rendered":"\u6cf0\u56fd\u533b\u7597\u5668\u68b0\u7533\u62a5\u7c7b\u578b\u4e0e CSDT \u8981\u6c42\uff1a\u4ece\u98ce\u9669\u5206\u7c7b\u5230\u8d44\u6599\u6e05\u5355"},"content":{"rendered":"\n<style>.postid-6639 .entry-header{display:none}.postid-6639 #primary{width:100%;margin:0}.postid-6639 #secondary{display:none}.postid-6639 #content .ast-container{max-width:844px!important;width:100%;padding:0!important}.postid-6639 .ast-article-single{padding:50px 22px!important}.mp-editorial{width:100%;max-width:800px!important;margin:auto;font:16px\/1.75 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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-6639 .ast-article-single{padding:32px 22px!important}}.postid-6639 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 \u533b\u7597\u5668\u68b0<\/p>\n<h1>\u6cf0\u56fd\u533b\u7597\u5668\u68b0\u7533\u62a5\u7c7b\u578b\u4e0e CSDT \u8981\u6c42\uff1a\u4ece\u98ce\u9669\u5206\u7c7b\u5230\u8d44\u6599\u6e05\u5355<\/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=\"2026-07-03T10:00:00+08:00\">2026\u5e747\u67083\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>\u5728\u6cf0\u56fd\u51c6\u5907\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8d44\u6599\uff0c\u8981\u5206\u4e24\u6b65\u56de\u7b54\u3002\u7b2c\u4e00\u6b65\uff1a\u4ea7\u54c1\u5c5e\u4e8e\u54ea\u4e2a\u98ce\u9669\u7c7b\u522b\uff0c\u5bf9\u5e94\u54ea\u79cd\u6cd5\u5b9a\u7533\u8bf7\u3002\u6cf0\u56fd\u536b\u751f\u90e8\u516c\u544a\u89c4\u5b9a\uff0cClass 4 \u987b\u53d6\u5f97\u8bb8\u53ef\uff08Licence\uff09\uff0cClass 2 \u4e0e Class 3 \u987b\u8be6\u7ec6\u7533\u62a5\uff08Notification\uff09\uff0cClass 1 \u987b\u767b\u8bb0\uff08Listing\uff09\u3002\u7b2c\u4e8c\u6b65\uff1a\u5728 Class 2 \u81f3 4 \u7684\u7533\u8bf7\u4e0b\uff0c\u91c7\u7528 Full CSDT\u3001Abridged \u8fd8\u662f\u76d1\u7ba1\u4f9d\u8d56\u8def\u5f84\uff0c\u4ee5\u53ca\u5404\u8def\u5f84\u8981\u4ea4\u54ea\u4e9b\u6587\u4ef6\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/research.psu.ac.th\/wp-content\/uploads\/2025\/03\/27.%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B8%81%E0%B8%B2%E0%B8%A8%E0%B8%81%E0%B8%A3%E0%B8%B0%E0%B8%97%E0%B8%A3%E0%B8%A7%E0%B8%87%E0%B8%AA%E0%B8%B2%E0%B8%98%E0%B8%B2%E0%B8%A3%E0%B8%93%E0%B8%AA%E0%B8%B8%E0%B8%82-%E0%B9%80%E0%B8%A3%E0%B8%B7%E0%B9%88%E0%B8%AD%E0%B8%87-%E0%B8%81%E0%B8%B2%E0%B8%A3%E0%B8%88%E0%B8%B1%E0%B8%94%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%95%E0%B8%B2%E0%B8%A1%E0%B8%A3%E0%B8%B0%E0%B8%94%E0%B8%B1%E0%B8%9A%E0%B8%84%E0%B8%A7%E0%B8%B2%E0%B8%A1%E0%B9%80%E0%B8%AA%E0%B8%B5%E0%B9%88%E0%B8%A2%E0%B8%87-%E0%B8%9E.%E0%B8%A8.-%E0%B9%92%E0%B9%95%E0%B9%96%E0%B9%92.pdf\" target=\"_blank\" rel=\"noopener\">\u536b\u751f\u90e8 2562 \u5e74\u98ce\u9669\u5206\u7ea7\u516c\u544a<\/a>\uff0c\u7b2c 5 \u6761\uff09<\/span>\u4e24\u6b65\u5206\u5f00\u5224\u65ad\uff0c\u624d\u80fd\u4f30\u51c6\u6280\u672f\u8d44\u6599\u7684\u5de5\u4f5c\u91cf\u3002<\/p>\n<p>\u672c\u6587\u9762\u5411\u8ba1\u5212\u5546\u4e1a\u8fdb\u53e3\u6cf0\u56fd\u7684\u4eba\u7528\u533b\u7597\u5668\u68b0\uff08GMD\uff09\u4e0e\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff08IVD\uff09\u5236\u9020\u5546\uff0c\u91cd\u70b9\u662f\u628a\u5206\u7c7b\u7ed3\u8bba\u8f6c\u6210\u53ef\u6267\u884c\u7684\u8d44\u6599\u6e05\u5355\u3002\u672c\u5730\u6301\u8bc1\u4e3b\u4f53\u3001\u5206\u7ec4\u4e0e\u6574\u4f53\u6d41\u7a0b\uff0c\u8bf7\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>\u3002<\/p>\n\n<aside class=\"summary\">\n<p class=\"eyebrow\">\u8981\u70b9\u901f\u89c8<\/p>\n<dl>\n<dt>\u6cd5\u5b9a\u7533\u8bf7\u7c7b\u578b<\/dt><dd>Class 1 \u4e3a Listing\uff08\u0e08\u0e14\u0e41\u0e08\u0e49\u0e07\uff09\uff0cClass 2\u30013 \u4e3a Notification\uff08\u0e41\u0e08\u0e49\u0e07\u0e23\u0e32\u0e22\u0e01\u0e32\u0e23\u0e25\u0e30\u0e40\u0e2d\u0e35\u0e22\u0e14\uff09\uff0cClass 4 \u4e3a Licence\uff08\u0e43\u0e1a\u0e2d\u0e19\u0e38\u0e0d\u0e32\u0e15\uff09\uff1b\u53e6\u6709\u4e13\u95e8\u516c\u544a\u7684\u4ea7\u54c1\uff0c\u6309\u4e13\u95e8\u516c\u544a\u6267\u884c\u3002<\/dd>\n<dt>\u5206\u7c7b\u4f9d\u636e<\/dt><dd>2562 \u5e74\u98ce\u9669\u5206\u7ea7\u516c\u544a\uff1aIVD \u9002\u7528\u9644\u4ef6\u4e00\uff087 \u6761\u89c4\u5219\uff09\uff0c\u975e IVD \u9002\u7528\u9644\u4ef6\u4e8c\uff0816 \u6761\u89c4\u5219\uff09\uff1b\u5206\u7c7b\u6709\u4e89\u8bae\u65f6\u7531 FDA \u79d8\u4e66\u957f\u88c1\u5b9a\u3002<\/dd>\n<dt>\u8d44\u6599\u8def\u5f84<\/dt><dd>Full CSDT \u987b\u63d0\u4ea4 Summary V&amp;V \u4e0e\u98ce\u9669\u7ba1\u7406\u6587\u4ef6\uff1bAbridged \u4ee5\u53c2\u8003\u673a\u6784\u6279\u51c6\u53ca\u58f0\u660e\u4ee3\u66ff\u8fd9\u4e24\u9879\uff1bHSA \u76d1\u7ba1\u4f9d\u8d56\u53e6\u987b\u63d0\u4ea4 HSA \u6279\u51c6\u53ca\u53c2\u4e0e\u6587\u4ef6\u3002<\/dd>\n<dt>IVD Abridged \u95e8\u69db<\/dt><dd>\u5728\u8ba4\u53ef\u673a\u6784\u6709\u6ee1 1 \u5e74\u7684\u6ce8\u518c\u5386\u53f2\uff08Listing\u3001Class A\/1\u3001\u4ec5\u51fa\u53e3\u6279\u51c6\u4e0d\u7b97\uff09\uff1b\u4e0d\u5c5e\u4e8e HIV\u3001\u7532\u57fa\u82ef\u4e19\u80fa\u5c3f\u68c0\u7b49\u4e13\u95e8\u7ba1\u5236\u4ea7\u54c1\uff1b\u4e0a\u5e02\u4ee5\u6765\u65e0\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff0c\u4e14\u65e0\u672a\u7ed3 FSCA\u3002<\/dd>\n<dt>\u5148\u505a\u4ec0\u4e48<\/dt><dd>\u5148\u6309\u62df\u5728\u6cf0\u56fd\u9500\u552e\u7684\u578b\u53f7\u548c\u7528\u9014\u786e\u5b9a\u7c7b\u522b\uff0c\u518d\u9010\u9879\u6838\u5bf9\u53c2\u8003\u6279\u51c6\u8986\u76d6\u8303\u56f4\uff0c\u6700\u540e\u624d\u786e\u5b9a\u8def\u5f84\u548c\u62a5\u4ef7\u3002<\/dd>\n<\/dl>\n<\/aside>\n\n<h2>\u7b2c\u4e00\u6b65\uff1a\u98ce\u9669\u7c7b\u522b\u51b3\u5b9a\u6cd5\u5b9a\u7533\u8bf7\u7c7b\u578b<\/h2>\n<p>\u6cf0\u56fd\u536b\u751f\u90e8 2562 \u5e74\uff082019 \u5e74\uff09\u98ce\u9669\u5206\u7ea7\u516c\u544a\u628a\u533b\u7597\u5668\u68b0\u5206\u4e3a IVD \u548c\u975e IVD \u4e24\u7ec4\uff0c\u5404\u5206 Class 1 \u81f3 Class 4\uff0c\u5e76\u5728\u7b2c 5 \u6761\u89c4\u5b9a\u4e09\u79cd\u7ba1\u7406\u65b9\u5f0f\u30022563 \u5e74\uff082020 \u5e74\uff09\u7684\u4e09\u4efd\u914d\u5957\u516c\u544a\u5217\u660e\u4e86\u5404\u7c7b\u4ea7\u54c1\uff0c\u4e8e 2021 \u5e74 2 \u6708 15 \u65e5\u5728\u653f\u5e9c\u516c\u62a5\u520a\u767b\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/ratchakitcha.soc.go.th\/documents\/17158353.pdf\" target=\"_blank\" rel=\"noopener\">\u8bb8\u53ef\u7c7b\u516c\u544a<\/a>\uff1b<a href=\"https:\/\/ratchakitcha.soc.go.th\/documents\/17158354.pdf\" target=\"_blank\" rel=\"noopener\">\u8be6\u7ec6\u7533\u62a5\u7c7b\u516c\u544a\uff08\u7b2c 2 \u53f7\uff09<\/a>\uff1b<a href=\"https:\/\/ratchakitcha.soc.go.th\/documents\/17158355.pdf\" target=\"_blank\" rel=\"noopener\">\u767b\u8bb0\u7c7b\u516c\u544a<\/a>\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u98ce\u9669\u7c7b\u522b<\/th><th>\u6cd5\u5b9a\u7533\u8bf7\uff08\u6cf0\u6587\uff0f\u82f1\u6587\uff09<\/th><th>\u4f9d\u636e<\/th><th>\u51c6\u5907\u65f6\u5173\u6ce8\u4ec0\u4e48<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>Class 1<\/td><td>\u0e08\u0e14\u0e41\u0e08\u0e49\u0e07\uff0fListing<\/td><td>\u767b\u8bb0\u7c7b\u516c\u544a\u7b2c 2\u30013 \u6761\uff08\u975e IVD \u4e0e IVD\uff09<\/td><td>\u90e8\u4ee4\u8981\u6c42\u7684\u8d44\u6599\u4e3a\u4ea7\u54c1\u540d\u79f0\u53ca\u8bf4\u660e\u3001\u6807\u7b7e\u3001\u4ea7\u54c1\u89c4\u683c\uff0c\u6709 IFU \u7684\u53e6\u9644 IFU\u3002<\/td><\/tr>\n<tr><td>Class 2\u3001Class 3<\/td><td>\u0e41\u0e08\u0e49\u0e07\u0e23\u0e32\u0e22\u0e01\u0e32\u0e23\u0e25\u0e30\u0e40\u0e2d\u0e35\u0e22\u0e14\uff0fNotification<\/td><td>\u8be6\u7ec6\u7533\u62a5\u7c7b\u516c\u544a\uff08\u7b2c 2 \u53f7\uff09\u7b2c 1\u30012 \u6761<\/td><td>\u786e\u5b9a\u91c7\u7528 Full CSDT\u3001Abridged \u8fd8\u662f\u76d1\u7ba1\u4f9d\u8d56\u8def\u5f84\uff0c\u518d\u6309\u5bf9\u5e94\u68c0\u67e5\u8868\u51c6\u5907\u3002<\/td><\/tr>\n<tr><td>Class 4<\/td><td>\u0e43\u0e1a\u0e2d\u0e19\u0e38\u0e0d\u0e32\u0e15\uff0fLicence<\/td><td>\u8bb8\u53ef\u7c7b\u516c\u544a\u7b2c 2 \u6761<\/td><td>\u540c\u6837\u987b\u9009\u62e9\u8d44\u6599\u8def\u5f84\u3002\u4ee5 IVD \u4e3a\u4f8b\uff0cThai FDA \u7684 Full CSDT \u4e0e Abridged \u68c0\u67e5\u8868\u90fd\u8986\u76d6 Class 2 \u81f3 4\uff0c\u4f46 Class 4 \u7684\u4e34\u5e8a\u62a5\u544a\u8981\u6c42\u6700\u9ad8\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p><span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/ratchakitcha.soc.go.th\/documents\/17201114.pdf\" target=\"_blank\" rel=\"noopener\">\u767b\u8bb0\u90e8\u4ee4\u52d8\u8bef<\/a>\uff0c\u7b2c 2 \u6761\u7b2c\uff083\uff09\u9879\uff09<\/span><\/p>\n<p>\u5206\u7c7b\u5e94\u4f9d\u636e\u4ea7\u54c1\u5728\u6cf0\u56fd\u62df\u552e\u7684\u9884\u671f\u7528\u9014\u3001\u4f7f\u7528\u8005\u548c\u5de5\u4f5c\u539f\u7406\uff0c\u5957\u7528\u5bf9\u5e94\u9644\u4ef6\u7684\u89c4\u5219\uff1b\u540c\u4e00\u4ea7\u54c1\u7b26\u5408\u591a\u6761\u89c4\u5219\u65f6\uff0c\u53d6\u6700\u9ad8\u7c7b\u522b\u3002\u4e0d\u80fd\u76f4\u63a5\u6cbf\u7528\u5176\u4ed6\u56fd\u5bb6\u7684\u7c7b\u522b\u7f16\u53f7\u3002Thai FDA \u63d0\u4f9b\u5728\u7ebf\u81ea\u52a9\u5206\u7c7b\u5de5\u5177\uff0c\u5efa\u8bae\u53ea\u4f5c\u521d\u6b65\u5224\u65ad\uff1b\u5206\u7c7b\u6709\u4e89\u8bae\u65f6\uff0c\u6309 2562 \u5e74\u516c\u544a\u7b2c 4 \u6761\u7531 FDA \u79d8\u4e66\u957f\u88c1\u5b9a\u3002\u53e6\u5916\uff0c\u8be6\u7ec6\u7533\u62a5\u7c7b\u516c\u544a\u7b2c 9 \u6761\u548c\u8bb8\u53ef\u7c7b\u516c\u544a\u7b2c 7 \u6761\u89c4\u5b9a\uff0c\u67d0\u7c7b\u4ea7\u54c1\u5df2\u6709\u4e13\u95e8\u516c\u544a\u7684\uff0c\u4ee5\u4e13\u95e8\u516c\u544a\u4e3a\u51c6\uff0c\u56e0\u6b64\u5e94\u540c\u65f6\u68c0\u7d22\u4ea7\u54c1\u662f\u5426\u53e6\u6709\u4e13\u95e8\u89c4\u5b9a\u3002<\/p>\n\n<h2>\u7b2c\u4e8c\u6b65\uff1aFull CSDT\u3001Abridged \u4e0e\u76d1\u7ba1\u4f9d\u8d56\uff0c\u8d44\u6599\u5dee\u5728\u54ea\u91cc<\/h2>\n<p>CSDT \u662f\u6280\u672f\u8d44\u6599\u7684\u7ec4\u7ec7\u683c\u5f0f\uff0cFull\u3001Abridged \u548c\u76d1\u7ba1\u4f9d\u8d56\u662f\u4e09\u79cd\u8bc4\u4f30\u8def\u5f84\uff0c\u6240\u9700\u6587\u4ef6\u4e0d\u540c\u3002\u4e0b\u8868\u7efc\u5408 Thai FDA 2026 \u5e74 5 \u6708\u53d1\u5e03\u7684 IVD \u68c0\u67e5\u8868\uff0c\u4ee5\u53ca Thai FDA \u533b\u7597\u5668\u68b0\u7ba1\u7406\u5904\u4ecb\u7ecd Abridged \u8def\u5f84\u7684\u6f14\u793a\u6587\u4ef6\u3002\u6f14\u793a\u6587\u4ef6\u672a\u6ce8\u660e\u65e5\u671f\uff0c\u76d1\u7ba1\u4f9d\u8d56\u4e00\u680f\u53ea\u4f5c\u80cc\u666f\u53c2\u8003\uff0c\u9012\u4ea4\u524d\u5e94\u4ee5 Thai FDA \u73b0\u884c\u6e05\u5355\u4e3a\u51c6\u3002\u672c\u8282\u4e4b\u540e\u7684\u7b5b\u67e5\u6761\u4ef6\u548c\u68c0\u67e5\u8868\u8981\u6c42\u5747\u51fa\u81ea IVD \u68c0\u67e5\u8868\uff0cGMD \u4e0d\u80fd\u76f4\u63a5\u5957\u7528\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\">IVD Full CSDT \u68c0\u67e5\u8868<\/a>\uff1b<a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/07\/1KJ3JNOzAR9k2O7OLF9yTvh5.pdf\" target=\"_blank\" rel=\"noopener\">IVD Abridged \u68c0\u67e5\u8868<\/a>\uff1b<a href=\"https:\/\/www.pmda.go.jp\/files\/000280251.pdf\" target=\"_blank\" rel=\"noopener\">Thai FDA \u6f14\u793a\u6587\u4ef6<\/a>\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u8d44\u6599\u9879\u76ee<\/th><th>Full CSDT<\/th><th>Abridged<\/th><th>HSA \u76d1\u7ba1\u4f9d\u8d56<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u6807\u7b7e\u3001IFU\u3001\u6267\u884c\u6458\u8981\u3001\u5668\u68b0\u8bf4\u660e\u3001\u57fa\u672c\u539f\u5219\uff08EP\uff09\u3001\u751f\u4ea7\u6d41\u7a0b\u3001QMS \u8bc1\u4e66\u3001DoC\u3001LOA<\/td><td>\u9700\u8981<\/td><td>\u9700\u8981<\/td><td>\u9700\u8981<\/td><\/tr>\n<tr><td>Summary V&amp;V\uff08\u542b\u6027\u80fd\u53ca\u4e34\u5e8a\u62a5\u544a\uff09<\/td><td>\u9700\u8981<\/td><td>\u4e0d\u9700\u8981<\/td><td>\u9700\u8981<\/td><\/tr>\n<tr><td>\u98ce\u9669\u7ba1\u7406\u6587\u4ef6\uff08ISO 14971\uff09<\/td><td>\u9700\u8981<\/td><td>\u4e0d\u9700\u8981<\/td><td>\u9700\u8981<\/td><\/tr>\n<tr><td>\u9884\u671f\u7528\u9014\u3001\u4e0a\u5e02\u5386\u53f2\u53ca\u5b89\u5168\u58f0\u660e\uff08Thai FDA \u683c\u5f0f\uff09<\/td><td>\u4e0d\u9002\u7528<\/td><td>\u9700\u8981<\/td><td>\u4e0d\u9700\u8981<\/td><\/tr>\n<tr><td>\u53c2\u8003\u673a\u6784\u6279\u51c6\u8bc1\u660e<\/td><td>\u4e0d\u9002\u7528<\/td><td>\u9700\u8981\uff0c\u683c\u5f0f\u6309\u673a\u6784\u53ca\u7c7b\u522b\u89c4\u5b9a<\/td><td>HSA \u6279\u51c6\u8bc1\u660e<\/td><\/tr>\n<tr><td>HSA \u53d8\u66f4\u6279\u51c6\u3001\u53c2\u4e0e\u51fd\u3001\u540c\u610f\u4e66<\/td><td>\u4e0d\u9002\u7528<\/td><td>\u4e0d\u9002\u7528<\/td><td>\u9700\u8981\uff08\u53d8\u66f4\u6279\u51c6\u89c6\u60c5\u51b5\uff09<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u7531\u6b64\u53ef\u89c1\uff0cAbridged \u7701\u6389\u7684\u662f Summary V&amp;V \u548c\u98ce\u9669\u7ba1\u7406\u6587\u4ef6\uff0c\u4ee5\u53c2\u8003\u6279\u51c6\u53ca\u4e09\u4efd\u58f0\u660e\u4ee3\u66ff\uff1b\u76d1\u7ba1\u4f9d\u8d56\u5e76\u4e0d\u7701\u7565\u8fd9\u4e24\u9879\uff0c\u800c\u662f\u4f9d\u6258 HSA \u5df2\u5b8c\u6210\u7684\u8bc4\u5ba1\u3002\u9009\u62e9\u8def\u5f84\u524d\uff0c\u5e94\u5148\u786e\u8ba4\u4ea7\u54c1\u662f\u5426\u771f\u6b63\u5177\u5907\u76f8\u5e94\u8d44\u683c\u3002\u9a6c\u6765\u897f\u4e9a MDA \u6279\u51c6\u7684\u8ba4\u53ef\u5b89\u6392\u53e6\u6709\u6761\u4ef6\uff0c\u53ef\u53c2\u9605<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/thailand-fda-malaysia-mda-reliance-2026\/\">\u6cf0\u56fd FDA \u8ba4\u53ef\u9a6c\u6765\u897f\u4e9a MDA<\/a>\u3002<\/p>\n\n<h2>IVD \u80fd\u5426\u8d70 Abridged\uff1f\u5148\u8fc7\u4e09\u9879\u7b5b\u67e5<\/h2>\n<p>Thai FDA \u7684 IVD Class 2\u20134 Abridged \u68c0\u67e5\u8868\uff08IVD_MDCD_CL_AB Rev.1\uff0c2026 \u5e74 5 \u6708 25 \u65e5\uff09\u7b2c 1 \u90e8\u5206\u5217\u51fa\u4e09\u9879\u7b5b\u67e5\u6761\u4ef6\uff0c\u987b\u5168\u90e8\u6ee1\u8db3\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/07\/1KJ3JNOzAR9k2O7OLF9yTvh5.pdf\" target=\"_blank\" rel=\"noopener\">IVD Abridged \u68c0\u67e5\u8868<\/a>\uff0c\u7b2c 1 \u9875\uff09<\/span><\/p>\n<ul>\n<li><strong>\u6ce8\u518c\u5386\u53f2\uff1a<\/strong>\u5728 Thai FDA \u8ba4\u53ef\u7684\u673a\u6784\u6709 1 \u5e74\u4ee5\u4e0a\u6ce8\u518c\u5386\u53f2\uff0c\u5373 TGA\u3001Health