{"id":6659,"date":"2026-05-06T10:00:00","date_gmt":"2026-05-06T02:00:00","guid":{"rendered":"https:\/\/aseanmedipass.com\/?p=6659"},"modified":"2026-10-30T00:29:08","modified_gmt":"2026-10-29T16:29:08","slug":"indonesia-ivd-grouping-panels-models-applications","status":"publish","type":"post","link":"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-ivd-grouping-panels-models-applications\/","title":{"rendered":"\u5370\u5c3c IVD \u6ce8\u518c\u5206\u7ec4\uff1a\u54ea\u4e9b\u4ea7\u54c1\u53ef\u4ee5\u653e\u5728\u540c\u4e00\u7533\u8bf7\uff1f"},"content":{"rendered":"\n<style>.postid-6659 .entry-header{display:none}.postid-6659 #primary{width:100%;margin:0}.postid-6659 #secondary{display:none}.postid-6659 #content .ast-container{max-width:844px!important;width:100%;padding:0!important}.postid-6659 .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-6659 .ast-article-single{padding:32px 22px!important}}.postid-6659 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\">\u5370\u5c3c \u00b7 \u533b\u7597\u5668\u68b0<\/p>\n<h1>\u5370\u5c3c IVD \u6ce8\u518c\u5206\u7ec4\uff1a\u54ea\u4e9b\u4ea7\u54c1\u53ef\u4ee5\u653e\u5728\u540c\u4e00\u7533\u8bf7\uff1f<\/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=\"2026-05-06T10:00:00+08:00\">2026\u5e745\u67086\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>\u89c4\u5212\u5370\u5c3c IVD \u6ce8\u518c\u6570\u91cf\u65f6\uff0c\u5148\u56de\u7b54\u4e00\u4e2a\u95ee\u9898\uff1a\u62df\u653e\u5728\u4e00\u8d77\u7684\u4ea7\u54c1\uff0c\u662f\u540c\u4e00\u4ea7\u54c1\u7684\u5141\u8bb8\u53d8\u4f53\u3001\u5171\u540c\u5b8c\u6210\u4e00\u4e2a\u68c0\u6d4b\u7528\u9014\u7684\u8bd5\u5242\u7ec4\u4ef6\uff0c\u8fd8\u662f\u4f9d\u8d56\u4eea\u5668\u7684\u95ed\u5408\u7cfb\u7edf\uff1f\u4e09\u79cd\u5173\u7cfb\u5bf9\u5e94\u4e0d\u540c\u7684\u5206\u7ec4\u6761\u4ef6\u3002\u53ea\u770b\u54c1\u724c\u3001\u75c5\u539f\u4f53\u7c7b\u522b\u6216\u9500\u552e\u5305\u88c5\uff0c\u65e0\u6cd5\u786e\u5b9a\u9700\u8981\u51e0\u4efd\u7533\u8bf7\u3002<\/p>\n<p>\u536b\u751f\u90e8\u4ecd\u516c\u5f00\u63d0\u4f9b 2019 \u5e74\u300a\u533b\u7597\u5668\u68b0\u4e0e IVD \u5206\u7ec4\u6307\u5357\u300b\uff08Pedoman Grouping\uff09\uff0c\u6307\u5357\u7ed3\u8bba\u90e8\u5206\u8bf4\u660e\u5176\u4f9b\u8bc4\u5ba1\u4eba\u5458\u8bc4\u4f30\u5206\u7ec4\u7533\u8bf7\u65f6\u53c2\u7167\u3002\u8be5\u6307\u5357\u4ee5 Permenkes 62\/2017 \u4e3a\u4f9d\u636e\uff0c\u800c 62\/2017 \u5df2\u88ab 2026 \u5e74 5 \u6708 4 \u65e5\u9881\u5e03\u7684 Permenkes 5\/2026 \u7b2c 125 \u6761\u5e9f\u6b62\uff1b5\/2026 \u7b2c 124 \u6761\u89c4\u5b9a\uff0c\u539f\u6709\u5b9e\u65bd\u6027\u89c4\u5b9a\u5728\u4e0d\u4e0e\u5176\u51b2\u7a81\u7684\u8303\u56f4\u5185\u7ee7\u7eed\u6709\u6548\u3002\u56e0\u6b64\u53ef\u4ee5\u7528\u6307\u5357\u68b3\u7406\u4ea7\u54c1\u5173\u7cfb\uff0c\u4f46\u5177\u4f53\u9879\u76ee\u4ecd\u5e94\u6838\u5bf9\u73b0\u884c\u89c4\u5b9a\u548c\u529e\u7406\u8981\u6c42\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Pedoman%20Grouping%20Alkes.pdf\" target=\"_blank\" rel=\"noopener\">\u5206\u7ec4\u6307\u5357<\/a>\uff0c\u7b2c 2\u300118 \u9875\uff1b<a href=\"https:\/\/jdih.kemkes.go.id\/documents\/peraturan-menteri-kesehatan-nomor-5-tahun-2026\" target=\"_blank\" rel=\"noopener\">JDIH Permenkes 5\/2026 \u6cd5\u89c4\u9875<\/a>\uff09<\/span>\u516d\u7c7b\u5206\u7ec4\u7684\u603b\u4f53\u4ecb\u7ecd\u89c1<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-medical-device-registration\/\">\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1\u9875<\/a>\uff0c\u672c\u6587\u53ea\u8ba8\u8bba IVD \u5382\u5546\u5e38\u9047\u5230\u7684\u51e0\u79cd\u5177\u4f53\u60c5\u5f62\u3002<\/p>\n\n<aside class=\"summary\">\n<p class=\"eyebrow\">\u8981\u70b9\u901f\u89c8<\/p>\n<dl>\n<dt>\u5224\u65ad\u4f9d\u636e<\/dt><dd>2019 \u5e74\u5206\u7ec4\u6307\u5357\u4ecd\u662f\u8bc4\u5ba1\u53c2\u7167\uff1b\u5176\u4f9d\u636e 62\/2017 \u5df2\u88ab Permenkes 5\/2026 \u5e9f\u6b62\uff0c5\/2026 \u7b2c 124 \u6761\u4fdd\u7559\u4e0d\u51b2\u7a81\u7684\u539f\u5b9e\u65bd\u6027\u89c4\u5b9a\u3002<\/dd>\n<dt>\u8054\u68c0\u7ec4\u5408<\/dt><dd>\u6307\u5357\u4ee5\u793a\u4f8b\u65b9\u5f0f\u5217\u51fa\u5141\u8bb8\u53d8\u4f53\uff0cIVD \u76f8\u5173\u7684\u662f\u5feb\u68c0\u7684 strip\u3001cassette\u3001midstream \u5f62\u6001\uff1b\u793a\u4f8b\u672a\u6db5\u76d6\u7684\u5dee\u5f02\uff0c\u4f8b\u5982\u589e\u51cf\u5206\u6790\u7269\uff0c\u5e94\u4f5c\u4e3a\u7528\u9014\u5dee\u5f02\u5355\u72ec\u8bba\u8bc1\u3002<\/dd>\n<dt>Tes