{"id":5939,"date":"2026-03-18T10:00:00","date_gmt":"2026-03-18T02:00:00","guid":{"rendered":"https:\/\/aseanmedipass.com\/?p=5939"},"modified":"2026-10-27T20:24:17","modified_gmt":"2026-10-27T12:24:17","slug":"thailand-medical-device-amendment-change-2026","status":"publish","type":"post","link":"https:\/\/aseanmedipass.com\/zh-hans\/thailand-medical-device-amendment-change-2026\/","title":{"rendered":"\u6cf0\u56fd\u533b\u7597\u5668\u68b0\u53d8\u66f4\u7533\u62a5\uff1a2026 \u5e74\u51c6\u5219\u7684\u5206\u7c7b\u3001\u8d39\u7528\u4e0e\u7cfb\u7edf"},"content":{"rendered":"\n<style>.postid-5939 .entry-header{display:none}.postid-5939 #primary{width:100%;margin:0}.postid-5939 #secondary{display:none}.postid-5939 #content .ast-container{max-width:844px!important;width:100%;padding:0!important}.postid-5939 .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-5939 .ast-article-single{padding:32px 22px!important}}.postid-5939 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\u53d8\u66f4\u7533\u62a5\uff1a2026 \u5e74\u51c6\u5219\u7684\u5206\u7c7b\u3001\u8d39\u7528\u4e0e\u7cfb\u7edf<\/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=\"2026-03-18T10:00:00+08:00\">2026\u5e743\u670818\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>\u5236\u9020\u5546\u7684\u533b\u7597\u5668\u68b0\uff08GMD\uff09\u4e0e\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff08IVD\uff09\u5728\u6cf0\u56fd\u62ff\u5230\u8bc1\u4e66\u4e00\u5e74\u540e\uff0c\u603b\u90e8\u901a\u77e5\uff1a\u6cd5\u5b9a\u5236\u9020\u5546\u66f4\u540d\u3001\u65b0\u589e\u4e24\u4e2a\u578b\u53f7\u3001\u8bf4\u660e\u4e66\u6539\u7248\u3001ISO 13485 \u8bc1\u4e66\u6362\u4e86\u8ba4\u8bc1\u673a\u6784\u3002\u6cf0\u56fd\u6301\u8bc1\u4eba\u8981\u56de\u7b54\u7684\u7b2c\u4e00\u4e2a\u95ee\u9898\uff0c\u4e0d\u662f&#8221;\u8981\u4ec0\u4e48\u6587\u4ef6&#8221;\uff0c\u800c\u662f&#8221;\u6bcf\u4e00\u9879\u6539\u52a8\u5728 2026 \u5e74\u51c6\u5219\u91cc\u5c5e\u4e8e\u54ea\u4e00\u79cd\uff1a\u8bc4\u4f30\u540e\u6279\u51c6\u3001\u81ea\u52a8\u6838\u51c6\uff0c\u8fd8\u662f\u6839\u672c\u4e0d\u80fd\u53d8\u66f4\u3001\u53ea\u80fd\u91cd\u65b0\u6ce8\u518c&#8221;\u3002<\/p>\n<p><strong>\u6cf0\u56fd FDA 2026 \u5e74\u53d8\u66f4\u51c6\u5219\u6309\u53d8\u66f4\u7c7b\u578b\u800c\u4e0d\u662f\u98ce\u9669\u7b49\u7ea7\u51b3\u5b9a\u8def\u5f84\uff1a\u540c\u4e3a Class 2\u20134\uff0c\u6709\u7684\u53d8\u66f4\u987b\u7ecf\u5b98\u5458\u6216\u5916\u90e8\u4e13\u5bb6\u8bc4\u4f30\u540e\u6279\u51c6\uff0c\u6709\u7684\u63d0\u4ea4\u540e\u7531\u7cfb\u7edf\u81ea\u52a8\u6838\u51c6\uff1bClass 1 \u540c\u6837\u4e24\u79cd\u60c5\u5f62\u90fd\u6709\u3002\u8d39\u7528\u3001\u6587\u4ef6\u4e0e\u53ef\u5b9e\u65bd\u65f6\u70b9\u90fd\u968f\u8fd9\u4e2a\u5206\u7c7b\u800c\u5b9a\u3002<\/strong><\/p>\n<aside class=\"summary\"><p class=\"eyebrow\">\u8981\u70b9\u901f\u89c8<\/p><dl>\n<dt>\u7a0b\u5e8f\/\u7c7b\u522b<\/dt><dd>2026 \u5e74\u51c6\u5219\u5206\u4e24\u7ea7\uff1a\u8bc4\u4f30\u540e\u6279\u51c6\uff08\u7531\u5b98\u5458\u6216\u5916\u90e8\u4e13\u5bb6\u8bc4\u4f30\uff09\u4e0e\u7cfb\u7edf\u81ea\u52a8\u6838\u51c6\uff08Auto approve\uff09\uff1b\u53e6\u6709\u4e0d\u80fd\u53d8\u66f4\u3001\u987b\u91cd\u65b0\u6ce8\u518c\u7684\u60c5\u5f62\u3002<\/dd>\n<dt>\u8d39\u7528<\/dt><dd>Class 2\u20134\uff1a\u6bcf\u4efd\u7533\u8bf7 500 \u6cf0\u94e2\uff0c\u6279\u51c6\u540e\u7f34\u4ed8\uff1b\u5982\u9700\u5916\u90e8\u4e13\u5bb6\u8bc4\u4f30\uff0c\u53e6\u6536\u8be6\u7ec6\u7533\u62a5\u7c7b\u5236\u9020 19,200 \/ \u8fdb\u53e3 24,000\uff0c\u8bb8\u53ef\u7c7b\u5236\u9020 24,000 \/ \u8fdb\u53e3 30,000 \u6cf0\u94e2\u3002Class 1 \u4e00\u822c\u514d\u8d39\uff0c\u9700\u4e13\u5bb6\u8bc4\u4f30\u65f6 15,000 \u6cf0\u94e2\u3002<\/dd>\n<dt>\u65f6\u9650<\/dt><dd>\u5b98\u65b9\u672a\u516c\u5e03\u9002\u7528\u4e8e\u65b0\u51c6\u5219\u5168\u90e8\u53d8\u66f4\u7c7b\u578b\u7684\u7edf\u4e00\u5ba1\u8bc4\u65f6\u9650\u3002<\/dd>\n<dt>\u7cfb\u7edf\/\u6e20\u9053<\/dt><dd>\u5168\u90e8\u7ecf Skynet \u7535\u5b50\u63d0\u4ea4\uff1b\u51c6\u5219\u4e0e\u64cd\u4f5c\u624b\u518c\u4e8e 2026 \u5e74 3 \u6708\u53d1\u5e03\u3002<\/dd>\n<dt>\u5173\u952e\u70b9<\/dt><dd>\u4ea7\u54c1\u6240\u6709\u4eba\u7531 A \u6cd5\u4eba\u6539\u4e3a B \u6cd5\u4eba\u4e0d\u80fd\u8d70\u53d8\u66f4\uff1b\u98ce\u9669\u7b49\u7ea7\u6539\u53d8\u5bfc\u81f4\u8bc1\u4e66\u7c7b\u578b\u6539\u53d8\u3001\u65e0\u6cd5\u5f52\u5165\u539f\u7ec4\u522b\u6216\u901a\u7528\u540d\u79f0\u4e0d\u540c\u7684\uff0c\u987b\u91cd\u65b0\u6ce8\u518c\u3002<\/dd>\n<\/dl><\/aside>\n\n<h2>\u54ea\u4e9b\u6539\u52a8\u6839\u672c\u4e0d\u80fd\u8d70\u53d8\u66f4\u7533\u62a5\uff1f<\/h2>\n<p>2026 \u5e74\u51c6\u5219\u7b2c 2 \u8282\u5148\u6392\u9664\u4e0d\u80fd\u53d8\u66f4\u7684\u60c5\u5f62\u3002\u98ce\u9669\u7b49\u7ea7\u6539\u53d8\u5e76\u5bfc\u81f4\u8bc1\u4e66\u7c7b\u578b\u6539\u53d8\uff08\u4f8b\u5982\u7531\u8be6\u7ec6\u7533\u62a5\u53d8\u4e3a\u8bb8\u53ef\uff09\u3001\u65b0\u589e\u4ea7\u54c1\u65e0\u6cd5\u4e0e\u539f\u8bc1\u4e66\u5f52\u7ec4\uff0c\u6216\u901a\u7528\u540d\u79f0\u4e0d\u540c\u7684\uff0c\u987b\u6309\u65b0\u4ea7\u54c1\u7533\u8bf7\u6ce8\u518c\u3002\u4ea7\u54c1\u6240\u6709\u4eba\u7531 A \u6cd5\u4eba\u53d8\u4e3a B \u6cd5\u4eba\uff0c\u4e5f\u4e0d\u80fd\u5728\u539f\u8bc1\u4e0a\u4fee\u6539\uff1b\u82e5\u662f\u5408\u5e76\u540e\u4ecd\u4e3a\u540c\u4e00\u6cd5\u4eba\uff0c\u5219\u53ef\u7533\u8bf7\u53d8\u66f4\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/medical.fda.moph.go.th\/product\/rules-for-amendments-new\" target=\"_blank\" rel=\"noopener\">Thai FDA, \u0e2b\u0e25\u0e31\u0e01\u0e40\u0e01\u0e13\u0e11\u0e4c\u0e01\u0e32\u0e23\u0e41\u0e01\u0e49\u0e44\u0e02\u0e40\u0e1b\u0e25\u0e35\u0e48\u0e22\u0e19\u0e41\u0e1b\u0e25\u0e07\u0e2a\u0e33\u0e2b\u0e23\u0e31\u0e1a\u0e07\u0e32\u0e19\u0e1c\u0e25\u0e34\u0e15\u0e20\u0e31\u0e13\u0e11\u0e4c\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c, 2026-03-16, \u00a72.1\u20132.2<\/a>\uff09<\/span><\/p>\n<p>\u66f4\u6362\u6cf0\u56fd\u6301\u8bc1\u4eba\uff08\u8fdb\u53e3\u5546\uff09\u540c\u6837\u4e0d\u662f\u53d8\u66f4\u7533\u62a5\uff0c\u800c\u662f\u6d89\u53ca\u539f\u6301\u8bc1\u4eba\u540c\u610f\u4e0e\u539f\u8bc1\u6ce8\u9500\u7684\u8f6c\u8bc1\u7a0b\u5e8f\uff08\u89c1\u5ef6\u4f38\u9605\u8bfb\uff09\u3002\u628a\u8fd9\u4e9b\u60c5\u5f62\u5148\u5254\u9664\uff0c\u518d\u5bf9\u5269\u4f59\u6539\u52a8\u9010\u9879\u5206\u7c7b\u3002<\/p>\n\n<h2>&#8220;\u8bc4\u4f30\u540e\u6279\u51c6&#8221;\u548c&#8221;\u81ea\u52a8\u6838\u51c6&#8221;\u5982\u4f55\u533a\u5206\uff1f<\/h2>\n<p>\u51c6\u5219\u7b2c 3.1 \u8282\u5217\u51fa\u987b\u5728\u6279\u51c6\u524d\u8bc4\u4f30\u7684\u53d8\u66f4\u3002Class 2\u20134 \u5305\u62ec\u516b\u7c7b\uff0c\u4e3b\u8981\u6d89\u53ca\u5236\u9020\u573a\u5730\u3001\u751f\u4ea7\u5de5\u827a\u4e0e\u8d28\u91cf\u4f53\u7cfb\u3001\u8bbe\u8ba1\u6216\u89c4\u683c\u3001\u8f6f\u4ef6\u3001\u6750\u6599\u3001\u6807\u7b7e\u4e0e\u8bf4\u660e\u4e66\uff0c\u4ee5\u53ca\u5728\u7ec4\u5185\u65b0\u589e\u578b\u53f7\u7b49\uff1b\u8bc4\u4f30\u7531\u5b98\u5458\u8fdb\u884c\uff0c\u5fc5\u8981\u65f6\u4ea4\u5916\u90e8\u4e13\u5bb6\u3002Class 1 \u4e5f\u6709\u9700\u8981\u8bc4\u4f30\u7684\u53d8\u66f4\uff0c\u5982\u6807\u7b7e\u6587\u5b57\u3001\u5206\u7ec4\u8c03\u6574\u7b49\u3002\u51c6\u5219\u6240\u79f0\u6b21\u8981\u53d8\u66f4\uff08Minor\uff09\u6307\u7531\u5b98\u5458\u8bc4\u4f30\u540e\u6279\u51c6\uff0c\u91cd\u5927\u53d8\u66f4\uff08Major\uff09\u6307\u7531\u5916\u90e8\u4e13\u5bb6\u6216\u5b98\u5458\u8bc4\u4f30\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/medical.fda.moph.go.th\/product\/rules-for-amendments-new\" target=\"_blank\" rel=\"noopener\">Thai FDA, \u0e2b\u0e25\u0e31\u0e01\u0e40\u0e01\u0e13\u0e11\u0e4c\u0e01\u0e32\u0e23\u0e41\u0e01\u0e49\u0e44\u0e02\u0e40\u0e1b\u0e25\u0e35\u0e48\u0e22\u0e19\u0e41\u0e1b\u0e25\u0e07\u0e2a\u0e33\u0e2b\u0e23\u0e31\u0e1a\u0e07\u0e32\u0e19\u0e1c\u0e25\u0e34\u0e15\u0e20\u0e31\u0e13\u0e11\u0e4c\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c, 2026-03-16, \u00a73.1<\/a>\uff09<\/span><\/p>\n<p>\u7b2c 3.2 \u8282\u5217\u51fa\u7cfb\u7edf\u81ea\u52a8\u6838\u51c6\u7684\u53d8\u66f4\u3002Class 2\u20134 \u5305\u62ec QMS \u8bc1\u4e66\u8303\u56f4\u66f4\u65b0\u3001\u66f4\u6362\u8ba4\u8bc1\u673a\u6784\u3001ISO \u8bc1\u4e66\u66f4\u65b0\u3001\u573a\u6240\u4fe1\u606f\u53d8\u66f4\u548c\u5220\u51cf\u578b\u53f7\uff1bClass 1 \u5305\u62ec\u5883\u5916\u5236\u9020\u5546\u540d\u79f0\u6216\u5730\u5740\u53d8\u66f4\uff08\u672a\u642c\u8fc1\uff09\u3001\u5408\u5e76\u540e\u7684\u4ea7\u54c1\u6240\u6709\u4eba\u540d\u79f0\u53d8\u66f4\u3001\u7b26\u5408\u6027\u58f0\u660e\u66f4\u65b0\u3001\u5220\u51cf\u54c1\u9879\u3001\u8f6f\u4ef6\u4fe1\u606f\u548c\u573a\u6240\u4fe1\u606f\u53d8\u66f4\u3002\u81ea\u52a8\u6838\u51c6\u662f\u6307\u7cfb\u7edf\u5b8c\u6210\u6838\u51c6\uff0c\u4e0d\u7b49\u4e8e\u63d0\u4ea4\u5373\u53ef\u5b9e\u65bd\uff1b\u5e94\u4ee5\u7cfb\u7edf\u6838\u51c6\u4e3a\u51c6\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/medical.fda.moph.go.th\/product\/rules-for-amendments-new\" target=\"_blank\" rel=\"noopener\">Thai FDA, \u0e2b\u0e25\u0e31\u0e01\u0e40\u0e01\u0e13\u0e11\u0e4c\u0e01\u0e32\u0e23\u0e41\u0e01\u0e49\u0e44\u0e02\u0e40\u0e1b\u0e25\u0e35\u0e48\u0e22\u0e19\u0e41\u0e1b\u0e25\u0e07\u0e2a\u0e33\u0e2b\u0e23\u0e31\u0e1a\u0e07\u0e32\u0e19\u0e1c\u0e25\u0e34\u0e15\u0e20\u0e31\u0e13\u0e11\u0e4c\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c, 2026-03-16, \u00a73.2<\/a>\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u5206\u7c7b<\/th><th>Class 2\u20134\uff08\u8be6\u7ec6\u7533\u62a5 \/ \u8bb8\u53ef\uff09<\/th><th>Class 1\uff08\u5217\u540d\uff09<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u8bc4\u4f30\u540e\u6279\u51c6\uff08\u5b98\u5458\u6216\u5916\u90e8\u4e13\u5bb6\uff09<\/td><td>\u5236\u9020\u573a\u5730\/\u5de5\u827a\/QMS\u3001\u8bbe\u8ba1\u6216\u89c4\u683c\u3001\u8f6f\u4ef6\u3001\u6750\u6599\u3001\u6807\u7b7e\u4e0e\u8bf4\u660e\u4e66\u3001\u7ec4\u5185\u65b0\u589e\u578b\u53f7\u7b49\u516b\u7c7b\uff1b500 \u6cf0\u94e2\uff0c\u6279\u51c6\u540e\u7f34\u4ed8\uff1b\u9700\u4e13\u5bb6\u8bc4\u4f30\u65f6\u53e6\u6536\u4e13\u5bb6\u8d39<\/td><td>\u6807\u7b7e\u6587\u5b57\u3001\u5206\u7ec4\u8c03\u6574\u7b49\uff1b\u514d\u8d39\uff0c\u9700\u4e13\u5bb6\u8bc4\u4f30\u65f6 