{"id":6624,"date":"2026-10-07T10:00:00","date_gmt":"2026-10-07T02:00:00","guid":{"rendered":"https:\/\/aseanmedipass.com\/?p=6624"},"modified":"2026-10-30T00:26:48","modified_gmt":"2026-10-29T16:26:48","slug":"singapore-general-medical-device-risk-classification-gn13","status":"publish","type":"post","link":"https:\/\/aseanmedipass.com\/zh-hans\/singapore-general-medical-device-risk-classification-gn13\/","title":{"rendered":"\u65b0\u52a0\u5761\u4e00\u822c\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\uff1aGN-13 \u600e\u6837\u4ece\u7528\u9014\u5224\u5230\u9002\u7528\u89c4\u5219"},"content":{"rendered":"\n<style>.postid-6624 .entry-header{display:none}.postid-6624 #primary{width:100%;margin:0}.postid-6624 #secondary{display:none}.postid-6624 #content .ast-container{max-width:844px!important;width:100%;padding:0!important}.postid-6624 .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-6624 .ast-article-single{padding:32px 22px!important}}.postid-6624 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\">\u65b0\u52a0\u5761 \u00b7 \u533b\u7597\u5668\u68b0<\/p>\n<h1>\u65b0\u52a0\u5761\u4e00\u822c\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\uff1aGN-13 \u600e\u6837\u4ece\u7528\u9014\u5224\u5230\u9002\u7528\u89c4\u5219<\/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=\"2026-10-07T10:00:00+08:00\">2026\u5e7410\u67087\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\u65b0\u52a0\u5761\u5224\u65ad\u4e00\u822c\u533b\u7597\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\uff0c\u8d77\u70b9\u662f\u62df\u5728\u5f53\u5730\u9500\u552e\u7684<strong>\u9884\u671f\u7528\u9014<\/strong>\u3002\u4ea7\u54c1\u540d\u79f0\u76f8\u540c\uff0c\u9002\u7528\u4f24\u53e3\u3001\u63a5\u89e6\u90e8\u4f4d\u3001\u4f7f\u7528\u65f6\u95f4\u6216\u4e34\u5e8a\u529f\u80fd\u4e0d\u540c\uff0c\u5c31\u53ef\u80fd\u843d\u5165\u4e0d\u540c\u89c4\u5219\u3002\u76f4\u63a5\u6cbf\u7528\u5883\u5916\u7b49\u7ea7\u6216\u540c\u7c7b\u4ea7\u54c1\u7684\u7b49\u7ea7\uff0c\u5bb9\u6613\u628a\u540e\u7eed\u7533\u8bf7\u8def\u7ebf\u3001\u8d44\u6599\u548c\u9884\u7b97\u4e00\u8d77\u5e26\u504f\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/isomer-user-content.by.gov.sg\/409\/5c0b7242-e829-4f8d-baca-0b9542170bb5\/gn-13-r2-1-guidance-on-the-risk-classification-of-general-medical-devices-%2818sep-pub%29.pdf\" target=\"_blank\" rel=\"noopener\">HSA GN-13 R2.1<\/a>\uff0c\u7b2c 4 \u8282\uff09<\/span><\/p>\n<p>\u672c\u6587\u53ea\u8ba8\u8bba\u4e00\u4e2a\u95ee\u9898\uff1a\u5382\u5546\u600e\u6837\u628a\u624b\u4e0a\u7684 IFU\u3001\u89c4\u683c\u548c\u578b\u53f7\u8d44\u6599\uff0c\u6574\u7406\u6210\u80fd\u8bf4\u660e\u201c\u4e3a\u4ec0\u4e48\u8fd9\u6837\u5224\u7c7b\u201d\u7684\u4f9d\u636e\u3002\u65b0\u52a0\u5761\u6574\u4f53\u51c6\u5165\u5b89\u6392\uff08\u5206\u7c7b\u3001\u5206\u7ec4\u3001\u8def\u7ebf\u548c\u8d39\u7528\u6982\u89c8\uff09\u53ef\u53c2\u9605 <a href=\"https:\/\/aseanmedipass.com\/zh-hans\/singapore-medical-device-registration\/\">MediPass \u65b0\u52a0\u5761\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>\u5148\u9009\u89c4\u5219<\/dt><dd>\u4e00\u822c\u533b\u7597\u5668\u68b0\u6309 GN-13 R2.1\uff1bIVD \u6309 GN-14 R3\uff1b\u72ec\u7acb\u8f6f\u4ef6\u53e6\u7ed3\u5408 GL-07 R2\uff1b\u662f\u5426\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\uff0c\u5148\u770b GL-06 R2\u3002<\/dd>\n<dt>\u5224\u7c7b\u8d77\u70b9<\/dt><dd>\u6309 GN-13 \u7b2c 4 \u8282\uff1a\u5148\u786e\u8ba4\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\uff0c\u518d\u8bb0\u5f55\u9884\u671f\u7528\u9014\uff0c\u7136\u540e\u8003\u8651\u5168\u90e8\u89c4\u5219\u3002<\/dd>\n<dt>\u591a\u6761\u89c4\u5219\u9002\u7528<\/dt><dd>\u91c7\u7528\u6700\u9ad8\u7684\u9002\u7528\u7b49\u7ea7\uff1b\u4f46\u6bcf\u6761\u89c4\u5219\u90fd\u8981\u6709\u4ea7\u54c1\u4e8b\u5b9e\u652f\u6301\uff0c\u4e0d\u80fd\u4e3a\u6c42\u7a33\u6216\u4e3a\u8d70\u4f4e\u6210\u672c\u8def\u7ebf\u589e\u5220\u7528\u9014\u3002<\/dd>\n<dt>\u7ec4\u5408\u4e0e\u914d\u4ef6<\/dt><dd>\u914d\u5957\u4f7f\u7528\u7684\u5668\u68b0\u5206\u522b\u9002\u7528\u5206\u7c7b\u89c4\u5219\uff1b\u7ec4\u5408\u5f62\u6210\u65b0\u7528\u9014\u65f6\uff0c\u6309\u65b0\u7528\u9014\u5206\u7c7b\u3002<\/dd>\n<dt>\u5206\u7c7b\u4e4b\u540e<\/dt><dd>Class A \u514d\u4ea7\u54c1\u6ce8\u518c\uff0c\u4f46\u4ecd\u987b\u5728 SHARE \u63d0\u4ea4\u4ea7\u54c1\u901a\u62a5\uff1bClass B\u3001C\u3001D \u7684\u8bc4\u4f30\u8def\u7ebf\u53d6\u51b3\u4e8e\u7b49\u7ea7\u53ca\u5883\u5916\u53c2\u8003\u6279\u51c6\u60c5\u51b5\u3002<\/dd>\n<\/dl>\n<\/aside>\n\n<h2>\u5148\u786e\u8ba4\u5e94\u4f7f\u7528\u54ea\u5957\u89c4\u5219<\/h2>\n<p>HSA \u73b0\u884c\u6307\u5357\u76ee\u5f55\u5217\u51fa\u4e86\u4ee5\u4e0b\u5206\u7c7b\u76f8\u5173\u6587\u4ef6\u3002\u5148\u5224\u65ad\u4ea7\u54c1\u5c5e\u6027\uff0c\u518d\u9009\u62e9\u89c4\u5219\uff0c\u907f\u514d\u628a\u8bd5\u5242\u3001\u5206\u6790\u4eea\u3001\u8f6f\u4ef6\u548c\u666e\u901a\u786c\u4ef6\u5f53\u4f5c\u540c\u4e00\u79cd\u60c5\u5f62\u5904\u7406\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/www.hsa.gov.sg\/medical-devices\/guidance-documents\/\" target=\"_blank\" rel=\"noopener\">HSA \u533b\u7597\u5668\u68b0\u6307\u5357\u76ee\u5f55<\/a>\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u4ea7\u54c1\u60c5\u5f62<\/th><th>\u9002\u7528\u6587\u4ef6\uff08\u73b0\u884c\u7248\u672c\uff09<\/th><th>\u9700\u8981\u6ce8\u610f<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u5c1a\u4e0d\u786e\u5b9a\u662f\u5426\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\uff08\u836f\u68b0\u8fb9\u754c\u3001\u5065\u5eb7\u7c7b\u4ea7\u54c1\u7b49\uff09<\/td><td>GL-06 R2 Medical Devices Product Classification Guide\uff082023 \u5e74 10 \u6708\uff09<\/td><td>\u5148\u89e3\u51b3\u201c\u662f\u5426\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\u201d\uff0c\u518d\u8c08\u98ce\u9669\u7b49\u7ea7\u3002<\/td><\/tr>\n<tr><td>\u4e00\u822c\u533b\u7597\u5668\u68b0\uff08GMD\uff09<\/td><td>GN-13 R2.1\uff082018 \u5e74 9 \u6708\uff09<\/td><td>GN-13 \u9002\u7528\u8303\u56f4\u4e0d\u5305\u62ec\u7528\u4e8e\u4eba\u4f53\u6837\u672c\u4f53\u5916\u68c0\u67e5\u7684\u5668\u68b0\u3002<\/td><\/tr>\n<tr><td>\u4f53\u5916\u8bca\u65ad\u5668\u68b0\uff08IVD\uff09<\/td><td>GN-14 R3\uff082023 \u5e74 7 \u6708\uff0c2023 \u5e74 7 \u6708 24 \u65e5\u751f\u6548\uff09<\/td><td>\u5171 7 \u6761\u89c4\u5219\uff1b\u6821\u51c6\u54c1\u3001\u8d28\u63a7\u54c1\u53ca\u5d4c\u5165\u5f0f\u8f6f\u4ef6\u53e6\u6709\u5904\u7406\u539f\u5219\u3002<\/td><\/tr>\n<tr><td>\u72ec\u7acb\u533b\u7597\u8f6f\u4ef6\uff08SaMD\uff09\u53ca\u4e34\u5e8a\u51b3\u7b56\u652f\u6301\u8f6f\u4ef6\uff08CDSS\uff09<\/td><td>GL-07 R2\uff082025 \u5e74 7 \u6708\uff09\u914d\u5408 GN-13<\/td><td>GN-13 \u5c06\u72ec\u7acb\u8f6f\u4ef6\u89c6\u4e3a\u6709\u6e90\u533b\u7597\u5668\u68b0\uff1bGL-07 R2 \u7ec6\u5316\u4e86\u6309 GN-13 Rule 10(i) \u5224\u4e3a Class B \u7684\u6761\u4ef6\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p><span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/isomer-user-content.by.gov.sg\/409\/5c0b7242-e829-4f8d-baca-0b9542170bb5\/gn-13-r2-1-guidance-on-the-risk-classification-of-general-medical-devices-%2818sep-pub%29.pdf\" target=\"_blank\" rel=\"noopener\">GN-13<\/a> \u7b2c 1.3 \u8282\u3001\u7b2c 12 \u9875\uff1b<a href=\"https:\/\/isomer-user-content.by.gov.sg\/409\/7d66d1b0-fdb2-4fd9-851e-110645210592\/gn-14-r3-guidance-on-the-risk-classification-of-in-vitro-diagnostic-md-%282023-jul%29-pub.pdf\" target=\"_blank\" rel=\"noopener\">GN-14 R3<\/a>\uff1b<a href=\"https:\/\/www.hsa.gov.sg\/announcements\/update-for-guidelines-on-risk-classification-of-samd-and-qualification-of-clinical-decision-support-software--cdss-\/\" target=\"_blank\" rel=\"noopener\">HSA \u5173\u4e8e GL-07 \u66f4\u65b0\u7684\u516c\u544a<\/a>\uff09<\/span><\/p>\n<p>\u8425\u9500\u8d44\u6599\u65b0\u589e\u8bca\u65ad\u3001\u6cbb\u7597\u6216\u75be\u75c5\u76d1\u6d4b\u58f0\u79f0\u65f6\uff0c\u5efa\u8bae\u56de\u5934\u68c0\u67e5\u8fd9\u4e9b\u58f0\u79f0\u662f\u5426\u6539\u53d8\u4e86\u4ea7\u54c1\u5c5e\u6027\u6216\u5206\u7c7b\u7ed3\u8bba\uff0c\u4e0d\u80fd\u53ea\u770b\u5305\u88c5\u4e0a\u662f\u5426\u5370\u6709\u201c\u533b\u7597\u201d\u4e8c\u5b57\u3002<\/p>\n\n<h2>\u9012\u4ea4\u5224\u7c7b\u4e4b\u524d\uff0c\u5148\u628a\u4ea7\u54c1\u4e8b\u5b9e\u5199\u5b8c\u6574<\/h2>\n<p>GN-13 \u6307\u51fa\uff0c\u5668\u68b0\u98ce\u9669\u90e8\u5206\u53d6\u51b3\u4e8e\u9884\u671f\u4f7f\u7528\u8005\u3001\u5de5\u4f5c\u65b9\u5f0f\u548c\u6240\u7528\u6280\u672f\uff1b\u7b2c 2 \u8282\u5217\u51fa\u7684\u5206\u7c7b\u56e0\u7d20\u5305\u62ec\u4e0e\u4eba\u4f53\u63a5\u89e6\u7684\u65f6\u95f4\u3001\u4fb5\u5165\u7a0b\u5ea6\u3001\u662f\u5426\u5411\u60a3\u8005\u8f93\u9001\u836f\u7269\u6216\u80fd\u91cf\u3001\u662f\u5426\u4ea7\u751f\u751f\u7269\u5b66\u6548\u5e94\uff0c\u4ee5\u53ca\u5c40\u90e8\u6216\u5168\u8eab\u4f5c\u7528\u3002\u4e0b\u8868\u662f\u636e\u6b64\u6574\u7406\u7684\u9879\u76ee\u5de5\u4f5c\u8868\uff0c\u5e76\u975e