Kit DIV<\/dt><dd>\u8bd5\u5242\u5171\u540c\u5b9e\u73b0\u4e00\u4e2a\u68c0\u6d4b\u7528\u9014\uff0c\u4ee5\u540c\u4e00\u8bd5\u5242\u76d2\u540d\u79f0\u9500\u552e\uff0c\u7f6e\u4e8e\u540c\u4e00\u4e8c\u7ea7\u6216\u4e09\u7ea7\u5305\u88c5\uff1b\u5206\u6790\u4eea\u4e0d\u5728\u5176\u5185\u3002<\/dd>\n<dt>Sistem DIV<\/dt><dd>\u53ea\u9002\u7528\u4e8e\u4e00\u4e2a\u68c0\u6d4b\u53c2\u6570\u7684\u95ed\u5408\u7cfb\u7edf\uff1b\u53ef\u7528\u4e8e\u5176\u4ed6\u5382\u5546\u4eea\u5668\u7684\u8bd5\u5242\uff0c\u6309\u5355\u72ec DIV\uff08Tunggal\uff09\u6ce8\u518c\u3002<\/dd>\n<dt>\u4e13\u4e1a\u4e0e\u81ea\u6d4b<\/dt><dd>2016 \u5e74\u5206\u7c7b\u6307\u5357\u89c4\u5219 4 \u5c06\u81ea\u6d4b IVD \u4e00\u822c\u5217\u4e3a C \u7c7b\uff1b\u98ce\u9669\u7ea7\u522b\u6216\u7528\u9014\u4e0d\u540c\uff0c\u5373\u4e0d\u6ee1\u8db3 Famili \u6761\u4ef6\u3002<\/dd>\n<\/dl>\n<\/aside>\n\n<h2>\u5148\u5224\u65ad\u4ea7\u54c1\u4e4b\u95f4\u662f\u54ea\u4e00\u79cd\u5173\u7cfb<\/h2>\n<p>\u6307\u5357\u7b2c\u4e8c\u7ae0\u628a\u5206\u7ec4\u539f\u5219\u5f52\u4e3a\u4e09\u70b9\uff1a\u76f8\u540c\u7684\u9884\u671f\u7528\u9014\u3001\u7ec4\u5408\u4f7f\u7528\u4ee5\u5b9e\u73b0\u9884\u671f\u7528\u9014\u3001\u4ea7\u54c1\u4e4b\u95f4\u7684\u76f8\u4f3c\u6027\uff1b\u5206\u7ec4\u7533\u8bf7\u987b\u63d0\u4ea4\u6bcf\u4e2a\u4ea7\u54c1\u7684\u5168\u90e8\u4fe1\u606f\u3002\u7b2c\u4e09\u7ae0\u5217\u51fa\u516d\u7c7b\uff1aTunggal\u3001Sistem\u3001Famili\u3001Tes Kit DIV\u3001Sistem DIV \u548c Grup\uff0c\u5176\u4e2d Tes Kit DIV \u4e0e Sistem DIV \u662f IVD \u4e13\u7528\u5206\u7ec4\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a\u5206\u7ec4\u6307\u5357\u7b2c\u4e8c\u7ae0\uff0c\u7b2c 7\u20148 \u9875\uff09<\/span>\u4e0b\u8868\u53ea\u5217 IVD \u5224\u65ad\u4e2d\u6700\u5e38\u51fa\u9519\u7684\u6761\u4ef6\u3002<\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u62df\u5408\u5e76\u5173\u7cfb<\/th><th>\u6307\u5357\u7684\u5173\u952e\u6761\u4ef6<\/th><th>IVD \u9879\u76ee\u5e38\u89c1\u8bef\u533a<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>Tunggal \u5355\u72ec\u4ea7\u54c1<\/td><td>\u53ef\u6309\u4e0d\u540c\u5305\u88c5\u6570\u91cf\u9500\u552e\uff1b\u65e0\u6cd5\u5f52\u5165\u5176\u4ed6\u5206\u7ec4\u7684\u4ea7\u54c1\u5355\u72ec\u6ce8\u518c\u3002\uff08\u7b2c 9 \u9875\uff09<\/td><td>\u628a\u201c\u6bcf\u76d2 20 \u4eba\u4efd\u4e0e 25 \u4eba\u4efd\u201d\u5f53\u6210\u9700\u8981\u5206\u5f00\u7533\u8bf7\u7684\u4ea7\u54c1\u3002<\/td><\/tr>\n<tr><td>Famili \u4ea7\u54c1\u65cf<\/td><td>\u540c\u4e00\u5236\u9020\u5546\uff1b\u5546\u54c1\u540d\u4e0e\u4ea7\u54c1\u7c7b\u578b\u76f8\u540c\uff1b\u98ce\u9669\u7ea7\u522b\u76f8\u540c\uff1b\u9884\u671f\u7528\u9014\u76f8\u540c\uff1b\u8bbe\u8ba1\u53ca\u5236\u9020\u8fc7\u7a0b\u76f8\u540c\uff1b\u53d8\u4f53\u5c5e\u4e8e\u5141\u8bb8\u8303\u56f4\u3002\uff08\u7b2c 11\u201412 \u9875\uff09<\/td><td>\u4ee5\u201c\u540c\u4e00\u5e73\u53f0\u3001\u540c\u4e00\u54c1\u724c\u201d\u4ee3\u66ff\u9010\u9879\u6ee1\u8db3\u516d\u4e2a\u6761\u4ef6\u3002<\/td><\/tr>\n<tr><td>Tes Kit DIV \u8bd5\u5242\u76d2<\/td><td>\u8bd5\u5242\u6216\u88c5\u7f6e\u6765\u81ea\u540c\u4e00\u4ea7\u54c1\u6240\u6709\u4eba\uff0c\u5171\u540c\u5b9e\u73b0\u7279\u5b9a\u68c0\u6d4b\u7528\u9014\uff0c\u4ee5\u540c\u4e00\u8bd5\u5242\u76d2\u540d\u79f0\u9500\u552e\uff0c\u5404\u7ec4\u6210\u7684\u6807\u7b7e\u6216 IFU \u5199\u660e\u4f5c\u4e3a\u8bd5\u5242\u76d2\u4f7f\u7528\uff0c\u76f8\u4e92\u517c\u5bb9\uff0c\u7f6e\u4e8e\u540c\u4e00\u4e8c\u7ea7\u6216\u4e09\u7ea7\u5305\u88c5\uff1b\u4e0d\u542b\u5206\u6790\u4eea\u7b49\u4eea\u5668\u3002\uff08\u7b2c 13 \u9875\uff09<\/td><td>\u628a\u53ef\u5355\u72ec\u4f7f\u7528\u7684\u4ea7\u54c1\u88c5\u8fdb\u4e00\u4e2a\u76d2\u5b50\uff0c\u5c31\u8ba4\u5b9a\u4e3a\u8bd5\u5242\u76d2\u3002<\/td><\/tr>\n<tr><td>Sistem DIV \u4f53\u5916\u8bca\u65ad\u7cfb\u7edf<\/td><td>\u540c\u4e00\u4ea7\u54c1\u6240\u6709\u4eba\uff0c\u7ec4\u4ef6\u5171\u540c\u5b9e\u73b0\u540c\u4e00\u7528\u9014\u5e76\u76f8\u4e92\u517c\u5bb9\uff0c\u4ee5\u540c\u4e00\u7cfb\u7edf\u540d\u79f0\u6ce8\u518c\u6216\u5728\u6807\u7b7e\u4e2d\u5199\u660e\u914d\u5957\u4f7f\u7528\uff1b\u4ec5\u9650\u4e00\u4e2a\u68c0\u6d4b\u53c2\u6570\u7684\u95ed\u5408\u7cfb\u7edf\u3002\uff08\u7b2c 14 \u9875\uff09<\/td><td>\u628a\u5206\u6790\u4eea\u53ef\u8fd0\u884c\u7684\u5168\u90e8\u68c0\u6d4b\u9879\u76ee\u88c5\u8fdb\u540c\u4e00\u4e2a\u7cfb\u7edf\u7533\u8bf7\u3002<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u6307\u5357\u5b9a\u4e49\u7684\u201c\u9884\u671f\u7528\u9014\u201d\uff08tujuan