{"id":5929,"date":"2026-05-06T10:00:00","date_gmt":"2026-05-06T02:00:00","guid":{"rendered":"https:\/\/aseanmedipass.com\/?p=5929"},"modified":"2026-10-27T20:23:15","modified_gmt":"2026-10-27T12:23:15","slug":"indonesia-perubahan-izin-edar-alkes","status":"publish","type":"post","link":"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-perubahan-izin-edar-alkes\/","title":{"rendered":"\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u540e\u53d8\u66f4\uff1aperubahan izin edar \u7684\u56db\u6761\u8def\u5f84"},"content":{"rendered":"\n<style>.postid-5929 .entry-header{display:none}.postid-5929 #primary{width:100%;margin:0}.postid-5929 #secondary{display:none}.postid-5929 #content .ast-container{max-width:844px!important;width:100%;padding:0!important}.postid-5929 .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 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.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-5929 .ast-article-single{padding:32px 22px!important}}.postid-5929 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\u533b\u7597\u5668\u68b0\u6ce8\u518c\u540e\u53d8\u66f4\uff1aperubahan izin edar \u7684\u56db\u6761\u8def\u5f84<\/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>\u4e00\u5bb6\u6b27\u6d32\u5236\u9020\u5546\u5728\u5370\u5c3c\u7684 izin edar \u521a\u6ee1\u4e24\u5e74\uff0c\u4eca\u5e74\u8981\u540c\u65f6\u5904\u7406\u56db\u4ef6\u4e8b\uff1a\u66f4\u6362\u5916\u5305\u88c5\u4f9b\u5e94\u5546\u3001\u5728\u8bf4\u660e\u4e66\u4e2d\u589e\u52a0\u5370\u5c3c\u8bed\u3001\u7ed9\u65b0\u578b\u53f7\u589e\u52a0\u4ea7\u54c1\u4ee3\u7801\uff0c\u4ee5\u53ca\u628a\u4e00\u6761\u751f\u4ea7\u7ebf\u642c\u5230\u65b0\u5382\u533a\u3002\u6301\u8bc1\u5206\u9500\u5546\uff08PAK\uff09\u95ee\uff1a&#8221;\u8fd9\u4e9b\u662f\u8d70\u4e00\u6b21\u53d8\u66f4\uff0c\u8fd8\u662f\u5206\u5f00\u529e\uff1f&#8221;\u5236\u9020\u5546\u7684\u53d8\u66f4\u63a7\u5236\u8bb0\u5f55\u628a\u5b83\u4eec\u5168\u90e8\u5f52\u4e3a&#8221;\u5c0f\u53d8\u66f4&#8221;\uff0c\u4f46\u5370\u5c3c\u6cd5\u89c4\u5e76\u4e0d\u8fd9\u6837\u5206\u3002<\/p>\n<p><strong>\u5370\u5c3c\u5bf9\u533b\u7597\u5668\u68b0\uff08GMD\uff09\u4e0e\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff08IVD\uff09\u7684\u6ce8\u518c\u540e\u53d8\u66f4\u6ca1\u6709\u5355\u4e00\u7684&#8221;\u53d8\u66f4\u7533\u62a5&#8221;\u901a\u9053\uff0c\u800c\u662f\u6309\u53d8\u66f4\u5bf9\u5b89\u5168\u3001\u8d28\u91cf\u548c\u6027\u80fd\u7684\u5f71\u54cd\u5206\u6210\u56db\u6761\u8def\u5f84\u2014\u2014\u65b0\u7533\u8bf7\u3001\u539f\u8bc1\u53f7\u4e0b\u7684 perubahan\u3001\u5411\u603b\u53f8\u957f\u7684 pemberitahuan\u3001\u4ee5\u53ca\u4ec5\u5728\u8d28\u91cf\u4f53\u7cfb\u5185\u8bb0\u5f55\uff1b\u628a\u8def\u5f84\u5224\u9519\uff0c\u8f7b\u5219\u8865\u4ef6\u9000\u56de\uff0c\u91cd\u5219\u539f\u8bc1\u53f7\u4f5c\u5e9f\u3001\u91cd\u65b0\u6ce8\u518c\u3002<\/strong><\/p>\n<aside class=\"summary\"><p class=\"eyebrow\">\u8981\u70b9\u901f\u89c8<\/p><dl>\n<dt>\u7a0b\u5e8f\/\u7c7b\u522b<\/dt><dd>\u56db\u79cd\u673a\u5236\uff1aizin edar \u65b0\u7533\u8bf7\uff1bperubahan izin edar\uff08\u8bc1\u53f7\u4e0d\u53d8\uff09\uff1bpemberitahuan\uff08\u901a\u77e5\uff09\uff1b\u4ec5 QMS \u8bb0\u5f55<\/dd>\n<dt>\u6cd5\u89c4\u4f9d\u636e<\/dt><dd>2021 \u5e74\u300a\u53d8\u66f4\u7ba1\u7406\u6307\u5357\u300b\uff08Pedoman\uff09\u3002\u5176\u539f\u4f9d\u636e Permenkes 62\/2017 \u5df2\u88ab Permenkes 5\/2026\uff082026 \u5e74 5 \u6708 4 \u65e5\u9881\u5e03\uff09\u5e9f\u6b62\uff1b5\/2026 \u7b2c 124 \u6761\u4fdd\u7559\u4e0d\u51b2\u7a81\u7684\u539f\u5b9e\u65bd\u6027\u89c4\u5b9a<\/dd>\n<dt>\u8d39\u7528<\/dt><dd>perubahan \u8d39\u7528\u672a\u89c1\u5b98\u65b9\u516c\u5e03\uff1b\u65b0\u7533\u8bf7 PNBP\uff1aA \u7c7b Rp1,500,000\uff0cB\/C \u7c7b Rp3,000,000\uff0cD \u7c7b Rp5,000,000<\/dd>\n<dt>\u65f6\u9650<\/dt><dd>PP 28\/2025 \u9644\u4ef6 II\uff1a\u53d8\u66f4\u6216\u5e26\u53d8\u66f4\u7684\u7eed\u8bc1 16 \u5929\uff1b\u539f 62\/2017 \u7684\u8bc4\u4f30\u3001\u7b7e\u53d1\u671f\u9650\u968f\u5176\u5e9f\u6b62\u4e0d\u518d\u4f5c\u4e3a\u73b0\u884c\u4f9d\u636e<\/dd>\n<dt>\u7cfb\u7edf\/\u6e20\u9053<\/dt><dd>regalkes.kemkes.go.id\uff08\u7ecf INSW\/OSS \u8fdb\u5165\uff09\uff1b\u90e8\u5206\u4e3b\u4f53\u4fe1\u606f\u53d8\u66f4\u987b\u5148\u9012\u4ea4\u7eb8\u9762\u51fd\u4ef6<\/dd>\n<\/dl><\/aside>\n\n<h2>\u5370\u5c3c\u7684&#8221;\u53d8\u66f4&#8221;\u4e3a\u4ec0\u4e48\u5206\u6210\u56db\u6761\u8def\u5f84\uff1f<\/h2>\n<p>\u539f Permenkes 62\/2017\uff08\u5df2\u4e8e 2026 \u5e74 5 \u6708\u88ab 5\/2026 \u5e9f\u6b62\uff09\u7b2c 30 \u6761\u7b2c 1 \u6b3e\u66fe\u628a perubahan izin edar \u9650\u5b9a\u5728\u4e94\u7c7b\uff1a\u5c3a\u5bf8\u3001\u5305\u88c5\u3001\u6807\u8bc6\uff08penandaan\uff09\u3001\u8bc1\u4e66\u6240\u9644\u914d\u4ef6\u6216\u9644\u4ef6\u3001\u5236\u9020\u5546\u6388\u6743\u4ee3\u8868\u7684\u540d\u79f0\u6216\u5730\u5740\uff1b\u7b2c 2 \u6b3e\u89c4\u5b9a\u8fd9\u7c7b\u53d8\u66f4\u4e0d\u6539\u53d8\u8bc1\u53f7\uff1b\u7b2c 3 \u6b3e\u89c4\u5b9a\u5176\u4f59\u53d8\u66f4\u987b\u91cd\u65b0\u7533\u8bf7\u30022021 \u5e74\u6307\u5357\u6b63\u662f\u5728\u8fd9\u5957\u6846\u67b6\u4e0a\u5efa\u7acb\u5206\u7c7b\uff0c\u5b9e\u52a1\u4e2d\u4ecd\u6cbf\u7528\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/jdih.kemkes.go.id\/storage\/documents\/pdfs\/2017permenkes062.pdf\" target=\"_blank\" rel=\"noopener\">Permenkes No. 62\/2017, 2017-12-29, Pasal 30<\/a>\uff09<\/span><\/p>\n<p>\u539f\u7b2c 31 \u6761\u53e6\u8bbe\u901a\u77e5\u8def\u5f84\uff1a\u5f71\u54cd\u5236\u9020\u5546\u5168\u90e8\u4ea7\u54c1\u6807\u8bc6\u3001\u4f46\u4e0d\u5f71\u54cd\u5b89\u5168\u3001\u8d28\u91cf\u548c\u6548\u7528\u7684\u53d8\u66f4\uff0c\u6301\u8bc1\u4eba\u5411\u603b\u53f8\u957f\u63d0\u4ea4 pemberitahuan \u5373\u53ef\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/jdih.kemkes.go.id\/storage\/documents\/pdfs\/2017permenkes062.pdf\" target=\"_blank\" rel=\"noopener\">Permenkes No. 62\/2017, 2017-12-29, Pasal 31<\/a>\uff09<\/span><\/p>\n<p>2021 \u5e74 12 \u6708\u536b\u751f\u90e8\u836f\u68b0\u603b\u53f8\u53d1\u5e03\u7684\u300aPedoman Manajemen Perubahan Izin Edar\u300b\u628a\u6761\u6587\u7ec6\u5316\u4e3a\u5206\u7c7b\u8868\uff1a\u5f71\u54cd\u5b89\u5168\u3001\u8d28\u91cf\u3001\u6548\u7528\u6216\u6027\u80fd\u7684\u53d8\u66f4\u8d70\u65b0\u7533\u8bf7\uff1b\u4e0d\u5f71\u54cd\u7684\u8d70 perubahan\uff1b\u5f71\u54cd\u5168\u90e8\u4ea7\u54c1\u6807\u8bc6\u7684\u8d70\u901a\u77e5\u3002\u8868\u683c&#8221;\u6ce8\u518c\u7c7b\u578b&#8221;\u4e00\u680f\u8fd8\u6709\u7b2c\u56db\u79cd\u5904\u7406\u2014\u2014&#8221;\u5728\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5185\u8bb0\u5f55&#8221;\uff0c\u65e0\u9700\u5411\u4e3b\u7ba1\u673a\u5173\u7533\u62a5\u3002\u6307\u5357\u4ee5 AHWP\/WG2-WG1-WG3\/F001:2019 \u4e3a\u534f\u8c03\u53c2\u8003\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\">Pedoman Manajemen Perubahan Izin Edar Alkes dan Alkes IVD, 2021-12-03, \u00a72.2\u3001\u00a72.4<\/a>\uff09<\/span><\/p>\n\n<h2>\u54ea\u4e9b\u53d8\u66f4\u5fc5\u987b\u91cd\u65b0\u7533\u8bf7 izin