15,000 \u6cf0\u94e2<\/td><\/tr>\n<tr><td>\u7cfb\u7edf\u81ea\u52a8\u6838\u51c6<\/td><td>QMS \u8bc1\u4e66\u8303\u56f4\u3001\u66f4\u6362\u8ba4\u8bc1\u673a\u6784\u3001ISO \u66f4\u65b0\u3001\u573a\u6240\u4fe1\u606f\u3001\u5220\u51cf\u578b\u53f7\uff1b500 \u6cf0\u94e2<\/td><td>\u5883\u5916\u5236\u9020\u5546\u540d\u79f0\/\u5730\u5740\uff08\u672a\u642c\u8fc1\uff09\u3001\u5408\u5e76\u540e\u4ea7\u54c1\u6240\u6709\u4eba\u540d\u79f0\u3001DoC\u3001\u5220\u51cf\u54c1\u9879\u3001\u8f6f\u4ef6\u4fe1\u606f\u3001\u573a\u6240\u4fe1\u606f\uff1b\u514d\u8d39<\/td><\/tr>\n<tr><td>\u4e0d\u80fd\u53d8\u66f4<\/td><td colspan=\"2\">\u98ce\u9669\u7b49\u7ea7\u6539\u53d8\u5bfc\u81f4\u8bc1\u4e66\u7c7b\u578b\u6539\u53d8\u3001\u65e0\u6cd5\u5f52\u7ec4\u3001\u901a\u7528\u540d\u79f0\u4e0d\u540c\uff1b\u4ea7\u54c1\u6240\u6709\u4eba A \u6cd5\u4eba\u6539\u4e3a B \u6cd5\u4eba \u2192 \u91cd\u65b0\u6ce8\u518c<\/td><\/tr>\n<\/tbody><\/table><\/div>\n\n<h2>\u8d39\u7528\u600e\u6837\u8ba1\u7b97\uff1f\u4e13\u5bb6\u8d39\u662f\u4e0d\u662f\u5fc5\u6536\uff1f<\/h2>\n<p>Class 2\u20134 \u6bcf\u4efd\u53d8\u66f4\u7533\u8bf7 500 \u6cf0\u94e2\uff0c\u5728\u6279\u51c6\u540e\u7f34\u4ed8\u3002\u5916\u90e8\u4e13\u5bb6\u8bc4\u4f30\u8d39\u53ea\u5728\u7533\u8bf7\u786e\u9700\u4e13\u5bb6\u8bc4\u4f30\u65f6\u6536\u53d6\uff0c\u5e76\u975e\u6240\u6709&#8221;\u91cd\u5927&#8221;\u53d8\u66f4\u7684\u56fa\u5b9a\u8d39\u7528\uff1a\u8be6\u7ec6\u7533\u62a5\u7c7b\u5236\u9020 19,200 \u6cf0\u94e2\u3001\u8fdb\u53e3 24,000 \u6cf0\u94e2\uff0c\u8bb8\u53ef\u7c7b\u5236\u9020 24,000 \u6cf0\u94e2\u3001\u8fdb\u53e3 30,000 \u6cf0\u94e2\u3002Class 1 \u53d8\u66f4\u4e00\u822c\u514d\u8d39\uff0c\u9700\u4e13\u5bb6\u8bc4\u4f30\u65f6\u4e3a 15,000 \u6cf0\u94e2\u3002\u5b9e\u9645\u91d1\u989d\u4ee5 FDA \u51fa\u5177\u7684\u7f34\u8d39\u901a\u77e5\u4e3a\u51c6\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/medical.fda.moph.go.th\/product\/rules-for-amendments-new\" target=\"_blank\" rel=\"noopener\">Thai FDA, \u0e2b\u0e25\u0e31\u0e01\u0e40\u0e01\u0e13\u0e11\u0e4c\u0e01\u0e32\u0e23\u0e41\u0e01\u0e49\u0e44\u0e02\u0e40\u0e1b\u0e25\u0e35\u0e48\u0e22\u0e19\u0e41\u0e1b\u0e25\u0e07\u0e2a\u0e33\u0e2b\u0e23\u0e31\u0e1a\u0e07\u0e32\u0e19\u0e1c\u0e25\u0e34\u0e15\u0e20\u0e31\u0e13\u0e11\u0e4c\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c, 2026-03-16, \u00a73.1\u20133.2<\/a>\uff1b<a href=\"https:\/\/medical.fda.moph.go.th\/active-head\/pdtregist-expense\/\" target=\"_blank\" rel=\"noopener\">Thai FDA, \u0e04\u0e48\u0e32\u0e18\u0e23\u0e23\u0e21\u0e40\u0e19\u0e35\u0e22\u0e21\/\u0e04\u0e48\u0e32\u0e43\u0e0a\u0e49\u0e08\u0e48\u0e32\u0e22, 2024-02-20<\/a>\uff09<\/span><\/p>\n\n<h2>\u6587\u4ef6\u600e\u6837\u51c6\u5907\uff1f<\/h2>\n<p>\u51c6\u5219\u6309\u53d8\u66f4\u7c7b\u578b\u5217\u51fa\u9644\u4ef6\u6e05\u5355\uff0c\u6587\u4ef6\u5e94\u9010\u9879\u5bf9\u7167\u5bf9\u5e94\u7c7b\u578b\u51c6\u5907\uff0c\u800c\u4e0d\u662f\u5957\u7528\u4e00\u4efd\u7edf\u4e00\u6e05\u5355\u3002\u6280\u672f\u6027\u53d8\u66f4\u5e38\u89c1\u7684\u9644\u4ef6\u5305\u62ec\u65b0\u65e7\u5bf9\u6bd4\u8868\u3001\u9a8c\u8bc1\u4e0e\u786e\u8ba4\uff08V&amp;V\uff09\u6458\u8981\u3001\u98ce\u9669\u5206\u6790\u548c\u66f4\u65b0\u540e\u7684\u6807\u7b7e\u4e0e\u8bf4\u660e\u4e66\uff1b\u53c2\u8003\u56fd\u6279\u51c6\u8bc1\u636e\u3001\u4e34\u5e8a\u8bc1\u636e\u6216\u7f51\u7edc\u5b89\u5168\u6587\u4ef6\u53ea\u5728\u5bf9\u5e94\u53d8\u66f4\u7c7b\u578b\u8981\u6c42\u65f6\u63d0\u4ea4\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/medical.fda.moph.go.th\/product\/rules-for-amendments-new\" target=\"_blank\" rel=\"noopener\">Thai