{"id":7027,"date":"2026-07-09T09:09:58","date_gmt":"2026-07-09T02:09:58","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-07-15T21:24:56","modified_gmt":"2026-07-15T14:24:56","slug":"idak-and-cdakb-medical-device-distribution-indonesia","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/idak-and-cdakb-medical-device-distribution-indonesia\/","title":{"rendered":"\u4e86\u89e3IDAK\u548cCDAKB\uff1a\u5370\u5c3c\u533b\u7597\u5668\u68b0\u5206\u9500\u7684\u4e24\u5927\u652f\u67f1"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u4efb\u4f55\u8ba1\u5212\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u5206\u9500\u533b\u7597\u5668\u68b0\u7684\u4eba\u90fd\u4f1a\u5f88\u5feb\u9047\u5230\u4e24\u4e2a\u7f29\u5199\u8bcd\uff1a <strong>IDAK<\/strong> \u548c <strong>CDAKB<\/strong>. \u5b83\u4eec\u7ecf\u5e38\u88ab\u653e\u5728\u4e00\u8d77\u63d0\u53ca\uff0c\u4f46\u5e76\u975e\u540c\u4e00\u56de\u4e8b\u3002\u4e00\u4e2a\u662f\u8425\u4e1a\u6267\u7167\uff0c\u53e6\u4e00\u4e2a\u662f\u8d28\u91cf\u7ba1\u7406\u6807\u51c6\u3002\u4e86\u89e3\u5b83\u4eec\u7684\u533a\u522b\u4ee5\u53ca\u5b83\u4eec\u5982\u4f55\u534f\u540c\u8fd0\u4f5c\uff0c\u662f\u6df1\u5165\u4e86\u89e3\u5404\u81ea\u6280\u672f\u7ec6\u8282\u7684\u7b2c\u4e00\u6b65\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"801\" height=\"484\" src=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2.webp\" alt=\"IDAK \u548c CDAKB \u89e3\u91ca\u4e86\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u533b\u7597\u5668\u68b0\u5206\u9500\u89c4\u5219\" class=\"wp-image-7029\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2.webp 801w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2-300x181.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2-768x464.webp 768w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/07\/IDAK-and-CDAKB-Explained-Medical-Device-Distribution-Rules-in-Indonesia-2-18x12.webp 18w\" sizes=\"(max-width: 801px) 100vw, 801px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4ec0\u4e48\u662fIDAK\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>IDAK<\/strong> \u4ee3\u8868 <strong>\u4f0a\u8f9b\u5206\u9500\u963f\u62c9\u7279\u00b7\u514b\u585e\u54c8\u5766<\/strong>, \uff0c \u6216\u8005 <strong>\u533b\u7597\u5668\u68b0\u5206\u9500\u8bb8\u53ef\u8bc1<\/strong>. \u8fd9\u662f\u4f01\u4e1a\u5b9e\u4f53\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u5408\u6cd5\u91c7\u8d2d\u3001\u50a8\u5b58\u3001\u5206\u9500\u6216\u4f9b\u5e94\u533b\u7597\u5668\u68b0\uff08\u65e0\u8bba\u662f\u6279\u53d1\u8fd8\u662f\u96f6\u552e\uff09\u4e4b\u524d\u5fc5\u987b\u6301\u6709\u7684\u5b98\u65b9\u8bb8\u53ef\u8bc1\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IDAK\u662f\u901a\u8fc7\u5370\u5c3c\u57fa\u4e8e\u98ce\u9669\u7684\u8bb8\u53ef\u5236\u5ea6\u9881\u53d1\u7684\u3002, <strong>OSS-RBA\uff08\u5728\u7ebf\u5355\u4e00\u63d0\u4ea4 - \u57fa\u4e8e\u98ce\u9669\u7684\u65b9\u6cd5\uff09<\/strong>, \u6839\u636e\u5546\u4e1a\u5206\u7c7b\u4ee3\u7801 <strong><a href=\"https:\/\/kbli.co.id\/id\/46691\" target=\"_blank\" rel=\"noopener\">KBLI 46691<\/a><\/strong>, \u6db5\u76d6\u836f\u54c1\u3001\u5b9e\u9a8c\u5ba4\u8bbe\u5907\u548c\u533b\u7597\u5668\u68b0\u7684\u5927\u89c4\u6a21\u8d38\u6613\u3002\u8be5\u8bb8\u53ef\u8bc1\u672c\u8eab\u5df2\u83b7\u5f97\u6280\u672f\u8bb8\u53ef\u3002 <strong><a href=\"https:\/\/www.kemkes.go.id\/id\/home\" target=\"_blank\" rel=\"noopener\">\u536b\u751f\u90e8\uff08Kemenkes\uff09<\/a><\/strong>, \u901a\u8fc7 <a href=\"https:\/\/farmalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\"><strong>\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u603b\u5c40\uff08Ditjen Farmalkes\uff09<\/strong>.<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IDAK\u5b9e\u9645\u4e0a\u662f\u4ee5\u524d\u79f0\u4e3aIDAK\u7684\u672f\u8bed\u7684\u65b0\u540d\u79f0\u3002 <strong>IPAK (Izin Penyalur Alat Kesehatan)<\/strong>, \u53d7\u76d1\u7ba1 <strong>\u536b\u751f\u90e8\u957f\u6761\u4f8b\uff08Permenkes\uff09\u7b2c1191\/Menkes\/Per\/VIII\/2010\u53f7\uff0c\u5173\u4e8e\u533b\u7597\u5668\u68b0\u5206\u9500<\/strong>. \u5f53\u5370\u5c3c\u8f6c\u5411\u96c6\u6210\u5f0fOSS-RBA\u8bb8\u53ef\u6846\u67b6\u65f6\uff0c\u8fd9\u90e8\u5206\u5185\u5bb9\u88ab\u7eb3\u5165\u5176\u4e2d\u3002 <strong><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/203315\/permenkes-no-14-tahun-2021\" target=\"_blank\" rel=\"noopener\">2021\u5e74\u7b2c14\u53f7\u6cd5\u4ee4<\/a> \u5173\u4e8e\u533b\u7597\u536b\u751f\u9886\u57df\u57fa\u4e8e\u98ce\u9669\u7684\u5546\u4e1a\u8bb8\u53ef\u4e2d\u5546\u4e1a\u6d3b\u52a8\u548c\u4ea7\u54c1\u7684\u6807\u51c6<\/strong>, \u73b0\u5728\uff0c\u8fd9\u5df2\u6210\u4e3a\u7b7e\u53d1 IDAK \u7684\u4e3b\u8981\u6cd5\u5f8b\u4f9d\u636e\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8981\u83b7\u5f97IDAK\u8ba4\u8bc1\uff0c\u516c\u53f8\u901a\u5e38\u9700\u8981\u8bc1\u660e\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4f9d\u6cd5\u6210\u7acb\u7684\u5546\u4e1a\u5b9e\u4f53\uff08PT \u6216\u5408\u4f5c\u793e\uff09\uff0c\u62e5\u6709\u6709\u6548\u7684\u6210\u7acb\u5951\u7ea6\uff0c\u8868\u660e\u5176\u5728\u533b\u7597\u5668\u68b0\u9886\u57df\u5f00\u5c55\u4e1a\u52a1\u3002.<\/li>\n\n\n\n<li>KBLI 46691 \u4e0b\u7684\u5546\u4e1a\u8bc6\u522b\u53f7\u7801 (NIB)\u3002.<\/li>\n\n\n\n<li>\u5b9e\u4f53\u529e\u516c\u573a\u6240\uff08\u529e\u516c\u5ba4\u548c\u4ed3\u5e93\uff09\u5fc5\u987b\u7b26\u5408\u5206\u9500\u6807\u51c6\uff08\u865a\u62df\u529e\u516c\u5ba4\u4e0d\u7b26\u5408\u8981\u6c42\uff09\u3002\u91cd\u8981\u7684\u662f\uff0c\u8bb8\u53ef\u8bc1\u4e0e\u6b64\u7279\u5b9a\u6ce8\u518c\u5730\u5740\u7ed1\u5b9a\uff0c\u56e0\u6b64\uff0c\u5982\u679c\u516c\u53f8\u65e5\u540e\u642c\u8fc1\u529e\u516c\u5ba4\u6216\u4ed3\u5e93\uff0c\u5219\u5fc5\u987b\u76f8\u5e94\u5730\u66f4\u65b0\u6216\u91cd\u65b0\u529e\u7406\u5176 IDAK\uff0c\u800c\u4e0d\u80fd\u7b80\u5355\u5730\u5c06\u73b0\u6709\u8bb8\u53ef\u8bc1\u8f6c\u79fb\u5230\u65b0\u5730\u70b9\u3002.