edar\uff1f<\/h2>\n<p>\u6307\u5357 2.4.9 \u5217\u51fa\u4e03\u9879\u5fc5\u987b\u4f5c\u4e3a\u65b0\u7533\u8bf7\u529e\u7406\u7684\u53d8\u66f4\uff1a\u4ea7\u54c1\u540d\u79f0\uff1b\u5206\u9500\u5546\u7684\u66f4\u6362\u3001\u8f6c\u8ba9\u6216\u8fc1\u79fb\uff1b\u5236\u9020\u5546\u53d8\u66f4\uff1b\u5236\u9020\u5546\u5730\u70b9\u53d8\u66f4\uff1b\u4ea7\u54c1\u89c4\u683c\u53d8\u66f4\uff1b\u6539\u53d8\u89c4\u683c\u6216\u529f\u80fd\u7684\u539f\u6599\u6216\u914d\u65b9\u53d8\u66f4\uff1b\u4ee5\u53ca\u58f0\u79f0\u6216\u9002\u5e94\u75c7\u53d8\u66f4\u3002\u7b2c 3 \u7ae0\u7684\u591a\u91cd\u53d8\u66f4\u793a\u4f8b\u4e2d\uff0c\u706d\u83cc\u65b9\u6cd5\u53d8\u66f4\u4e5f\u88ab\u5f52\u4e3a\u65b0\u7533\u8bf7\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\">Pedoman Manajemen Perubahan, 2021-12-03, \u00a72.4.9\u3001\u00a73<\/a>\uff09<\/span><\/p>\n<p>\u5206\u9500\u5546\u66f4\u6362\u88ab\u5217\u4e3a\u65b0\u7533\u8bf7\uff0c\u6839\u6e90\u5728\u4e8e izin edar \u7684\u6301\u8bc1\u7ed3\u6784\uff1a\u539f 62\/2017 \u7b2c 13\u300125\u300149 \u6761\u628a izin edar \u4e0e PAK \u7684\u72ec\u5bb6\u59d4\u4efb\u53ca\u5176\u671f\u9650\u7ed1\u5b9a\u3002\u73b0\u884c Permenkes 5\/2026 \u7b2c 51 \u6761\u7b2c 1 \u6b3e d \u9879\u628a\u5236\u9020\u5546\u7ec8\u6b62\u59d4\u4efb\u5217\u4e3a\u64a4\u8bc1\u4e8b\u7531\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/jdih.kemkes.go.id\/storage\/documents\/pdfs\/2017permenkes062.pdf\" target=\"_blank\" rel=\"noopener\">Permenkes No. 62\/2017, 2017-12-29, Pasal 13\u300125\u300149<\/a>\uff1b<a href=\"https:\/\/farmalkes.kemkes.go.id\/wp-content\/uploads\/2026\/07\/Permenkes-Nomor-5-Tahun-2026.pdf\" target=\"_blank\" rel=\"noopener\">Permenkes No. 5\/2026, 2026-05-04, Pasal 51(1)(d)<\/a>\uff09<\/span>\u66f4\u6362\u6301\u8bc1\u5206\u9500\u5546\u7684\u5b8c\u6574\u8def\u5f84\u4e0e\u5e93\u5b58\u8fc7\u6e21\u5b89\u6392\uff0c\u89c1<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-change-distributor-izin-edar\/\">\u5370\u5c3c\u66f4\u6362\u6301\u8bc1\u5206\u9500\u5546\u4e13\u6587<\/a>\u3002<\/p>\n\n<h2>\u54ea\u4e9b\u53d8\u66f4\u53ef\u4ee5\u5728\u539f\u8bc1\u53f7\u4e0b\u529e\u7406\uff0c\u54ea\u4e9b\u53ea\u9700\u901a\u77e5\uff1f<\/h2>\n<p>\u6307\u5357 2.4.8 \u7ed9\u51fa perubahan izin edar \u7684\u5341\u4e09\u9879\u793a\u4f8b\uff08a\u2013m\uff09\uff1a\u5c3a\u5bf8\u4e0e\u88c5\u91cf\u3001\u5305\u88c5\u89c4\u683c\u4e0e\u6750\u8d28\u3001\u6807\u8bc6\uff08\u8bf4\u660e\u4e66\u8bed\u8a00\u3001\u6807\u5fd7\u6216\u7b26\u53f7\u3001\u6709\u6548\u671f\u3001\u4ea7\u54c1\u4ee3\u7801\u6216\u578b\u53f7\u3001\u50a8\u5b58\u6e29\u5ea6\u3001\u540d\u79f0\u52d8\u8bef\u3001\u6807\u8bc6\u8bbe\u8ba1\uff09\u3001\u914d\u4ef6\u4e0e\u578b\u53f7\u589e\u51cf\u3001principal \u540d\u5740\u3001\u5236\u9020\u5546\u6cd5\u4eba\u5b9e\u4f53\u3001\u4e0d\u642c\u8fc1\u7684\u5236\u9020\u5546\u5730\u5740\u3001\u4ea7\u54c1\u6240\u6709\u4eba\u540d\u5740\u3001\u540c\u4e00 NIB \u4e0b\u7684\u5206\u9500\u5546\u540d\u79f0\u3001\u5206\u9500\u5546\u5730\u5740\uff0c\u4ee5\u53ca\u8bc1\u4e66\u6587\u5b57\u52d8\u8bef\u3002\u5176\u4e2d i\u3001k\u3001l \u4e09\u9879\u987b\u5148\u5411\u5668\u68b0\u8bc4\u4f30\u53f8\u9012\u4ea4\u7eb8\u9762\u51fd\u4ef6\u53ca\u652f\u6301\u6587\u4ef6\u4ee5\u66f4\u65b0 e-regalkes \u4f01\u4e1a\u6570\u636e\u5e93\uff0c\u4e4b\u540e\u624d\u80fd\u5728\u7ebf\u63d0\u4ea4\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\">Pedoman Manajemen Perubahan, 2021-12-03, \u00a72.4.8<\/a>\uff09<\/span><\/p>\n<div