FDA, \u0e2b\u0e25\u0e31\u0e01\u0e40\u0e01\u0e13\u0e11\u0e4c\u0e01\u0e32\u0e23\u0e41\u0e01\u0e49\u0e44\u0e02\u0e40\u0e1b\u0e25\u0e35\u0e48\u0e22\u0e19\u0e41\u0e1b\u0e25\u0e07\u0e2a\u0e33\u0e2b\u0e23\u0e31\u0e1a\u0e07\u0e32\u0e19\u0e1c\u0e25\u0e34\u0e15\u0e20\u0e31\u0e13\u0e11\u0e4c\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c, 2026-03-16<\/a>\uff09<\/span><\/p>\n<p>\u5b9e\u52a1\u4e0a\u6700\u5e38\u62d6\u6162\u8fdb\u5ea6\u7684\u662f\u65b0\u65e7\u5bf9\u6bd4\u8868\uff1a\u603b\u90e8\u53d8\u66f4\u901a\u77e5\u5e38\u53ea\u5199&#8221;\u66f4\u65b0&#8221;\uff0c\u800c\u6cf0\u56fd\u7533\u62a5\u9700\u8981\u9010\u9879\u5199\u6e05\u5dee\u5f02\u3002\u542f\u52a8\u524d\u5e94\u4e0e\u603b\u90e8 RA \u5bf9\u9f50\u5bf9\u6bd4\u5185\u5bb9\u548c\u6240\u9700\u8bc1\u4e66\u3002<\/p>\n\n<h2>\u65f6\u9650\u548c\u7cfb\u7edf\u73b0\u5728\u662f\u4ec0\u4e48\u60c5\u51b5\uff1f<\/h2>\n<p>\u6cf0\u56fd FDA \u5728 2026 \u5e74 3 \u6708 2 \u65e5\u53d1\u5e03\u65b0\u53d8\u66f4\u7cfb\u7edf\u901a\u544a\uff0c3 \u6708 16 \u65e5\u5728\u53d8\u66f4\u7a0b\u5e8f\u680f\u76ee\u53d1\u5e03\u65b0\u51c6\u5219\uff1b\u5168\u90e8\u53d8\u66f4\u7ecf Skynet \u7535\u5b50\u63d0\u4ea4\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/medical.fda.moph.go.th\/press-release\/new-system-edit-2026\" target=\"_blank\" rel=\"noopener\">Thai FDA, \u0e40\u0e15\u0e23\u0e35\u0e22\u0e21\u0e1e\u0e23\u0e49\u0e2d\u0e21\u0e40\u0e02\u0e49\u0e32\u0e2a\u0e39\u0e48\u0e23\u0e30\u0e1a\u0e1a\u0e41\u0e01\u0e49\u0e44\u0e02\u0e40\u0e1b\u0e25\u0e35\u0e48\u0e22\u0e19\u0e41\u0e1b\u0e25\u0e07\u0e23\u0e30\u0e1a\u0e1a\u0e43\u0e2b\u0e21\u0e48, 2026-03-02<\/a>\uff1b<a href=\"https:\/\/medical.fda.moph.go.th\/product\/rules-for-amendments-new\" target=\"_blank\" rel=\"noopener\">Thai FDA, \u0e2b\u0e25\u0e31\u0e01\u0e40\u0e01\u0e13\u0e11\u0e4c\u0e01\u0e32\u0e23\u0e41\u0e01\u0e49\u0e44\u0e02\u0e40\u0e1b\u0e25\u0e35\u0e48\u0e22\u0e19\u0e41\u0e1b\u0e25\u0e07\u0e2a\u0e33\u0e2b\u0e23\u0e31\u0e1a\u0e07\u0e32\u0e19\u0e1c\u0e25\u0e34\u0e15\u0e20\u0e31\u0e13\u0e11\u0e4c\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c, 2026-03-16<\/a>\uff09<\/span> MediPass \u4f5c\u4e3a\u6cf0\u56fd\u6301\u8bc1\u4e3b\u4f53\u7684\u5b9e\u52a1\u7ecf\u9a8c\u662f\uff0c\u8fd9\u5957\u65b0\u5236\u5ea6\u76ee\u524d\u5df2\u5728\u4f7f\u7528\u3002<\/p>\n<p>\u5b98\u65b9\u672a\u516c\u5e03\u9002\u7528\u4e8e\u65b0\u51c6\u5219\u5168\u90e8\u53d8\u66f4\u7c7b\u578b\u7684\u7edf\u4e00\u5ba1\u8bc4\u65f6\u9650\u3002\u6cf0\u56fd FDA 2024 \u5e74\u66fe\u516c\u544a\u6b21\u8981\u53d8\u66f4\u7535\u5b50\u63d0\u4ea4\u7684\u5ba1\u6279\u65f6\u9650\u4e3a 15 \u4e2a\u5de5\u4f5c\u65e5\uff0c\u4f46\u672a\u80fd\u786e\u8ba4\u8be5\u65f6\u9650\u9002\u7528\u4e8e\u65b0\u51c6\u5219\u4e0b\u7684\u5168\u90e8\u7533\u8bf7\uff0c\u6392\u671f\u65f6\u4e0d\u5b9c\u4f5c\u4e3a\u627f\u8bfa\u3002\u81ea\u52a8\u6838\u51c6\u7c7b\u53d8\u66f4\u901a\u5e38\u6700\u5feb\uff1b\u9700\u4e13\u5bb6\u8bc4\u4f30\u7684\u53d8\u66f4\u5e94\u9884\u7559\u8bc4\u4f30\u4e0e\u8865\u4ef6\u5f80\u8fd4\u65f6\u95f4\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/en.fda.moph.go.th\/news\/fda-shortened-duration-on-permission-request-depending-on-medical-device-risk-based-classification\" target=\"_blank\" rel=\"noopener\">Thai