<\/li>\n\n\n\n<li>A <strong>Penanggung Jawab Teknis (PJT)<\/strong>, \u6216\u5177\u6709\u76f8\u5173\u6559\u80b2\u80cc\u666f\uff08\u5982\u836f\u5b66\u3001\u7535\u5b50\u533b\u7597\u5de5\u7a0b\u3001\u533b\u5b66\u5b9e\u9a8c\u5ba4\u6280\u672f\u6216\u516c\u5171\u536b\u751f\uff09\u7684\u8d1f\u8d23\u6280\u672f\u4eba\u5458\uff0c\u5e76\u5728\u536b\u751f\u90e8\u4fe1\u606f\u7cfb\u7edf\u4e2d\u6ce8\u518c\u3002.<\/li>\n\n\n\n<li>\u9075\u5b88 <strong>CDAKB<\/strong>, \u4e0b\u6587\u5c06\u8ba8\u8bba\u826f\u597d\u7684\u5206\u9500\u89c4\u8303\u6807\u51c6\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u6ca1\u6709 IDAK\uff0c\u516c\u53f8\u5c31\u4e0d\u80fd\u5408\u6cd5\u5730\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u8fdb\u53e3\u3001\u50a8\u5b58\u6216\u5206\u9500\u533b\u7597\u5668\u68b0\uff0c\u8fd9\u6837\u505a\u5c06\u88ab\u89c6\u4e3a\u672a\u7ecf\u6388\u6743\u7684\u5206\u9500\uff0c\u5e76\u53ef\u80fd\u6839\u636e\u5370\u5ea6\u5c3c\u897f\u4e9a\u536b\u751f\u6cd5\u5f15\u53d1\u884c\u653f\u5904\u7f5a\u6216\u6cd5\u5f8b\u540e\u679c\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>CDAKB\u662f\u4ec0\u4e48\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>CDAKB<\/strong> \u4ee3\u8868 <strong>\u5361\u62c9\u00b7\u5206\u914d\u897f\u00b7\u963f\u62c9\u7279\u00b7\u514b\u585e\u54c8\u5766\u00b7\u6768\u00b7\u62dc\u514b<\/strong>, \uff0c \u6216\u8005 <strong>\u533b\u7597\u5668\u68b0\u826f\u597d\u5206\u9500\u89c4\u8303<\/strong>. \u5176\u4e2d IDAK \u662f <em>\u7ecf\u8425\u8bb8\u53ef\u8bc1<\/em>, CDAKB\u662f <em>\u8fd0\u8425\u548c\u8d28\u91cf\u6807\u51c6<\/em> \u5206\u9500\u5546\u5728\u8fd0\u8425\u540e\u5fc5\u987b\u5b9e\u9645\u9075\u5b88\u7684\u89c4\u5b9a\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">CDAKB\u7684\u6cd5\u5f8b\u57fa\u7840\u662f <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/116710\/permenkes-no-4-tahun-2014\" target=\"_blank\" rel=\"noopener\"><strong>2014\u5e74\u7b2c4\u53f7\u536b\u751f\u90e8\u957f\u6761\u4f8b\uff08Permenkes\uff09\u5173\u4e8e\u533b\u7597\u5668\u68b0\u826f\u597d\u5206\u9500\u89c4\u8303<\/strong>. <\/a>\u6839\u636e\u536b\u751f\u90e8\u53d1\u5e03\u7684\u5173\u4e8e\u6b64\u6cd5\u89c4\u7684\u6a21\u5757\uff0c\u300a2014\u5e74\u7b2c4\u53f7\u536b\u751f\u6761\u4f8b\u300b\u7b2c2\u6761\u7b2c1\u6b3e\u89c4\u5b9a\uff0c\u6240\u6709\u533b\u7597\u5668\u68b0\u5206\u9500\u5546\u53ca\u5176\u6240\u6709\u5206\u652f\u673a\u6784\u5728\u5f00\u5c55\u5206\u9500\u6d3b\u52a8\u65f6\u5fc5\u987b\u5b9e\u65bdCDAKB\u3002\u536b\u751f\u90e8\u6307\u51fa\uff0cCDAKB\u662f\u53c2\u7167\u56fd\u9645\u6807\u51c6\u5236\u5b9a\u7684\u3002 <strong>\u826f\u597d\u5206\u9500\u89c4\u8303\uff08GDP\uff09<\/strong>, \u5e76\u6839\u636e\u5370\u5c3c\u7684\u76d1\u7ba1\u73af\u5883\u8fdb\u884c\u4e86\u8c03\u6574\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">CDAKB \u5217\u51fa\u4e86\u6db5\u76d6\u4ee5\u4e0b\u65b9\u9762\u7684\u8981\u6c42\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb<\/strong>, \u6709\u636e\u53ef\u67e5\u3001\u7ed3\u6784\u6e05\u6670\u4e14\u59cb\u7ec8\u5982\u4e00\u5730\u5e94\u7528\u3002.<\/li>\n\n\n\n<li><strong>\u4eba\u4e8b\u7ba1\u7406<\/strong>, \u5305\u62ec\u64cd\u4f5c\u533b\u7597\u5668\u68b0\u7684\u5de5\u4f5c\u4eba\u5458\u7684\u80fd\u529b\u548c\u57f9\u8bad\u8bb0\u5f55\u3002.<\/li>\n\n\n\n<li><strong>\u8bbe\u65bd\u548c\u57fa\u7840\u8bbe\u65bd<\/strong>, \u9002\u5f53\u7684\u50a8\u5b58\u6761\u4ef6\uff0c\u4ee5\u9632\u6b62\u635f\u574f\u6216\u6c61\u67d3\u3002.<\/li>\n\n\n\n<li><strong>\u91c7\u8d2d\u3001\u4ed3\u50a8\u548c\u8fd0\u8f93<\/strong>, \u786e\u4fdd\u6574\u4e2a\u4f9b\u5e94\u94fe\u4e2d\u8bbe\u5907\u7684\u5b8c\u6574\u6027\u3002.<\/li>\n\n\n\n<li><strong>\u53ef\u8ffd\u6eaf\u6027<\/strong>, \u80fd\u591f\u8ffd\u8e2a\u4ea7\u54c1\u7684\u6d41\u5411\uff0c\u8fd9\u6709\u52a9\u4e8e\u9a8c\u8bc1\u4ea7\u54c1\u7684\u771f\u5b9e\u6027\uff0c\u5e76\u9632\u6b62\u5047\u5192\u6216\u4e0d\u5408\u683c\u7684\u8bbe\u5907\u5230\u8fbe\u6700\u7ec8\u7528\u6237\u624b\u4e2d\u3002.<\/li>\n\n\n\n<li><strong>\u5bf9\u5916\u5305\u6d3b\u52a8\u7684\u63a7\u5236<\/strong>, \u5176\u4e2d\u7b2c\u4e09\u65b9\u53c2\u4e0e\u4e86\u5206\u9500\u8fc7\u7a0b\u7684\u90e8\u5206\u73af\u8282\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">CDAKB \u9002\u7528\u4e8e\u53d7\u76d1\u7ba1\u533b\u7597\u5668\u68b0\u7684\u4e3b\u8981\u7c7b\u522b\uff1a\u57fa\u4e8e\u8f90\u5c04\u7684\u7535\u7597\u8bbe\u5907\u3001\u975e\u8f90\u5c04\u7535\u7597\u8bbe\u5907\u3001\u65e0\u83cc\u975e\u7535\u7597\u8bbe\u5907\u3001\u975e\u65e0\u83cc\u975e\u7535\u7597\u8bbe\u5907\u548c\u4f53\u5916\u8bca\u65ad\u8bbe\u5907\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>IDAK \u548c CDAKB \u5982\u4f55\u5408\u4f5c<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u6837\u60f3\u6216\u8bb8\u4f1a\u6709\u5e2e\u52a9\uff1a <strong>IDAK \u662f\u6210\u4e3a\u5206\u9500\u5546\u7684\u8bb8\u53ef\uff1bCDAKB \u662f\u5206\u9500\u5546\u77e5\u9053\u5982\u4f55\u6b63\u786e\u64cd\u4f5c\u7684\u8bc1\u660e\u3002.<\/strong> \u5b9e\u9645\u4e0a\uff0c\u7533\u8bf7IDAK\u7684\u516c\u53f8\u9700\u8981\u5728\u8bb8\u53ef\u8fc7\u7a0b\u4e2d\u8bc1\u660e\u5176\u7b26\u5408CDAKB\u7684\u8981\u6c42\uff0c\u56e0\u4e3a\u82ac\u5170\u56fd\u5bb6\u836f\u54c1\u7ba1\u7406\u5c40\uff08Kemenkes\uff09\u5c06\u8fd0\u8425\u6807\u51c6\u4e0e\u8bb8\u53ef\u8bc1\u672c\u8eab\u6302\u94a9\u3002\u516c\u53f8\u4e0d\u80fd\u4ec5\u4ec5\u6301\u6709\u5408\u6cd5\u8bb8\u53ef\u8bc1\uff0c\u800c\u5ffd\u7565\u5176\u5b9e\u9645\u7684\u8bbe\u5907\u5b58\u50a8\u6216\u8fd0\u8f93\u65