penggunaan\uff09\uff0c\u662f\u4ea7\u54c1\u6240\u6709\u4eba\u5728\u6807\u7b7e\u3001\u4f7f\u7528\u8bf4\u660e\u548c\uff0f\u6216\u5ba3\u4f20\u6750\u6599\u4e2d\u5199\u660e\u7684\u7528\u9014\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a\u5206\u7ec4\u6307\u5357\u7b2c\u4e00\u7ae0 F \u8282\uff0c\u7b2c 6 \u9875\uff09<\/span>\u56e0\u6b64\u5224\u65ad\u65f6\u5e94\u4ee5 IFU \u7684\u5b9e\u9645\u5199\u6cd5\u4e3a\u51c6\uff0c\u800c\u4e0d\u662f\u4ee5\u5185\u90e8\u4ea7\u54c1\u7ebf\u540d\u79f0\u4e3a\u51c6\u3002<\/p>\n\n<h2>\u4e0d\u540c\u5f62\u6001\u3001\u5305\u88c5\u6570\u91cf\u4e0e\u4e0d\u540c\u68c0\u6d4b\u7ec4\u5408\uff0c\u8981\u5206\u5f00\u5224\u65ad<\/h2>\n<p>\u6307\u5357\u5141\u8bb8\u5355\u72ec\u4ea7\u54c1\u4ee5\u4e0d\u540c\u5305\u88c5\u6570\u91cf\u9500\u552e\uff0c\u5e76\u5728 Famili \u5141\u8bb8\u53d8\u4f53\u4e2d\u5217\u51fa\u201c\u5f62\u6001\u4e0d\u540c\uff08strip\u3001cassette\u3001midstream\uff09\u7684 IVD \u5feb\u68c0\u201d\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a\u5206\u7ec4\u6307\u5357\u7b2c 9\u300112 \u9875\uff09<\/span>\u8fd9\u7c7b\u793a\u4f8b\u4ecd\u987b\u4e0e Famili \u7684\u516d\u9879\u6761\u4ef6\u4e00\u8d77\u4f7f\u7528\uff1a\u540c\u4e00\u8bd5\u5242\u4ec5\u6539\u53d8\u5242\u578b\u6216\u6bcf\u76d2\u4eba\u4efd\uff0c\u4e0e\u4ece\u4e09\u8054\u68c0\u6539\u4e3a\u4e94\u8054\u68c0\uff0c\u662f\u6027\u8d28\u4e0d\u540c\u7684\u4e24\u79cd\u5dee\u5f02\u3002<\/p>\n<p>\u6307\u5357\u7684\u5141\u8bb8\u53d8\u4f53\u6e05\u5355\u6ca1\u6709\u63d0\u5230\u68c0\u6d4b\u7ec4\u5408\u6216\u5206\u6790\u7269\u6570\u91cf\u7684\u5dee\u5f02\uff0c\u4e5f\u6ca1\u6709\u201c\u540c\u4e00\u7c7b\u547c\u5438\u9053\u8054\u68c0\u5747\u53ef\u4f5c\u4e3a\u4e00\u4e2a\u4ea7\u54c1\u65cf\u201d\u7684\u4e00\u822c\u7ed3\u8bba\u3002\u589e\u52a0\u6216\u51cf\u5c11\u5206\u6790\u7269\uff0c\u4f1a\u6539\u53d8\u6807\u7b7e\u548c IFU \u4e2d\u7684\u68c0\u6d4b\u76ee\u7684\uff0c\u5e76\u5e26\u6765\u65b0\u7684\u6027\u80fd\u3001\u5e72\u6270\u548c\u7ed3\u679c\u89e3\u91ca\u8d44\u6599\u3002\u62df\u628a\u4e0d\u540c\u7ec4\u5408\u653e\u8fdb\u4e00\u4e2a Famili \u65f6\uff0c\u5e94\u9010\u9879\u8bf4\u660e\u9884\u671f\u7528\u9014\u3001\u98ce\u9669\u7ea7\u522b\u3001\u8bbe\u8ba1\u548c\u5236\u9020\u8fc7\u7a0b\u4e3a\u4f55\u4ecd\u7136\u76f8\u540c\uff1b\u65e0\u6cd5\u8bf4\u660e\u7684\uff0c\u5b9c\u6309\u5355\u72ec\u7533\u8bf7\u9884\u7b97\u3002<\/p>\n\n<h2>\u8bd5\u5242\u76d2\u3001\u95ed\u5408\u7cfb\u7edf\u4e0e\u5f00\u653e\u5f0f\u8bd5\u5242\u600e\u6837\u533a\u5206<\/h2>\n<p>\u6307\u5357\u4ee5 HIV ELISA \u4e3a\u4f8b\uff1a\u5bf9\u7167\u3001\u6821\u51c6\u54c1\u3001\u6d17\u6da4\u7f13\u51b2\u6db2\u53ca\u5176\u4ed6\u914d\u5957\u7ec4\u4ef6\u5171\u540c\u7528\u4e8e\u68c0\u6d4b\uff0c\u53ef\u4f5c\u4e3a Tes Kit DIV\u3002\u82e5\u7533\u8bf7\u4eba\u628a\u6765\u81ea\u4e0d\u540c\u4ea7\u54c1\u6240\u6709\u4eba\u7684\u7ec4\u4ef6\u7ec4\u5408\u5728\u4e00\u8d77\uff0c\u987b\u53d6\u5f97\u5404\u6765\u6e90\u6240\u6709\u4eba\u7684\u4e66\u9762\u6388\u6743\uff0c\u63d0\u4ea4\u5404\u8bd5\u5242\u5728\u8bd5\u5242\u76d2\u4e2d\u80fd\u6b63\u5e38\u53d1\u6325\u6027\u80fd\u7684\u6570\u636e\uff0c\u5e76\u627f\u62c5\u4e0a\u5e02\u540e\u63a7\u5236\u548c\u552e\u540e\u670d\u52a1\u8d23\u4efb\u3002\u4e00\u4efd\u7ecf\u9500\u6388\u6743\u4e0d\u80fd\u4ee3\u66ff\u8fd9\u4e9b\u8d44\u6599\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a\u5206\u7ec4\u6307\u5357\u7b2c 7\u20148\u300113 \u9875\uff09<\/span><\/p>\n<p>Sistem DIV \u53ef\u4ee5\u5305\u62ec\u4eea\u5668\u3001\u8bd5\u5242\uff08\u542b\u8bd5\u6761\uff09\u548c\u914d\u5957\u7ec4\u4ef6\uff0c\u6307\u5357\u793a\u4f8b\u4e3a\u8840\u7cd6\u4eea\u3001\u8bd5\u6761\u3001\u8d28\u63a7\u6db2\u53ca\u7ebf\u6027\u6db2\u7ec4\u6210\u7684\u8840\u7cd6\u76d1\u6d4b\u7cfb\u7edf\u3002\u95ed\u5408\u7cfb\u7edf\u6307\u4eea\u5668\u4e0e\u8bd5\u5242\u6765\u81ea\u540c\u4e00\u4ea7\u54c1\u6240\u6709\u4eba\uff0c\u4e0d\u80fd\u4ee5\u5176\u4ed6\u8bd5\u5242\u6216\u914d\u5957\u7ec4\u4ef6\u66ff\u4ee3\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a\u5206\u7ec4\u6307\u5357\u7b2c 14 \u9875\uff09<\/span>\u6307\u5357\u8fd8\u5728 Tunggal \u90e8\u5206\u4e3e\u4f8b\uff1a\u53ef\u5728\u5176\u4ed6\u4ea7\u54c1\u6240\u6709\u4eba\u7684\u591a\u79cd\u4eea\u5668\u4e0a\u4f7f\u7528\u7684\u8bd5\u5242\uff0c\u6309\u5355\u72ec DIV \u6ce8\u518c\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a\u5206\u7ec4\u6307\u5357\u7b2c 9 \u9875\uff09<\/span>\u591a\u9879\u76ee\u5206\u6790\u5e73\u53f0\u5e94\u5148\u5217\u51fa\u4eea\u5668\u3001\u5404\u8bd5\u5242\u548c\u914d\u5957\u7ec4\u4ef6\u4e4b\u95f4\u7684\u5173\u7cfb\uff1b\u6307\u5357\u6ca1\u6709\u89c4\u5b9a\u591a\u53c2\u6570\u5e73\u53f0\u7684\u6574\u4f53\u6253\u5305\u65b9\u5f0f\uff0c\u5177\u4f53\u7533\u8bf7\u5b89\u6392\u5e94\u5411\u8bc4\u5ba1\u65b9\u786e\u8ba4\u3002<\/p>\n\n<h2>\u4e13\u4e1a\u7248\u4e0e\u81ea\u6d4b\u7248\u80fd\u5426\u653e\u5728\u4e00\u8d77\uff1f<\/h2>\n<p>\u5206\u7ec4\u6307\u5357\u6ca1\u6709\u63d0\u5230\u81ea\u6d4b\u6216\u975e\u4e13\u4e1a\u4f7f\u7528\u8005\u3002\u4f46 Famili \u8981\u6c42\u98ce\u9669\u7ea7\u522b\u548c\u9884\u671f\u7528\u9014\u76f8\u540c\uff0c\u800c 2016 \u5e74\u300a\u533b\u7597\u5668\u68b0\u4e0e IVD \u5206\u7c7b\u6307\u5357\u300b\u89c4\u5219 4 \u5c06\u7528\u4e8e\u81ea\u6d4b\u7684 IVD \u4e00\u822c\u5217\u4e3a C \u7c7b\uff1b\u4e0d\u7528\u4e8e\u533b\u5b66\u5224\u5b9a\u6216\u4ec5\u4f5c\u521d\u6b65\u7ed3\u679c\u7684\uff0c\u5982\u81ea\u6d4b\u598a\u5a20\u3001\u751f\u80b2\u529b\u68c0\u6d4b\u548c\u5c3f\u6db2\u8bd5\u6761\uff0c\u5217\u4e3a B \u7c7b\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a2016 \u5e74\u5206\u7c7b\u6307\u5357\uff0c\u7b2c 14\u201415 \u9875\uff1b\u536b\u751f\u90e8\u539f\u5b98\u65b9\u94fe\u63a5\u76ee\u524d\u65e0\u6cd5\u8bbf\u95ee\uff09<\/span>Permenkes 5\/2026 \u7b2c 55 \u6761\u4fdd\u7559 A \u81f3 D \u56db\u7ea7\u98ce\u9669\u5206\u7c7b\uff0c\u5e76\u89c4\u5b9a\u5206\u7c7b\u6280\u672f\u6307\u5357\u7531\u90e8\u957f\u5236\u5b9a\uff0c\u5e94\u786e\u8ba4\u6240\u7528\u5206\u7c7b\u6307\u5357\u662f\u5426\u5df2\u6709\u65b0\u7248\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/jdih.kemkes.go.id\/storage\/documents\/pdfs\/2026permenkes005.pdf\" target=\"_blank\" rel=\"noopener\">Permenkes 5\/2026<\/a>\uff0c\u7b2c 55 \u6761\uff09<\/span><\/p>\n<p>\u81ea\u6d4b\u7248\u672c\u4e0e\u4e13\u4e1a\u7248\u7684\u98ce\u9669\u7ea7\u522b\u4e0d\u540c\uff0c\u5c31\u4e0d\u6ee1\u8db3 Famili \u7684\u540c\u4e00\u98ce\u9669\u7ea7\u522b\u6761\u4ef6\uff1b\u5373\u4f7f\u7ea7\u522b\u76f8\u540c\uff0c\u9884\u671f\u4f7f\u7528\u8005\u3001\u53d6\u6837\u65b9\u5f0f\u3001\u64cd\u4f5c\u6b65\u9aa4\u548c\u7ed3\u679c\u5224\u8bfb\u8bf4\u660e\u4e0d\u540c\uff0c\u4e5f\u4f1a\u4f7f IFU \u4e2d\u7684\u7528\u9014\u51fa\u73b0\u5dee\u5f02\u3002\u5b9e\u52a1\u4e0a\uff0c\u81ea\u6d4b\u7248\u672c\u5e94\u5355\u72ec\u8bc4\u4f30\u5206\u7c7b\u3001\u8bc1\u636e\u548c\u7533\u8bf7\u5b89\u6392\uff0c\u4e0d\u5b9c\u9ed8\u8ba4\u5e76\u5165\u4e13\u4e1a\u7248\u7684\u4ea7\u54c1\u65cf\u3002<\/p>\n\n<h2>\u8bf4\u660e\u6027\u60c5\u666f\uff1a\u4e09\u79cd\u547c\u5438\u9053\u8054\u68c0\u7248\u672c\u600e\u6837\u505a\u8303\u56f4\u8868<\/h2>\n<p>\u5047\u8bbe\u67d0\u5382\u5546\u6709\u4e09\u4e2a\u7248\u672c\uff1aA \u4e3a\u4e09\u9879\u547c\u5438\u9053\u6297\u539f\u8054\u68c0\uff0cB \u5728 A \u57fa\u7840\u4e0a\u589e\u52a0\u4e24\u9879\u75c5\u539f\u4f53\uff0cC \u4e0e B \u68c0\u6d4b\u7ec4\u5408\u76f8\u540c\u4f46\u6539\u4e3a\u81ea\u6d4b\u3002\u4e09\u4e2a\u7248\u672c\u54c1\u724c\u76f8\u540c\uff0c\u90e8\u5206\u8bd5\u6761\u5171\u7528\u3002\u6b64\u4f8b\u4ec5\u8bf4\u660e\u8d44\u6599\u6574\u7406\u65b9\u6cd5\uff0c\u4e0d\u4ee3\u8868\u5370\u5c3c\u5df2\u63a5\u53d7\u6216\u62d2\u7edd\u4efb\u4f55\u5206\u7ec4\u3002<\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u6bd4\u8f83\u9879\u76ee<\/th><th>A \u4e0e B \u5e94\u6838\u5bf9<\/th><th>B \u4e0e C \u5e94\u6838\u5bf9<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u9884\u671f\u7528\u9014\u4e0e\u5206\u6790\u7269<\/td><td>\u65b0\u589e\u5206\u6790\u7269\u53ca\u5176\u4e34\u5e8a\u7528\u9014\uff0cIFU \u4e2d\u68c0\u6d4b\u76ee\u7684\u662f\u5426\u6539\u53d8<\/td><td>\u9884\u671f\u4f7f\u7528\u8005\u4e0e\u4f7f\u7528\u573a\u666f\uff08\u4e13\u4e1a\u4eba\u5458\u4e0e\u975e\u4e13\u4e1a\u4eba\u5458\uff09<\/td><\/tr>\n<tr><td>\u98ce\u9669\u7ea7\u522b<\/td><td>\u65b0\u589e\u75c5\u539f\u4f53\u662f\u5426\u6539\u53d8\u9002\u7528\u7684\u5206\u7c7b\u89c4\u5219<\/td><td>\u6309\u89c4\u5219 4 \u81ea\u6d4b\u662f\u5426\u4e3a C \u7c7b\uff0c\u662f\u5426\u4e0e B \u4e00\u81f4<\/td><\/tr>\n<tr><td>\u8bbe\u8ba1\u4e0e\u5236\u9020<\/td><td>\u65b0\u589e\u8bd5\u6761\u3001\u8bd5\u5242\u914d\u65b9\u4e0e\u7ec4\u5408\u65b9\u5f0f<\/td><td>\u53d6\u6837\u5668\u5177\u3001\u64cd\u4f5c\u6b65\u9aa4\u548c\u7ed3\u679c\u5224\u8bfb\u8bbe\u8ba1<\/td><\/tr>\n<tr><td>\u6027\u80fd\u8bc1\u636e<\/td><td>\u5404\u5206\u6790\u7269\u6027\u80fd\u3001\u4ea4\u53c9\u53cd\u5e94\u53ca\u7ec4\u5408\u9a8c\u8bc1<\/td><td>\u975e\u4e13\u4e1a\u4eba\u5458\u64cd\u4f5c\u548c\u5224\u8bfb\u7684\u8bc1\u636e<\/td><\/tr>\n<tr><td>\u521d\u6b65\u7ed3\u8bba\u5199\u6cd5<\/td><td>\u5217\u660e\u5df2\u6ee1\u8db3\u4e0e\u5f85\u786e\u8ba4\u7684 