{"id":6629,"date":"2025-10-15T10:00:00","date_gmt":"2025-10-15T02:00:00","guid":{"rendered":"https:\/\/aseanmedipass.com\/?p=6629"},"modified":"2026-10-30T00:26:56","modified_gmt":"2026-10-29T16:26:56","slug":"malaysia-medical-device-models-family-grouping","status":"publish","type":"post","link":"https:\/\/aseanmedipass.com\/zh-hans\/malaysia-medical-device-models-family-grouping\/","title":{"rendered":"\u9a6c\u6765\u897f\u4e9a\u591a\u4e2a\u578b\u53f7\u80fd\u5426\u653e\u5728\u540c\u4e00\u7533\u8bf7\uff1f\u5206\u7ec4\u4e0e\u62c6\u5206\u600e\u6837\u5224\u65ad"},"content":{"rendered":"\n<style>.postid-6629 .entry-header{display:none}.postid-6629 #primary{width:100%;margin:0}.postid-6629 #secondary{display:none}.postid-6629 #content .ast-container{max-width:844px!important;width:100%;padding:0!important}.postid-6629 .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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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-6629 .ast-article-single{padding:32px 22px!important}}.postid-6629 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\">\u9a6c\u6765\u897f\u4e9a \u00b7 \u533b\u7597\u5668\u68b0<\/p>\n<h1>\u9a6c\u6765\u897f\u4e9a\u591a\u4e2a\u578b\u53f7\u80fd\u5426\u653e\u5728\u540c\u4e00\u7533\u8bf7\uff1f\u5206\u7ec4\u4e0e\u62c6\u5206\u600e\u6837\u5224\u65ad<\/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=\"2025-10-15T10:00:00+08:00\">2025\u5e7410\u670815\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>\u4e00\u5f20\u76ee\u5f55\u6709\u4e8c\u5341\u4e2a\u578b\u53f7\uff0c\u9a6c\u6765\u897f\u4e9a\u6ce8\u518c\u7a76\u7adf\u9012\u4ea4\u4e00\u4efd\u7533\u8bf7\u8fd8\u662f\u4e8c\u5341\u4efd\uff1f\u7b54\u6848\u53d6\u51b3\u4e8e\u8fd9\u4e9b\u578b\u53f7\u4e4b\u95f4\u7684\u5b9e\u9645\u5dee\u5f02\u3002\u76f8\u540c\u54c1\u724c\u3001\u76f8\u540c\u5de5\u5382\u6216\u540c\u4e00\u7cfb\u5217\u7f16\u53f7\uff0c\u5355\u72ec\u4efb\u4f55\u4e00\u9879\u90fd\u4e0d\u8db3\u4ee5\u8bc1\u660e\u53ef\u4ee5\u5408\u5e76\u3002MDA \u5141\u8bb8\u7b26\u5408\u6761\u4ef6\u7684\u5668\u68b0\u6309\u5206\u7ec4\u653e\u5165\u540c\u4e00\u4efd\u7533\u8bf7\uff0c\u4f46\u5206\u7ec4\u5fc5\u987b\u540c\u65f6\u6ee1\u8db3\u201c\u4e00\u4e2a\u4e13\u6709\u540d\u79f0\u3001\u4e00\u4e2a\u5236\u9020\u5546\u3001\u4e00\u4e2a\u5171\u540c\u9884\u671f\u7528\u9014\u201d\u4e09\u9879\u57fa\u672c\u89c4\u5219\uff0c\u4ee5\u53ca\u6240\u9009\u7c7b\u522b\u7684\u5177\u4f53\u6761\u4ef6\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/www.mda.gov.my\/index.php\/announcement\/1352-second-edition-guidance-document-mda-gd-0005-general-medical-device-grouping\" target=\"_blank\" rel=\"noopener\">MDA\/GD\/0005 \u7b2c\u4e8c\u7248<\/a>\uff0c\u7b2c 4.1\u20144.2 \u8282\uff1b<a href=\"https:\/\/portal.mda.gov.my\/index.php\/documents\/guidance-documents\/1986-gd-ivd-product-grouping-mdagd0054\/file\" target=\"_blank\" rel=\"noopener\">MDA\/GD\/0054 \u7b2c\u4e8c\u7248<\/a>\uff0c\u7b2c 4 \u8282\uff09<\/span><\/p>\n<p>\u672c\u6587\u53ea\u8ba8\u8bba\u9996\u6b21\u6ce8\u518c\u65f6\u600e\u6837\u786e\u5b9a\u7533\u8bf7\u8303\u56f4\u3002\u5df2\u6ce8\u518c\u4ea7\u54c1\u52a0\u578b\u53f7\u6216\u6539\u7528\u9014\uff0c\u5e94\u6309\u53d8\u66f4\u89c4\u5219\u53e6\u884c\u5224\u65ad\uff1b\u6ce8\u518c\u4e3b\u4f53\u3001CAB \u548c\u6574\u4f53\u6d41\u7a0b\u53ef\u5148\u53c2\u9605<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/malaysia-medical-device-registration\/\">\u9a6c\u6765\u897f\u4e9a\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>\u9002\u7528\u6307\u5357<\/dt><dd>\u4e00\u822c\u533b\u7597\u5668\u68b0\u7528 MDA\/GD\/0005 \u7b2c\u4e8c\u7248\uff082024 \u5e74 1 \u6708\uff09\uff1bIVD \u7528 MDA\/GD\/0054 \u7b2c\u4e8c\u7248\uff082021 \u5e74 1 \u6708\uff09\u3002GD\/0005 \u7684\u9002\u7528\u8303\u56f4\u660e\u786e\u6392\u9664 