Canada\u3001EU Notified Body\u3001\u65e5\u672c MHLW\u3001US FDA \u6216 WHO \u9884\u8ba4\u8bc1\u3002Listing\u3001Class A\/Class 1 \u53ca\u4ec5\u51fa\u53e3\u6279\u51c6\u7b49\u672a\u7ecf\u8d28\u91cf\u3001\u5b89\u5168\u548c\u6027\u80fd\u8bc4\u4ef7\u7684\u6279\u51c6\u4e0d\u8ba1\u5165\u3002<\/li>\n<li><strong>\u975e\u4e13\u95e8\u7ba1\u5236\u4ea7\u54c1\uff1a<\/strong>\u4e0d\u5c5e\u4e8e\u536b\u751f\u90e8\u4e13\u95e8\u516c\u544a\u7ba1\u5236\u7684 HIV \u68c0\u6d4b\u8bd5\u5242\u3001HIV \u81ea\u6211\u7b5b\u67e5\u8bd5\u5242\u53ca\u7532\u57fa\u82ef\u4e19\u80fa\u5c3f\u6db2\u68c0\u6d4b\u8bd5\u5242\u3002<\/li>\n<li><strong>\u5b89\u5168\u8bb0\u5f55\uff1a<\/strong>\u4e0a\u5e02\u4ee5\u6765\u6ca1\u6709\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff0c\u4e5f\u6ca1\u6709\u672a\u7ed3\u7684\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\uff08FSCA\uff09\u3002<\/li>\n<\/ul>\n<p>\u901a\u8fc7\u7b5b\u67e5\uff0c\u4e5f\u4e0d\u4ee3\u8868\u8bc4\u5ba1\u4f1a\u6309 Abridged \u7ed3\u675f\uff1a\u68c0\u67e5\u8868\u6ce8\u660e\uff0c\u5ba1\u8bc4\u4eba\u5458\u5bf9\u8d28\u91cf\u3001\u6027\u80fd\u6216\u5b89\u5168\u6709\u7591\u95ee\u65f6\uff0c\u53ef\u8981\u6c42\u8865\u5145\u8d44\u6599\uff0c\u4e5f\u53ef\u4ea4\u5916\u90e8\u4e13\u5bb6\u8bc4\u4f30\u3002\u53e6\u987b\u6ce8\u610f\uff0c\u53c2\u8003\u6279\u51c6\u8bc1\u660e\u7684\u683c\u5f0f\u968f\u673a\u6784\u548c\u7c7b\u522b\u53d8\u5316\u3002\u4ee5 EU IVDR \u4e3a\u4f8b\uff0cClass A\uff08\u975e\u65e0\u83cc\uff09\u53ea\u9700 DoC\uff1bClass A\uff08\u65e0\u83cc\uff09\u53ca Class B\u3001C \u53e6\u9700 Notified Body \u7b7e\u53d1\u7684 QMS \u8bc1\u4e66\uff1b\u8fd1\u60a3\u8005\u68c0\u6d4b\u3001\u81ea\u6d4b\u3001\u4f34\u968f\u8bca\u65ad\u53ca Class D \u8fd8\u9700\u6280\u672f\u6587\u4ef6\u8bc4\u4f30\u8bc1\u4e66\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a\u540c\u4e0a\uff0c\u7b2c 12 \u9879\uff09<\/span>\u672c\u6587\u53ea\u6838\u5bf9\u4e86 IVD \u68c0\u67e5\u8868\uff0cGMD \u5e94\u6309 Thai FDA \u5bf9\u5e94\u7684 GMD \u68c0\u67e5\u8868\u53e6\u884c\u6838\u5bf9\u3002<\/p>\n\n<h2>IVD Full CSDT \u4e2d\u5bb9\u6613\u4f4e\u4f30\u7684\u56db\u9879\u8981\u6c42<\/h2>\n<p>\u4ee5\u4e0b\u8981\u6c42\u6458\u81ea Thai FDA \u7684 IVD Class 2\u20134 Full CSDT \u68c0\u67e5\u8868\uff08IVD_MDCD_CL_FU Rev.01\uff0c2026 \u5e74 5 \u6708 25 \u65e5\uff09\u3002Thai FDA \u7684 IVD \u8d44\u6599\u9875\u8bf4\u660e\uff0c2026 \u5e74 5 \u6708 25 \u65e5\u4fee\u8ba2\u7684\u68c0\u67e5\u8868\u548c\u8bc4\u4f30\u8868\uff0c\u9002\u7528\u4e8e\u81ea 2026 \u5e74 7 \u6708 1 \u65e5\u8d77\u7f34\u7eb3\u7533\u8bf7\u8d39\u7684\u7533\u8bf7\uff1b2025 \u5e74\u6807\u7b7e\u516c\u544a\u5219\u4e8e 2026 \u5e74 6 \u6708 20 \u65e5\u751f\u6548\u3002\u4ee5\u4e0b\u56db\u9879\u5747\u9488\u5bf9 IVD\uff0cGMD \u5e94\u6309 Thai FDA \u5bf9\u5e94\u7684 GMD \u68c0\u67e5\u8868\u53e6\u884c\u6838\u5bf9\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/medical.fda.moph.go.th\/ivd-head\/ivd-02-02-03-document\" target=\"_blank\" rel=\"noopener\">Thai FDA IVD \u7533\u8bf7\u8d44\u6599\u9875<\/a>\uff1b<a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/06\/pwsETXUtwPxhT8wSpPJ5LDsc.pdf\" target=\"_blank\" rel=\"noopener\">IVD Full CSDT \u68c0\u67e5\u8868<\/a>\uff0c\u7b2c 1\u30013\u300113\u300119 \u9875\uff09<\/span><\/p>\n<ul>\n<li><strong>\u4e34\u5e8a\u62a5\u544a\u6df1\u5ea6\u968f\u7c7b\u522b\u9012\u589e\uff1a<\/strong>\u4f9d IMDRF\uff08GHTF\/SG5\/N8:2012\uff09\uff0cClass 2 \u53ea\u9700\u7814\u7a76\u65b9\u6848\u3001\u7ed3\u679c\u548c\u7ed3\u8bba\u7684\u6458\u8981\uff1bClass 3 \u987b\u63d0\u4ea4\u5b8c\u6574\u62a5\u544a\uff1bClass 4 \u987b\u63d0\u4ea4\u5b8c\u6574\u62a5\u544a\u53ca\u539f\u59cb\u6570\u636e\u3002<\/li>\n<li><strong>QMS \u8bc1\u4e66\u8303\u56f4\uff1a<\/strong>ISO 13485 \u5e94\u8986\u76d6\u8bbe\u8ba1\u5f00\u53d1\u3001\u751f\u4ea7\u548c\u5206\u9500\uff1b\u6709\u5b9e\u9645\u751f\u4ea7\u5546\u7684\uff0c\u987b\u540c\u65f6\u63d0\u4ea4\u4ea7\u54c1\u6240\u6709\u8005\u548c\u5b9e\u9645\u751f\u4ea7\u5546\u7684\u8bc1\u4e66\uff1b\u8303\u56f4\u4e0d\u5168\u7684\uff0c\u987b\u9644\u5ba1\u6838\u62a5\u544a\u3002<\/li>\n<li><strong>\u4e13\u95e8\u516c\u544a\u4ea7\u54c1\uff1a<\/strong>HIV \u7b49\u53d7\u4e13\u95e8\u516c\u544a\u7ba1\u5236\u7684\u4ea7\u54c1\uff0c\u987b\u53e6\u9644\u6cf0\u56fd\u533b\u5b66\u79d1\u5b66\u5385\uff08\u0e01\u0e23\u0e21\u0e27\u0e34\u0e17\u0e22\u0e4c\u0e2f\uff09\u7684\u68c0\u6d4b\u7ed3\u679c\u3002<\/li>\n<li><strong>\u8bed\u8a00\u4e0e\u9012\u4ea4\uff1a<\/strong>\u8d44\u6599\u7531\u4ea7\u54c1\u6240\u6709\u8005\u6216\u5236\u9020\u5546\u7f16\u5236\uff0c\u4f7f\u7528\u82f1\u6587\uff08\u6cf0\u56fd\u672c\u5730\u5236\u9020\u5546\u53ef\u7528\u6cf0\u6587\uff09\uff0c\u7ecf e-submission \u7cfb\u7edf\u9012\u4ea4\uff0c\u5883\u5916\u5236\u9020\u5546\u4e0d\u80fd\u76f4\u63a5\u5411 Thai FDA \u9012\u4ea4\u3002\u6807\u7b7e\u53ca IFU \u8fd8\u987b\u7b26\u5408 2026 \u5e74 6 \u6708 20 \u65e5\u751f\u6548\u7684 2568 \u5e74\u6807\u7b7e\u516c\u544a\u3002<\/li>\n<\/ul>\n<p>\u65e7\u9879\u76ee\u6587\u4ef6\u4e2d\u53ef\u80fd\u51fa\u73b0 Partial \u7b49\u65e9\u671f\u8def\u5f84\u540d\u79f0\u30022026 \u5e74 IVD \u68c0\u67e5\u8868\u53ea\u6709 Full CSDT \u548c Abridged \u4e24\u79cd\u3002\u5bf9\u4ee5 Partial 2 \u9012\u4ea4\u3001\u90e8\u5206\u8d44\u6599\u83b7\u8c41\u514d\u672a\u4ea4\u7684\u65e2\u6709\u4ea7\u54c1\uff0cThai FDA \u7684 IVD \u8d44\u6599\u9875\u7b54\u590d\uff1a\u6ee1 5 \u5e74\u540e\u5982\u9700\u7ee7\u7eed\u751f\u4ea7\u6216\u8fdb\u53e3\uff0c\u987b\u7533\u8bf7\u7eed\u671f\uff0c\u53ef\u901a\u8fc7\u201c\u8865\u5145\u6587\u4ef6\u7cfb\u7edf\u201d\uff08\u0e23\u0e30\u0e1a\u0e1a\u0e40\u0e1e\u0e34\u0e48\u0e21\u0e40\u0e15\u0e34\u0e21\u0e40\u0e2d\u0e01\u0e2a\u0e32\u0e23\uff09\u628a\u7533\u8bf7\u7531 Partial \u8c03\u6574\u4e3a Full CSDT\u3002\u65b0\u7533\u8bf7\u4e0d\u80fd\u51ed\u65e7\u8bb0\u5f55\u6cbf\u7528 Partial \u8def\u5f84\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/medical.fda.moph.go.th\/ivd-head\/ivd-02-02-03-document\" target=\"_blank\" rel=\"noopener\">Thai FDA IVD \u7533\u8bf7\u8d44\u6599\u9875<\/a>\uff09<\/span><\/p>\n\n<h2>\u8bf4\u660e\u6027\u793a\u4f8b\uff1a\u4e00\u5f20 CE \u8bc1\u4e66\u80fd\u63a8\u5bfc\u51fa\u4ec0\u4e48<\/h2>\n<p>\u4ee5\u4e0b\u4e3a\u8bf4\u660e\u6027\u5047\u8bbe\uff0c\u4e0d\u4ee3\u8868\u4efb\u4f55\u4ea7\u54c1\u7684\u6b63\u5f0f\u5206\u7c7b\u6216\u5ba1\u6279\u7ed3\u679c\u3002\u67d0\u5236\u9020\u5546\u62df\u8fdb\u53e3\u4e00\u6b3e\u4e13\u4e1a\u7528 IVD\uff0c\u7ecf\u6cf0\u56fd\u89c4\u5219\u5224\u5b9a\u4e3a Class 2\uff0c\u56e0\u6b64\u6cd5\u5b9a\u7533\u8bf7\u4e3a Notification\u3002\u8be5\u4ea7\u54c1\u6301\u6709 EU IVDR Class B \u7684 Notified Body \u8bc1\u4e66\uff0c\u5728\u6b27\u76df\u5df2\u6ce8\u518c 18 \u4e2a\u6708\u3002<\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u68c0\u67e5\u70b9<\/th><th>\u672c\u4f8b\u60c5\u51b5<\/th><th>\u7ed3\u8bba\u6216\u4e0b\u4e00\u6b65<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u53c2\u8003\u673a\u6784\u53ca\u6ce8\u518c\u5386\u53f2<\/td><td>EU Notified Body\uff0c\u5df2\u6ee1 18 \u4e2a\u6708<\/td><td>\u7b26\u5408\u201c1 \u5e74\u4ee5\u4e0a\u201d\uff0c\u4fdd\u5b58\u9996\u6b21\u6279\u51c6\u65e5\u671f\u7684\u8bc1\u660e\u3002<\/td><\/tr>\n<tr><td>\u4e13\u95e8\u7ba1\u5236\u4ea7\u54c1<\/td><td>\u4e0d\u5c5e\u4e8e HIV \u6216\u7532\u57fa\u82ef\u4e19\u80fa\u68c0\u6d4b<\/td><td>\u7b26\u5408\uff1b\u5982\u7528\u9014\u6539\u53d8\u987b\u91cd\u65b0\u6838\u5bf9\u3002<\/td><\/tr>\n<tr><td>\u5b89\u5168\u8bb0\u5f55<\/td><td>\u987b\u7531\u5236\u9020\u5546\u786e\u8ba4<\/td><td>\u53d6\u5f97\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u53ca FSCA \u8bb0\u5f55\uff0c\u6309 Thai FDA \u683c\u5f0f\u7b7e\u7f72\u58f0\u660e\u3002<\/td><\/tr>\n<tr><td>\u53c2\u8003\u6279\u51c6\u8bc1\u660e<\/td><td>IVDR Class B<\/td><td>\u51c6\u5907 DoC \u53ca Notified Body \u7b7e\u53d1\u7684 QMS \u8bc1\u4e66\u3002<\/td><\/tr>\n<tr><td>\u578b\u53f7\u8986\u76d6<\/td><td>\u8bc1\u4e66\u8986\u76d6 A\u3001B \u4e24\u6b3e\uff0c\u6cf0\u56fd\u62df\u589e\u52a0 C \u6b3e<\/td><td>C \u6b3e\u5355\u72ec\u5217\u51fa\uff1b\u5982\u53c2\u8003\u6279\u51c6\u4e0d\u8986\u76d6 C \u6b3e\uff0cC \u6b3e\u4e0d\u80fd\u6cbf\u7528 A\u3001B \u4e24\u6b3e\u7684 Abridged \u4f9d\u636e\uff0c\u5e94\u53e6\u884c\u8bc4\u4f30\u8def\u5f84\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u62a5\u4ef7\u9636\u6bb5\u53ef\u6309 Abridged \u521d\u6b65\u4f30\u7b97\uff0c\u4f46\u5e94\u5199\u660e\u4ee5\u8868\u4e2d\u5404\u9879\u80fd\u53d6\u5f97\u4e66\u9762\u8bc1\u636e\u4e3a\u524d\u63d0\uff1b\u9012\u4ea4\u524d\u4efb\u4f55\u4e00\u9879\u65e0\u6cd5\u8bc1\u660e\uff0c\u5c31\u9700\u6539\u6309 Full CSDT \u51c6\u5907\uff0c\u9884\u7559 Summary V&amp;V \u4e0e\u98ce\u9669\u7ba1\u7406\u6587\u4ef6\u7684\u5de5\u4f5c\u91cf\u3002<\/p>\n\n<h2>\u7528\u4e00\u5f20\u4e00\u81f4\u6027\u5bf9\u7167\u8868\u7ba1\u7406\u63d0\u4ea4\u8303\u56f4<\/h2>\n<p>\u4ee5\u4e0b\u662f MediPass \u5efa\u8bae\u7684\u9879\u76ee\u7ba1\u7406\u65b9\u6cd5\uff0c\u5e76\u975e\u5b98\u65b9\u8868\u683c\u3002\u68c0\u67e5\u8868\u8981\u6c42\u591a\u4efd\u6587\u4ef6\u4e2d\u7684\u540c\u4e00\u4fe1\u606f\u4fdd\u6301\u4e00\u81f4\uff0c\u53ef\u4ee5\u628a\u8fd9\u4e9b\u8981\u6c42\u6574\u7406\u6210\u5bf9\u7167\u8868\uff0c\u5728\u7ffb\u8bd1\u548c\u7b7e\u5b57\u524d\u5b8c\u6210\u6838\u5bf9\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/07\/1KJ3JNOzAR9k2O7OLF9yTvh5.pdf\" target=\"_blank\" rel=\"noopener\">IVD Abridged \u68c0\u67e5\u8868<\/a>\uff0c\u7b2c 2\u20133 \u9875\uff1b<a href=\"https:\/\/cms-media.fda.moph.go.th\/461115679123316736\/2026\/06\/pwsETXUtwPxhT8wSpPJ5LDsc.pdf\" target=\"_blank\" rel=\"noopener\">IVD Full CSDT \u68c0\u67e5\u8868<\/a>\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u6838\u5bf9\u9879<\/th><th>\u987b\u4fdd\u6301\u4e00\u81f4\u7684\u6587\u4ef6<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u82f1\u6587\u4ea7\u54c1\u540d\u79f0<\/td><td>\u7533\u8bf7\u8868\u3001\u6807\u7b7e\u3001IFU\u3001\u578b\u53f7\u6e05\u5355\u3001DoC\u3001LOA<\/td><\/tr>\n<tr><td>\u4ea7\u54c1\u6240\u6709\u8005\u540d\u79f0\u53ca\u5730\u5740<\/td><td>\u7533\u8bf7\u8868\u3001\u6807\u7b7e\u3001DoC<\/td><\/tr>\n<tr><td>\u5883\u5916\u5236\u9020\u5546\u53ca\u751f\u4ea7\u573a\u6240<\/td><td>\u578b\u53f7\u6e05\u5355\u3001DoC \u6240\u5217\u5b9e\u9645\u751f\u4ea7\u5546\u3001\u751f\u4ea7\u6d41\u7a0b\u3001QMS \u8bc1\u4e66<\/td><\/tr>\n<tr><td>\u9884\u671f\u7528\u9014<\/td><td>\u5668\u68b0\u8bf4\u660e\u3001IFU\u3001\u5404\u56fd\u6279\u51c6\u5386\u53f2\u8868<\/td><\/tr>\n<tr><td>\u9002\u7528\u6807\u51c6\u53ca\u7248\u672c<\/td><td>DoC\u3001\u57fa\u672c\u539f\u5219\uff08EP\uff09\u8868<\/td><\/tr>\n<tr><td>\u98ce\u9669\u7c7b\u522b<\/td><td>\u7533\u8bf7\u8868\u3001DoC<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u5efa\u8bae\u5148\u89e3\u51b3\u7528\u9014\u3001\u4f7f\u7528\u8005\u548c\u578b\u53f7\u8303\u56f4\u65b9\u9762\u7684\u5dee\u5f02\uff0c\u56e0\u4e3a\u5b83\u4eec\u51b3\u5b9a\u54ea\u4e9b\u62a5\u544a\u53ef\u4ee5\u5171\u7528\u3001\u53c2\u8003\u6279\u51c6\u80fd\u5426\u9002\u7528\uff1b\u4e4b\u540e\u518d\u5b89\u6392\u7ffb\u8bd1\u3001\u8865\u6d4b\u548c\u5236\u9020\u5546\u7b7e\u5b57\u6587\u4ef6\u3002<\/p>\n\n<section class=\"faq\">\n<h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n<p><strong>Class 2 \u6216 Class 3 \u4ea7\u54c1\u90fd\u53ef\u4ee5\u8d70 Abridged \u5417\uff1f<\/strong><br\/>\u4e0d\u80fd\u3002\u98ce\u9669\u7c7b\u522b\u53ea\u51b3\u5b9a\u6cd5\u5b9a\u7533\u8bf7\u7c7b\u578b\u3002\u80fd\u5426\u8d70 Abridged\uff0c\u8981\u770b\u53c2\u8003\u6279\u51c6\u3001\u6ce8\u518c\u5386\u53f2\u3001\u4e13\u95e8\u516c\u544a\u548c\u5b89\u5168\u8bb0\u5f55\u7b49\u7b5b\u67e5\u6761\u4ef6\uff1b\u4ee5 IVD \u4e3a\u4f8b\uff0c\u4efb\u4f55\u4e00\u9879\u4e0d\u6ee1\u8db3\uff0c\u5c31\u5e94\u6309 Full CSDT \u51c6\u5907\u3002<\/p>\n<p><strong>Class 4 IVD \u80fd\u5426\u91c7\u7528 Abridged\uff1f<\/strong><br\/>Thai FDA \u7684 IVD Abridged \u68c0\u67e5\u8868\u9002\u7528\u4e8e Class 2 \u81f3 4\uff0cClass 4 \u5e76\u4e0d\u5f53\u7136\u6392\u9664\u3002\u4f46 HIV \u76f8\u5173\u68c0\u6d4b\u8bd5\u5242\u7b49\u4e13\u95e8\u7ba1\u5236\u4ea7\u54c1\u4e0d\u9002\u7528\uff0c\u5176\u4ed6\u7b5b\u67e5\u6761\u4ef6\u4e5f\u987b\u5168\u90e8\u6ee1\u8db3\u3002<\/p>\n<p><strong>Full CSDT \u662f\u5426\u610f\u5473\u7740\u6240\u6709\u68c0\u6d4b\u90fd\u8981\u5728\u6cf0\u56fd\u91cd\u505a\uff1f<\/strong><br\/>IVD Full CSDT \u68c0\u67e5\u8868\u6ca1\u6709\u4e00\u822c\u6027\u5730\u8981\u6c42\u5728\u6cf0\u56fd\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\uff0c\u4e3b\u8981\u8981\u6c42\u6027\u80fd\u548c\u4e34\u5e8a\u62a5\u544a\u7b26\u5408\u89c4\u5b9a\u7684\u7ed3\u6784\u548c\u6df1\u5ea6\u3002\u4f8b\u5916\u662f HIV \u7b49\u4e13\u95e8\u516c\u544a\u4ea7\u54c1\uff0c\u987b\u53e6\u9644\u6cf0\u56fd\u533b\u5b66\u79d1\u5b66\u5385\u7684\u68c0\u6d4b\u7ed3\u679c\u3002<\/p>\n<p><strong>\u6b27\u76df\u81ea\u6211\u58f0\u660e\u7684 CE \u80fd\u4f5c\u4e3a Abridged \u7684\u53c2\u8003\u6279\u51c6\u5417\uff1f<\/strong><br\/>\u987b\u540c\u65f6\u6ee1\u8db3\u4e24\u9879\u8981\u6c42\uff1a\u68c0\u67e5\u8868\u7b2c 12 \u9879\u5217\u660e\u4e86\u5404\u7c7b\u6b27\u76df\u6279\u51c6\u7684\u8bc1\u660e\u6587\u4ef6\u683c\u5f0f\uff0c\u4f46\u7b2c 1 \u9879\u7b5b\u67e5\u6392\u9664 Listing\u3001Class A\/Class 1 \u7b49\u672a\u7ecf\u8d28\u91cf\u3001\u5b89\u5168\u548c\u6027\u80fd\u8bc4\u4ef7\u7684\u6279\u51c6\u3002\u5e94\u6309\u4ea7\u54c1\u5728\u6b27\u76df\u7684\u5b9e\u9645\u7c7b\u522b\u9010\u9879\u6838\u5bf9\uff0c\u4e0d\u5b9c\u7b3c\u7edf\u5730\u8ba4\u4e3a CE \u5373\u53ef\u3002<\/p>\n<p><strong>\u5df2\u6709\u8fdb\u53e3\u573a\u6240\u8bb8\u53ef\uff0c\u662f\u5426\u8fd8\u8981\u529e\u4ea7\u54c1\u7533\u8bf7\uff1f<\/strong><br\/>\u8981\u3002\u4e09\u4efd\u516c\u544a\u5206\u522b\u89c4\u5b9a\u4e86\u5236\u9020\u5546\u6216\u8fdb\u53e3\u5546\u987b\u53d6\u5f97\u8bb8\u53ef\u3001\u8be6\u7ec6\u7533\u62a5\u6216\u767b\u8bb0\u7684\u4ea7\u54c1\u8303\u56f4\uff0c\u573a\u6240\u8bb8\u53ef\u4e0d\u80fd\u66ff\u4ee3\u4ea7\u54c1\u7533\u8bf7\u3002IVD Full CSDT \u68c0\u67e5\u8868\u8fd8\u8981\u6c42\u7533\u8bf7\u4eba\u7684\u573a\u6240\u8bb8\u53ef\u8986\u76d6\u6240\u7533\u8bf7\u7684\u8303\u56f4\u3002\u573a\u6240\u8bb8\u53ef\u53ef\u53c2\u9605 <a href=\"https:\/\/aseanmedipass.com\/zh-hans\/establishment-licensing\/\">MediPass \u573a\u6240\u8bb8\u53ef\u670d\u52a1<\/a>\u3002<\/p>\n<\/section>\n\n<aside class=\"article-cta\"><p class=\"eyebrow\">\u6cf0\u56fd\u6ce8\u518c\u8def\u5f84\u8bc4\u4f30<\/p><h3>\u5148\u786e\u8ba4\u7c7b\u522b\u4e0e\u8d44\u6599\u8def\u5f84\uff0c\u518d\u62a5\u4ef7\u6392\u671f<\/h3><p>\u8bf7\u5148\u63d0\u4f9b <strong>\u4ea7\u54c1\u540d\u79f0\u53ca\u62df\u552e\u578b\u53f7\u3001\u9884\u671f\u7528\u9014\uff0c\u4ee5\u53ca\u5df2\u6709\u7684\u5883\u5916\u6279\u51c6<\/strong>\uff0c\u5176\u4ed6\u8d44\u6599\u53ef\u5728\u9879\u76ee\u542f\u52a8\u540e\u518d\u8865\u5145\u3002MediPass \u53ef\u636e\u6b64\u521d\u6b65\u5224\u65ad\u6cf0\u56fd\u7c7b\u522b\u548c\u53ef\u884c\u7684\u8d44\u6599\u8def\u5f84\uff0c\u5e76\u7ed9\u51fa\u62a5\u4ef7\uff1b\u53c2\u8003\u6279\u51c6\u8986\u76d6\u8303\u56f4\u7684\u6838\u5bf9\u548c\u8d44\u6599\u6e05\u5355\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\/\">\u54a8\u8be2\u6cf0\u56fd\u6ce8\u518c\u8def\u5f84<\/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\u670d\u52a1<\/strong><span>\u5206\u7c7b\u3001\u5206\u7ec4\u3001\u672c\u5730\u6301\u8bc1\u4e0e\u6ce8\u518c\u6d41\u7a0b\u6982\u89c8\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/thailand-fda-malaysia-mda-reliance-2026\/\"><strong>\u6cf0\u56fd FDA \u8ba4\u53ef\u9a6c\u6765\u897f\u4e9a MDA<\/strong><span>\u4ee5\u9a6c\u6765\u897f\u4e9a\u6279\u51c6\u7533\u8bf7\u6cf0\u56fd\u6ce8\u518c\u7684\u6761\u4ef6\u4e0e\u8d44\u6599\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<\/strong><span>\u83b7\u6279\u540e\u589e\u52a0\u578b\u53f7\u6216\u4fee\u6539\u8d44\u6599\u65f6\u7684\u53d8\u66f4\u7533\u8bf7\u3002<\/span><\/a><\/li>\n<\/ul><\/section>\n\n<section class=\"references\"><h2>\u5b98\u65b9\u53c2\u8003\u8d44\u6599<\/h2><ol>\n<li>\u6cf0\u56fd\u536b\u751f\u90e8\uff0c\u0e1b\u0e23\u0e30\u0e01\u0e32\u0e28\u0e01\u0e23\u0e30\u0e17\u0e23\u0e27\u0e07\u0e2a\u0e32\u0e18\u0e32\u0e23\u0e13\u0e2a\u0e38\u0e02 \u0e40\u0e23\u0e37\u0e48\u0e2d\u0e07 \u0e01\u0e32\u0e23\u0e08\u0e31\u0e14\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c\u0e15\u0e32\u0e21\u0e23\u0e30\u0e14\u0e31\u0e1a\u0e04\u0e27\u0e32\u0e21\u0e40\u0e2a\u0e35\u0e48\u0e22\u0e07 \u0e1e.\u0e28. \u0e52\u0e55\u0e56\u0e52\uff08\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7ea7\u516c\u544a\uff09\uff0c\u7b2c 1\u20145 \u6761\u53ca\u9644\u4ef6\u4e00\u3001\u4e8c\uff0c2019-11-14 \u7b7e\u7f72\uff0c\u653f\u5e9c\u516c\u62a5\u7b2c 136 \u5377\u7279\u520a 308 \u0e07\uff0c\u7b2c 53\u201454 \u9875\uff0c2019-12-18 \u520a\u767b\uff0c<a href=\"https:\/\/research.psu.ac.th\/wp-content\/uploads\/2025\/03\/27.%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B8%81%E0%B8%B2%E0%B8%A8%E0%B8%81%E0%B8%A3%E0%B8%B0%E0%B8%97%E0%B8%A3%E0%B8%A7%E0%B8%87%E0%B8%AA%E0%B8%B2%E0%B8%98%E0%B8%B2%E0%B8%A3%E0%B8%93%E0%B8%AA%E0%B8%B8%E0%B8%82-%E0%B9%80%E0%B8%A3%E0%B8%B7%E0%B9%88%E0%B8%AD%E0%B8%87-%E0%B8%81%E0%B8%B2%E0%B8%A3%E0%B8%88%E0%B8%B1%E0%B8%94%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%95%E0%B8%B2%E0%B8%A1%E0%B8%A3%E0%B8%B0%E0%B8%94%E0%B8%B1%E0%B8%9A%E0%B8%84%E0%B8%A7%E0%B8%B2%E0%B8%A1%E0%B9%80%E0%B8%AA%E0%B8%B5%E0%B9%88%E0%B8%A2%E0%B8%87-%E0%B8%9E.%E0%B8%A8.-%E0%B9%92%E0%B9%95%E0%B9%96%E0%B9%92.pdf\" target=\"_blank\" rel=\"noopener\">\u516c\u62a5\u6587\u672c\u526f\u672c\uff08research.psu.ac.th\uff09<\/a><\/li>\n<li>\u6cf0\u56fd\u536b\u751f\u90e8\uff0c\u0e1b\u0e23\u0e30\u0e01\u0e32\u0e28\u0e01\u0e23\u0e30\u0e17\u0e23\u0e27\u0e07\u0e2a\u0e32\u0e18\u0e32\u0e23\u0e13\u0e2a\u0e38\u0e02 \u0e40\u0e23\u0e37\u0e48\u0e2d\u0e07 \u0e01\u0e25\u0e38\u0e48\u0e21\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c\u0e2b\u0e23\u0e37\u0e2d\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c\u0e17\u0e35\u0e48\u0e1c\u0e39\u0e49\u0e1c\u0e25\u0e34\u0e15\u0e2b\u0e23\u0e37\u0e2d\u0e1c\u0e39\u0e49\u0e19\u0e33\u0e40\u0e02\u0e49\u0e32\u0e15\u0e49\u0e2d\u0e07\u0e44\u0e14\u0e49\u0e23\u0e31\u0e1a\u0e2d\u0e19\u0e38\u0e0d\u0e32\u0e15 \u0e1e.\u0e28. \u0e52\u0e55\u0e56\u0e53\uff08\u987b\u53d6\u5f97\u8bb8\u53ef\u7684\u533b\u7597\u5668\u68b0\u516c\u544a\uff09\uff0c\u7b2c 2\u30017\u30018 \u6761\uff0c\u653f\u5e9c\u516c\u62a5\u7b2c 138 \u5377\u7279\u520a 35 \u0e07\uff0c\u7b2c 57\u201460 \u9875\uff0c2021-02-15\uff0c<a href=\"https:\/\/ratchakitcha.soc.go.th\/documents\/17158353.pdf\" target=\"_blank\" rel=\"noopener\">ratchakitcha.soc.go.th<\/a><\/li>\n<li>\u6cf0\u56fd\u536b\u751f\u90e8\uff0c\u0e1b\u0e23\u0e30\u0e01\u0e32\u0e28\u0e01\u0e23\u0e30\u0e17\u0e23\u0e27\u0e07\u0e2a\u0e32\u0e18\u0e32\u0e23\u0e13\u0e2a\u0e38\u0e02 \u0e40\u0e23\u0e37\u0e48\u0e2d\u0e07 \u0e01\u0e25\u0e38\u0e48\u0e21\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c\u0e2b\u0e23\u0e37\u0e2d\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c\u0e17\u0e35\u0e48\u0e1c\u0e39\u0e49\u0e1c\u0e25\u0e34\u0e15\u0e2b\u0e23\u0e37\u0e2d\u0e1c\u0e39\u0e49\u0e19\u0e33\u0e40\u0e02\u0e49\u0e32\u0e15\u0e49\u0e2d\u0e07\u0e41\u0e08\u0e49\u0e07\u0e23\u0e32\u0e22\u0e01\u0e32\u0e23\u0e25\u0e30\u0e40\u0e2d\u0e35\u0e22\u0e14 (\u0e09\u0e1a\u0e31\u0e1a\u0e17\u0e35\u0e48 \u0e52) \u0e1e.