b9\u5f0f\uff1b\u8fd9\u4e24\u8005\u5fc5\u987b\u4f5c\u4e3a\u4e00\u4e2a\u7edf\u4e00\u7684\u8d23\u4efb\u4f53\u7cfb\u8fd0\u4f5c\uff0c\u6db5\u76d6\u4ece\u6587\u4ef6\u5230\u4ed3\u5e93\u73b0\u573a\u7684\u6bcf\u4e00\u4e2a\u73af\u8282\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u79cd\u8054\u7cfb\u4e5f\u53cd\u6620\u4e86\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u80cc\u540e\u7684\u66f4\u5e7f\u6cdb\u610f\u56fe\uff1a\u786e\u4fdd\u5230\u8fbe\u533b\u9662\u3001\u8bca\u6240\u6216\u60a3\u8005\u7684\u6bcf\u4ef6\u533b\u7597\u5668\u68b0\u90fd\u7ecf\u8fc7\u4e86\u4ece\u8fdb\u53e3\u6216\u5236\u9020\u5230\u4f7f\u7528\u70b9\u7684\u8bb8\u53ef\u3001\u76d1\u63a7\u548c\u8d28\u91cf\u63a7\u5236\u7684\u76d1\u7ba1\u94fe\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4e3a\u4ec0\u4e48\u8fd9\u5bf9\u8fdb\u5165\u5370\u5c3c\u5e02\u573a\u7684\u4f01\u4e1a\u81f3\u5173\u91cd\u8981<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u5916\u56fd\u5236\u9020\u5546\u548c\u672c\u5730\u5206\u9500\u5546\u800c\u8a00\uff0cIDAK \u548c CDAKB \u5e76\u975e\u53ef\u6709\u53ef\u65e0\u7684\u624b\u7eed\uff0c\u800c\u662f\u5408\u6cd5\u5728\u5370\u5c3c\u533b\u7597\u5668\u68b0\u884c\u4e1a\u8fd0\u8425\u7684\u5148\u51b3\u6761\u4ef6\uff0c\u5e76\u4e14\u4e0e\u83b7\u5f97\u76f8\u5173\u8bb8\u53ef\u5bc6\u5207\u76f8\u5173\u3002 <strong>\u4ea7\u54c1\u4e0a\u5e02\u8bb8\u53ef\uff08Izin Edar\uff09<\/strong> \u6b64\u5916\uff0c\u5ffd\u89c6\u8fd9\u4e9b\u8981\u6c42\u7684\u516c\u53f8\u53ef\u80fd\u4f1a\u9762\u4e34\u8fd0\u8425\u5ef6\u8bef\u3001\u7533\u8bf7\u88ab\u62d2\u6216\u8fd0\u8425\u5f00\u59cb\u540e\u53d7\u5230\u76d1\u7ba1\u5904\u7f5a\u7684\u98ce\u9669\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7531\u4e8e\u8fd9\u4e24\u4e2a\u6846\u67b6\u90fd\u6d89\u53ca\u8be6\u7ec6\u7684\u6280\u672f\u3001\u7ba1\u7406\u548c\u4eba\u529b\u8d44\u6e90\u8981\u6c42\uff0c\u4f01\u4e1a\u901a\u5e38\u4f1a\u4e0e\u7ecf\u9a8c\u4e30\u5bcc\u7684\u76d1\u7ba1\u987e\u95ee\u5408\u4f5c\uff0c\u4ee5\u987a\u5229\u5b8c\u6210 OSS-RBA \u7684\u7533\u8bf7\u6d41\u7a0b\uff0c\u5e76\u786e\u4fdd\u5176\u8fd0\u8425\u4ece\u4e00\u5f00\u59cb\u5c31\u7b26\u5408 CDAKB \u7684\u8981\u6c42\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u9700\u8981\u5e2e\u52a9\u786e\u4fdd\u7b26\u5408 IDAK \u548c CDAKB \u6807\u51c6\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u6ca1\u6709\u5408\u9002\u7684\u672c\u5730\u4e13\u4e1a\u77e5\u8bc6\uff0c\u529e\u7406 IDAK \u8bb8\u53ef\u548c CDAKB \u8ba4\u8bc1\u53ef\u80fd\u4f1a\u975e\u5e38\u8017\u65f6\uff0c\u4ece\u51c6\u5907\u6b63\u786e\u7684 SOP \u5230\u4efb\u547d\u5408\u683c\u7684 Penanggung Jawab Teknis \u5e76\u901a\u8fc7 Kemenkes \u8bc4\u4f30\u3002. <strong><a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/medical-device-registration-indonesia\/\">\u5370\u5ea6\u5c3c\u897f\u4e9a\u4ea7\u54c1\u6ce8\u518c<\/a><\/strong> \u5e2e\u52a9\u5916\u56fd\u5236\u9020\u5546\u548c\u5f53\u5730\u5206\u9500\u5546\u7ba1\u7406\u6574\u4e2a\u6d41\u7a0b\uff0c\u4ece