class=\"table-wrap\"><table>\n<thead><tr><th>\u8def\u5f84<\/th><th>\u5178\u578b\u53d8\u66f4<\/th><th>\u6cd5\u89c4\u4f9d\u636e<\/th><th>\u7ed3\u679c<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>\u65b0\u7533\u8bf7 izin edar<\/td><td>\u4ea7\u54c1\u540d\u79f0\u3001\u6301\u8bc1\u5206\u9500\u5546\u3001\u5236\u9020\u5546\u6216\u5382\u5740\u3001\u89c4\u683c\u3001\u6539\u53d8\u89c4\u683c\u7684\u914d\u65b9\u3001\u58f0\u79f0\u6216\u9002\u5e94\u75c7\u3001\u706d\u83cc\u65b9\u6cd5<\/td><td>\u6307\u5357 \u00a72.4.9\u3001\u00a73<\/td><td>\u65b0\u8bc1\u53f7<\/td><\/tr>\n<tr><td>perubahan izin edar<\/td><td>\u5c3a\u5bf8\u3001\u5305\u88c5\u3001\u6807\u8bc6\u5185\u5bb9\u3001\u914d\u4ef6\u6216\u578b\u53f7\u3001\u4ee3\u8868\u6216\u5236\u9020\u5546\u540d\u5740\uff08\u4e0d\u642c\u8fc1\uff09\u3001\u540c NIB \u5206\u9500\u5546\u540d\u5740<\/td><td>\u6307\u5357 \u00a72.4.8<\/td><td>\u8bc1\u53f7\u4e0d\u53d8<\/td><\/tr>\n<tr><td>pemberitahuan\uff08\u901a\u77e5\uff09<\/td><td>\u5f71\u54cd\u5168\u90e8\u4ea7\u54c1\u6807\u8bc6\u3001\u4e0d\u5f71\u54cd\u5b89\u5168\u4e0e\u6027\u80fd\uff0c\u5982\u516c\u53f8\u6807\u5fd7\u66f4\u6362<\/td><td>\u6307\u5357 \u00a72.2<\/td><td>\u901a\u77e5\u603b\u53f8\u957f<\/td><\/tr>\n<tr><td>\u4ec5 QMS \u8bb0\u5f55<\/td><td>\u4e0d\u6539\u6d4b\u8bd5\u53c2\u6570\u7684\u91cf\u5177\u66f4\u6362\u3001\u975e\u5173\u952e\u4f9b\u5e94\u5546\u66f4\u6362\u3001\u540c\u6d53\u5ea6 EtO \u9884\u6df7\u6539\u540e\u6df7<\/td><td>\u6307\u5357 \u00a72.4 \u793a\u4f8b\u8868<\/td><td>\u65e0\u9700\u7533\u62a5<\/td><\/tr>\n<\/tbody><\/table><\/div>\n<p>\u901a\u77e5\u8def\u5f84\u7684\u524d\u63d0\u662f&#8221;\u5168\u90e8\u4ea7\u54c1&#8221;\u7684\u6807\u8bc6\u53d8\u5316\uff1b\u53ea\u5bf9\u5355\u4e00\u4ea7\u54c1\u66f4\u6362\u8bf4\u660e\u4e66\u8bed\u8a00\u6216\u589e\u52a0\u7b26\u53f7\uff0c\u6309\u6307\u5357\u4ecd\u5c5e 2.4.8(c) \u7684 perubahan\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\">Pedoman Manajemen Perubahan, 2021-12-03, \u00a72.2\u3001\u00a72.4.8(c)<\/a>\uff09<\/span><\/p>\n\n<h2>\u591a\u9879\u53d8\u66f4\u540c\u65f6\u53d1\u751f\uff0c\u600e\u6837\u5f52\u7c7b\uff1f<\/h2>\n<p>\u6307\u5357\u7b2c 3 \u7ae0\u5904\u7406\u540c\u4e00\u4ea7\u54c1\u7684\u591a\u91cd\u53d8\u66f4\uff1a\u6bcf\u9879\u53d8\u66f4\u5148\u6309\u5206\u7c7b\u8868\u5355\u72ec\u5224\u5b9a\uff0c\u7533\u8bf7\u4eba\u53ef\u4ee5\u628a\u5168\u90e8\u53d8\u66f4\u5408\u5e76\u4e3a\u4e00\u6b21\u63d0\u4ea4\uff0c\u4f46\u6ce8\u518c\u7c7b\u578b&#8221;\u6309\u6240\u505a\u53d8\u66f4\u4e2d\u6700\u9ad8\u7684\u7c7b\u522b\u786e\u5b9a&#8221;\u3002\u6307\u5357\u7684\u793a\u4f8b\u662f\u706d\u83cc\u65b9\u6cd5\u53d8\u66f4\uff08\u65b0\u7533\u8bf7\uff09\u3001\u5305\u88c5\u7248\u9762\u53d8\u66f4\uff08perubahan\uff09\u4e0e\u5236\u9020\u5546\u6807\u5fd7\u53d8\u66f4\uff08\u901a\u77e5\uff09\u4e09\u8005\u5e76\u5b58\uff0c\u7ed3\u679c\u662f\u6574\u4f53\u4f5c\u4e3a\u4e00\u6b21\u65b0\u7533\u8bf7\u63d0\u4ea4\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\">Pedoman Manajemen Perubahan, 2021-12-03, \u00a73<\/a>\uff09<\/span><\/p>\n<p>\u56de\u5230\u5f00\u5934\u7684\u6848\u4f8b\uff1a\u5305\u88c5\u4f9b\u5e94\u5546\u66f4\u6362\u82e5\u4e0d\u6539\u53d8\u6750\u8d28\u4e0e\u89c4\u683c\uff0c\u5c5e QMS \u8bb0\u5f55\uff1b\u589e\u52a0\u8bf4\u660e\u4e66\u8bed\u8a00\u548c\u4ea7\u54c1\u4ee3\u7801\u5c5e perubahan\uff1b\u751f\u4ea7\u7ebf\u642c\u8fc1\u5fc5\u987b\u65b0\u7533\u8bf7\u3002\u56db\u9879\u5408\u5e76\u63d0\u4ea4\u7b49\u4e8e\u6574\u4f53\u8d70\u65b0\u7533\u8bf7\uff1b\u82e5\u5e0c\u671b\u6807\u8bc6\u53d8\u66f4\u5148\u884c\u751f\u6548\uff0c\u5c31\u5e94\u62c6\u6210\u4e24\u6b21\u63d0\u4ea4\u3002<\/p>\n\n<h2>\u6cd5\u89c4\u65f6\u9650\u548c\u8d39\u7528\u662f\u600e\u6837\u89c4\u5b9a\u7684\uff1f<\/h2>\n<p>perubahan \u7533\u8bf7\u901a\u8fc7 regalkes.kemkes.go.id\uff08\u7ecf INSW\/OSS\uff09\u5728\u7ebf\u63d0\u4ea4\u3002\u539f 62\/2017 \u7b2c 33\u201334 \u6761\u66fe\u89c4\u5b9a\u8bc4\u4f30\u4e0e\u7b7e\u53d1\u5404\u4e0d\u8d85\u8fc7 10 \u5929\uff0c\u4f46\u8be5\u90e8\u4ee4\u5df2\u5e9f\u6b62\uff0c\u4e0d\u5b9c\u518d\u4f5c\u4e3a\u73b0\u884c\u65f6\u9650\u5f15\u7528\u3002<\/p>\n<p>Permenkes 11\/2025 \u7684\u8fdb\u53e3\u5668\u68b0 izin edar \u6807\u51c6\uff08\u9644\u4ef6\u7b2c 409 \u9875\uff09\u89c4\u5b9a\uff1a\u53d8\u66f4\u6ce8\u518c\u6700\u957f 16 \u5929\uff0c\u901a\u77e5\u7c7b\uff08Notifikasi\uff09izin edar \u7684\u65b0\u529e\u3001\u7eed\u8bc1\u3001\u53d8\u66f4\u5404 12 \u5929\uff0c\u7eed\u8bc1 13 \u5929\uff1b\u8865\u6b63\u6700\u591a 2 \u6b21\u3001\u6bcf\u6b21 10 \u5929\uff08D \u7c7b 15 \u5929\uff09\u3002\u5f71\u54cd\u5236\u9020\u5546\u5168\u90e8\u4ea7\u54c1\u6807\u8bc6\u7684\u884c\u653f\u6027\u53d8\u66f4\u987b\u5411\u536b\u751f\u90e8\u63d0\u4ea4 pemberitahuan\uff0c\u672a\u53e6\u8bbe\u529e\u7406\u65f6\u9650\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 No. 11\/2025, Lampiran, Standar Izin Edar Alat Kesehatan Impor, hlm. 406\u3001409\u2013410<\/a>\uff09<\/span><\/p>\n<p>\u53ef\u5bf9\u7167\u7684\u53e6\u4e00\u5b98\u65b9\u65f6\u9650\u6765\u81ea PP 28\/2025 \u9644\u4ef6 II \u7684\u536b\u751f\u90e8\u95e8\u8bb8\u53ef\u6e05\u5355\uff1a\u8fdb\u53e3\u5668\u68b0 izin edar \u65b0\u7533\u8bf7 A \u7c7b 21 \u5929\u3001B\/C \u7c7b 36 \u5929\u3001D \u7c7b 55 \u5929\uff0c\u7eed\u8bc1 13 \u5929\uff0c&#8221;\u53d8\u66f4\u6216\u5e26\u53d8\u66f4\u7684\u7eed\u8bc1&#8221;16 \u5929\uff1b\u56fd\u4ea7\u5668\u68b0\u65b0\u7533\u8bf7\u4e3a 16\/26\/40 \u5929\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/peraturan.bpk.go.id\/Download\/394948\/PP%20Nomor%2028%20Tahun%202025%20-%20Lampiran%20II.pdf\" target=\"_blank\" rel=\"noopener\">PP No. 28\/2025 Lampiran II \u2013 Sektor Kesehatan, 2025-06-05, Izin Edar Alat Kesehatan Dalam Negeri\/Impor<\/a>\uff09<\/span><\/p>\n<p>\u8d39\u7528\u4ee5 regalkes \u51fa\u5177\u7684 PNBP \u8d26\u5355\u4e3a\u51c6\u3002\u4f5c\u53c2\u8003\uff0c\u536b\u751f\u90e8 2019 \u5e74 11 \u6708\u7684\u300aPedoman Penilaian Alat Kesehatan\u300b\u66fe\u4f9d\u636e PP 64\/2019 \u5217\u51fa\u65b0\u7533\u8bf7 PNBP\uff1aA \u7c7b Rp1,500,000\uff0cB\/C \u7c7b Rp3,000,000\uff0cD \u7c7b Rp5,000,000\uff1b\u7eed\u8bc1 A \u7c7b Rp500,000\uff0cB\/C\/D \u7c7b Rp1,000,000\uff0c\u4e14\u7eed\u8bc1\u4ec5\u9002\u7528\u4e8e\u8bc1\u4e66\u6570\u636e\u65e0\u53d8\u5316\u7684\u60c5\u5f62\u3002perubahan \u7684\u5355\u72ec\u6536\u8d39\u6807\u51c6\u6211\u4eec\u672a\u80fd\u5728\u5b98\u65b9\u6587\u4ef6\u4e2d\u6838\u5b9e\uff0c\u672c\u6587\u4e0d\u4f5c\u9648\u8ff0\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Pedoman%20Penilaian%20Alkes%20Permenkes.pdf\" target=\"_blank\" rel=\"noopener\">Pedoman Penilaian Alat Kesehatan Sesuai Permenkes 62\/2017, 2019-11, \u00a72.2.B\u3001\u00a72.3.B<\/a>\uff09<\/span><\/p>\n\n<h2>Permenkes 5\/2026 \u751f\u6548\u540e\uff0c\u5e94\u6309\u54ea\u5957\u89c4\u5219\u51c6\u5907\uff1f<\/h2>\n<p>Permenkes 5\/2026\u300aPerbekalan Kesehatan\u300b\u4e8e 2026 \u5e74 4 \u6708 17 \u65e5\u7b7e\u7f72\u30015 \u6708 4 \u65e5\u9881\u5e03\uff0c\u536b\u751f\u90e8\u6cd5\u89c4\u5e93\u5c06 Permenkes 62\/2017 \u5217\u5165\u5176\u5e9f\u6b62\u6e05\u5355\u3002\u8be5\u6cd5\u89c4\u7b2c 122 \u6761\u7ed9\u4e88\u76f8\u5173\u4e3b\u4f53\u6700\u957f 1 \u5e74\u7684\u8c03\u6574\u671f\uff0c\u7b2c 124 \u6761\u89c4\u5b9a\u539f\u6709\u5b9e\u65bd\u6027\u89c4\u5b9a\u5728\u4e0d\u4e0e\u65b0\u6cd5\u89c4\u51b2\u7a81\u7684\u8303\u56f4\u5185\u7ee7\u7eed\u6709\u6548\u3002<span class=\"src\">\uff08\u6765\u6e90\uff1a<a href=\"https:\/\/jdih.kemkes.go.id\/documents\/peraturan-menteri-kesehatan-nomor-5-tahun-2026\" target=\"_blank\" rel=\"noopener\">JDIH Kemenkes \u2013 Permenkes No. 5\/2026 \u6cd5\u89c4\u72b6\u6001\u9875, 2026-05-04<\/a>\uff1b<a href=\"https:\/\/farmalkes.kemkes.go.id\/wp-content\/uploads\/2026\/07\/Permenkes-Nomor-5-Tahun-2026.pdf\" target=\"_blank\" rel=\"noopener\">Permenkes No. 5\/2026, 2026-05-04, Pasal 122\u3001124<\/a>\uff09<\/span><\/p>\n<p>\u56e0\u6b64\uff0c62\/2017 \u5df2\u4e0d\u662f\u73b0\u884c\u6cd5\u89c4\uff1b\u4f46\u4ece MediPass \u5f53\u524d\u529e\u7406\u7684\u9879\u76ee\u770b\uff0cregalkes \u4e2d\u7684\u53d8\u66f4\u7533\u62a5\u5b9e\u52a1\u4e0a\u4ecd\u6cbf\u7528 2021 \u5e74\u6307\u5357\u7684\u5206\u7c7b\u4e0e\u539f\u6709\u6d41\u7a0b\u3002\u89c4\u5212 2026\u20132027 \u5e74\u7684\u53d8\u66f4\u65f6\uff0c\u5efa\u8bae\u6309\u6307\u5357\u5206\u7c7b\u51c6\u5907\u6587\u4ef6\uff0c\u5f15\u7528\u6cd5\u5f8b\u4f9d\u636e\u65f6\u4ee5 Permenkes 5\/2026 \u548c PP 28\/2025 \u4e3a\u51c6\uff0c\u5e76\u9884\u7559\u65b0\u5b9e\u65bd\u7ec6\u5219\u51fa\u53f0\u540e\u8c03\u6574\u8def\u5f84\u7684\u7a7a\u95f4\u3002<\/p>\n<p>\u6392\u671f\u4e0a\uff0c\u5370\u5c3c\u7684\u7533\u8bf7\u4eba\u53ea\u80fd\u662f\u6301\u8bc1 PAK\uff0c\u5236\u9020\u5546\u65e0\u6cd5\u76f4\u63a5\u63d0\u4ea4\u3002\u5047\u8bbe\u6027\u573a\u666f\uff1a\u5236\u9020\u5546\u8ba1\u5212 2027 \u5e74\u7b2c\u4e00\u5b63\u5ea6\u542f\u7528\u65b0\u5382\u5740\uff0c\u540c\u65f6\u8bf4\u660e\u4e66\u9700\u589e\u52a0\u5370\u5c3c\u8bed\u3002\u5408\u7406\u987a\u5e8f\u662f\u5148\u4ee5 perubahan \u5b8c\u6210\u8bf4\u660e\u4e66\u53d8\u66f4\uff0c\u518d\u5728\u65b0\u5382\u5740 QMS \u8bc1\u4e66\u53d6\u5f97\u540e\u542f\u52a8\u65b0 izin edar \u7533\u8bf7\uff0c\u5e76\u6838\u5bf9\u539f\u8bc1\u4e0e\u59d4\u4efb\u4e66\u7684\u5230\u671f\u65e5\uff0c\u907f\u514d\u8bc1\u53f7\u5207\u6362\u4e0e\u59d4\u4efb\u671f\u9650\u8131\u8282\u3002<\/p>\n\n<section class=\"faq\"><h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n<p><strong>\u66f4\u6362\u6301\u8bc1\u5206\u9500\u5546\u53ef\u4ee5\u7528 perubahan \u529e\u7406\u5417\uff1f<\/strong><br\/>\u4e0d\u80fd\u3002\u6307\u5357 2.4.9(b) \u628a\u5206\u9500\u5546\u66f4\u6362\u3001\u8f6c\u8ba9\u6216\u8fc1\u79fb\u5217\u4e3a\u65b0\u7533\u8bf7\uff1b\u53ea\u6709\u540c\u4e00 NIB \u4e0b\u7684\u66f4\u540d\u6216\u8fc1\u5740\u5c5e\u4e8e perubahan\uff082.4.8 k\u3001l\uff09\u3002<\/p>\n<p><strong>\u53ea\u6539\u8bf4\u660e\u4e66\u8bed\u8a00\uff0c\u63d0\u4ea4 pemberitahuan \u5c31\u53ef\u4ee5\u5417\uff1f<\/strong><br\/>\u6309\u6307\u5357 \u00a72.2\uff0c\u901a\u77e5\u8def\u5f84\u4ec5\u9002\u7528\u4e8e\u5f71\u54cd\u5236\u9020\u5546\u5168\u90e8\u4ea7\u54c1\u7684\u6807\u8bc6\u53d8\u66f4\u3002\u5355\u4e00\u4ea7\u54c1\u7684\u8bf4\u660e\u4e66\u8bed\u8a00\u53d8\u66f4\u6309 2.4.8(c) \u5c5e\u4e8e perubahan\u3002<\/p>\n<p><strong>perubahan \u4f1a\u6539\u53d8 izin edar \u53f7\u7801\u5417\uff1f<\/strong><br\/>\u4e0d\u4f1a\u3002\u6309 2021 \u5e74\u6307\u5357\uff0cperubahan \u5728\u539f\u8bc1\u53f7\u4e0b\u529e\u7406\uff1b\u65b0\u7533\u8bf7\u5219\u4ea7\u751f\u65b0\u8bc1\u53f7\u3002<\/p>\n<p><strong>Permenkes 