Famili \u6761\u4ef6<\/td><td>\u9ed8\u8ba4\u6309\u5355\u72ec\u7533\u8bf7\u9884\u7b97\uff0c\u9664\u975e\u80fd\u8bc1\u660e\u6761\u4ef6\u5168\u90e8\u6ee1\u8db3<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u7528\u8fd9\u5f20\u8868\u5f62\u6210\u62df\u5206\u7ec4\u65b9\u6848\u540e\uff0c\u5e94\u4fdd\u7559\u62c6\u5206\u9884\u7b97\u3002\u8303\u56f4\u672a\u786e\u8ba4\u524d\uff0c\u4e0d\u5b9c\u5411\u5546\u4e1a\u56e2\u961f\u627f\u8bfa\u201c\u4e00\u4efd\u7533\u8bf7\u8986\u76d6\u4e09\u4e2a\u7248\u672c\u201d\u3002<\/p>\n\n<h2>\u83b7\u8bc1\u540e\u589e\u52a0\u578b\u53f7\u6216\u68c0\u6d4b\u9879\u76ee\uff0c\u6309\u53d8\u66f4\u89c4\u5219\u5904\u7406<\/h2>\n<p>\u9996\u6b21\u7533\u62a5\u53ef\u4ee5\u6bd4\u8f83\u4e0d\u540c\u5206\u7ec4\u65b9\u6848\uff1b\u5df2\u6709\u8bc1\u4e66\u540e\u589e\u52a0\u578b\u53f7\u6216\u6539\u53d8\u7ec4\u5408\uff0c\u5219\u5e94\u6309\u53d8\u66f4\u89c4\u5219\u5224\u65ad\uff0c\u4e0d\u80fd\u4ee5\u6700\u521d\u53ef\u4ee5\u5206\u7ec4\u4e3a\u7531\u81ea\u884c\u6269\u5927\u6279\u51c6\u8303\u56f4\u3002\u536b\u751f\u90e8 2021 \u5e74\u300a\u6ce8\u518c\u53d8\u66f4\u7ba1\u7406\u6307\u5357\u300b\u89c4\u5b9a\uff1a\u4e0d\u5f71\u54cd\u5b89\u5168\u3001\u8d28\u91cf\u548c\u6027\u80fd\u7684\u53d8\u66f4\u6309\u53d8\u66f4\u7533\u8bf7\u529e\u7406\uff0c\u5f71\u54cd\u5b89\u5168\u3001\u8d28\u91cf\u548c\u6027\u80fd\u7684\u987b\u91cd\u65b0\u7533\u8bf7\uff1b\u53d8\u66f4\u4e00\u822c\u4e0d\u6539\u53d8\u8bc1\u53f7\uff0c\u4f46\u98ce\u9669\u7ea7\u522b\u3001\u7c7b\u522b\u6216\u5b50\u7c7b\u522b\u6539\u53d8\u7684\u9664\u5916\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Pedoman%20Manajemen%20Perubahan.pdf\" target=\"_blank\" rel=\"noopener\">\u53d8\u66f4\u7ba1\u7406\u6307\u5357<\/a>\uff0c\u7b2c 2.2 \u8282\uff0c\u7b2c 8 \u9875\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u83b7\u8bc1\u540e\u7684\u60c5\u5f62<\/th><th>2021 \u5e74\u53d8\u66f4\u6307\u5357\u7684\u5904\u7406<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u589e\u51cf\u5c3a\u5bf8\u3001\u5185\u5bb9\u91cf\uff0c\u6216\u66f4\u6539\u8bc1\u4e66\u6240\u5217\u578b\u53f7\u3001\u4ea7\u54c1\u4ee3\u7801<\/td><td>\u4e0d\u5f71\u54cd\u5b89\u5168\u3001\u8d28\u91cf\u548c\u6027\u80fd\u7684\uff0c\u53ef\u6309\u53d8\u66f4\u7533\u8bf7\u529e\u7406\uff08\u7b2c 2.4.8 \u8282\uff0c\u7b2c 32\u201433 \u9875\uff09<\/td><\/tr>\n<tr><td>\u8bbe\u8ba1\u53d8\u66f4\u4f7f\u9884\u671f\u7528\u9014\u589e\u52a0\u6216\u6269\u5927\uff0c\u5982\u808c\u9150\u68c0\u6d4b\u589e\u52a0\u5c3f\u6db2\u6837\u672c<\/td><td>\u91cd\u5927\u53d8\u66f4\uff0c\u91cd\u65b0\u7533\u8bf7\uff08\u7b2c 2.4.2 \u8282\uff0c\u7b2c 21\u201422 \u9875\uff09<\/td><\/tr>\n<tr><td>\u7531\u5b9a\u91cf\u68c0\u6d4b\u6539\u4e3a\u5b9a\u6027\u68c0\u6d4b<\/td><td>\u91cd\u5927\u53d8\u66f4\uff0c\u91cd\u65b0\u7533\u8bf7\uff08\u7b2c 21 \u9875\uff09<\/td><\/tr>\n<tr><td>\u6807\u7b7e\u7531\u201c\u4ec5\u9650\u4e13\u4e1a\u4f7f\u7528\u201d\u6539\u4e3a\u201c\u5bb6\u7528\u201d<\/td><td>\u91cd\u5927\u53d8\u66f4\uff0c\u6309\u53d8\u66f4\u7533\u8bf7\u529e\u7406\uff08\u7b2c 2.4.7 \u8282\uff0c\u7b2c 31 \u9875\uff09\uff1b\u98ce\u9669\u7ea7\u522b\u968f\u4e4b\u6539\u53d8\u7684\uff0c\u8bc1\u53f7\u4e5f\u4f1a\u6539\u53d8<\/td><\/tr>\n<tr><td>\u540c\u65f6\u53d1\u751f\u591a\u9879\u53d8\u66f4<\/td><td>\u6309\u5176\u4e2d\u6700\u9ad8\u7c7b\u522b\u7684\u53d8\u66f4\u529e\u7406\uff08\u7b2c 3 \u8282\uff0c\u7b2c 34 \u9875\uff09<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u6307\u5357\u6ca1\u6709\u76f4\u63a5\u5217\u51fa\u201c\u8054\u68c0\u589e\u52a0\u5206\u6790\u7269\u201d\u7684\u793a\u4f8b\uff1b\u6700\u63a5\u8fd1\u7684\u662f\u6269\u5927\u9884\u671f\u7528\u9014\u987b\u91cd\u65b0\u7533\u8bf7\uff0c\u56e0\u6b64\u589e\u52a0\u68c0\u6d4b\u9879\u76ee\u5b9c\u6309\u65b0\u7533\u8bf7\u9884\u7b97\u3002\u8be5\u6307\u5357\u540c\u6837\u4ee5 62\/2017 \u4e3a\u4f9d\u636e\uff0c\u9002\u7528\u65f6\u5e94\u7ed3\u5408 5\/2026 \u7b2c 124 \u6761\u53ca\u5f53\u524d\u529e\u7406\u8981\u6c42\u786e\u8ba4\u3002Permenkes 11\/2025 \u53e6\u89c4\u5b9a\uff0c\u8bb8\u53ef\u6587\u4ef6\u53ef\u9644\u6280\u672f\u9644\u4ef6\uff0c\u8bb8\u53ef\u6240\u9644\u7684\u6280\u672f\u6570\u636e\u53ef\u4ee5\u53d8\u66f4\uff0c\u5e76\u987b\u5728 OSS \u7cfb\u7edf\u4e2d\u540c\u6b65\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/jdih.kemkes.go.id\/storage\/documents\/pdfs\/2025permenkes011.pdf\" target=\"_blank\" rel=\"noopener\">Permenkes 11\/2025<\/a>\uff0c\u7b2c 14\u300119 \u6761\uff09<\/span>\u5176\u9644\u4ef6\u4e2d\u7684\u8fdb\u53e3\u5668\u68b0\u6807\u51c6\u8fdb\u4e00\u6b65\u89c4\u5b9a\uff1a\u591a\u4e2a\u4ea7\u54c1\u53ef\u4ee5\u4e00\u4e2a paket\uff0fgrouping \u6ce8\u518c\uff1b\u7533\u8bf7\u65f6\u63d0\u4ea4\u7684\u9644\u4ef6\u3001\u5c3a\u5bf8\u3001\u53d8\u4f53\u3001\u578b\u53f7\u6216\u4ea7\u54c1\u4ee3\u7801\u6e05\u5355\u5c06\u6210\u4e3a izin edar \u7684\u9644\u4ef6\uff1b\u6280\u672f\u9644\u4ef6\u81f3\u5c11\u8f7d\u660e\u54c1\u724c\u3001\u4ea7\u54c1\u7ec4\u3001\u98ce\u9669\u7b49\u7ea7\u3001\u578b\u53f7\uff0f\u5c3a\u5bf8\u3001\u5305\u88c5\u3001\u5236\u9020\u5546\uff0f\u4ea7\u54c1\u6240\u6709\u8005\u7b49\u4fe1\u606f\uff0c\u4fee\u6539\u987b\u901a\u8fc7 OSS \u63d0\u4ea4\u53d8\u66f4\u7533\u8bf7\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1aPermenkes 11\/2025 \u9644\u4ef6\u201cIzin Edar Alat Kesehatan Impor\u201d\uff0cPDF \u7b2c 401\u3001403\u3001405 \u9875\uff09<\/span>\u56e0\u6b64\u9996\u6b21\u7533\u62a5\u65f6\u5217\u5165\u7684\u578b\u53f7\u548c\u5305\u88c5\uff0c\u76f4\u63a5\u51b3\u5b9a\u65e5\u540e\u54ea\u4e9b\u8c03\u6574\u5c5e\u4e8e\u53d8\u66f4\u3002\u53d8\u66f4\u8def\u5f84\u7684\u5b8c\u6574\u8bf4\u660e\u89c1<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-perubahan-izin-edar-alkes\/\">\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u53d8\u66f4<\/a>\uff1b\u5982\u540c\u65f6\u66f4\u6362\u6301\u8bc1\u5206\u9500\u5546\uff0c\u53e6\u89c1<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-change-distributor-izin-edar\/\">\u5370\u5c3c\u66f4\u6362\u6301\u8bc1\u5206\u9500\u5546<\/a>\u3002<\/p>\n\n<h2>\u9001\u5ba1\u524d\uff0c\u7528\u4e00\u5f20\u8d44\u6599\u5bf9\u7167\u8868\u652f\u6301\u5206\u7ec4\u65b9\u6848<\/h2>\n<p>\u4ee5\u4e0b\u662f MediPass \u5efa\u8bae\u7684\u6574\u7406\u65b9\u5f0f\uff0c\u4e0d\u662f\u4e3b\u7ba1\u673a\u5173\u89c4\u5b9a\u7684\u8868\u683c\u3002\u6bcf\u4e00\u884c\u5bf9\u5e94\u4e00\u4e2a\u578b\u53f7\u6216\u7248\u672c\uff0c\u6bcf\u4e00\u5217\u56de\u7b54\u4e00\u9879\u5206\u7ec4\u6761\u4ef6\uff1a<\/p>\n<ul>\n<li><strong>\u4ea7\u54c1\u8eab\u4efd\uff1a<\/strong>\u4ea7\u54c1\u540d\u79f0\u3001\u578b\u53f7\u4e0e\u4ee3\u7801\u3001\u5546\u54c1\u540d\u3001\u4ea7\u54c1\u6240\u6709\u4eba\u53ca\u5236\u9020\u5546\u3002<\/li>\n<li><strong>\u7528\u9014\uff1a<\/strong>IFU \u4e2d\u7684\u68c0\u6d4b\u5bf9\u8c61\u3001\u6837\u672c\u7c7b\u578b\u3001\u9884\u671f\u4f7f\u7528\u8005\uff08\u4e13\u4e1a\u6216\u81ea\u6d4b\uff09\u4e0e\u4f7f\u7528\u573a\u666f\u3002<\/li>\n<li><strong>\u98ce\u9669\u7ea7\u522b\uff1a<\/strong>\u6240\u4f9d\u636e\u7684\u5206\u7c7b\u89c4\u5219\u53ca\u7ed3\u8bba\uff0c\u6807\u660e\u4e0e\u5176\u4ed6\u7248\u672c\u662f\u5426\u4e00\u81f4\u3002<\/li>\n<li><strong>\u8bbe\u8ba1\u4e0e\u5236\u9020\uff1a<\/strong>\u539f\u7406\u3001\u7ec4\u6210\u3001\u914d\u65b9\u548c\u751f\u4ea7\u573a\u6240\u7684\u5dee\u5f02\u3002<\/li>\n<li><strong>\u8bc1\u636e\u8986\u76d6\uff1a<\/strong>\u6bcf\u4efd\u6027\u80fd\u62a5\u544a\u3001IFU \u548c\u6807\u7b7e\u8986\u76d6\u54ea\u4e9b\u578b\u53f7\uff0c\u54ea\u4e9b\u5dee\u5f02\u9700\u8981\u5355\u72ec\u652f\u6301\u3002<\/li>\n<\/ul>\n<p>\u9700\u8981\u5411\u8bc4\u5ba1\u65b9\u786e\u8ba4\u5206\u7ec4\u65f6\uff0c\u63d0\u4ea4\u5177\u4f53\u5dee\u5f02\uff0c\u6bd4\u53ea\u95ee\u201c\u80fd\u5426\u4e00\u4e2a\u8bc1\u201d\u66f4\u6709\u6548\u3002\u95ee\u9898\u53ef\u4ee5\u5199\u6210\uff1a\u62df\u5f52\u5165\u54ea\u4e00\u7c7b\u5206\u7ec4\u3001\u5bf9\u5e94\u6307\u5357\u54ea\u9879\u6761\u4ef6\u3001\u54ea\u9879\u5dee\u5f02\u5c1a\u65e0\u660e\u786e\u4f9d\u636e\u3001\u6240\u9644\u8bc1\u636e\u662f\u5426\u8db3\u4ee5\u652f\u6301\u3002<\/p>\n\n<section class=\"faq\">\n<h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n<p><strong>\u540c\u4e00\u54c1\u724c\u7684\u5168\u90e8 IVD \u80fd\u5426\u5171\u7528\u4e00\u4efd\u7533\u8bf7\uff1f<\/strong><br\/>\u4e0d\u80fd\u4ec5\u51ed\u54c1\u724c\u51b3\u5b9a\u3002Famili \u8981\u6c42\u5546\u54c1\u540d\u3001\u4ea7\u54c1\u7c7b\u578b\u3001\u98ce\u9669\u7ea7\u522b\u3001\u9884\u671f\u7528\u9014\u3001\u8bbe\u8ba1\u53ca\u5236\u9020\u8fc7\u7a0b\u76f8\u540c\uff0c\u53d8\u4f53\u8fd8\u987b\u5728\u5141\u8bb8\u8303\u56f4\u5185\uff1b\u54c1\u724c\u76f8\u540c\u53ea\u6ee1\u8db3\u5176\u4e2d\u4e00\u90e8\u5206\u3002<\/p>\n<p><strong>\u88c5\u5728\u540c\u4e00\u4e2a\u76d2\u5b50\u91cc\u5c31\u5c5e\u4e8e