\u0e28. \u0e52\u0e55\u0e56\u0e53\uff08\u987b\u8be6\u7ec6\u7533\u62a5\u7684\u533b\u7597\u5668\u68b0\u516c\u544a\uff09\uff0c\u7b2c 1\u20143\u30019 \u6761\uff0c\u653f\u5e9c\u516c\u62a5\u7b2c 138 \u5377\u7279\u520a 35 \u0e07\uff0c\u7b2c 61\u201468 \u9875\uff0c2021-02-15\uff0c<a href=\"https:\/\/ratchakitcha.soc.go.th\/documents\/17158354.pdf\" target=\"_blank\" rel=\"noopener\">ratchakitcha.soc.go.th<\/a><\/li>\n<li>\u6cf0\u56fd\u536b\u751f\u90e8\uff0c\u0e1b\u0e23\u0e30\u0e01\u0e32\u0e28\u0e01\u0e23\u0e30\u0e17\u0e23\u0e27\u0e07\u0e2a\u0e32\u0e18\u0e32\u0e23\u0e13\u0e2a\u0e38\u0e02 \u0e40\u0e23\u0e37\u0e48\u0e2d\u0e07 \u0e01\u0e25\u0e38\u0e48\u0e21\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c\u0e2b\u0e23\u0e37\u0e2d\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c\u0e17\u0e35\u0e48\u0e1c\u0e39\u0e49\u0e1c\u0e25\u0e34\u0e15\u0e2b\u0e23\u0e37\u0e2d\u0e1c\u0e39\u0e49\u0e19\u0e33\u0e40\u0e02\u0e49\u0e32\u0e15\u0e49\u0e2d\u0e07\u0e08\u0e14\u0e41\u0e08\u0e49\u0e07 \u0e1e.\u0e28. \u0e52\u0e55\u0e56\u0e53\uff08\u987b\u767b\u8bb0\u7684\u533b\u7597\u5668\u68b0\u516c\u544a\uff09\uff0c\u7b2c 2\u30013\u30018 \u6761\uff0c\u653f\u5e9c\u516c\u62a5\u7b2c 138 \u5377\u7279\u520a 35 \u0e07\uff0c\u7b2c 69\u201473 \u9875\uff0c2021-02-15 \u520a\u767b\uff0c\u520a\u767b\u540e 30 \u65e5\u751f\u6548\uff0c<a href=\"https:\/\/ratchakitcha.soc.go.th\/documents\/17158355.pdf\" target=\"_blank\" rel=\"noopener\">ratchakitcha.soc.go.th<\/a><\/li>\n<li>Thai FDA\uff0c\u5173\u4e8e 2563 \u5e74\u533b\u7597\u5668\u68b0\u767b\u8bb0\u90e8\u4ee4\uff08\u0e01\u0e0e\u0e01\u0e23\u0e30\u0e17\u0e23\u0e27\u0e07 \u0e01\u0e32\u0e23\u0e08\u0e14\u0e41\u0e08\u0e49\u0e07\u0e41\u0e25\u0e30\u0e01\u0e32\u0e23\u0e2d\u0e2d\u0e01\u0e43\u0e1a\u0e23\u0e31\u0e1a\u0e08\u0e14\u0e41\u0e08\u0e49\u0e07\u0e1c\u0e25\u0e34\u0e15\u0e2b\u0e23\u0e37\u0e2d\u0e19\u0e33\u0e40\u0e02\u0e49\u0e32\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c \u0e1e.\u0e28. \u0e52\u0e55\u0e56\u0e53\uff09\u7684\u52d8\u8bef\u516c\u544a\uff0c\u7b2c 2 \u6761\u7b2c\uff083\uff09\u9879\uff1a\u767b\u8bb0\u8d44\u6599\uff0c\u653f\u5e9c\u516c\u62a5\u7b2c 139 \u5377 16 \u0e01\uff0c\u7b2c 21 \u9875\uff0c2022-03-10\uff0c<a href=\"https:\/\/ratchakitcha.soc.go.th\/documents\/17201114.pdf\" target=\"_blank\" rel=\"noopener\">ratchakitcha.soc.go.th<\/a><\/li>\n<li>Thai FDA \u533b\u7597\u5668\u68b0\u7ba1\u7406\u5904\uff0cIVD Class 2\u20134 Full CSDT \u68c0\u67e5\u8868\uff08IVD_MDCD_CL_FU Rev.01\uff09\uff0c\u7b2c 1 \u9875\uff08\u6807\u7b7e\u516c\u544a\u751f\u6548\u65e5\uff09\u3001\u7b2c 3 \u9875\uff08\u8bed\u8a00\u53ca e-submission \u9012\u4ea4\uff09\u3001\u7b2c 13 \u9875\uff08\u4e34\u5e8a\u62a5\u544a\u6df1\u5ea6\u3001\u4e13\u95e8\u516c\u544a\u4ea7\u54c1\uff09\u3001\u7b2c 19 \u9875\uff08QMS \u8bc1\u4e66\u8303\u56f4\uff09\uff0c2026-05-25\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\u7406\u5904\uff0cIVD Class 2\u20134 Abridged \u68c0\u67e5\u8868\uff08IVD_MDCD_CL_AB Rev.1\uff09\uff0c\u7b2c 1\u20143 \u9875\u7b5b\u67e5\u6761\u4ef6\u53ca\u7533\u8bf7\u5b57\u6bb5\u3001\u7b2c 12 \u9879\u53c2\u8003\u6279\u51c6\u8bc1\u660e\uff0c2026-05-25\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 \u533b\u7597\u5668\u68b0\u7ba1\u7406\u5904\uff0cAbridged Pathway Review for Medical Device Regulation in Thailand\uff08\u6f14\u793a\u6587\u4ef6\uff0cFull\u3001Abridged \u4e0e\u76d1\u7ba1\u4f9d\u8d56\u8def\u5f84\u8d44\u6599\u5bf9\u6bd4\uff09\uff0c\u672a\u6ce8\u660e\u65e5\u671f\uff0c<a href=\"https:\/\/www.pmda.go.jp\/files\/000280251.pdf\" target=\"_blank\" rel=\"noopener\">pmda.go.jp\uff08PDF\uff09<\/a><\/li>\n<li>Thai FDA \u533b\u7597\u5668\u68b0\u7ba1\u7406\u53f8\uff0cIVD \u7533\u8bf7\u8d44\u6599\u9875\uff08\u68c0\u67e5\u8868\u9002\u7528\u4e8e 2026-07-01 \u8d77\u7f34\u8d39\u7684\u7533\u8bf7\uff1bPartial 2 \u7eed\u671f\u95ee\u7b54\uff09\uff0c<a href=\"https:\/\/medical.fda.moph.go.th\/ivd-head\/ivd-02-02-03-document\" target=\"_blank\" rel=\"noopener\">medical.fda.moph.go.th<\/a><\/li>\n<\/ol><p class=\"note\">\u672c\u6587\u4f9d\u636e\u622a\u81f3 2026 \u5e74 7 \u6708 3 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