5\/2026 \u751f\u6548\u540e\uff0c2021 \u5e74\u6307\u5357\u8fd8\u80fd\u7528\u5417\uff1f<\/strong><br\/>5\/2026 \u7b2c 124 \u6761\u4fdd\u7559\u4e0d\u4e0e\u5176\u51b2\u7a81\u7684\u539f\u6709\u5b9e\u65bd\u6027\u89c4\u5b9a\u3002\u5b9e\u52a1\u4e0a\u76ee\u524d\u4ecd\u6309 2021 \u5e74\u6307\u5357\u5206\u7c7b\u63d0\u4ea4\uff0c\u4f46 62\/2017 \u5df2\u88ab\u5e9f\u6b62\uff0c\u5e94\u5173\u6ce8 5\/2026 \u7684\u540e\u7eed\u5b9e\u65bd\u7ec6\u5219\u3002<\/p>\n<\/section>\n\n<aside class=\"article-cta\"><p class=\"eyebrow\">\u5370\u5c3c\u53d8\u66f4\u7533\u62a5\u652f\u6301<\/p><h3>\u5148\u628a\u53d8\u66f4\u5f52\u7c7b\uff0c\u518d\u51b3\u5b9a\u63d0\u4ea4\u987a\u5e8f<\/h3><p>MediPass \u7684\u5370\u5c3c\u5b9e\u4f53\u53ef\u534f\u52a9\u5224\u5b9a\u53d8\u66f4\u8def\u5f84\u3001\u51c6\u5907\u7533\u8bf7\u6587\u4ef6\u5e76\u901a\u8fc7 regalkes \u63d0\u4ea4\u3002\u4e86\u89e3<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/post-market-support\/#changes-id\">\u5370\u5c3c\u53d8\u66f4\u7533\u62a5\u670d\u52a1<\/a>\u4e0e<a href=\"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-medical-device-registration\/\">\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6307\u5357<\/a>\u3002<\/p><a class=\"button\" href=\"https:\/\/aseanmedipass.com\/zh-hans\/%e8%81%94%e7%b3%bb%e6%96%b9%e5%bc%8f\/\">\u54a8\u8be2\u5370\u5c3c\u53d8\u66f4\u7533\u62a5<\/a><\/aside>\n\n<section class=\"related\"><h2>\u5ef6\u4f38\u9605\u8bfb<\/h2><ul>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-alkes-post-market-e-report-e-watch\/\"><strong>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u4e0a\u5e02\u540e\u4e49\u52a1\uff1ae-report\u3001e-watch \u4e0e\u7eed\u8bc1<\/strong><span>\u5b9a\u671f\u62a5\u544a\u3001\u4e0d\u826f\u4e8b\u4ef6\u3001\u53ec\u56de\u4e0e\u7eed\u8bc1\u89c4\u5219\u7684\u5b9e\u64cd\u68b3\u7406<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/indonesia-change-distributor-izin-edar\/\"><strong>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u66f4\u6362\u6301\u8bc1\u5206\u9500\u5546\uff1a\u65b0\u7533\u8bf7\u4e0e\u65e7\u5e93\u5b58\u8fc7\u6e21\u89c4\u5219<\/strong><span>\u5206\u9500\u5546\u66f4\u6362\u4e3a\u4f55\u662f\u65b0\u7533\u8bf7\uff0c\u4ee5\u53ca\u516d\u4e2a\u6708\u552e\u7f44\u671f\u7684\u6761\u4ef6<\/span><\/a><\/li>\n<li><a href=\"https:\/\/aseanmedipass.com\/zh-hans\/post-market-support\/#changes-id\"><strong>\u4e0a\u5e02\u540e\u652f\u6301\uff1a\u5370\u5c3c\u53d8\u66f4\u7533\u62a5<\/strong><span>MediPass \u5728\u4e94\u4e2a ASEAN \u5e02\u573a\u7684\u53d8\u66f4\u4e0e\u4e0a\u5e02\u540e\u670d\u52a1\u8303\u56f4<\/span><\/a><\/li>\n<\/ul><\/section>\n\n<section class=\"references\"><h2>\u5b98\u65b9\u53c2\u8003\u8d44\u6599<\/h2><ol>\n<li>Kementerian Kesehatan RI, Peraturan Menteri Kesehatan Nomor 62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro dan PKRT, 2017-12-29\uff082018-01-12 \u9881\u5e03\uff09, <a href=\"https:\/\/jdih.kemkes.go.id\/storage\/documents\/pdfs\/2017permenkes062.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/jdih.kemkes.go.id\/storage\/documents\/pdfs\/2017permenkes062.pdf<\/a><\/li>\n<li>Direktorat Jenderal Kefarmasian dan Alat Kesehatan, Pedoman Manajemen Perubahan Izin Edar Alat Kesehatan dan Alat Kesehatan Diagnostik In Vitro, 2021-12-03, <a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Pedoman%20Manajemen%20Perubahan.