HSA \u89c4\u5b9a\u7684\u683c\u5f0f\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGN-13 \u7b2c 1.2 \u8282\u3001\u7b2c 2 \u8282\uff0c\u7b2c 4\u300111 \u9875\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u9700\u8981\u8bf4\u6e05\u7684\u4e8b\u5b9e<\/th><th>\u4ece\u54ea\u91cc\u6838\u5bf9<\/th><th>\u7f3a\u5c11\u4fe1\u606f\u4f1a\u5f71\u54cd\u4ec0\u4e48<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u9884\u671f\u7528\u9014\u548c\u4e34\u5e8a\u529f\u80fd<\/td><td>IFU\u3001\u6807\u7b7e\u3001\u89c4\u683c\u4e2d\u7684\u539f\u6587<\/td><td>\u9002\u7528\u54ea\u6761\u89c4\u5219\uff0c\u4ee5\u53ca\u6700\u9ad8\u98ce\u9669\u7528\u9014\u662f\u4ec0\u4e48<\/td><\/tr>\n<tr><td>\u9884\u671f\u60a3\u8005\u548c\u4f7f\u7528\u8005<\/td><td>\u9002\u7528\u4eba\u7fa4\u3001\u7981\u5fcc\u3001\u4f7f\u7528\u73af\u5883<\/td><td>\u8f93\u51fa\u7ed3\u679c\u6216\u64cd\u4f5c\u5bf9\u60a3\u8005\u7684\u5f71\u54cd<\/td><\/tr>\n<tr><td>\u63a5\u89e6\u90e8\u4f4d\u53ca\u4fb5\u5165\u65b9\u5f0f<\/td><td>\u7ed3\u6784\u56fe\u3001\u4f7f\u7528\u6b65\u9aa4\u3001\u63a5\u89e6\u6750\u6599<\/td><td>\u533a\u5206\u5b8c\u6574\u76ae\u80a4\u3001\u53d7\u4f24\u76ae\u80a4\u3001\u4f53\u8154\u5b54\u9053\u6216\u5916\u79d1\u4fb5\u5165<\/td><\/tr>\n<tr><td>\u6301\u7eed\u4f7f\u7528\u65f6\u95f4<\/td><td>\u5355\u6b21\u65f6\u95f4\u3001\u8fde\u7eed\u4f7f\u7528\u548c\u66f4\u6362\u5b89\u6392<\/td><td>\u843d\u5165\u6682\u65f6\u3001\u77ed\u671f\u8fd8\u662f\u957f\u671f\u4f7f\u7528<\/td><\/tr>\n<tr><td>\u5de5\u4f5c\u539f\u7406<\/td><td>\u4f9b\u80fd\u3001\u4fe1\u53f7\u5904\u7406\u3001\u836f\u7269\u6216\u80fd\u91cf\u8f93\u9001\u3001\u63a7\u5236\u65b9\u5f0f<\/td><td>\u662f\u5426\u5c5e\u4e8e\u6709\u6e90\u5668\u68b0\uff0c\u4ee5\u53ca\u6cbb\u7597\u3001\u8bca\u65ad\u89c4\u5219\u53ca\u5176\u4f8b\u5916<\/td><\/tr>\n<tr><td>\u914d\u5957\u5173\u7cfb\u548c\u578b\u53f7\u5dee\u5f02<\/td><td>\u914d\u7f6e\u8868\u3001\u9644\u4ef6\u6e05\u5355\u3001\u578b\u53f7\u5bf9\u6bd4<\/td><td>\u662f\u5426\u9700\u8981\u5206\u522b\u5224\u7c7b\u6216\u8865\u5145\u8bf4\u660e<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u4f7f\u7528\u65f6\u95f4\u6309 GN-13 \u7684\u5b9a\u4e49\u5224\u65ad\uff1a\u6682\u65f6\u4f7f\u7528\u4e3a\u8fde\u7eed\u4f7f\u7528\u4e0d\u8d85\u8fc7 60 \u5206\u949f\uff0c\u77ed\u671f\u4f7f\u7528\u4e3a 60 \u5206\u949f\u81f3 30 \u5929\uff0c\u957f\u671f\u4f7f\u7528\u4e3a\u8d85\u8fc7 30 \u5929\u3002\u201c\u8fde\u7eed\u4f7f\u7528\u201d\u4e0d\u56e0\u4e34\u65f6\u4e2d\u65ad\u800c\u4e2d\u6b62\uff0c\u7528\u53e6\u4e00\u4ef6\u540c\u7c7b\u5668\u68b0\u7acb\u5373\u66ff\u6362\u540e\u7684\u7d2f\u8ba1\u65f6\u95f4\u4e5f\u8ba1\u5165\u3002\u56e0\u6b64\uff0c\u6807\u6ce8\u201c\u5355\u6b21\u4f7f\u7528\u3001\u53ef\u968f\u65f6\u66f4\u6362\u201d\u7684\u4ea7\u54c1\uff0c\u4ecd\u8981\u8bf4\u660e\u5b9e\u9645\u4e34\u5e8a\u4e0a\u662f\u5426\u4f1a\u8fde\u7eed\u66ff\u6362\u4f7f\u7528\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGN-13 \u7b2c 1.4 \u8282\u5b9a\u4e49\uff0c\u7b2c 7\u20148 \u9875\uff09<\/span><\/p>\n<p>\u518d\u5982\uff0c\u8d44\u6599\u53ea\u5199\u201c\u76d1\u6d4b\u60a3\u8005\u53c2\u6570\u201d\uff0c\u65e0\u6cd5\u770b\u51fa\u5b83\u7528\u4e8e\u91cd\u8981\u751f\u7406\u8fc7\u7a0b\u7684\u4e00\u822c\u76d1\u6d4b\uff0c\u8fd8\u662f\u4e13\u95e8\u76d1\u6d4b\u53d8\u5316\u53ef\u80fd\u4f7f\u60a3\u8005\u9677\u5165\u5373\u65f6\u5371\u9669\u7684\u91cd\u8981\u751f\u7406\u53c2\u6570\u3002\u6309 GN-13 Rule 10\uff0c\u524d\u8005\u4e00\u822c\u4e3a Class B\uff0c\u540e\u8005\u4e3a Class C\u3002\u5206\u7c7b\u4eba\u5458\u9700\u8981\u56de\u5230 IFU \u4e2d\u7684\u4e34\u5e8a\u7528\u9014\u548c\u62a5\u8b66\u529f\u80fd\uff0c\u4e0d\u80fd\u53ea\u51ed\u663e\u793a\u5c4f\u3001\u4f20\u611f\u5668\u6216\u4fbf\u643a\u5916\u89c2\u63a8\u65ad\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGN-13 Rule 10\uff0c\u7b2c 23\u201424 \u9875\uff09<\/span><\/p>\n\n<h2>\u600e\u6837\u4ece\u4ea7\u54c1\u4e8b\u5b9e\u4e00\u6b65\u6b65\u8d70\u5230\u5206\u7c7b\u7ed3\u8bba\uff1f<\/h2>\n<p>GN-13 \u7b2c 4 \u8282\u8981\u6c42\u4ea7\u54c1\u6240\u6709\u4eba\uff1a\u5148\u7528\u9002\u5f53\u5b9a\u4e49\u786e\u8ba4\u4ea7\u54c1\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\uff0c\u518d\u8bb0\u5f55\u9884\u671f\u7528\u9014\uff0c\u7136\u540e\u8003\u8651\u5168\u90e8\u89c4\u5219\uff1b\u591a\u4e2a\u7b49\u7ea7\u540c\u65f6\u9002\u7528\u65f6\uff0c\u91c7\u7528\u6700\u9ad8\u7684\u9002\u7528\u7b49\u7ea7\u3002\u4e0b\u8868\u628a\u8fd9\u4e00\u987a\u5e8f\u6574\u7406\u6210\u53ef\u6267\u884c\u7684\u5224\u7c7b\u6d41\u7a0b\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGN-13 \u7b2c 2\u30014 \u8282\uff0c\u7b2c 11\u300113 \u9875\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u6b65\u9aa4<\/th><th>\u8981\u56de\u7b54\u7684\u95ee\u9898<\/th><th>\u5efa\u8bae\u7559\u4e0b\u7684\u8bb0\u5f55<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>1. \u4ea7\u54c1\u5c5e\u6027<\/td><td>\u662f\u5426\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\uff1f\u662f IVD\u3001\u8f6f\u4ef6\u8fd8\u662f\u4e00\u822c\u5668\u68b0\uff1f<\/td><td>\u5c5e\u6027\u7ed3\u8bba\u53ca\u4f9d\u636e\uff08GL-06 R2\u3001GN-14\u3001GL-07 \u7684\u76f8\u5173\u6761\u76ee\uff09<\/td><\/tr>\n<tr><td>2. \u9501\u5b9a\u7528\u9014<\/td><td>\u62df\u5728\u65b0\u52a0\u5761\u6807\u793a\u7684\u7528\u9014\u3001\u60a3\u8005\u3001\u4f7f\u7528\u8005\u548c\u573a\u6240\u662f\u4ec0\u4e48\uff1f<\/td><td>\u7ecf\u4ea7\u54c1\u6240\u6709\u4eba\u786e\u8ba4\u7684\u82f1\u6587\u7528\u9014\u539f\u6587\u53ca\u6587\u4ef6\u7248\u672c<\/td><\/tr>\n<tr><td>3. \u9010\u7ec4\u7b5b\u67e5\u89c4\u5219<\/td><td>\u975e\u4fb5\u5165\uff08Rule 1\u20144\uff09\u3001\u4fb5\u5165\uff08Rule 5\u20148\uff09\u3001\u6709\u6e90\uff08Rule 9\u201412\uff09\u3001\u9644\u52a0\u89c4\u5219\uff08Rule 13\u201416\uff09\u4e2d\uff0c\u54ea\u4e9b\u53ef\u80fd\u9002\u7528\uff1f<\/td><td>\u6bcf\u6761\u89c4\u5219\u201c\u9002\u7528\uff0f\u4e0d\u9002\u7528\u201d\u7684\u5224\u65ad\u53ca\u5bf9\u5e94\u4e8b\u5b9e<\/td><\/tr>\n<tr><td>4. \u6838\u5bf9\u9650\u5236\u4e0e\u4f8b\u5916<\/td><td>\u65f6\u957f\u3001\u90e8\u4f4d\u3001\u80fd\u91cf\u3001\u836f\u7269\u7b49\u6761\u4ef6\u662f\u5426\u6ee1\u8db3\uff1f\u4f8b\u5916\u662f\u5426\u6210\u7acb\uff1f<\/td><td>\u4f8b\u5916\u6761\u4ef6\u7684\u6210\u7acb\u6216\u6392\u9664\u7406\u7531<\/td><\/tr>\n<tr><td>5. \u53d6\u6700\u9ad8\u7b49\u7ea7<\/td><td>\u6240\u6709\u9002\u7528\u89c4\u5219\u4e2d\uff0c\u6700\u9ad8\u7b49\u7ea7\u662f\u54ea\u4e00\u7ea7\uff1f<\/td><td>\u6700\u7ec8\u7b49\u7ea7\u53ca\u51b3\u5b9a\u6027\u89c4\u5219<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u201c\u91c7\u7528\u6700\u9ad8\u7b49\u7ea7\u201d\u7684\u524d\u63d0\u662f\u76f8\u5e94\u89c4\u5219\u786e\u5b9e\u9002\u7528\u3002\u4e0d\u80fd\u4e3a\u6c42\u7a33\u59a5\u52a0\u5165\u6ca1\u6709\u4e8b\u5b9e\u652f\u6301\u7684\u9ad8\u98ce\u9669\u7528\u9014\uff0c\u4e5f\u4e0d\u80fd\u4e3a\u4e86\u8d70\u8d39\u7528\u8f83\u4f4e\u7684\u8def\u7ebf\u5220\u6539\u771f\u5b9e\u7528\u9014\u3002\u8d44\u6599\u524d\u540e\u4e0d\u4e00\u81f4\u65f6\uff0c\u5e94\u5148\u8bf7\u4ea7\u54c1\u6240\u6709\u4eba\u786e\u8ba4\u62df\u7533\u62a5\u7248\u672c\u3002<\/p>\n<p>GN-13 \u9644\u5f55 A \u7684\u6d41\u7a0b\u56fe\u9002\u5408\u68c0\u67e5\u662f\u5426\u6f0f\u770b\u5206\u652f\uff0c\u4f46\u6307\u5357\u660e\u786e\u6d41\u7a0b\u56fe\u4ec5\u4f5c\u8bf4\u660e\uff0c\u5206\u7c7b\u987b\u4ee5\u89c4\u5219\u672c\u8eab\u4e3a\u51c6\u3002\u5efa\u8bae\u628a\u9002\u7528\u6761\u6587\u3001\u4e8b\u5b9e\u8bc1\u636e\u548c\u7ed3\u8bba\u653e\u5728\u540c\u4e00\u4efd\u5224\u7c7b\u8bb0\u5f55\u4e2d\uff0c\u8ba9\u540e\u7eed\u6ce8\u518c\u4eba\u5458\u80fd\u8ffd\u6eaf\u5230\u5177\u4f53 IFU \u6bb5\u843d\u6216\u578b\u53f7\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGN-13 \u9644\u5f55 A\uff0c\u7b2c 29 \u9875\uff09<\/span><\/p>\n\n<h2>\u8bf4\u660e\u6027\u793a\u4f8b\uff1a\u540c\u4e3a\u6577\u6599\uff0c\u4e3a\u4ec0\u4e48\u8fd8\u8981\u770b\u4f24\u53e3\u7528\u9014<\/h2>\n<p>\u4ee5\u4e0b\u662f\u6309 GN-13 Rule 1\uff08\u63a5\u89e6\u53d7\u4f24\u76ae\u80a4\u7684\u975e\u4fb5\u5165\u5668\u68b0\uff09\u6574\u7406\u7684<strong>\u5047\u8bbe\u60c5\u5f62<\/strong>\uff0c\u4ec5\u7528\u4e8e\u8bf4\u660e\u7528\u9014\u5982\u4f55\u5f71\u54cd\u5224\u65ad\uff0c\u4e0d\u4ee3\u8868\u4efb\u4f55\u5177\u4f53\u4ea7\u54c1\u7684\u5206\u7c7b\u7ed3\u8bba\u3002\u5047\u8bbe\u4ea7\u54c1\u7b26\u5408\u8be5\u89c4\u5219\u7684\u975e\u4fb5\u5165\u3001\u63a5\u89e6\u53d7\u4f24\u76ae\u80a4\u6761\u4ef6\uff0c\u4e14\u6ca1\u6709\u5176\u4ed6\u89c4\u5219\u5bfc\u81f4\u66f4\u9ad8\u7b49\u7ea7\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGN-13 Rule 1\uff0c\u7b2c 14\u201415 \u9875\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u5047\u8bbe\u7684\u6807\u7b7e\u7528\u9014<\/th><th>Rule 1 \u5bf9\u5e94\u7b49\u7ea7<\/th><th>\u6307\u5357\u793a\u4f8b<\/th><th>\u5382\u5546\u9700\u8981\u652f\u6301\u7684\u4e8b\u5b9e<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u4ec5\u4f5c\u673a\u68b0\u5c4f\u969c\u3001\u52a0\u538b\u6216\u5438\u6536\u6e17\u51fa\u6db2\uff0c\u7528\u4e8e\u4e00\u671f\u6108\u5408\u7684\u4f24\u53e3<\/td><td>Class