{"id":9268,"date":"2025-11-26T17:41:51","date_gmt":"2025-11-26T09:41:51","guid":{"rendered":"https:\/\/regask.com\/?p=9268"},"modified":"2025-12-02T20:09:25","modified_gmt":"2025-12-02T12:09:25","slug":"%e6%96%b0%e5%8a%a0%e5%9d%a1%e5%8d%ab%e7%94%9f%e7%a7%91%e5%ad%a6%e5%b1%80%e5%8f%91%e5%b8%83%e4%ba%86%e5%85%b3%e4%ba%8e%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e5%90%88%e8%a7%84%e5%88%86%e7%bb%84%e5%92%8c","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/hsa-singapore-issues-updated-guidance-on-medical-device-compliance-grouping-and-submission-requirements\/","title":{"rendered":"\u65b0\u52a0\u5761\u536b\u751f\u79d1\u5b66\u5c40\u53d1\u5e03\u533b\u7597\u5668\u68b0\u6700\u65b0\u6307\u5357\u2026\u2026"},"content":{"rendered":"<p>2025\u5e7411\u67085\u65e5\uff0c <strong><a href=\"https:\/\/www.hsa.gov.sg\/\">\u536b\u751f\u79d1\u5b66\u5c40\uff08HSA\uff09<\/a><\/strong> \u65b0\u52a0\u5761\u53d1\u5e03\u4e86\u65b0\u7684\u6307\u5bfc\u6587\u4ef6\uff0c\u6982\u8ff0\u4e86\u76d1\u7ba1\u8981\u6c42\u3002 <strong>\u533b\u7597\u5668\u68b0\u6ce8\u518c\u3001\u5408\u89c4\u6027\u3001\u5206\u7ec4\u6807\u51c6\u548c\u63d0\u4ea4\u6d41\u7a0b\u3002.<\/strong> \u6b64\u6b21\u66f4\u65b0\u65e8\u5728\u7b80\u5316\u76d1\u7ba1\u6d41\u7a0b\uff0c\u540c\u65f6\u5f3a\u5316\u5bf9\u65b0\u52a0\u5761\u4f9b\u5e94\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u8981\u6c42\u3002\u8be5\u6307\u5357\u9002\u7528\u4e8e\uff1a <strong>\u5236\u9020\u5546\u3001\u8fdb\u53e3\u5546\u3001\u6279\u53d1\u5546\u548c\u5176\u4ed6\u5229\u76ca\u76f8\u5173\u8005<\/strong> \u4e1a\u52a1\u904d\u53ca\u533b\u7597\u5668\u68b0\u4f9b\u5e94\u94fe\u3002.<\/p>\n<div class=\"row\"  id=\"row-1835297038\">\n\n\t<div id=\"col-2144154793\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>\u66f4\u65b0\u6307\u5357\u6982\u8ff0<\/h3>\n\t<div id=\"gap-582960418\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-582960418 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u65b0\u53d1\u5e03\u7684\u51fa\u7248\u7269\u9610\u660e\u4e86\u4ee5\u4e0b\u6807\u51c6\uff1a <strong>\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u5206\u6790\u4eea\u7684\u5141\u8bb8\u548c\u4e0d\u5141\u8bb8\u7684\u53d8\u4f53<\/strong> \u6839\u636e <strong>\u5bb6\u5ead\u5206\u7ec4<\/strong> \u6846\u67b6\u3002\u6539\u53d8\u8bca\u65ad\u529f\u80fd\u7684\u53d8\u4f53\u9700\u8981\u5355\u72ec\u5217\u51fa\uff0c\u800c\u5141\u8bb8\u7684\u53d8\u4f53\u53ef\u4ee5\u6839\u636e\u73b0\u6709\u89c4\u5219\u66f4\u6709\u6548\u5730\u5206\u7ec4\u3002.<\/p>\n<p>\u8be5\u6307\u5357\u8fd8\u63d0\u51fa\u4e86\u8be6\u7ec6\u7684\u9884\u671f\uff0c\u5305\u62ec\uff1a <strong>\u5177\u5907\u673a\u5668\u5b66\u4e60\u529f\u80fd\u7684\u533b\u7597\u8bbe\u5907,<\/strong> \u9700\u8981\u8bb0\u5f55\u6a21\u578b\u8bad\u7ec3\u3001\u9a8c\u8bc1\u3001\u6f5c\u5728\u6f0f\u6d1e\u4ee5\u53ca\u4e0e\u4e34\u5e8a\u5de5\u4f5c\u6d41\u7a0b\u7684\u96c6\u6210\u60c5\u51b5\u3002.