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Pedoman%20Manajemen%20Perubahan.pdf<\/a>\uff08\u53d1\u5e03\u9875\uff1a<a href=\"https:\/\/farmalkes.kemkes.go.id\/unduh\/pedoman-manajemen-perubahan-izin-edar-alat-kesehatan-dan-alat-kesehatan-diagnostik-in-vitro\/\" target=\"_blank\" rel=\"noopener\">farmalkes.kemkes.go.id<\/a>\uff09<\/li>\n<li>Kementerian Kesehatan RI, Peraturan Menteri Kesehatan Nomor 5 Tahun 2026 tentang Perbekalan Kesehatan, 2026-05-04, <a href=\"https:\/\/farmalkes.kemkes.go.id\/wp-content\/uploads\/2026\/07\/Permenkes-Nomor-5-Tahun-2026.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/farmalkes.kemkes.go.id\/wp-content\/uploads\/2026\/07\/Permenkes-Nomor-5-Tahun-2026.pdf<\/a>\uff1b\u6cd5\u89c4\u72b6\u6001\u9875 <a href=\"https:\/\/jdih.kemkes.go.id\/documents\/peraturan-menteri-kesehatan-nomor-5-tahun-2026\" target=\"_blank\" rel=\"noopener\">https:\/\/jdih.kemkes.go.id\/documents\/peraturan-menteri-kesehatan-nomor-5-tahun-2026<\/a><\/li>\n<li>Peraturan Pemerintah Nomor 28 Tahun 2025 tentang Penyelenggaraan Perizinan Berusaha Berbasis Risiko, Lampiran II (Sektor Kesehatan), 2025-06-05, <a href=\"https:\/\/peraturan.bpk.go.id\/Download\/394948\/PP%20Nomor%2028%20Tahun%202025%20-%20Lampiran%20II.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/peraturan.bpk.go.id\/Download\/394948\/PP Nomor 28 Tahun 2025 &#8211; Lampiran II.pdf<\/a><\/li>\n<li>Direktorat Jenderal Kefarmasian dan Alat Kesehatan, Pedoman Penilaian Alat Kesehatan Sesuai dengan Permenkes Nomor 62 Tahun 2017, 2019-11, <a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Pedoman%20Penilaian%20Alkes%20Permenkes.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Pedoman%20Penilaian%20Alkes%20Permenkes.pdf<\/a><\/li>\n<\/ol><p class=\"note\">\u672c\u6587\u7528\u4e8e\u4e00\u822c\u5408\u89c4\u51c6\u5907\uff1b\u5177\u4f53\u8def\u5f84\u3001\u6587\u4ef6\u4e0e\u65f6\u9650\u5e94\u7ed3\u5408\u4ea7\u54c1\u3001\u6ce8\u518c\u72b6\u6001\u53ca\u4e3b\u7ba1\u673a\u5173\u4e2a\u6848\u8981\u6c42\u786e\u8ba4\u3002<\/p><\/section>\n<\/article>\n","protected":false},"excerpt":{"rendered":"<p>\u5370\u5c3c\u6ca1\u6709\u5355\u4e00\u7684\u53d8\u66f4\u7533\u62a5\u901a\u9053\uff1a\u65b0\u7533\u8bf7\u3001perubahan\u3001pemberitahuan \u4e0e QMS \u8bb0\u5f55\u56db\u6761\u8def\u5f84\u5982\u4f55\u5212\u5206\uff1bPermenkes 5\/2026 \u5e9f\u6b62 62\/2017 \u540e\uff0c2021 \u5e74\u6307\u5357\u4e0e PP 28\/2025 \u65f6\u9650\u7684\u9002\u7528\u3002<\/p>\n","protected":false},"author":2,"featured_media":6510,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"disabled","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"disabled","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[32,35],"tags":[],"class_list":["post-5929","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-32","category-35"],"_links":{"self":[{"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts\/5929","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=5929"}],"version-history":[{"count":3,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts\/5929\/revisions"}],"predecessor-version":[{"id":6051,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/posts\/5929\/revisions\/6051"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/media\/6510"}],"wp:attachment":[{"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=5929"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=5929"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/aseanmedipass.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=5929"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}