IVD\u3002<\/dd>\n<dt>\u57fa\u672c\u89c4\u5219<\/dt><dd>\u4e00\u4e2a\u4e13\u6709\u540d\u79f0\u3001\u4e00\u4e2a\u5236\u9020\u5546\u3001\u4e00\u4e2a\u5171\u540c\u9884\u671f\u7528\u9014\uff0c\u4e09\u9879\u987b\u540c\u65f6\u6ee1\u8db3\uff0c\u5206\u7ec4\u624d\u6210\u7acb\u3002<\/dd>\n<dt>Family \u6761\u4ef6<\/dt><dd>\u540c\u4e00\u5236\u9020\u5546\u3001\u540c\u4e00\u98ce\u9669\u7c7b\u522b\u3001\u540c\u4e00\u4e13\u6709\u540d\u79f0\u3001\u5171\u540c\u9884\u671f\u7528\u9014\u3001\u76f8\u540c\u8bbe\u8ba1\u4e0e\u5236\u9020\u8fc7\u7a0b\uff0c\u5dee\u5f02\u9650\u4e8e\u5141\u8bb8\u53d8\u578b\uff08\u5c01\u95ed\u5f0f\u6b63\u9762\u6e05\u5355\uff09\uff1b\u6750\u6599\u5dee\u5f02\u539f\u5219\u4e0a\u4e0d\u5c5e\u4e8e\u5141\u8bb8\u53d8\u578b\uff0c\u9644\u4ef6 C \u5bf9\u7279\u5b9a\u5668\u68b0\u5217\u660e\u7684\u6750\u6599\u7c7b\u53d8\u578b\u9664\u5916\u3002<\/dd>\n<dt>\u4e0a\u5e02\u8303\u56f4<\/dt><dd>\u53ea\u6709\u6700\u7ec8\u5217\u5165\u6ce8\u518c\u767b\u8bb0\u7684 Family \u6210\u5458\u624d\u53ef\u4e0a\u5e02\uff1b\u76ee\u5f55\u4e2d\u5176\u4ed6\u578b\u53f7\u4e0d\u4f1a\u56e0\u540c\u5c5e\u4e00\u4e2a\u7cfb\u5217\u800c\u81ea\u52a8\u8986\u76d6\u3002<\/dd>\n<dt>\u5148\u505a\u4ec0\u4e48<\/dt><dd>\u5efa\u7acb\u578b\u53f7\u77e9\u9635\uff0c\u9010\u9879\u8bf4\u660e\u6bcf\u4e2a\u5dee\u5f02\u5bf9\u5e94\u54ea\u6761\u5206\u7ec4\u6761\u6587\uff0c\u518d\u51b3\u5b9a\u5408\u5e76\u8fd8\u662f\u62c6\u5206\u3002<\/dd>\n<\/dl>\n<\/aside>\n\n<h2>\u5148\u786e\u5b9a\u8be5\u7528\u54ea\u4e00\u4efd\u5206\u7ec4\u6307\u5357<\/h2>\n<p>\u4e00\u822c\u533b\u7597\u5668\u68b0\u4f7f\u7528 MDA\/GD\/0005\u300aGeneral Medical Device \u2013 Grouping\u300b\u7b2c\u4e8c\u7248\u3002\u8be5\u7248\u7b2c 2 \u8282\u5199\u660e\u9002\u7528\u8303\u56f4\u4e0d\u5305\u62ec\u4f53\u5916\u8bca\u65ad\u5668\u68b0\uff0c\u6ce8\u91ca\u6307\u5411 IVD \u4e13\u7528\u7684 MDA\/GD\/0054\u3002\u628a\u68c0\u6d4b\u8bd5\u5242\u76f4\u63a5\u5957\u7528 GMD \u7684 Family \u6216 Set \u6761\u4ef6\uff0c\u4ece\u7b2c\u4e00\u6b65\u5c31\u9009\u9519\u4e86\u6846\u67b6\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGD\/0005 \u7b2c\u4e8c\u7248\uff0c\u7b2c 2 \u8282\uff09<\/span><\/p>\n<p>\u4e24\u4efd\u6307\u5357\u7684\u5206\u7ec4\u7c7b\u522b\u4e0d\u540c\uff1a<\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u6307\u5357<\/th><th>\u5206\u7ec4\u7c7b\u522b<\/th><th>\u53e6\u6709\u4e13\u95e8\u89c4\u5b9a<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>GD\/0005\uff08\u4e00\u822c\u533b\u7597\u5668\u68b0\uff09<\/td><td>Single\u3001System\u3001Family\u3001Set<\/td><td>IVF \u5668\u68b0\uff084.3.5\uff09\u3001\u52a9\u542c\u5668\uff084.3.6\uff09<\/td><\/tr>\n<tr><td>GD\/0054\uff08IVD\uff09<\/td><td>Single\u3001System\u3001Family\u3001IVD Test Kit\u3001IVD Cluster<\/td><td>\u514d\u75ab\u7ec4\u5316\uff08IHC\uff0c6.1\uff09\u3001FISH \u63a2\u9488\uff086.2\uff09<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u5224\u65ad\u987a\u5e8f\u5efa\u8bae\u662f\uff1a\u5148\u95ee\u6bcf\u4e2a\u578b\u53f7\u80fd\u5426\u72ec\u7acb\u5b8c\u6210\u81ea\u5df1\u7684\u533b\u7597\u7528\u9014\uff0c\u8fd8\u662f\u5fc5\u987b\u4e0e\u5176\u4ed6\u90e8\u4ef6\u914d\u5408\u4f7f\u7528\uff1b\u518d\u5224\u65ad\u5b83\u4eec\u4e4b\u95f4\u662f\u201c\u540c\u4e00\u4ea7\u54c1\u7684\u53d8\u578b\u201d\uff08Family\uff09\u3001\u201c\u914d\u5408\u4f7f\u7528\u7684\u7ec4\u4ef6\u201d\uff08System\uff09\uff0c\u8fd8\u662f\u201c\u7531\u5236\u9020\u5546\u7ec4\u88c5\u6210\u4e00\u4e2a\u5305\u88c5\u7684\u591a\u4ef6\u5668\u68b0\u201d\uff08Set\uff09\u3002Family \u5e76\u975e\u9ed8\u8ba4\u9009\u9879\uff1b\u5305\u88c5\u4e2d\u88c5\u4e86\u51e0\u4ef6\u5668\u68b0\uff0c\u4e5f\u4e0d\u8db3\u4ee5\u76f4\u63a5\u8ba4\u5b9a\u4e3a Set\u3002<\/p>\n\n<h2>Family\uff1a\u516d\u9879\u6761\u4ef6\u8981\u9010\u4e00\u6709\u8bc1\u636e<\/h2>\n<p>GD\/0005 \u7b2c 4.3.3.1 \u6761\u89c4\u5b9a\uff0cFamily \u6210\u5458\u987b\uff1a\u6765\u81ea\u540c\u4e00\u5236\u9020\u5546\uff1b\u98ce\u9669\u7c7b\u522b\u76f8\u540c\uff1b\u533b\u7597\u5668\u68b0\u4e13\u6709\u540d\u79f0\u76f8\u540c\uff1b\u9884\u671f\u7528\u9014\u5171\u540c\uff1b\u8bbe\u8ba1\u53ca\u5236\u9020\u8fc7\u7a0b\u76f8\u540c\uff1b\u5dee\u5f02\u9650\u4e8e\u5141\u8bb8\u53d8\u578b\u3002\u5efa\u8bae\u628a\u8fd9\u516d\u9879\u9010\u4e00\u5199\u8fdb\u578b\u53f7\u6bd4\u8f83\u8868\uff0c\u518d\u7528\u6807\u7b7e\u3001\u89c4\u683c\u3001\u5de5\u827a\u8bf4\u660e\u548c\u9a8c\u8bc1\u8d44\u6599\u652f\u6301\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGD\/0005 \u7b2c\u4e8c\u7248\uff0c\u7b2c 4.3.3.1 \u6761\uff0c\u7b2c 4 \u9875\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u578b\u53f7\u4e4b\u95f4\u7684\u5b9e\u9645\u5dee\u5f02<\/th><th>\u9700\u8981\u6838\u5bf9\u7684\u4f9d\u636e<\/th><th>\u5bf9\u7533\u8bf7\u8303\u56f4\u7684\u5f71\u54cd<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u4ec5\u5305\u88c5\u5185\u6570\u91cf\u4e0d\u540c<\/td><td>\u5668\u68b0\u672c\u8eab\u3001\u7528\u9014\u548c\u89c4\u683c\u662f\u5426\u5b8c\u5168\u76f8\u540c<\/td><td>\u6307\u5357\u793a\u4f8b\uff1a3\u300112\u3001144 \u53ea\u88c5\u7684\u907f\u5b55\u5957\u53ef\u6309\u4e00\u4e2a Single \u6ce8\u518c\uff084.3.1\uff09\uff0c\u4e0d\u5fc5\u4e3a\u5305\u88c5\u5dee\u5f02\u53e6\u8bbe Family\u3002<\/td><\/tr>\n<tr><td>\u957f\u5ea6\u3001\u5c3a\u5bf8\u3001\u8154\u6570\u7b49\u4e0d\u540c<\/td><td>\u9644\u4ef6 C \u662f\u5426\u5217\u6709\u8be5\u5dee\u5f02\uff0c\u4ee5\u53ca\u5176\u4ed6\u4e94\u9879 Family \u6761\u4ef6<\/td><td>\u6761\u4ef6\u5168\u90e8\u6ee1\u8db3\u65f6\u53ef\u8003\u8651\u540c\u4e00 Family\uff1b\u6307\u5357\u793a\u4f8b\u5305\u62ec\u4e0d\u540c\u7ba1\u8def\u957f\u5ea6\u7684\u8f93\u6db2\u5668\u3001\u4e0d\u540c\u8154\u6570\u548c\u957f\u5ea6\u7684\u5fc3\u5bfc\u7ba1\uff084.3.3.2\uff09\u3002<\/td><\/tr>\n<tr><td>\u6750\u6599\u4e0d\u540c<\/td><td>\u5177\u4f53\u6750\u6599\u5dee\u5f02\u53ca\u5176\u8bbe\u8ba1\u3001\u98ce\u9669\u5f71\u54cd<\/td><td>\u4e00\u822c\u89c4\u5219\u662f\u201c\u6750\u6599\u4e0d\u88ab\u89c6\u4e3a\u5141\u8bb8\u53d8\u578b\u201d\uff0c\u793a\u4f8b\u4e3a\u949b\u4e0e\u4e0d\u9508\u94a2\u5668\u68b0\u4e0d\u5f97\u653e\u5165\u540c\u4e00 Family\uff084.3.3.4\uff09\u3002\u4f46\u9644\u4ef6 C \u5bf9\u7279\u5b9a\u5668\u68b0\u53e6\u5217\u6750\u6599\u7c7b\u53d8\u578b\uff0c\u4f8b\u5982\u7259\u79d1\u6258\u69fd\u7684\u6258\u69fd\u6750\u6599\u3001\u7259\u79d1\u624b\u673a\u7684\u624b\u673a\u6750\u6599\u3001X \u5c04\u7ebf\u63a2\u6d4b\u5668\u7684\u95ea\u70c1\u4f53\u6750\u6599\uff0c\u4ee5\u53ca\u4ec5\u7528\u4e8e\u6da6\u6ed1\u7684\u6d82\u5c42\u6750\u6599\u3002\u5668\u68b0\u4e0d\u5728\u8fd9\u4e9b\u6761\u76ee\u5185\u7684\uff0c\u901a\u5e38\u5e94\u62c6\u5206\u3002<\/td><\/tr>\n<tr><td>\u9884\u671f\u7528\u9014\u6216\u8bbe\u8ba1\u4e0d\u540c<\/td><td>IFU\u3001\u6027\u80fd\u53ca\u8bbe\u8ba1\u5236\u9020\u5dee\u5f02<\/td><td>\u6307\u5357\u793a\u4f8b\uff1a\u73af\u66f2\u9762\u4e0e\u7403\u9762\u9690\u5f62\u773c\u955c\u7528\u9014\u3001\u8bbe\u8ba1\u4e0d\u540c\uff0c\u4e0d\u5c5e\u540c\u4e00 Family\uff084.3.3.2(f)\uff09\u3002<\/td><\/tr>\n<tr><td>\u4e13\u6709\u540d\u79f0\u6216\u5236\u9020\u5546\u4e0d\u540c<\/td><td>\u6807\u7b7e\u4e0a\u7684\u4e13\u6709\u540d\u79f0\u3001\u6cd5\u5b9a\u5236\u9020\u5546\u8d44\u6599<\/td><td>\u4e0d\u7b26\u5408\u4e09\u9879\u57fa\u672c\u89c4\u5219\uff0c\u4e0d\u80fd\u4f5c\u4e3a\u540c\u4e00 Family\uff1b\u6bcf\u4e2a\u6210\u5458\u7684\u6807\u7b7e\u90fd\u987b\u6807\u793a\u8be5\u4e13\u6709\u540d\u79f0\uff084.3.3.4\uff09\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u9644\u4ef6 C \u7684\u5141\u8bb8\u53d8\u578b\u662f\u201c\u5c01\u95ed\u5f0f\u6b63\u9762\u6e05\u5355\u201d\uff0c\u5e94\u8fde\u540c\u5177\u4f53\u6761\u6587\u548c\u793a\u4f8b\u9605\u8bfb\u3002\u67d0\u79cd\u5dee\u5f02\u5728\u4e00\u7c7b\u5668\u68b0\u4e2d\u83b7\u5141\u8bb8\uff0c\u4e0d\u8868\u793a\u6240\u6709\u5668\u68b0\u90fd\u53ef\u4ee5\u7528\u540c\u4e00\u7406\u7531\u5408\u5e76\u3002\u6e05\u5355\u65e0\u6cd5\u652f\u6301\u7684\u5dee\u5f02\uff0c\u5e94\u5148\u5411 