<\/p>\n<p>\u4e3a\u4e86 <strong>\u8054\u7f51\u533b\u7597\u8bbe\u5907,<\/strong> HSA \u8981\u6c42\u63d0\u4ea4 <strong>\u7f51\u7edc\u5b89\u5168<\/strong> \u63d0\u4f9b\u8bc1\u636e\u4ee5\u53ca\u6301\u7eed\u5a01\u80c1\u68c0\u6d4b\u548c\u7ba1\u7406\u8ba1\u5212\u3002.<\/p>\n<p>\u6b64\u5916\uff0c\u6b64\u6b21\u66f4\u65b0\u4e5f\u5f3a\u8c03\u4e86\u4ee5\u4e0b\u65b9\u9762\u7684\u5fc5\u8981\u6027\uff1a <strong>ISO 13485 \u6216 SS 620\uff08GDPMDS \u2013 \u533b\u7597\u5668\u68b0\u826f\u597d\u5206\u9500\u89c4\u8303\uff09<\/strong> \u9664\u4ee5\u4e0b\u60c5\u51b5\u5916\uff0c\u6574\u4e2a\u4f9b\u5e94\u94fe\u5747\u9700\u8fdb\u884c\u8ba4\u8bc1\uff1a <strong>A\u7c7b\u8bbe\u5907<\/strong> \u7b26\u5408\u7279\u5b9a\u7533\u62a5\u8981\u6c42\u3002\u5229\u76ca\u76f8\u5173\u65b9\u8fd8\u5fc5\u987b\u786e\u4fdd\u53ca\u65f6\u7533\u62a5\u3002<strong> \u901a\u8fc7 SHARE \u7cfb\u7edf\uff08\u65b0\u52a0\u5761\u5065\u5eb7\u4ea7\u54c1\u51c6\u5165\u548c\u76d1\u7ba1\u7535\u5b50\u7cfb\u7edf\uff09\u7eed\u7b7e\u7ecf\u9500\u5546\u8bb8\u53ef\u8bc1\uff0c,<\/strong> GIRO \u7528\u6237\u53ef\u4f7f\u7528\u81ea\u52a8\u7eed\u671f\u529f\u80fd\uff0c\u4e14\u5fc5\u987b\u66f4\u65b0 <strong>A\u7c7b\u533b\u7597\u5668\u68b0\u901a\u77e5<\/strong> \u8fdb\u53e3\u6216\u4f9b\u5e94\u4e4b\u524d\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2144154793 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2095653122\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>\u4e3a\u4ec0\u4e48\u8fd9\u5f88\u91cd\u8981<\/h3>\n\t<div id=\"gap-877896896\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-877896896 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u66f4\u65b0\u540e\u7684\u6307\u5357\u66f4\u6e05\u6670\u5730\u9610\u8ff0\u4e86\u8bbe\u5907\u5206\u7ec4\u3001\u4eba\u5de5\u667a\u80fd\u8d4b\u80fd\u7684\u8bbe\u5907\u6587\u6863\u3001\u7f51\u7edc\u5b89\u5168\u4fdd\u969c\u63aa\u65bd\u4ee5\u53ca\u4f9b\u5e94\u94fe\u8d28\u91cf\u8ba4\u8bc1\u7b49\u65b9\u9762\u7684\u8981\u6c42\u3002\u8fd9\u4e9b\u8981\u6c42\u6709\u52a9\u4e8e\u4fdd\u6301\u76d1\u7ba1\u4e00\u81f4\u6027\uff0c\u7b80\u5316\u4ea7\u54c1\u6ce8\u518c\u6d41\u7a0b\uff0c\u5e76\u786e\u4fdd\u4ea7\u54c1\u6301\u7eed\u7b26\u5408\u65b0\u52a0\u5761\u7684\u5b89\u5168\u548c\u6027\u80fd\u6807\u51c6\uff0c\u540c\u65f6\u907f\u514d\u589e\u52a0\u4e0d\u5fc5\u8981\u7684\u884c\u653f\u8d1f\u62c5\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2095653122 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2507351\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>\u8c01\u5e94\u8be5\u5ba1\u6838\u6b64\u66f4\u65b0<\/h3>\n\t<div