Tes Kit DIV \u5417\uff1f<\/strong><br\/>\u8fd8\u8981\u6ee1\u8db3\u5171\u540c\u5b9e\u73b0\u7279\u5b9a\u68c0\u6d4b\u7528\u9014\u3001\u540c\u4e00\u8bd5\u5242\u76d2\u540d\u79f0\u3001\u5404\u7ec4\u6210\u6807\u7b7e\u6216 IFU \u5199\u660e\u4f5c\u4e3a\u8bd5\u5242\u76d2\u4f7f\u7528\u3001\u76f8\u4e92\u517c\u5bb9\u7b49\u6761\u4ef6\u3002\u53ef\u5355\u72ec\u4f7f\u7528\u7684\u4ea7\u54c1\u7ec4\u5408\u9500\u552e\uff0c\u4e0d\u80fd\u81ea\u52a8\u8bc1\u660e\u7b26\u5408\u8be5\u7c7b\u522b\u3002<\/p>\n<p><strong>\u5206\u6790\u4eea\u80fd\u505a\u591a\u4e2a\u9879\u76ee\uff0c\u80fd\u6309\u4e00\u4e2a Sistem DIV \u6ce8\u518c\u5417\uff1f<\/strong><br\/>\u6307\u5357\u5c06 Sistem DIV \u9650\u5b9a\u4e3a\u4e00\u4e2a\u68c0\u6d4b\u53c2\u6570\u7684\u95ed\u5408\u7cfb\u7edf\uff0c\u800c\u4e14 Tes Kit DIV \u4e0d\u5305\u542b\u5206\u6790\u4eea\u3002\u591a\u9879\u76ee\u5e73\u53f0\u5e94\u5148\u7406\u6e05\u4eea\u5668\u4e0e\u5404\u8bd5\u5242\u7684\u5173\u7cfb\uff0c\u518d\u786e\u5b9a\u5404\u81ea\u7684\u7533\u8bf7\u5b89\u6392\u3002<\/p>\n<p><strong>strip \u548c cassette \u4e24\u79cd\u5f62\u6001\u7684\u540c\u4e00\u5feb\u68c0\uff0c\u53ef\u4ee5\u4e00\u8d77\u7533\u8bf7\u5417\uff1f<\/strong><br\/>\u6307\u5357\u628a\u5f62\u6001\u4e0d\u540c\u7684 IVD \u5feb\u68c0\u5217\u4e3a Famili \u5141\u8bb8\u53d8\u4f53\uff0c\u524d\u63d0\u662f\u5176\u4f59\u4e94\u9879\u6761\u4ef6\u540c\u65f6\u6ee1\u8db3\uff0c\u4f8b\u5982\u98ce\u9669\u7ea7\u522b\u548c\u9884\u671f\u7528\u9014\u76f8\u540c\u3001\u8bbe\u8ba1\u53ca\u5236\u9020\u8fc7\u7a0b\u76f8\u540c\u3002<\/p>\n<p><strong>\u5df2\u83b7\u8bc1\u7684\u4e13\u4e1a\u7248\u4ea7\u54c1\uff0c\u80fd\u5426\u901a\u8fc7\u53d8\u66f4\u589e\u52a0\u81ea\u6d4b\u7248\uff1f<\/strong><br\/>2021 \u5e74\u53d8\u66f4\u6307\u5357\u628a\u201c\u4ec5\u9650\u4e13\u4e1a\u4f7f\u7528\u201d\u6539\u4e3a\u201c\u5bb6\u7528\u201d\u7684\u6807\u7b7e\u53d8\u66f4\u5217\u4e3a\u91cd\u5927\u53d8\u66f4\uff1b\u81ea\u6d4b\u901a\u5e38\u8fd8\u6d89\u53ca\u98ce\u9669\u7ea7\u522b\u3001\u4f7f\u7528\u8005\u8bc1\u636e\u548c IFU \u7684\u53d8\u5316\uff0c\u98ce\u9669\u7ea7\u522b\u6539\u53d8\u65f6\u8bc1\u53f7\u4e5f\u4f1a\u6539\u53d8\u3002\u5e94\u5148\u5b8c\u6210\u5206\u7c7b\u548c\u8bc1\u636e\u8bc4\u4f30\uff0c\u518d\u786e\u5b9a\u6309\u53d8\u66f4\u6216\u65b0\u7533\u8bf7\u529e\u7406\u3002<\/p>\n<\/section>\n\n<aside class=\"article-cta\"><p class=\"eyebrow\">\u5370\u5c3c IVD \u7533\u8bf7\u8303\u56f4<\/p><h3>\u5148\u544a\u8bc9\u6211\u4eec\u4ea7\u54c1\u7ec4\u5408\uff0c\u518d\u5224\u65ad\u7533\u8bf7\u8303\u56f4<\/h3><p>\u5148\u544a\u8bc9\u6211\u4eec <strong>\u62df\u552e\u578b\u53f7\u6216 panel \u6e05\u5355\uff0c\u4ee5\u53ca\u4e13\u4e1a\u7528\u6216\u81ea\u6d4b\u7528\u9014<\/strong> \u5373\u53ef\uff0cIFU \u548c\u6027\u80fd\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\u5927\u81f4\u7533\u8bf7\u6570\u91cf\uff0c\u5e76\u7ed9\u51fa\u62a5\u4ef7\uff1b\u5206\u7ec4\u6761\u4ef6\u4e0e\u8d44\u6599\u8986\u76d6\u7684\u9010\u9879\u6bd4\u5bf9\u5728\u9879\u76ee\u542f\u52a8\u540e\u8fdb\u884c\u3002\u8d44\u6599\u51c6\u5907\u548c\u672c\u5730\u6301\u8bc1\u5b89\u6392\uff0c\u53ef\u53c2\u9605<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/ivd-registration\/\">IVD \u6ce8\u518c\u670d\u52a1<\/a>\u3002<\/p><a class=\"button\" href=\"https:\/\/aseanmedipass.com\/zh-hans\/%e8%81%94%e7%b3%bb%e6%96%b9%e5%bc%8f\/\">\u8bc4\u4f30\u5370\u5c3c IVD \u7533\u8bf7\u8303\u56f4<\/a><\/aside>\n\n<section class=\"related\"><h2>\u5ef6\u4f38\u9605\u8bfb<\/h2><ul>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-medical-device-registration\/\"><strong>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4e0e Kemenkes \u6cd5\u89c4\u670d\u52a1<\/strong><span>\u98ce\u9669\u5206\u7c7b\u3001\u5206\u7ec4\u7c7b\u522b\u3001\u6ce8\u518c\u8def\u5f84\u4e0e\u672c\u5730\u6301\u8bc1\u5b89\u6392\u7684\u603b\u4f53\u4ecb\u7ecd\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-perubahan-izin-edar-alkes\/\"><strong>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u53d8\u66f4<\/strong><span>\u83b7\u8bc1\u540e\u589e\u52a0\u578b\u53f7\u3001\u4fee\u6539\u6807\u7b7e\u6216\u7528\u9014\u65f6\uff0c\u600e\u6837\u533a\u5206\u53d8\u66f4\u4e0e\u65b0\u7533\u8bf7\u3002<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/ivd-registration\/\"><strong>MediPass IVD \u6ce8\u518c\u670d\u52a1<\/strong><span>IVD \u5206\u7c7b\u3001\u6027\u80fd\u8d44\u6599\u4e0e\u7533\u62a5\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>\u5370\u5c3c\u536b\u751f\u90e8\u836f\u68b0\u603b\u53f8\uff0cPedoman