FDA, FDA Shortened Duration on Permission Request, 2024-04-20<\/a>\uff09<\/span><\/p>\n\n<h2>\u5bf9\u9879\u76ee\u6392\u671f\u610f\u5473\u7740\u4ec0\u4e48\uff1f<\/h2>\n<p>\u4ee5\u5f00\u5934\u7684\u53d8\u66f4\u5305\u4e3a\u4f8b\uff08\u5047\u8bbe\u6027\u573a\u666f\uff0c\u5747\u4e3a Class 3 \u8fdb\u53e3\u8be6\u7ec6\u7533\u62a5\uff09\uff1aISO 13485 \u8bc1\u4e66\u66f4\u6362\u8ba4\u8bc1\u673a\u6784\u5c5e\u81ea\u52a8\u6838\u51c6\uff0c500 \u6cf0\u94e2\uff1b\u7ec4\u5185\u65b0\u589e\u4e24\u4e2a\u578b\u53f7\u3001\u8bf4\u660e\u4e66\u6539\u7248\u987b\u8bc4\u4f30\u540e\u6279\u51c6\uff0c\u5404 500 \u6cf0\u94e2\uff0c\u82e5\u5ba1\u67e5\u5458\u8ba4\u4e3a\u9700\u8981\u5916\u90e8\u4e13\u5bb6\uff0c\u53e6\u52a0 24,000 \u6cf0\u94e2\uff1b\u6cd5\u5b9a\u5236\u9020\u5546\u66f4\u540d\uff0c\u82e5\u4ec5\u662f\u540d\u79f0\u6216\u5730\u5740\u53d8\u66f4\u4e14\u672a\u642c\u8fc1\uff0c\u5e94\u5148\u6838\u5bf9\u51c6\u5219\u5bf9 Class 2\u20134 \u7684\u5f52\u7c7b\uff0c\u518d\u51b3\u5b9a\u5355\u72ec\u8fd8\u662f\u5408\u5e76\u63d0\u4ea4\u3002\u628a\u81ea\u52a8\u6838\u51c6\u9879\u5148\u63d0\u4ea4\uff0c\u8bc4\u4f30\u7c7b\u53d8\u66f4\u53e6\u884c\u6392\u671f\uff0c\u6cf0\u56fd\u4f9b\u8d27\u5c31\u4e0d\u4f1a\u88ab\u6700\u6162\u7684\u4e00\u9879\u62d6\u4f4f\u3002\u8d23\u4efb\u4e0a\uff0c\u6301\u8bc1\u4eba\u8d1f\u8d23 Skynet \u63d0\u4ea4\u4e0e\u7f34\u8d39\uff0c\u5236\u9020\u5546\u8d1f\u8d23\u6309\u9644\u4ef6\u6e05\u5355\u6309\u65f6\u4ea4\u4ed8\u6280\u672f\u6587\u4ef6\u3002<\/p>\n<p>\u53e6\u4e00\u4e2a\u8981\u70b9\u662f\u53d8\u66f4\u7684\u8d77\u56e0\uff1a\u56e0\u4e0d\u826f\u4e8b\u4ef6\u6216 FSCA \u89e6\u53d1\u7684\u8bbe\u8ba1\u6216\u6807\u7b7e\u53d8\u66f4\uff0c\u6cf0\u56fd FDA \u4f1a\u4e00\u5e76\u5ba1\u89c6\u76f8\u5173\u4e8b\u4ef6\u3002\u82e5\u4ea7\u54c1\u5728\u6cf0\u56fd\u6709\u8fdb\u884c\u4e2d\u7684 \u0e23.\u0e21.\u0e1e.3 \u62a5\u544a\uff0c\u53d8\u66f4\u7533\u62a5\u4e0e\u4e0a\u5e02\u540e\u62a5\u544a\u5e94\u7531\u540c\u4e00\u4eba\u7edf\u7b79\u3002<\/p>\n\n<section class=\"faq\"><h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n<p><strong>Class 1 \u5217\u540d\u8bc1\u4e66\u7684\u53d8\u66f4\u90fd\u662f\u81ea\u52a8\u6838\u51c6\u5417\uff1f<\/strong><br\/>\u4e0d\u662f\u3002\u51c6\u5219\u540c\u65f6\u5217\u51fa Class 1 \u9700\u8bc4\u4f30\u540e\u6279\u51c6\u7684\u53d8\u66f4\uff08\u5982\u6807\u7b7e\u6587\u5b57\u3001\u5206\u7ec4\u8c03\u6574\uff09\u548c\u53ef\u81ea\u52a8\u6838\u51c6\u7684\u53d8\u66f4\uff08\u5982\u5883\u5916\u5236\u9020\u5546\u540d\u79f0\u5730\u5740\u3001DoC\u3001\u8f6f\u4ef6\u4fe1\u606f\uff09\uff1b\u9700\u4e13\u5bb6\u8bc4\u4f30\u7684 Class 1 \u53d8\u66f4\u6536\u8d39 15,000 \u6cf0\u94e2\u3002<\/p>\n<p><strong>500 \u6cf0\u94e2\u548c\u4e13\u5bb6\u8bc4\u4f30\u8d39\u4ec0\u4e48\u65f6\u5019\u7f34\uff1f<\/strong><br\/>500 \u6cf0\u94e2\u7533\u8bf7\u8d39\u5728\u6279\u51c6\u540e\u7f34\u4ed8\uff1b\u4e13\u5bb6\u8bc4\u4f30\u8d39\u53ea\u5728\u786e\u9700\u5916\u90e8\u4e13\u5bb6\u8bc4\u4f30\u65f6\u6536\u53d6\uff0c\u4ee5 FDA \u7f34\u8d39\u901a\u77e5\u4e3a\u51c6\u3002<\/p>\n<p><strong>\u53d8\u66f4\u5c1a\u672a\u83b7\u6279\uff0c\u65e7\u7248\u6807\u7b7e\u7684\u5e93\u5b58\u53ef\u4ee5\u7ee7\u7eed\u9500\u552e\u5417\uff1f<\/strong><br\/>\u5b98\u65b9\u9875\u9762\u672a\u5bf9\u5e93\u5b58\u8fc7\u6e21\u4f5c\u51fa\u7edf\u4e00\u89c4\u5b9a\u3002\u5efa\u8bae\u7533\u62a5\u524d\u4e0e\u6301\u8bc1\u4eba\u786e\u8ba4\u5e93\u5b58\u4e0e\u6807\u7b7e\u7248\u672c\uff0c\u628a\u8fc7\u6e21\u5b89\u6392\u5199\u5165\u53d8\u66f4\u8ba1\u5212\uff0c\u5fc5\u8981\u65f6\u5411\u7ba1\u7406\u53f8\u786e\u8ba4\u3002<\/p>\n<p><strong>\u4ea7\u54c1\u6240\u6709\u4eba\u6362\u4e86\u516c\u53f8\uff0c\u53ef\u4ee5\u5728\u539f\u8bc1\u4e0a\u76f4\u63a5\u6539\u5417\uff1f<\/strong><br\/>\u7531 A \u6cd5\u4eba\u53d8\u4e3a B \u6cd5\u4eba\u4e0d\u80fd\u53d8\u66f4\uff0c\u987b\u91cd\u65b0\u6ce8\u518c\uff1b\u5408\u5e76\u540e\u4ecd\u4e3a\u540c\u4e00\u6cd5\u4eba\u7684\uff0c\u53ef\u7533\u8bf7\u53d8\u66f4\u3002\u66f4\u6362\u6cf0\u56fd\u6301\u8bc1\u4eba\u5219\u8d70\u8f6c\u8bc1\u7a0b\u5e8f\u3002<\/p>\n<\/section>\n\n<aside class=\"article-cta\"><p class=\"eyebrow\">\u6cf0\u56fd\u53d8\u66f4\u7533\u62a5\u652f\u6301<\/p><h3>\u51c6\u5907\u5411\u6cf0\u56fd FDA \u63d0\u4ea4\u53d8\u66f4\uff1f<\/h3><p>MediPass \u5728\u6cf0\u56fd\u6301\u6709\u81ea\u6709\u8fdb\u53e3\u8bb8\u53ef\uff0c\u53ef\u534f\u52a9\u5224\u5b9a\u53d8\u66f4\u7c7b\u578b\u3001\u6309\u51c6\u5219\u9644\u4ef6\u51c6\u5907\u6587\u4ef6\u5e76\u5728 Skynet \u4e2d\u63d0\u4ea4\u3002\u4e86\u89e3<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/post-market-support\/#changes-th\">\u6cf0\u56fd\u53d8\u66f4\u7533\u62a5\u670d\u52a1<\/a>\u4e0e<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/thailand-medical-device-registration\/\">\u6cf0\u56fd\u6ce8\u518c\u6307\u5357<\/a>\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\u53d8\u66f4\u7533\u62a5<\/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-adverse-event-fsca-reporting\/\"><strong>\u6cf0\u56fd\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u4e0e FSCA \u62a5\u544a\u4e49\u52a1<\/strong><span>\u0e23.\u0e21.\u0e1e.1\/2\/3 \u7684\u65f6\u9650\u3001\u5e74\u5ea6\u62a5\u544a\u4e0e\u4e94\u5e74\u7eed\u8bc1\u8981\u70b9\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/thailand-medical-device-licence-transfer\/\"><strong>\u6cf0\u56fd\u533b\u7597\u5668\u68b0\u8f6c\u8bc1\u6307\u5357<\/strong><span>\u66f4\u6362\u6301\u8bc1\u4eba\u65f6\u7684 Transfer \u6761\u4ef6\u3001\u540c\u610f\u4e66\u4e0e 30 \u5929\u6ce8\u9500\u4e49\u52a1\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/post-market-support\/#changes-th\"><strong>\u4e0a\u5e02\u540e\u652f\u6301\uff1a\u6cf0\u56fd\u53d8\u66f4\u7533\u62a5<\/strong><span>MediPass \u5728\u6cf0\u56fd\u7684\u53d8\u66f4\u5206\u7ea7\u3001\u6587\u4ef6\u51c6\u5907\u4e0e\u63d0\u4ea4\u670d\u52a1\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\u7406\u53f8\uff0c\u0e04\u0e48\u0e32\u0e18\u0e23\u0e23\u0e21\u0e40\u0e19\u0e35\u0e22\u0e21\/\u0e04\u0e48\u0e32\u0e43\u0e0a\u0e49\u0e08\u0e48\u0e32\u0e22\uff08\u8d39\u7528\u4e0e\u6536\u8d39\u9879\u76ee\uff09\uff0c2024-02-20\uff0c<a href=\"https:\/\/medical.fda.moph.go.th\/active-head\/pdtregist-expense\/\" target=\"_blank\" rel=\"noopener\">https:\/\/medical.fda.moph.go.th\/active-head\/pdtregist-expense\/<\/a><\/li>\n<li>Thai FDA \u533b\u7597\u5668\u68b0\u7ba1\u7406\u53f8\uff0c\u0e2b\u0e25\u0e31\u0e01\u0e40\u0e01\u0e13\u0e11\u0e4c\u0e01\u0e32\u0e23\u0e41\u0e01\u0e49\u0e44\u0e02\u0e40\u0e1b\u0e25\u0e35\u0e48\u0e22\u0e19\u0e41\u0e1b\u0e25\u0e07\u0e2a\u0e33\u0e2b\u0e23\u0e31\u0e1a\u0e07\u0e32\u0e19\u0e1c\u0e25\u0e34\u0e15\u0e20\u0e31\u0e13\u0e11\u0e4c\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c\uff08\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u53d8\u66f4\u51c6\u5219\uff09\uff0c2026-03-16\uff0c<a