A<\/td><td>\u52a0\u538b\u7ef7\u5e26\u3001\u8131\u8102\u68c9<\/td><td>\u4f5c\u7528\u65b9\u5f0f\uff0c\u4ee5\u53ca\u9002\u7528\u4f24\u53e3\u9650\u4e8e\u4e00\u671f\u6108\u5408<\/td><\/tr>\n<tr><td>\u7528\u4e8e\u7ba1\u7406\u4f24\u53e3\u5fae\u73af\u5883<\/td><td>Class B<\/td><td>\u4e0d\u542b\u836f\u7684\u6d78\u6e0d\u7eb1\u5e03\u6577\u6599<\/td><td>\u7ba1\u7406\u5fae\u73af\u5883\u7684\u529f\u80fd\u548c\u9002\u7528\u4f24\u53e3<\/td><\/tr>\n<tr><td>\u4e3b\u8981\u7528\u4e8e\u4e0d\u80fd\u4e00\u671f\u6108\u5408\u7684\u4f24\u53e3<\/td><td>Class C<\/td><td>\u6162\u6027\u6e83\u75a1\u4f24\u53e3\u3001\u4e25\u91cd\u70e7\u4f24\u7528\u6577\u6599<\/td><td>\u4f24\u53e3\u7c7b\u578b\u3001\u6108\u5408\u65b9\u5f0f\u53ca\u6807\u7b7e\u9002\u7528\u8303\u56f4<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u5982\u679c\u540c\u4e00\u4efd IFU \u540c\u65f6\u5199\u4e86\u4e0a\u8ff0\u4e09\u79cd\u7528\u9014\uff0c\u5c31\u4e0d\u80fd\u53ea\u6311\u6700\u7b80\u5355\u7684\u201c\u5438\u6536\u6e17\u51fa\u6db2\u201d\u6765\u5224\u7c7b\u3002\u53cd\u8fc7\u6765\uff0c\u5982\u679c\u4ea7\u54c1\u53ea\u83b7\u9a8c\u8bc1\u7528\u4e8e\u67d0\u7c7b\u4f24\u53e3\uff0c\u4e5f\u4e0d\u5b9c\u4e3a\u6269\u5927\u5ba3\u4f20\u5199\u5165\u5c1a\u65e0\u8bc1\u636e\u652f\u6301\u7684\u7528\u9014\u3002\u5206\u7c7b\u7ed3\u8bba\u5e94\u4e0e\u771f\u5b9e\u6027\u80fd\u3001\u4e34\u5e8a\u8bc1\u636e\u548c\u62df\u552e\u6807\u7b7e\u4fdd\u6301\u4e00\u81f4\u3002<\/p>\n\n<h2>\u4e3b\u673a\u3001\u914d\u4ef6\u548c\u7ec4\u5408\u4ea7\u54c1\u600e\u6837\u5904\u7406\uff1f<\/h2>\n<p>GN-13 \u89c4\u5b9a\uff0c\u4e00\u4ef6\u5668\u68b0\u4e0e\u53e6\u4e00\u4ef6\u5668\u68b0\u914d\u5957\u4f7f\u7528\u65f6\uff0c\u5206\u7c7b\u89c4\u5219\u5206\u522b\u9002\u7528\u4e8e\u6bcf\u4ef6\u5668\u68b0\uff1b\u7ec4\u5408\u5305\u88c5\u5982\u5f62\u6210\u65b0\u7684\u9884\u671f\u7528\u9014\uff0c\u5e94\u6309\u7ec4\u5408\u540e\u7684\u65b0\u7528\u9014\u5206\u7c7b\u3002\u4ec5\u4e3a\u4f7f\u7528\u4fbf\u5229\u800c\u7ec4\u5408\u3001\u4e14\u5404\u5668\u68b0\u7528\u9014\u672a\u53d8\u65f6\uff0c\u7528\u4e8e\u7b26\u5408\u6027\u58f0\u660e\u7684\u7ec4\u5408\u7b49\u7ea7\u4e0e\u5176\u4e2d\u6700\u9ad8\u7b49\u7ea7\u7684\u5668\u68b0\u76f8\u540c\u3002\u4e13\u4e3a\u67d0\u4e00\u5668\u68b0\u8bbe\u8ba1\u7684\u9644\u4ef6\uff0c\u9002\u7528\u8be5\u5668\u68b0\u672c\u8eab\u7684\u76d1\u7ba1\u8981\u6c42\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGN-13 \u7b2c 2 \u8282\uff0c\u7b2c 11\u201412 \u9875\uff09<\/span><\/p>\n<p>\u56e0\u6b64\uff0c\u53ef\u4ee5\u5148\u628a\u4e3b\u673a\u3001\u4e00\u6b21\u6027\u8017\u6750\u548c\u9644\u4ef6\u5217\u6210\u9010\u9879\u6e05\u5355\uff0c\u5199\u660e\u6bcf\u4e00\u9879\u7684\u4f9b\u5e94\u65b9\u5f0f\u3001\u529f\u80fd\u53ca\u4e0e\u4e3b\u673a\u7684\u5173\u7cfb\uff0c\u518d\u8ba8\u8bba\u5206\u7c7b\u548c\u7533\u8bf7\u5206\u7ec4\u3002\u5206\u7c7b\u56de\u7b54\u98ce\u9669\u7b49\u7ea7\uff0c\u5206\u7ec4\u56de\u7b54\u54ea\u4e9b\u9879\u76ee\u53ef\u4ee5\u653e\u8fdb\u540c\u4e00\u4efd\u7533\u8bf7\uff1b\u90e8\u5206\u5206\u7ec4\u65b9\u5f0f\u672c\u8eab\u5bf9\u98ce\u9669\u7b49\u7ea7\u6709\u8981\u6c42\uff0c\u4e24\u9879\u5224\u65ad\u5e94\u5206\u522b\u6709\u4f9d\u636e\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/www.hsa.gov.sg\/medical-devices\/registration-of-medical-devices\/register-your-device\/grouping\/\" target=\"_blank\" rel=\"noopener\">HSA \u5206\u7ec4\u8bf4\u660e\u9875<\/a>\uff09<\/span><\/p>\n\n<h2>\u4e00\u4efd\u6709\u7528\u7684\u5224\u7c7b\u8bb0\u5f55\u5e94\u7559\u4e0b\u4ec0\u4e48\uff1f<\/h2>\n<ul>\n<li>\u62df\u552e\u4ea7\u54c1\u548c\u578b\u53f7\u8303\u56f4\uff0c\u4ee5\u53ca\u786e\u8ba4\u540e\u7684\u7528\u9014\u539f\u6587\u548c\u6587\u4ef6\u7248\u672c\uff1b<\/li>\n<li>\u652f\u6301\u5224\u65ad\u7684\u4ea7\u54c1\u4e8b\u5b9e\uff08\u63a5\u89e6\u90e8\u4f4d\u3001\u65f6\u957f\u3001\u5de5\u4f5c\u539f\u7406\u3001\u914d\u5957\u5173\u7cfb\uff09\uff1b<\/li>\n<li>\u5168\u90e8\u8003\u8651\u8fc7\u7684\u89c4\u5219\u3001\u9002\u7528\u4e0e\u5426\u7684\u7406\u7531\uff0c\u4ee5\u53ca\u4f8b\u5916\u6761\u4ef6\u7684\u6392\u9664\u7406\u7531\uff1b<\/li>\n<li>\u6700\u7ec8\u7b49\u7ea7\u53ca\u51b3\u5b9a\u6027\u89c4\u5219\uff1b<\/li>\n<li>\u5c1a\u5f85\u786e\u8ba4\u7684\u4e8b\u9879\uff1a\u7f3a\u4ec0\u4e48\u4fe1\u606f\u3001\u7531\u8c01\u63d0\u4f9b\u3002\u5f85\u786e\u8ba4\u610f\u89c1\u4e0d\u8981\u5199\u8fdb\u6b63\u5f0f\u58f0\u660e\u3002<\/li>\n<\/ul>\n<p>\u5206\u7c7b\u786e\u5b9a\u540e\u518d\u6838\u7533\u8bf7\u8def\u7ebf\u548c\u6280\u672f\u8d44\u6599\u3002HSA \u8bf4\u660e\uff0cClass A \u533b\u7597\u5668\u68b0\u514d\u4ea7\u54c1\u6ce8\u518c\uff0c\u4f46\u5236\u9020\u5546\u6216\u8fdb\u53e3\u5546\u4ecd\u987b\u5728 SHARE \u63d0\u4ea4\u4ea7\u54c1\u901a\u62a5\uff1bClass B\u3001C\u3001D \u7684\u8bc4\u4f30\u8def\u7ebf\u53d6\u51b3\u4e8e\u98ce\u9669\u7b49\u7ea7\u3001\u5883\u5916\u53c2\u8003\u673a\u6784\u6279\u51c6\u7684\u6570\u91cf\u53ca\u5b89\u5168\u4e0a\u5e02\u5386\u53f2\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/www.hsa.gov.sg\/medical-devices\/registration-of-medical-devices\/register-your-device\/overview\/\" target=\"_blank\" rel=\"noopener\">HSA \u6ce8\u518c\u6982\u89c8\u9875<\/a>\uff09<\/span>\u6d89\u53ca IVD \u7684\u9879\u76ee\uff0c\u53ef\u53e6\u8bfb<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/singapore-covid-19-ivd-class-c-ivd-cluster-2026\/\">\u65b0\u52a0\u5761\u65b0\u51a0 IVD \u5206\u7c7b\u4e0e\u5206\u7ec4\u8bf4\u660e<\/a>\uff0c\u4e0d\u8981\u76f4\u63a5\u5957\u7528\u672c\u6587\u7684\u4e00\u822c\u5668\u68b0\u793a\u4f8b\u3002<\/p>\n\n<section class=\"faq\">\n<h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n<p><strong>CE \u6216 NMPA \u7b49\u7ea7\u53ef\u4ee5\u76f4\u63a5\u7528\u4e8e\u65b0\u52a0\u5761\u5417\uff1f<\/strong><br\/>\u5883\u5916\u5206\u7c7b\u53ef\u4ee5\u4f5c\u4e3a\u6bd4\u5bf9\u8d44\u6599\uff0c\u4f46\u65b0\u52a0\u5761\u7ed3\u8bba\u5e94\u6309 GN-13 \u89c4\u5219\u548c\u5b9e\u9645\u62df\u552e\u7528\u9014\u5f62\u6210\u3002\u5883\u5916\u6279\u51c6\u80fd\u5426\u652f\u6301\u7b80\u5316\u8def\u7ebf\uff0c\u662f\u53e6\u4e00\u4e2a\u95ee\u9898\uff1aHSA \u8ba4\u53ef\u7684\u53c2\u8003\u673a\u6784\u4e3a TGA\u3001\u6b27\u76df\u516c\u544a\u673a\u6784\u3001Health Canada\u3001\u65e5\u672c MHLW \u548c\u7f8e\u56fd FDA\uff0c\u4e14\u6279\u51c6\u987b\u9488\u5bf9\u62df\u5728\u65b0\u52a0\u5761\u9500\u552e\u7684\u540c\u4e00\u6807\u793a\u7528\u9014\uff1b\u4ee5 Class I \u6216 Class II \u8c41\u514d\u65b9\u5f0f\u83b7\u6279\u7684\uff0c\u4e0d\u80fd\u4f5c\u4e3a\u7b80\u5316\u3001\u52a0\u901f\u6216\u5373\u65f6\u8def\u7ebf\u7684\u4f9d\u636e\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/www.hsa.gov.sg\/medical-devices\/registration-of-medical-devices\/register-your-device\/overview\/\" target=\"_blank\" rel=\"noopener\">HSA \u6ce8\u518c\u6982\u89c8\u9875<\/a>\uff09<\/span><\/p>\n<p><strong>\u5916\u89c2\u548c\u5de5\u4f5c\u539f\u7406\u76f8\u540c\u7684\u578b\u53f7\uff0c\u4e00\u5b9a\u662f\u540c\u4e00\u7b49\u7ea7\u5417\uff1f<\/strong><br\/>\u4e0d\u4e00\u5b9a\u3002\u8fd8\u8981\u68c0\u67e5\u7528\u9014\u3001\u60a3\u8005\u3001\u63a5\u89e6\u90e8\u4f4d\u3001\u4f7f\u7528\u65f6\u957f\u548c\u4e34\u5e8a\u529f\u80fd\u662f\u5426\u6709\u5dee\u5f02\u3002\u5efa\u8bae\u5148\u5217\u578b\u53f7\u5dee\u5f02\u8868\uff0c\u9010\u9879\u5224\u65ad\u5dee\u5f02\u662f\u5426\u89e6\u53d1\u5176\u4ed6\u89c4\u5219\uff0c\u4e0d\u628a\u540c\u4e00\u7cfb\u5217\u540d\u79f0\u5f53\u4f5c\u540c\u7ea7\u7684\u8bc1\u636e\u3002<\/p>\n<p><strong>\u5bb6\u7528\u4ea7\u54c1\u4e00\u5b9a\u662f\u4f4e\u98ce\u9669\u5417\uff1f<\/strong><br\/>\u4f7f\u7528\u5730\u70b9\u672c\u8eab\u4e0d\u80fd\u66ff\u4ee3\u5224\u7c7b\uff0c\u4e00\u822c\u5668\u68b0\u4ecd\u8981\u6309\u529f\u80fd\u548c\u9884\u671f\u7528\u9014\u68c0\u67e5\u9002\u7528\u89c4\u5219\uff0c\u5e76\u5199\u660e\u9884\u671f\u4f7f\u7528\u8005\u548c\u4f7f\u7528\u73af\u5883\u3002IVD \u5219\u4e0d\u540c\uff1aGN-14 Rule 4 \u628a\u81ea\u6d4b\u548c\u5e8a\u65c1\u68c0\u6d4b\u4f5c\u4e3a\u5224\u7c7b\u56e0\u7d20\uff0c\u81ea\u6d4b\u4ea7\u54c1\u4e00\u822c\u4e3a Class C\uff1b\u7ed3\u679c\u4e0d\u51b3\u5b9a\u533b\u7597\u5371\u6025\u72b6\u6001\uff0c\u6216\u53ea\u662f\u521d\u6b65\u7ed3\u679c\u4e14\u987b\u4ee5\u9002\u5f53\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u786e\u8ba4\u7684\uff0c\u4e3a Class B\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGN-13 \u7b2c 1.2 \u8282\uff1b<a href=\"https:\/\/isomer-user-content.by.gov.sg\/409\/7d66d1b0-fdb2-4fd9-851e-110645210592\/gn-14-r3-guidance-on-the-risk-classification-of-in-vitro-diagnostic-md-%282023-jul%29-pub.pdf\" target=\"_blank\" rel=\"noopener\">GN-14 R3<\/a> Rule 4\uff0c\u7b2c 15 \u9875\uff09<\/span><\/p>\n<p><strong>HSA \u7684\u5728\u7ebf AI \u5206\u7c7b\u5de5\u5177\u7ed9\u51fa\u7684\u7ed3\u679c\uff0c\u53ef\u4ee5\u76f4\u63a5\u5199\u8fdb\u7533\u8bf7\u5417\uff1f<\/strong><br\/>\u4e0d\u5efa\u8bae\u3002HSA \u7684 AI \u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u5de5\u5177\u76ee\u524d\u5904\u4e8e\u6d4b\u8bd5\u9636\u6bb5\uff0c\u9875\u9762\u8bf4\u660e\u5176\u7ed3\u679c\u53ea\u662f\u4f9b\u53c2\u8003\u7684\u4f30\u8ba1\u5206\u7c7b\uff0c\u4e0d\u662f HSA \u7684\u6b63\u5f0f\u8ba4\u5b9a\uff0c\u4e0d\u5e94\u4f5c\u4e3a\u6ce8\u518c\u7533\u62a5\u6216\u5408\u89c4\u51b3\u5b9a\u7684\u4f9d\u636e\u3002\u53ef\u4ee5\u7528\u5b83\u505a\u521d\u6b65\u5bf9\u7167\uff0c\u7ed3\u8bba\u4ecd\u5e94\u56de\u5230 GN-13 \u89c4\u5219\u548c\u4ea7\u54c1\u4e8b\u5b9e\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/mdrc.hsa.gov.sg\/\" target=\"_blank\" rel=\"noopener\">HSA \u98ce\u9669\u5206\u7c7b\u5de5\u5177\uff08\u6d4b\u8bd5\u7248\uff09<\/a>\uff09<\/span><\/p>\n<p><strong>\u4fe1\u606f\u4e0d\u591f\u65f6\uff0c\u80fd\u5148\u6309\u8f83\u4f4e\u7b49\u7ea7\u63d0\u4ea4\u5417\uff1f<\/strong><br\/>\u5efa\u8bae\u5148\u8865\u9f50\u5f71\u54cd\u5224\u65ad\u7684 IFU\u3001\u7ed3\u6784\u548c\u4f7f\u7528\u4fe1\u606f\u3002\u8d44\u6599\u4e0d\u8db3\u65f6\u5f62\u6210\u7684\u521d\u6b65\u610f\u89c1\u5e94\u6ce8\u660e\u524d\u63d0\u6761\u4ef6\uff1b\u5982\u679c\u8fde\u62df\u552e\u7528\u9014\u90fd\u672a\u786e\u5b9a\uff0c\u8def\u7ebf\u548c\u8d39\u7528\u4f30\u7b97\u4e5f\u53ea\u80fd\u4f5c\u4e3a\u60c5\u666f\u9884\u7b97\u3002<\/p>\n<\/section>\n\n<aside class=\"article-cta\"><p class=\"eyebrow\">\u65b0\u52a0\u5761\u4ea7\u54c1\u5206\u7c7b<\/p><h3>\u51c6\u5907\u65b0\u52a0\u5761\u7533\u8bf7\uff1f\u5148\u8ba9\u5206\u7c7b\u4f9d\u636e\u4e0e\u8d44\u6599\u5bf9\u5f97\u4e0a<\/h3><p>\u5148\u544a\u8bc9\u6211\u4eec <strong>\u4ea7\u54c1\u540d\u79f0\u3001\u9884\u671f\u7528\u9014\uff0c\u4ee5\u53ca\u73b0\u6709\u7684\u5883\u5916\u6279\u51c6<\/strong> \u5373\u53ef\uff0cIFU \u7b49\u8d44\u6599\u53ef\u5728\u9879\u76ee\u542f\u52a8\u540e\u518d\u63d0\u4f9b\u3002MediPass \u53ef\u636e\u6b64\u521d\u6b65\u5224\u65ad\u65b0\u52a0\u5761\u7c7b\u522b\u4e0e\u53ef\u884c\u8def\u5f84\uff0c\u5e76\u7ed9\u51fa\u62a5\u4ef7\uff1b\u5206\u7c7b\u4f9d\u636e\u7684\u9010\u9879\u6574\u7406\u548c\u8d44\u6599\u51c6\u5907\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\/\">\u8054\u7cfb MediPass \u8ba8\u8bba\u4ea7\u54c1\u5206\u7c7b<\/a><\/aside>\n\n<section class=\"related\"><h2>\u5ef6\u4f38\u9605\u8bfb<\/h2><ul>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/singapore-medical-device-registration\/\"><strong>\u65b0\u52a0\u5761\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1<\/strong><span>HSA \u98ce\u9669\u5206\u7c7b\u3001\u5206\u7ec4\u3001\u8bc4\u4f30\u8def\u7ebf\u4e0e\u672c\u5730\u6ce8\u518c\u4eba\u5b89\u6392\u6982\u89c8\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>IVD \u9879\u76ee\u7684\u5206\u7c7b\u4e0e\u5206\u7ec4\u53d8\u5316\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/samd-registration\/\"><strong>\u533b\u7597\u8f6f\u4ef6\uff08SaMD\uff09\u6ce8\u518c<\/strong><span>\u72ec\u7acb\u8f6f\u4ef6\u7684\u5206\u7c7b\u5224\u65ad\u4e0e\u6ce8\u518c\u51c6\u5907\u3002<\/span><\/a><\/li>\n<\/ul><\/section>\n\n<section class=\"references\"><h2>\u5b98\u65b9\u53c2\u8003\u8d44\u6599<\/h2><ol>\n<li>HSA\uff0cGN-13 R2.1 Guidance on the Risk Classification of General Medical Devices\uff08\u4e00\u822c\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u6307\u5357\uff09\uff0c\u7b2c 1.2\u20141.4 \u8282\uff08\u7b2c 4\u201410 \u9875\uff09\u3001\u7b2c 2 \u8282\uff08\u7b2c 11\u201412 \u9875\uff09\u3001\u7b2c 4 \u8282\uff08\u7b2c 13 \u9875\uff09\u3001Rule 1\uff08\u7b2c 14\u201415 \u9875\uff09\u3001Rule 10\uff08\u7b2c 23\u201424 \u9875\uff09\u3001\u9644\u5f55 A\uff08\u7b2c 29 \u9875\uff09\uff0c2018 \u5e74 9 \u6708\uff0c<a href=\"https:\/\/isomer-user-content.by.gov.sg\/409\/5c0b7242-e829-4f8d-baca-0b9542170bb5\/gn-13-r2-1-guidance-on-the-risk-classification-of-general-medical-devices-%2818sep-pub%29.pdf\" target=\"_blank\" rel=\"noopener\">hsa.gov.sg\uff08PDF\uff09<\/a><\/li>\n<li>HSA\uff0cGN-14 R3 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices\uff08IVD \u98ce\u9669\u5206\u7c7b\u6307\u5357\uff09\uff0cRule 4\uff08\u7b2c 15 \u9875\uff09\uff0c2023 \u5e74 7 \u6708\uff082023-07-24 \u751f\u6548\uff09\uff0c<a href=\"https:\/\/isomer-user-content.by.gov.sg\/409\/7d66d1b0-fdb2-4fd9-851e-110645210592\/gn-14-r3-guidance-on-the-risk-classification-of-in-vitro-diagnostic-md-%282023-jul%29-pub.pdf\" target=\"_blank\" rel=\"noopener\">hsa.gov.sg\uff08PDF\uff09<\/a><\/li>\n<li>HSA\uff0cGL-07 