OSS-RBA \u8bb8\u53ef\u5230 CDAKB \u51c6\u5907\u548c\u533b\u7597\u5668\u68b0\u4e0a\u5e02\u8bb8\u53ef (Izin Edar)\uff0c\u4ee5\u4fbf\u60a8\u7684\u4ea7\u54c1\u53ef\u4ee5\u987a\u5229\u8fdb\u5165\u5370\u5c3c\u5e02\u573a\u5e76\u957f\u671f\u7559\u5728\u5370\u5c3c\u5e02\u573a\uff0c\u800c\u4e0d\u4f1a\u9047\u5230\u76d1\u7ba1\u65b9\u9762\u7684\u963b\u788d\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u6765\u6e90<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5370\u5ea6\u5c3c\u897f\u4e9a\u5171\u548c\u56fd\u536b\u751f\u90e8\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u603b\u5c40\uff08Ditjen Farmalkes Kemenkes RI\uff09, <em>\u533b\u7597\u5668\u68b0\u826f\u597d\u5206\u9500\u89c4\u8303\u6a21\u5757<\/em>, farmalkes.kemkes.go.id<\/li>\n\n\n\n<li>\u536b\u751f\u90e8\u957f\u6761\u4f8b (Permenkes) 2014 \u5e74\u7b2c 4 \u53f7\u5173\u4e8e\u533b\u7597\u5668\u68b0\u826f\u597d\u5206\u9500\u89c4\u8303 (Cara Distribusi Alat Kesehatan yang Baik)<\/li>\n\n\n\n<li>\u536b\u751f\u90e8\u957f\u6761\u4f8b\uff08Permenkes\uff09\u7b2c1191\/Menkes\/Per\/VIII\/2010\u53f7\uff0c\u5173\u4e8e\u533b\u7597\u5668\u68b0\u5206\u9500<\/li>\n\n\n\n<li>2021\u5e74\u7b2c14\u53f7\u536b\u751f\u90e8\u957f\u6761\u4f8b\uff08Permenkes\uff09\u5173\u4e8e\u536b\u751f\u9886\u57df\u57fa\u4e8e\u98ce\u9669\u7684\u5546\u4e1a\u8bb8\u53ef\u4e2d\u5546\u4e1a\u6d3b\u52a8\u548c\u4ea7\u54c1\u7684\u6807\u51c6<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Anyone planning to distribute medical devices in Indonesia will quickly run into two acronyms: IDAK and CDAKB. They are often mentioned together, but they are not the same thing. One is a business license, the other is a quality management standard. Understanding the difference, and how they work together is the first step before diving [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":7028,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7027","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","country-indonesia"],"acf":[],"_links":{"self":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7027","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/comments?post=7027"}],"version-history":[{"count":2,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7027\/revisions"}],"predecessor-version":[{"id":7031,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7027\/revisions\/7031"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/7028"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=7027"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=7027"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=7027"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=7027"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}