href=\"https:\/\/medical.fda.moph.go.th\/product\/rules-for-amendments-new\" target=\"_blank\" rel=\"noopener\">https:\/\/medical.fda.moph.go.th\/product\/rules-for-amendments-new<\/a><\/li>\n<li>Thai FDA \u533b\u7597\u5668\u68b0\u7ba1\u7406\u53f8\uff0c\u0e40\u0e15\u0e23\u0e35\u0e22\u0e21\u0e1e\u0e23\u0e49\u0e2d\u0e21\u0e40\u0e02\u0e49\u0e32\u0e2a\u0e39\u0e48\u0e23\u0e30\u0e1a\u0e1a\u0e41\u0e01\u0e49\u0e44\u0e02\u0e40\u0e1b\u0e25\u0e35\u0e48\u0e22\u0e19\u0e41\u0e1b\u0e25\u0e07\u0e07\u0e32\u0e19\u0e1c\u0e25\u0e34\u0e15\u0e20\u0e31\u0e13\u0e11\u0e4c\u0e40\u0e04\u0e23\u0e37\u0e48\u0e2d\u0e07\u0e21\u0e37\u0e2d\u0e41\u0e1e\u0e17\u0e22\u0e4c\u0e23\u0e30\u0e1a\u0e1a\u0e43\u0e2b\u0e21\u0e48\uff08\u65b0\u53d8\u66f4\u7cfb\u7edf\u901a\u544a\uff09\uff0c2026-03-02\uff0c<a href=\"https:\/\/medical.fda.moph.go.th\/press-release\/new-system-edit-2026\" target=\"_blank\" rel=\"noopener\">https:\/\/medical.fda.moph.go.th\/press-release\/new-system-edit-2026<\/a><\/li>\n<li>Thai FDA\uff0cFDA Shortened Duration on Permission Request, Depending on Medical Device Risk-Based Classification\uff0c2024-04-20\uff0c<a href=\"https:\/\/en.fda.moph.go.th\/news\/fda-shortened-duration-on-permission-request-depending-on-medical-device-risk-based-classification\" target=\"_blank\" rel=\"noopener\">https:\/\/en.fda.moph.go.th\/news\/fda-shortened-duration-on-permission-request-depending-on-medical-device-risk-based-classification<\/a><\/li>\n<\/ol><p class=\"note\">\u672c\u6587\u7528\u4e8e\u4e00\u822c\u5408\u89c4\u51c6\u5907\uff1b\u5177\u4f53\u8def\u5f84\u3001\u6587\u4ef6\u4e0e\u65f6\u9650\u5e94\u7ed3\u5408\u4ea7\u54c1\u3001\u6ce8\u518c\u72b6\u6001\u53ca\u4e3b\u7ba1\u673a\u5173\u4e2a\u6848\u8981\u6c42\u786e\u8ba4\u3002<\/p><\/section>\n<\/article>\n","protected":false},"excerpt":{"rendered":"<p>\u6cf0\u56fd FDA 2026 \u5e74\u53d8\u66f4\u51c6\u5219\u6309\u53d8\u66f4\u7c7b\u578b\u5206\u4e3a\u8bc4\u4f30\u540e\u6279\u51c6\u4e0e\u81ea\u52a8\u6838\u51c6\u4e24\u7ea7\uff1a\u54ea\u4e9b\u53d8\u66f4\u4e0d\u80fd\u4fee\u6539\u987b\u91cd\u65b0\u6ce8\u518c\u3001500 \u6cf0\u94e2\u4e0e\u6761\u4ef6\u6027\u4e13\u5bb6\u8bc4\u4f30\u8d39\uff0c\u4ee5\u53ca Skynet \u63d0\u4ea4\u4e0e\u65f6\u9650\u73b0\u72b6\u3002<\/p>\n","protected":false},"author":2,"featured_media":6510,"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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[32,36],"tags":[],"class_list":["post-5939","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-32","category-36"],"_links":{"self":[{"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts\/5939","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=5939"}],"version-history":[{"count":2,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts\/5939\/revisions"}],"predecessor-version":[{"id":5988,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts\/5939\/revisions\/5988"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/media\/6510"}],"wp:attachment":[{"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=5939"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=5939"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=5939"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}