CAB \u6216 MDA \u786e\u8ba4\uff0c\u4e0d\u80fd\u81ea\u884c\u628a\u201c\u6280\u672f\u4e0a\u76f8\u8fd1\u201d\u6269\u5c55\u4e3a\u6cd5\u89c4\u5141\u8bb8\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGD\/0005 \u7b2c\u4e8c\u7248\uff0c\u9644\u4ef6 C\uff0c\u7b2c 14\u201417 \u9875\uff09<\/span><\/p>\n\n<h2>\u8bf4\u660e\u6027\u793a\u4f8b\uff1a\u56db\u4e2a\u8f93\u6db2\u5668\u578b\u53f7\u600e\u6837\u6574\u7406<\/h2>\n<p>\u4ee5\u4e0b\u4e3a\u5047\u8bbe\u793a\u4f8b\uff0c\u53ea\u7528\u4e8e\u8bf4\u660e\u5de5\u4f5c\u65b9\u6cd5\uff0c\u4e0d\u4ee3\u8868\u4efb\u4f55\u4e2a\u6848\u7684\u5ba1\u8bc4\u7ed3\u8bba\u3002\u67d0\u5236\u9020\u5546\u62df\u7533\u62a5\u56db\u4e2a\u8f93\u6db2\u5668\u578b\u53f7\uff1aA \u548c B \u4ec5\u7ba1\u8def\u957f\u5ea6\u4e0d\u540c\uff1bC \u5728\u540c\u4e00\u57fa\u7840\u8bbe\u8ba1\u4e0a\u66f4\u6362\u4e86\u4e3b\u8981\u63a5\u89e6\u6750\u6599\uff1bD \u7528\u4e8e\u4e0d\u540c\u7684\u4e34\u5e8a\u7528\u9014\u3002<\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u578b\u53f7<\/th><th>\u4e0e A \u7684\u5dee\u5f02<\/th><th>\u521d\u6b65\u5224\u65ad<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>A\u3001B<\/td><td>\u4ec5\u7ba1\u8def\u957f\u5ea6<\/td><td>\u82e5\u98ce\u9669\u7c7b\u522b\u3001\u4e13\u6709\u540d\u79f0\u3001\u6750\u6599\u3001\u5236\u9020\u8fc7\u7a0b\u53ca\u7528\u9014\u76f8\u540c\uff0c\u53ef\u53c2\u7167\u6307\u5357\u4e2d\u8f93\u6db2\u5668\u7ba1\u8def\u957f\u5ea6\u7684\u793a\u4f8b\u8bc4\u4f30\u4e3a\u540c\u4e00 Family\u3002<\/td><\/tr>\n<tr><td>C<\/td><td>\u4e3b\u8981\u63a5\u89e6\u6750\u6599<\/td><td>\u9644\u4ef6 C \u672a\u5c31\u8f93\u6db2\u5668\u5217\u51fa\u6750\u6599\u7c7b\u53d8\u578b\uff0c\u6309\u4e00\u822c\u89c4\u5219\u4e0d\u80fd\u5e76\u5165 A\u3001B \u7684 Family\uff0c\u5e94\u53e6\u884c\u7533\u8bf7\u6216\u5148\u5411 CAB\uff0fMDA \u786e\u8ba4\u3002<\/td><\/tr>\n<tr><td>D<\/td><td>\u4e34\u5e8a\u7528\u9014<\/td><td>\u4e0d\u6ee1\u8db3\u5171\u540c\u9884\u671f\u7528\u9014\uff0c\u4e0d\u80fd\u51ed\u5171\u540c\u7684\u5546\u4e1a\u7cfb\u5217\u540d\u5e76\u5165\uff1b\u5e94\u6309\u5176\u7528\u9014\u5355\u72ec\u786e\u5b9a\u5206\u7ec4\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u521d\u6b65\u5206\u7ec4\u540e\uff0c\u518d\u628a\u62df\u552e\u578b\u53f7\u3001\u6807\u7b7e\u548c\u652f\u6301\u8bc1\u636e\u9010\u9879\u5bf9\u5e94\u3002\u8fd9\u6837\u5f97\u51fa\u7684\u7533\u8bf7\u6570\u91cf\u6709\u4f9d\u636e\uff0c\u800c\u4e0d\u662f\u5148\u9884\u5b9a\u4e00\u4efd\u7533\u8bf7\uff0c\u518d\u4fee\u6539\u4ea7\u54c1\u63cf\u8ff0\u6765\u8fc1\u5c31\u3002<\/p>\n\n<h2>System \u548c Set\uff1a\u8fd8\u8981\u770b\u5b9e\u9645\u600e\u6837\u9500\u552e<\/h2>\n<p>System \u8981\u6c42\u7ec4\u4ef6\u6765\u81ea\u540c\u4e00\u5236\u9020\u5546\u3001\u76f8\u4e92\u517c\u5bb9\u3001\u914d\u5408\u5b8c\u6210\u5171\u540c\u7528\u9014\uff0c\u5e76\u4ee5\u7cfb\u7edf\u540d\u79f0\u9500\u552e\u6216\u5728\u6807\u7b7e\u4e2d\u6ce8\u660e\u4f9b\u8be5\u7cfb\u7edf\u4f7f\u7528\u3002GD\/0005 \u7b2c 4.3.2 \u8282\u8fd8\u533a\u5206\u4e09\u79cd\u60c5\u51b5\uff1a<\/p>\n<ul>\n<li>\u4f5c\u4e3a\u7cfb\u7edf\u4e00\u90e8\u5206\u6ce8\u518c\u7684\u7ec4\u4ef6\uff0c\u53ea\u80fd\u4f9b\u8be5\u7cfb\u7edf\u4f7f\u7528\uff1b<\/li>\n<li>\u4f9b\u591a\u4e2a\u7cfb\u7edf\u4f7f\u7528\u7684\u7ec4\u4ef6\uff0c\u987b\u968f\u6bcf\u4e2a\u7cfb\u7edf\u4e00\u5e76\u6ce8\u518c\uff0c\u6216\u89c6\u60c5\u51b5\u5355\u72ec\u6ce8\u518c\uff1b<\/li>\n<li>\u7531\u4e0d\u540c\u5236\u9020\u5546\u5355\u72ec\u4f9b\u5e94\u7684\u9644\u4ef6\u6216\u7ec4\u4ef6\u987b\u5355\u72ec\u6ce8\u518c\uff1b\u6765\u81ea\u4e0d\u540c\u751f\u4ea7\u573a\u5730\u3001\u4f46\u4e0e\u5668\u68b0\u4e00\u8d77\u4f9b\u5e94\u4e14\u4f7f\u7528\u540c\u4e00\u4e13\u6709\u540d\u79f0\u7684\u9644\u4ef6\uff0c\u53ef\u653e\u5728\u540c\u4e00\u7533\u8bf7\u4e2d\u3002<\/li>\n<\/ul>\n<p>\u7ec4\u4ef6\u5728\u76ee\u5f55\u4e2d\u753b\u5728\u4e00\u8d77\uff0c\u4e0d\u80fd\u66ff\u4ee3\u517c\u5bb9\u6027\u548c\u4f9b\u5e94\u8303\u56f4\u7684\u8bc1\u636e\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGD\/0005 \u7b2c\u4e8c\u7248\uff0c\u7b2c 4.3.2 \u8282\uff0c\u7b2c 3\u20144 \u9875\uff09<\/span><\/p>\n<p>Set \u662f\u5236\u9020\u5546\u628a\u4e24\u4ef6\u6216\u4ee5\u4e0a\u5668\u68b0\u7ec4\u88c5\u4e3a\u4e00\u4e2a\u5305\u88c5\uff0c\u4f7f\u7528\u4e00\u4e2a Set \u540d\u79f0\u548c\u5171\u540c\u7528\u9014\uff0c\u6309 Set \u5185\u6700\u9ad8\u98ce\u9669\u5668\u68b0\u5b9a\u7c7b\u3002Set \u5185\u5168\u90e8\u5668\u68b0\u7684\u8d44\u6599\u987b\u5728\u540c\u4e00\u7533\u8bf7\u4e2d\u63d0\u4ea4\uff1b\u62df\u5355\u72ec\u4f9b\u5e94\u7684\u5668\u68b0\u987b\u53e6\u884c\u6ce8\u518c\u3002\u6ca1\u6709 Set \u540d\u79f0\u6216\u5171\u540c\u7528\u9014\u7684\u4fc3\u9500\u88c5\u3001\u4fbf\u5229\u88c5\uff0c\u4e0d\u6309 Set \u6ce8\u518c\uff0c\u5176\u4e2d\u6bcf\u4ef6\u5668\u68b0\u90fd\u987b\u6709\u81ea\u5df1\u7684 Single \u6ce8\u518c\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGD\/0005 \u7b2c\u4e8c\u7248\uff0c\u7b2c 4.3.4 \u8282\uff0c\u7b2c 7\u20148 \u9875\uff09<\/span>\u89c4\u5212\u65f6\u5e94\u628a\u201c\u6210\u5957\u9500\u552e\u201d\u548c\u201c\u5355\u5356\u66ff\u6362\u4ef6\u201d\u5199\u6e05\u695a\uff0c\u5426\u5219\u6ce8\u518c\u8303\u56f4\u53ef\u80fd\u8986\u76d6\u4e0d\u4e86\u9500\u552e\u90e8\u95e8\u8ba1\u5212\u7684\u4f9b\u8d27\u65b9\u5f0f\u3002<\/p>\n\n<h2>IVD\uff1a\u56de\u5230\u68c0\u6d4b\u7528\u9014\u548c\u4e13\u95e8\u89c4\u5219<\/h2>\n<p>GD\/0054 \u7684\u8bd5\u5242\u3001\u4eea\u5668\u548c\u6821\u51c6\u54c1\u5e76\u4e0d\u5929\u7136\u5c5e\u4e8e\u540c\u4e00\u7533\u8bf7\u3002\u4e0b\u8868\u5217\u51fa\u6700\u5e38\u88ab\u8bef\u7528\u7684\u51e0\u9879\u9650\u5236\uff1a<span class=\"src\">\uff08\u6765\u6e90\uff1aGD\/0054 \u7b2c\u4e8c\u7248\uff0c\u7b2c 5.2\u20145.5 \u8282\uff0c\u7b2c 6\u201411 \u9875\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u7c7b\u522b<\/th><th>\u5173\u952e\u6761\u4ef6<\/th><th>\u5bb9\u6613\u5ffd\u7565\u7684\u9650\u5236<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>System<\/td><td>\u540c\u4e00\u5236\u9020\u5546\u3001\u5171\u540c\u7528\u9014\u3001\u517c\u5bb9\uff0c\u53ef\u5305\u62ec\u5206\u6790\u4eea\u4e0e\u914d\u5957\u8bd5\u5242<\/td><td>\u540c\u4e00\u5206\u6790\u4eea\u4e0a\u7684\u68c0\u6d4b\u9879\u76ee\u53ef\u6309\u98ce\u9669\u7c7b\u522b\u5206\u6210\u591a\u4efd\u7533\u8bf7\uff085.2.11 \u793a\u4f8b\u4e3a\u4e00\u4efd Class D\u3001\u4e00\u4efd Class C\uff09\u3002<\/td><\/tr>\n<tr><td>Family<\/td><td>\u4e0e GMD \u76f8\u540c\u7684\u516d\u9879\u6761\u4ef6<\/td><td>\u5c3f\u6db2\u8bd5\u7eb8\u4e0d\u540c\u68c0\u6d4b\u7ec4\u5408\u53ef\u4e3a\u4e00\u4e2a Family\uff08\u8868 3 \u793a\u4f8b\uff09\uff0c\u4e0d\u80fd\u63a8\u53ca\u5176\u4ed6\u68c0\u6d4b\u3002<\/td><\/tr>\n<tr><td>IVD Test Kit<\/td><td>\u540c\u4e00\u5236\u9020\u5546\u3001\u914d\u5408\u5b8c\u6210\u7279\u5b9a\u7528\u9014\u3001\u4ee5\u4e00\u4e2a\u8bd5\u5242\u76d2\u540d\u79f0\u9500\u552e\u3001\u76f8\u4e92\u517c\u5bb9<\/td><td>\u4e0d\u5305\u62ec\u5b8c\u6210\u68c0\u6d4b\u6240\u9700\u7684\u5206\u6790\u4eea\u7b49\u4eea\u5668\uff085.4.2\uff09\uff1b\u5176\u4ed6\u5236\u9020\u5546\u7684\u8bd5\u5242\u987b\u63d0\u4f9b\u5176\u6388\u6743\u7b49\u8d44\u6599\u65b9\u53ef\u4e00\u5e76\u7533\u62a5\uff085.4.6\uff09\u3002<\/td><\/tr>\n<tr><td>IVD Cluster<\/td><td>\u540c\u4e00\u5236\u9020\u5546\u3001Class A \u6216 B\u3001\u76f8\u540c\u65b9\u6cd5\u5b66\u3001Cluster \u7c7b\u522b\u53ca\u68c0\u6d4b\u539f\u7406<\/td><td>Cluster \u7c7b\u522b\u4e3a\u9644\u4ef6 E \u7684\u5c01\u95ed\u6e05\u5355\uff1b\u8be5\u5206\u7ec4\u4ec5\u7528\u4e8e\u6ce8\u518c\u7533\u8bf7\uff0c\u4e0d\u80fd\u4f5c\u4e3a\u53d8\u66f4\u7533\u62a5\u52a0\u578b\u53f7\u7684\u4f9d\u636e\uff085.5.8\uff09\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u5bf9\u8054\u68c0\u4ea7\u54c1\uff0c\u5e94\u5148\u5217\u660e\u6bcf\u4e00\u914d\u7f6e\u7684\u68c0\u6d4b\u9879\u76ee\u3001\u6837\u672c\u7c7b\u578b\u3001\u4f7f\u7528\u8005\u3001\u7ed3\u679c\u8f93\u51fa\u548c\u6574\u4f53\u9884\u671f\u7528\u9014\uff0c\u518d\u6838\u5bf9\u9002\u7528\u5206\u7ec4\u3002\u4e13\u4e1a\u7248\u4e0e\u81ea\u6d4b\u7248\u7684\u4f7f\u7528\u8005\u4e0d\u540c\uff0c\u8fd8\u987b\u6838\u5bf9\u5206\u7c7b\u548c\u6027\u80fd\u8bc1\u636e\u662f\u5426\u4ecd\u652f\u6301\u5171\u540c\u7533\u62a5\u3002\u5173\u4e8e