id=\"gap-268632921\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-268632921 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u672c\u51fa\u7248\u7269\u4e0e\u4ee5\u4e0b\u65b9\u9762\u76f8\u5173\uff1a <strong>\u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u4eba\u5de5\u667a\u80fd\u548c\u8f6f\u4ef6\u5f00\u53d1\u56e2\u961f\u3001\u5236\u9020\u5546\u3001\u8fdb\u53e3\u5546\u3001,<\/strong> \u548c <strong>\u6279\u53d1\u5546<\/strong> \u5728\u65b0\u52a0\u5761\u4ece\u4e8b\u533b\u7597\u5668\u68b0\u4e1a\u52a1\uff0c\u7279\u522b\u662f\u7ba1\u7406\u4f53\u5916\u8bca\u65ad\u5206\u6790\u4eea\u3001\u8054\u7f51\u8bbe\u5907\u6216\u673a\u5668\u5b66\u4e60\u6280\u672f\u7684\u4e1a\u52a1\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2507351 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-220003990\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>\u4e0b\u4e00\u6b65<\/h3>\n\t<div id=\"gap-36172394\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-36172394 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u76ca\u76f8\u5173\u8005\u5e94\u5ba1\u67e5\u66f4\u65b0\u540e\u7684HSA\u6307\u5357\uff0c\u4ee5\u786e\u8ba4\u4ea7\u54c1\u5206\u7c7b\u4e0e\u6307\u5357\u4e00\u81f4\u3002 <strong>\u5bb6\u5ead\u5206\u7ec4<\/strong> \u76d1\u7ba1\u56e2\u961f\u5e94\u8bc4\u4f30\u76f8\u5173\u6587\u4ef6\uff0c\u5e76\u5236\u5b9a\u76f8\u5e94\u7684\u6807\u51c6\u3002 <strong>\u5177\u5907\u673a\u5668\u5b66\u4e60\u529f\u80fd\u7684\u8bbe\u5907<\/strong> \u548c\u8fde\u63a5\u7684\u8bbe\u5907 <strong>\u7f51\u7edc\u5b89\u5168\u8bc1\u636e,<\/strong> \u6838\u5b9e <strong>ISO 13485 \u6216 SS 620<\/strong> \u6574\u4e2a\u4f9b\u5e94\u94fe\u7684\u8ba4\u8bc1\uff0c\u5e76\u786e\u4fdd <strong>A\u7c7b\u901a\u77e5<\/strong> \u5728\u8fdb\u53e3\u6216\u4f9b\u5e94\u524d\u8fdb\u884c\u66f4\u65b0\u3002\u968f\u7740\u5404\u7ec4\u7ec7\u4e0d\u65ad\u5b8c\u5584\u5408\u89c4\u7b56\u7565\uff0c, <a href=\"https:\/\/regask.com\/zh\/\">RegASK<\/a> \u652f\u6301\u79ef\u6781\u4e3b\u52a8\u5730\u8fdb\u884c\u76d1\u6d4b\uff0c\u5e76\u4e0e\u65b0\u52a0\u5761\u536b\u751f\u79d1\u5b66\u5c40\u4e0d\u65ad\u53d8\u5316\u7684\u671f\u671b\u4fdd\u6301\u4e00\u81f4\u3002.<\/p>\n<p>RegASK \u662f\u9886\u5148\u7684 <strong>agentic AI \u76d1\u7ba1\u667a\u80fd\u548c\u5de5\u4f5c\u6d41\u7a0b\u7f16\u6392\u5e73\u53f0<\/strong> RegASK \u8d4b\u80fd\u5168\u7403\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u4f01\u4e1a\uff0c\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\u9886\u57df\uff0c\u4f7f\u5176\u80fd\u591f\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002\u901a\u8fc7\u5c06\u5148\u8fdb\u7684\u667a\u80fd\u4ee3\u7406\u4eba\u5de5\u667a\u80fd\u4e0e\u4e13\u5bb6\u56e2\u961f\u76f8\u7ed3\u5408\uff0cRegASK \u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u4e14\u53ef\u6267\u884c\u7684\u6d1e\u5bdf\u548c\u7aef\u5230\u7aef\u7684\u81ea\u52a8\u5316\u89e3\u51b3\u65b9\u6848\uff0c\u4ece\u800c\u7b80\u5316\u5408\u89c4\u6d41\u7a0b\u3001\u964d\u4f4e\u98ce\u9669\u5e76\u52a0\u901f\u4f01\u4e1a\u5728\u8d85\u8fc7 157 \u4e2a\u56fd\u5bb6\/\u5730\u533a\u7684\u5e02\u573a\u51c6\u5165\u3002.<\/p>\n<p><a href=\"https:\/\/regask.com\/zh\/%e4%ba%a7%e5%93%81\/\">\u4e86\u89e3\u66f4\u591a<\/a> \u6216\u8005 <a href=\"https:\/\/regask.com\/zh\/%e9%a2%84%e8%ae%a2%e6%bc%94%e7%a4%ba\/\">\u7acb\u5373\u9884\u7ea6\u6f14\u793a\u3002. <\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-220003990 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1705696792\">\n\n\t<div id=\"col-1172923916\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/h3>\n\t<div id=\"gap-293466877\" class=\"gap-element clearfix\" style=\"display:block; 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height:auto;\">\n\t\t\n<style>\n#gap-1222113556 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5236\u9020\u5546\u5fc5\u987b\u63d0\u4f9b\u6709\u5173\u6a21\u578b\u8bad\u7ec3\u3001\u9a8c\u8bc1\u3001\u6f0f\u6d1e\u4ee5\u53ca\u6a21\u578b\u5982\u4f55\u96c6\u6210\u5230\u9884\u671f\u4e34\u5e8a\u5de5\u4f5c\u6d41\u7a0b\u4e2d\u7684\u8be6\u7ec6\u4fe1\u606f\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1539176812 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-119097275\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u533b\u7597\u5668\u68b0\u4f9b\u5e94\u94fe\u76f8\u5173\u65b9\u662f\u5426\u6709\u65b0\u7684\u8ba4\u8bc1\u8981\u6c42\uff1f<\/h4>\n\t<div id=\"gap-560008709\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-560008709 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u662f\u7684\u3002\u9664\u7b26\u5408\u7279\u5b9a\u58f0\u660e\u6761\u4ef6\u7684A\u7c7b\u8bbe\u5907\u5916\uff0c\u6574\u4e2a\u4f9b\u5e94\u94fe\u90fd\u9700\u8981ISO 13485\u6216SS 620\uff08GDPMDS\uff09\u8ba4\u8bc1\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-119097275 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1428207242\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>RegASK \u5982\u4f55\u4e3a\u54cd\u5e94 HSA \u6700\u65b0\u6307\u5bfc\u610f\u89c1\u7684\u516c\u53f8\u63d0\u4f9b\u652f\u6301\uff1f<\/h4>\n\t<div id=\"gap-1548364023\" class=\"gap-element clearfix\" style=\"display:block; 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The update aims to streamline regulatory pathways while reinforcing safety and performance expectations for medical devices supplied in Singapore. 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