R2 Guidelines on Risk Classification of SaMD and Qualification of CDSS\uff08SaMD \u98ce\u9669\u5206\u7c7b\u53ca CDSS \u754c\u5b9a\u6307\u5357\uff09\uff0c2025 \u5e74 7 \u6708\uff0c<a href=\"https:\/\/isomer-user-content.by.gov.sg\/409\/ae814059-a3ff-4ce3-8192-4534a43ddc6f\/gl-07-r2-guidelines-risk-classification-samd-cdss-%282025-jul%29-pub.pdf\" target=\"_blank\" rel=\"noopener\">isomer-user-content.by.gov.sg\uff08PDF\uff09<\/a>\uff1b\u66f4\u65b0\u516c\u544a\uff08Rule 10(i) Class B \u6761\u4ef6\u3001CDSS \u975e\u533b\u7597\u5668\u68b0\u6761\u4ef6\uff09\uff0c2025-07-21\uff0c<a href=\"https:\/\/www.hsa.gov.sg\/announcements\/update-for-guidelines-on-risk-classification-of-samd-and-qualification-of-clinical-decision-support-software--cdss-\/\" target=\"_blank\" rel=\"noopener\">hsa.gov.sg<\/a><\/li>\n<li>HSA\uff0cGL-06 R2 Medical Devices Product Classification Guide\uff08\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5c5e\u6027\u5224\u65ad\u6307\u5357\uff09\uff0c2023 \u5e74 10 \u6708\uff0c<a href=\"https:\/\/isomer-user-content.by.gov.sg\/409\/99676d24-b351-42c3-8295-0edb5429fbf0\/gl-06-r2-medical-devices-product-classification-guide-%282023-oct%29-pub.pdf\" target=\"_blank\" rel=\"noopener\">isomer-user-content.by.gov.sg\uff08PDF\uff09<\/a><\/li>\n<li>HSA\uff0cGuidance documents for medical devices\uff08\u533b\u7597\u5668\u68b0\u6307\u5357\u76ee\u5f55\uff0c\u73b0\u884c\u7248\u672c\uff09\uff0c\u9875\u9762\u66f4\u65b0\u4e8e 2026-09-30\uff0c<a href=\"https:\/\/www.hsa.gov.sg\/medical-devices\/guidance-documents\/\" target=\"_blank\" rel=\"noopener\">hsa.gov.sg<\/a><\/li>\n<li>HSA\uff0cRegister your device: Overview\uff08\u6ce8\u518c\u6982\u89c8\uff1aClass A \u8c41\u514d\u53ca\u4ea7\u54c1\u901a\u62a5\u3001\u8bc4\u4f30\u8def\u7ebf\u3001\u53c2\u8003\u673a\u6784\u6279\u51c6\u6761\u4ef6\uff09\uff0c\u9875\u9762\u66f4\u65b0\u4e8e 2026-03-13\uff0c<a href=\"https:\/\/www.hsa.gov.sg\/medical-devices\/registration-of-medical-devices\/register-your-device\/overview\/\" target=\"_blank\" rel=\"noopener\">hsa.gov.sg<\/a><\/li>\n<li>HSA\uff0cGrouping of medical devices\uff08\u6ce8\u518c\u5206\u7ec4\uff09\uff0c\u9875\u9762\u66f4\u65b0\u4e8e 2026-10-05\uff0c<a href=\"https:\/\/www.hsa.gov.sg\/medical-devices\/registration-of-medical-devices\/register-your-device\/grouping\/\" target=\"_blank\" rel=\"noopener\">hsa.gov.sg<\/a><\/li>\n<li>HSA\uff0cAI-Enabled Medical Device Risk Classification Tool\uff08AI \u98ce\u9669\u5206\u7c7b\u5de5\u5177\uff0c\u6d4b\u8bd5\u7248\uff0c\u7ed3\u679c\u975e\u6b63\u5f0f\u8ba4\u5b9a\uff09\uff0c<a href=\"https:\/\/mdrc.hsa.gov.sg\/\" target=\"_blank\" rel=\"noopener\">mdrc.hsa.gov.sg<\/a><\/li>\n<\/ol><p class=\"note\">\u672c\u6587\u4f9d\u636e\u622a\u81f3 2026 \u5e74 10 \u6708 7 \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\u7b49\u7ea7\u5e94\u7ed3\u5408\u5b9e\u9645\u62df\u552e\u7528\u9014\u3001\u4ea7\u54c1\u4e8b\u5b9e\u548c HSA \u9002\u7528\u6307\u5357\u786e\u8ba4\u3002<\/p><\/section>\n<\/article>\n\n","protected":false},"excerpt":{"rendered":"<p>\u4ea7\u54c1\u540d\u79f0\u548c\u5883\u5916\u7b49\u7ea7\u4e0d\u8db3\u4ee5\u51b3\u5b9a\u65b0\u52a0\u5761\u98ce\u9669\u5206\u7c7b\u3002\u5148\u628a\u9884\u671f\u7528\u9014\u3001\u63a5\u89e6\u90e8\u4f4d\u3001\u4f7f\u7528\u65f6\u95f4\u4e0e\u5de5\u4f5c\u539f\u7406\u5199\u6e05\uff0c\u518d\u6309 GN-13 \u9010\u6761\u6838\u5bf9\u89c4\u5219\uff0c\u5e76\u4fdd\u7559\u652f\u6301\u7ed3\u8bba\u7684\u6587\u4ef6\u3002<\/p>\n","protected":false},"author":2,"featured_media":4096,"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":[33,32],"tags":[],"class_list":["post-6624","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-33","category-32"],"_links":{"self":[{"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts\/6624","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=6624"}],"version-history":[{"count":2,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts\/6624\/revisions"}],"predecessor-version":[{"id":6669,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts\/6624\/revisions\/6669"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/media\/4096"}],"wp:attachment":[{"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=6624"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=6624"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=6624"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}