IVD \u6ce8\u518c\u7684\u6574\u4f53\u5b89\u6392\uff0c\u53ef\u53c2\u9605 <a href=\"https:\/\/aseanmedipass.com\/zh-hans\/ivd-registration\/\">IVD \u6ce8\u518c\u670d\u52a1<\/a>\u3002<\/p>\n\n<h2>\u9012\u4ea4\u524d\u7528\u4e00\u4efd\u578b\u53f7\u77e9\u9635\u7edf\u4e00\u8d44\u6599<\/h2>\n<p>MDA \u7684\u6ce8\u518c\u9012\u4ea4\u6307\u5357\u8981\u6c42\u7533\u8bf7\u4e2d\u5217\u51fa\u5668\u68b0\u6e05\u5355\uff0c\u5305\u62ec\u6761\u7801\u3001\u76ee\u5f55\u53f7\u3001\u578b\u53f7\u6216\u90e8\u4ef6\u53f7\u3001UDI \u7b49\u6807\u8bc6\u53ca\u5668\u68b0\u63cf\u8ff0\uff0c\u5e76\u6ce8\u660e\u6e05\u5355\u6309 MDR 2012 \u7684\u5206\u7ec4\u6807\u51c6\u7f16\u5236\uff08\u4e00\u822c\u5668\u68b0\u53c2\u7167 GD\/0005\uff0cIVD \u53c2\u7167 GD\/0054\uff09\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/portal.mda.gov.my\/index.php\/documents\/ukk\/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition\/file\" target=\"_blank\" rel=\"noopener\">MDA\/GD\/0070 \u7b2c\u4e8c\u7248<\/a>\uff0c\u9644\u4ef6 4 \u7b2c 3 \u8282\uff0c\u7b2c 27 \u9875\uff09<\/span><\/p>\n<p>MediPass \u5efa\u8bae\u7684\u77e9\u9635\u81f3\u5c11\u5305\u62ec\u4ee5\u4e0b\u680f\u76ee\u3002\u8fd9\u662f\u9879\u76ee\u51c6\u5907\u5de5\u5177\uff0c\u4e0d\u66ff\u4ee3 MDA \u89c4\u5b9a\u7684\u8868\u5355\u548c\u6280\u672f\u8d44\u6599\uff1a<\/p>\n<ul>\n<li>\u578b\u53f7\uff0f\u8d27\u53f7\u3001UDI\u3001\u4e13\u6709\u540d\u79f0\u3001\u6cd5\u5b9a\u5236\u9020\u5546\u53ca\u751f\u4ea7\u573a\u5730\uff1b<\/li>\n<li>\u98ce\u9669\u7c7b\u522b\u53ca\u5224\u7c7b\u4f9d\u636e\u3001\u9884\u671f\u7528\u9014\u4e0e\u4f7f\u7528\u8005\uff1b<\/li>\n<li>\u5173\u952e\u89c4\u683c\u3001\u6750\u6599\u6216\u6210\u5206\u3001\u706d\u83cc\u65b9\u5f0f\u3001\u5305\u88c5\u53ca\u4f9b\u5e94\u65b9\u5f0f\uff08\u5355\u5356\u3001\u6210\u5957\u3001\u66ff\u6362\u4ef6\uff09\uff1b<\/li>\n<li>\u5bf9\u5e94\u7684\u6807\u7b7e\u3001IFU \u7248\u672c\u548c\u9a8c\u8bc1\u62a5\u544a\uff1b<\/li>\n<li>\u6bcf\u9879\u5dee\u5f02\u6240\u4f9d\u636e\u7684\u5206\u7ec4\u6761\u6587\u6216\u9644\u4ef6 C\uff0f\u9644\u4ef6 E \u6761\u76ee\u3002<\/li>\n<\/ul>\n<p>\u53e6\u5efa\u8bae\u6838\u5bf9\u51e0\u4efd\u8303\u56f4\u662f\u5426\u4e00\u81f4\uff1a\u5236\u9020\u5546\u6388\u6743\u7684\u578b\u53f7\u3001CAB \u8bc1\u4e66\u4e0e\u62a5\u544a\u8986\u76d6\u7684\u578b\u53f7\u3001ISO 13485 \u8bc1\u4e66\u8303\u56f4\u3001\u53c2\u8003\u56fd\u6279\u51c6\u8303\u56f4\uff08\u5982\u8d70\u9a8c\u8bc1\u9014\u5f84\uff09\uff0c\u4ee5\u53ca\u62df\u5728 MeDC@St \u9012\u4ea4\u7684\u578b\u53f7\u6e05\u5355\u3002GD\/0070 \u8981\u6c42\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\u8303\u56f4\u9002\u7528\u4e8e\u62df\u6ce8\u518c\u5668\u68b0\uff0c\u5e76\u8981\u6c42\u63d0\u4ea4 CAB \u8bc1\u4e66\u548c\u62a5\u544a\uff1b\u9010\u578b\u53f7\u5bf9\u5e94\u662f\u6211\u4eec\u7684\u5efa\u8bae\u505a\u6cd5\uff0c\u4e0d\u662f\u6307\u5357\u7684\u539f\u6587\u8981\u6c42\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aGD\/0070 \u7b2c\u4e8c\u7248\uff0c\u9644\u4ef6 4 \u7b2c 5\u30017 \u8282\uff09<\/span>\u9a8c\u8bc1\u9014\u5f84\u7684\u6761\u4ef6\u53ef\u53c2\u9605<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/malaysia-singapore-device-reliance-verification-2026\/\">\u65b0\u9a6c\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u4f9d\u8d56\u53cc\u5411\u8def\u5f84<\/a>\u3002<\/p>\n\n<section class=\"faq\">\n<h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n<p><strong>\u6240\u6709\u578b\u53f7\u90fd\u5728\u540c\u4e00\u5f20 CE \u8bc1\u4e66\u4e0a\uff0c\u80fd\u5426\u76f4\u63a5\u5408\u5e76\uff1f<\/strong><br\/>\u4e0d\u80fd\u76f4\u63a5\u5408\u5e76\uff0c\u4ecd\u987b\u9010\u9879\u6ee1\u8db3\u9a6c\u6765\u897f\u4e9a\u7684\u5206\u7ec4\u89c4\u5219\u3002\u5883\u5916\u8bc1\u4e66\u7684\u4ea7\u54c1\u8303\u56f4\u53ef\u4ee5\u4f5c\u4e3a\u6838\u5bf9\u6750\u6599\uff0c\u4f46\u5b83\u8986\u76d6\u54ea\u4e9b\u578b\u53f7\uff0c\u4e0e MDA \u4e00\u4efd\u7533\u8bf7\u80fd\u653e\u5165\u54ea\u4e9b\u578b\u53f7\uff0c\u9700\u8981\u5206\u522b\u5224\u65ad\u3002<\/p>\n<p><strong>\u540c\u4e00\u5236\u9020\u5546\u7684\u4e24\u4e2a\u54c1\u724c\u80fd\u5426\u5408\u4e3a\u4e00\u4e2a Family\uff1f<\/strong><br\/>\u4e0d\u80fd\u3002GD\/0005 \u7b2c\u4e8c\u7248\u7684\u57fa\u672c\u89c4\u5219\u548c Family \u6761\u4ef6\u90fd\u8981\u6c42\u76f8\u540c\u7684\u4e13\u6709\u540d\u79f0\uff0c\u540c\u4e00\u5236\u9020\u5546\u5e76\u4e0d\u80fd\u5f25\u8865\u540d\u79f0\u5dee\u5f02\u3002\u4e24\u4e2a\u54c1\u724c\u5e94\u6309\u5404\u81ea\u540d\u79f0\u5206\u522b\u786e\u5b9a\u5206\u7ec4\u3002<\/p>\n<p><strong>\u5148\u6ce8\u518c\u5c11\u6570\u578b\u53f7\uff0c\u4ee5\u540e\u53ef\u4ee5\u76f4\u63a5\u52a0\u8fdb\u53bb\u5417\uff1f<\/strong><br\/>\u65b0\u589e\u578b\u53f7\u987b\u53e6\u6309\u53d8\u66f4\u89c4\u5219\u5224\u65ad\u5176\u5dee\u5f02\u548c\u53d8\u66f4\u7c7b\u522b\uff0c\u521d\u6b21\u7533\u8bf7\u7684\u5206\u7ec4\u7ed3\u8bba\u4e0d\u7b49\u4e8e\u4ee5\u540e\u53ef\u65e0\u9650\u52a0\u578b\u53f7\u3002GD\/0054 \u8fd8\u660e\u786e IVD Cluster \u4e0d\u80fd\u4f5c\u4e3a\u53d8\u66f4\u7533\u62a5\u52a0\u578b\u53f7\u7684\u4f9d\u636e\u3002\u5177\u4f53\u53ef\u53c2\u9605<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/malaysia-mda-change-notification-gd-0020\/\">\u9a6c\u6765\u897f\u4e9a\u6ce8\u518c\u540e\u53d8\u66f4 GD\/0020<\/a>\u3002<\/p>\n<p><strong>\u4e3a\u4e86\u5c11\u4ea4\u5b98\u8d39\uff0c\u662f\u5426\u5e94\u5c3d\u91cf\u5408\u5e76\uff1f<\/strong><br\/>\u5e94\u5148\u786e\u5b9a\u7b26\u5408\u89c4\u5219\u7684\u7533\u8bf7\u8fb9\u754c\uff0c\u518d\u6bd4\u8f83\u8d39\u7528\u548c\u7ef4\u62a4\u5b89\u6392\u3002\u5f3a\u884c\u5408\u5e76\u4f1a\u8ba9\u6388\u6743\u3001\u6807\u7b7e\u548c\u8bc1\u636e\u65e0\u6cd5\u5bf9\u5e94\uff1b\u5408\u7406\u62c6\u5206\u4e5f\u53ef\u80fd\u4fbf\u4e8e\u4e0d\u540c\u4ea7\u54c1\u7ebf\u6309\u5404\u81ea\u8fdb\u5ea6\u9012\u4ea4\u3002<\/p>\n<p><strong>\u4e0d\u540c\u98ce\u9669\u7c7b\u522b\u7684 IVD \u80fd\u5426\u653e\u5728\u4e00\u4efd\u7533\u8bf7\u91cc\uff1f<\/strong><br\/>GD\/0054 \u6ca1\u6709\u4e00\u6982\u7981\u6b62\uff0c\u4f46 Family \u8981\u6c42\u540c\u4e00\u98ce\u9669\u7c7b\u522b\uff0cCluster \u53ea\u9650 Class A \u548c B\uff1b\u6307\u5357\u7684 System \u793a\u4f8b\u5219\u6309 Class D \u548c Class C \u5206\u6210\u4e24\u4efd\u7533\u8bf7\u3002\u5e94\u6309\u5177\u4f53\u7c7b\u522b\u7684\u6761\u4ef6\u5224\u65ad\u3002<\/p>\n<\/section>\n\n<aside class=\"article-cta\"><p class=\"eyebrow\">\u9a6c\u6765\u897f\u4e9a\u5206\u7ec4\u89c4\u5212<\/p><h3>\u51c6\u5907\u8fdb\u5165\u9a6c\u6765\u897f\u4e9a\uff1f\u5148\u786e\u8ba4\u578b\u53f7\u6e05\u5355\u548c\u7533\u8bf7\u8fb9\u754c<\/h3><p>\u5148\u544a\u8bc9\u6211\u4eec <strong>\u4ea7\u54c1\u540d\u79f0\u3001\u62df\u552e\u578b\u53f7\u6e05\u5355\uff0c\u4ee5\u53ca\u73b0\u6709\u7684\u5883\u5916\u6279\u51c6\u6216 CAB \u8bc1\u4e66<\/strong> \u5373\u53ef\uff0c\u5176\u4ed6\u8d44\u6599\u53ef\u5728\u9879\u76ee\u542f\u52a8\u540e\u518d\u63d0\u4f9b\u3002MediPass \u53ef\u636e\u6b64\u521d\u6b65\u5224\u65ad\u5206\u7ec4\u65b9\u6848\u548c\u7533\u8bf7\u6570\u91cf\uff0c\u5e76\u7ed9\u51fa\u62a5\u4ef7\uff1b\u5206\u7ec4\u6761\u4ef6\u7684\u9010\u9879\u6838\u5bf9\u548c\u9012\u4ea4\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\/\">\u8ba8\u8bba\u9a6c\u6765\u897f\u4e9a\u4ea7\u54c1\u5206\u7ec4\u4e0e\u6ce8\u518c<\/a><\/aside>\n\n<section class=\"related\"><h2>\u5ef6\u4f38\u9605\u8bfb<\/h2><ul>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/malaysia-medical-device-registration\/\"><strong>\u9a6c\u6765\u897f\u4e9a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1<\/strong><span>\u6ce8\u518c\u4e3b\u4f53\u3001CAB \u8bc4\u4f30\u3001\u5206\u7c7b\u4e0e\u6574\u4f53\u6d41\u7a0b\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/malaysia-mda-change-notification-gd-0020\/\"><strong>\u9a6c\u6765\u897f\u4e9a\u6ce8\u518c\u540e\u53d8\u66f4 GD\/0020<\/strong><span>\u5df2\u6ce8\u518c\u4ea7\u54c1\u52a0\u578b\u53f7\u3001\u6539\u6807\u7b7e\u6216\u6539\u7528\u9014\u65f6\u7684\u53d8\u66f4\u5224\u65ad\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/malaysia-singapore-device-reliance-verification-2026\/\"><strong>\u65b0\u9a6c\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u4f9d\u8d56\u53cc\u5411\u8def\u5f84<\/strong><span>\u501f\u52a9\u53c2\u8003\u56fd\u6279\u51c6\u8d70\u9a8c\u8bc1\u9014\u5f84\u7684\u6761\u4ef6\u3002<\/span><\/a><\/li>\n<\/ul><\/section>\n\n<section class=\"references\"><h2>\u5b98\u65b9\u53c2\u8003\u8d44\u6599<\/h2><ol>\n<li>Medical Device Authority\uff0cMDA\/GD\/0005 General Medical Device \u2013 Grouping\uff08\u4e00\u822c\u533b\u7597\u5668\u68b0\u5206\u7ec4\u6307\u5357\uff09\u7b2c\u4e8c\u7248\uff0c\u7b2c 2 \u8282\uff08\u8303\u56f4\uff0c\u6392\u9664 IVD\uff09\u3001\u7b2c 4.1\u20144.3.4 \u8282\uff08\u5206\u7ec4\u7c7b\u522b\u53ca\u6761\u4ef6\uff09\u3001\u9644\u4ef6 C\uff08\u5141\u8bb8\u53d8\u578b\uff09\uff0c\u5c01\u9762 2024 \u5e74 1 \u6708\uff0c\u5b98\u7f51\u53d1\u5e03 2024-01-30\uff0c<a href=\"https:\/\/www.mda.gov.my\/index.php\/announcement\/1352-second-edition-guidance-document-mda-gd-0005-general-medical-device-grouping\" target=\"_blank\" rel=\"noopener\">mda.gov.my<\/a><\/li>\n<li>Medical Device Authority\uff0cMDA\/GD\/0054 Guidance on the Product Grouping for In-Vitro Diagnostic (IVD) Medical Devices\uff08IVD \u4ea7\u54c1\u5206\u7ec4\u6307\u5357\uff09\u7b2c\u4e8c\u7248\uff0c\u7b2c 4 \u8282\u3001\u7b2c 5.2\u20145.5 \u8282\u3001\u9644\u4ef6 E\uff0c2021 \u5e74 1 \u6708\uff0c<a href=\"https:\/\/portal.mda.gov.my\/index.php\/documents\/guidance-documents\/1986-gd-ivd-product-grouping-mdagd0054\/file\" target=\"_blank\" rel=\"noopener\">portal.mda.gov.my\uff08PDF\uff09<\/a><\/li>\n<li>Medical Device Authority\uff0cMDA\/GD\/0070 Medical Device Registration Submission Guide for Conformity Assessment by way of Verification Process and Submission of Application in MeDC@St\uff08\u9a8c\u8bc1\u9014\u5f84\u6ce8\u518c\u9012\u4ea4\u6307\u5357\uff09\u7b2c\u4e8c\u7248\uff0c\u9644\u4ef6 4 \u7b2c 3\u30015\u30017 \u8282\uff0c2025 \u5e74 10 \u6708\uff08\u4fee\u8ba2\u8bb0\u5f55 2025-10-13\uff09\uff0c<a href=\"https:\/\/portal.mda.gov.my\/index.php\/documents\/ukk\/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition\/file\" target=\"_blank\" rel=\"noopener\">portal.mda.gov.my\uff08PDF\uff09<\/a><\/li>\n<\/ol><p class=\"note\">\u672c\u6587\u4f9d\u636e\u622a\u81f3 2025 \u5e74 10 \u6708 15 \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\u5206\u7ec4\u5e94\u7ed3\u5408\u5b9e\u9645\u7528\u9014\u3001\u8bbe\u8ba1\u548c\u9002\u7528\u6307\u5357\uff0c\u5e76\u4ee5 CAB \u53ca MDA \u7684\u786e\u8ba4\u4e3a\u51c6\u3002<\/p><\/section>\n<\/article>\n\n","protected":false},"excerpt":{"rendered":"<p>\u578b\u53f7\u591a\u5be1\u4e0d\u662f\u7533\u8bf7\u6570\u91cf\u7684\u5224\u65ad\u4f9d\u636e\u3002\u5148\u6838\u5bf9\u4e13\u6709\u540d\u79f0\u3001\u5236\u9020\u5546\u3001\u7528\u9014\u3001\u8bbe\u8ba1\u53ca\u5141\u8bb8\u53d8\u578b\uff0c\u518d\u628a\u62df\u552e\u914d\u7f6e\u3001\u6807\u7b7e\u548c\u652f\u6301\u8bc1\u636e\u5bf9\u5e94\u8d77\u6765\uff0c\u624d\u80fd\u5f62\u6210\u53ef\u9012\u4ea4\u7684\u5206\u7ec4\u65b9\u6848\u3002<\/p>\n","protected":false},"author":2,"featured_media":4095,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"disabled","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"disabled","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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