Grouping Alat Kesehatan dan Alat Kesehatan Diagnostik In Vitro\uff08\u533b\u7597\u5668\u68b0\u4e0e IVD \u5206\u7ec4\u6307\u5357\uff09\uff0c\u7b2c\u4e00\u7ae0 F \u8282\u7b2c 4\u20146 \u9875\uff1a\u5b9a\u4e49\uff1b\u7b2c\u4e8c\u7ae0\u7b2c 7\u20148 \u9875\uff1a\u5206\u7ec4\u539f\u5219\u53ca\u4e0d\u540c\u4ea7\u54c1\u6240\u6709\u4eba\uff1b\u7b2c\u4e09\u7ae0\u7b2c 9\u201415 \u9875\uff1aTunggal\u3001Famili\u3001Tes Kit DIV\u3001Sistem DIV\u3001Grup\uff1b\u7b2c\u56db\u7ae0\u7b2c 18 \u9875\uff0c2019 \u5e74 11 \u6708\uff0c<a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Pedoman%20Grouping%20Alkes.pdf\" target=\"_blank\" rel=\"noopener\">regalkes.kemkes.go.id\uff08PDF\uff09<\/a><\/li>\n<li>Peraturan Menteri Kesehatan Nomor 5 Tahun 2026 tentang Perbekalan Kesehatan\uff08\u536b\u751f\u7269\u8d44\u6761\u4f8b\uff09\uff0c\u7b2c 55 \u6761\uff1a\u98ce\u9669\u5206\u7c7b\uff1b\u7b2c 124 \u6761\uff1a\u539f\u5b9e\u65bd\u6027\u89c4\u5b9a\u7684\u6548\u529b\uff1b\u7b2c 125 \u6761\uff1a\u5e9f\u6b62 Permenkes 62\/2017\uff08\u7b2c 49\u201451 \u9875\uff09\uff0c2026-04-17 \u5236\u5b9a\uff0c2026-05-04 \u9881\u5e03\uff0c<a href=\"https:\/\/jdih.kemkes.go.id\/documents\/peraturan-menteri-kesehatan-nomor-5-tahun-2026\" target=\"_blank\" rel=\"noopener\">jdih.kemkes.go.id<\/a>\uff1b<a href=\"https:\/\/jdih.kemkes.go.id\/storage\/documents\/pdfs\/2026permenkes005.pdf\" target=\"_blank\" rel=\"noopener\">\u539f\u6587 PDF<\/a><\/li>\n<li>Peraturan Menteri Kesehatan Nomor 11 Tahun 2025\uff08\u536b\u751f\u5b50\u884c\u4e1a\u57fa\u4e8e\u98ce\u9669\u7684\u7ecf\u8425\u8bb8\u53ef\u6807\u51c6\uff09\uff0c\u7b2c 6 \u6761\u7b2c\uff082\uff09\u6b3e c \u9879\uff1a\u8fdb\u53e3\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\uff1b\u7b2c 14 \u6761\uff1a\u6280\u672f\u9644\u4ef6\uff1b\u7b2c 19 \u6761\uff1a\u8bb8\u53ef\u53d8\u66f4\uff1b\u9644\u4ef6\u201cIzin Edar Alat Kesehatan Impor\u201d\u6807\u51c6\uff08PDF \u7b2c 400\u2014406 \u9875\uff09\uff0c2025-10-03\uff0c<a href=\"https:\/\/jdih.kemkes.go.id\/storage\/documents\/pdfs\/2025permenkes011.pdf\" target=\"_blank\" rel=\"noopener\">jdih.kemkes.go.id\uff08PDF\uff09<\/a><\/li>\n<li>\u5370\u5c3c\u536b\u751f\u90e8\u836f\u68b0\u603b\u53f8\uff0cPedoman Manajemen Perubahan Izin Edar Alat Kesehatan dan Alat Kesehatan Diagnostik In Vitro\uff08\u6ce8\u518c\u53d8\u66f4\u7ba1\u7406\u6307\u5357\uff09\uff0c\u7b2c 2.2 \u8282\u7b2c 8 \u9875\uff1b\u7b2c 2.4.2 \u8282\u7b2c 21\u201422 \u9875\uff1b\u7b2c 2.4.7 \u8282\u7b2c 31 \u9875\uff1b\u7b2c 2.4.8 \u8282\u7b2c 32\u201433 \u9875\uff1b\u7b2c 3 \u8282\u7b2c 34 \u9875\uff0c2021-12-03\uff08\u524d\u8a00\u65e5\u671f\uff09\uff0c<a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Pedoman%20Manajemen%20Perubahan.pdf\" target=\"_blank\" rel=\"noopener\">regalkes.kemkes.go.id\uff08PDF\uff09<\/a><\/li>\n<li>\u5370\u5c3c\u536b\u751f\u90e8\u836f\u68b0\u603b\u53f8\uff0cPedoman Klasifikasi Alat Kesehatan\uff08\u533b\u7597\u5668\u68b0\u4e0e IVD \u5206\u7c7b\u6307\u5357\uff09\uff0cIVD \u89c4\u5219 4\uff1a\u81ea\u6d4b\uff0c\u7b2c 14\u201415 \u9875\uff0c2016 \u5e74 9 \u6708\uff08\u539f\u53d1\u5e03\u4e8e siklara.kemkes.go.id\uff0c\u8be5\u94fe\u63a5\u76ee\u524d\u65e0\u6cd5\u8bbf\u95ee\uff09<\/li>\n<\/ol><p class=\"note\">\u672c\u6587\u4f9d\u636e\u622a\u81f3 2026 \u5e74 5 \u6708 6 \u65e5\u53ef\u6838\u5b9e\u7684\u5b98\u65b9\u8d44\u6599\u7f16\u5199\uff0c\u7528\u4e8e\u5382\u5546\u89c4\u5212\u5370\u5c3c IVD \u7533\u8bf7\u8303\u56f4\uff1b\u5177\u4f53\u4ea7\u54c1\u80fd\u5426\u5206\u7ec4\uff0c\u5e94\u4ee5\u8bc4\u5ba1\u65b9\u5bf9\u5b9e\u9645\u7528\u9014\u3001\u98ce\u9669\u7ea7\u522b\u548c\u8bc1\u636e\u7684\u786e\u8ba4\u4e3a\u51c6\u3002<\/p><\/section>\n<\/article>\n\n","protected":false},"excerpt":{"rendered":"<p>\u540c\u4e00\u54c1\u724c\u3001\u540c\u4e00\u68c0\u6d4b\u5e73\u53f0\u6216\u540c\u4e00\u5305\u88c5\uff0c\u4e0d\u8db3\u4ee5\u786e\u5b9a\u5370\u5c3c IVD \u7533\u8bf7\u6570\u91cf\u3002\u672c\u6587\u6309\u5177\u4f53\u4ea7\u54c1\u5173\u7cfb\u89e3\u91ca Famili\u3001Tes Kit DIV \u4e0e Sistem DIV \u7684\u9002\u7528\u5224\u65ad\uff0c\u5e76\u8ba8\u8bba\u8054\u68c0\u7ec4\u5408\u3001\u4e13\u4e1a\u4e0e\u81ea\u6d4b\u7248\u672c\u53ca\u83b7\u8bc1\u540e\u589e\u52a0\u578b\u53f7\u3002<\/p>\n","protected":false},"author":2,"featured_media":4099,"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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