{"id":2104,"date":"2025-08-19T07:24:13","date_gmt":"2025-08-19T07:24:13","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=2104"},"modified":"2025-12-10T22:12:16","modified_gmt":"2025-12-10T15:12:16","slug":"medical-device-registration-in-indonesia-nie-risk-classes-regulatory-strategy","status":"publish","type":"post","link":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/medical-device-registration-in-indonesia-nie-risk-classes-regulatory-strategy\/","title":{"rendered":"\u5370\u5ea6\u5c3c\u897f\u4e9a\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff1aNIE\u3001\u98ce\u9669\u7b49\u7ea7\u53ca\u76d1\u7ba1\u7b56\u7565"},"content":{"rendered":"<p>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u536b\u751f\u90e8\u89c4\u5b9a\u6240\u6709\u533b\u7597\u5668\u68b0\uff0c\u5305\u62ec\u4f53\u5916\u8bca\u65ad\u5668\u68b0 (IVD) \u548c\u5bb6\u7528\u4fdd\u5065\u7528\u54c1\uff0c\u90fd\u5fc5\u987b\u83b7\u5f97\u5b98\u65b9\u6ce8\u518c\u7f16\u53f7\uff0c\u5373\u201cNomor Izin Edar\u201d\uff08NIE\uff09\u3002\u8fd9\u9879\u8981\u6c42\u57fa\u4e8e <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112243\/permenkes-no-62-tahun-2017\" target=\"_blank\" rel=\"noopener\">\u536b\u751f\u90e82017\u5e74\u7b2c62\u53f7\u6761\u4f8b<\/a>\uff0c\u5e76\u4e0e\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AMDD\uff09\u6846\u67b6\u76f8\u4e00\u81f4\u3002<\/p>\n\n\n\n<p>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u533b\u7597\u5668\u68b0\u5408\u6cd5\u8fdb\u53e3\u3001\u9500\u552e\u6216\u5206\u9500\u4e4b\u524d\uff0c\u5fc5\u987b\u8fdb\u884c\u6ce8\u518c\u3002\u6ce8\u518c\u6d41\u7a0b\u65e8\u5728\u786e\u8ba4\u4ea7\u54c1\u7b26\u5408\u56fd\u5bb6\u5b89\u5168\u3001\u8d28\u91cf\u548c\u529f\u6548\u6807\u51c6\u3002\u6b64\u5916\uff0c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u5bf9\u4e8e\u8fdb\u5165\u533b\u9662\u548c\u836f\u623f\u81f3\u5173\u91cd\u8981\uff0c\u56e0\u4e3a\u8fd9\u4e9b\u673a\u6784\u8981\u6c42\u4ea7\u54c1\u83b7\u5f97\u536b\u751f\u90e8 (MoH) \u7684\u6279\u51c6\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u76d1\u7ba1\u6846\u67b6\u548c\u8bbe\u5907\u5206\u7c7b<\/strong><\/h2>\n\n\n\n<p>\u5370\u5ea6\u5c3c\u897f\u4e9a\u91c7\u7528\u4e0e\u4e1c\u76df\u6807\u51c6\u76f8\u534f\u8c03\u7684\u57fa\u4e8e\u98ce\u9669\u7684\u5206\u7c7b\u7cfb\u7edf\u3002\u533b\u7597\u5668\u68b0\u5206\u4e3a\u56db\u7c7b\u98ce\u9669\uff1aA\u7c7b\uff08\u4f4e\u98ce\u9669\uff09\u81f3D\u7c7b\uff08\u9ad8\u98ce\u9669\uff09\u3002\u6bcf\u4e2a\u7ea7\u522b\u90fd\u89c4\u5b9a\u4e86\u6240\u9700\u7684\u6587\u4ef6\u3001\u8bc4\u4f30\u548c\u76d1\u7ba1\u5ba1\u67e5\u7684\u6570\u91cf\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>A \u7c7b\uff08\u4f4e\u98ce\u9669\uff09\uff1a<\/strong> \u4f8b\u5982\u7ef7\u5e26\u3001\u538b\u820c\u677f\u3001\u624b\u672f\u624b\u5957\u7b49\u975e\u65e0\u83cc\u6216\u7b80\u5355\u5668\u68b0\u3002\u8fd9\u4e9b\u5668\u68b0\u7ecf\u8fc7\u7cbe\u7b80\u7684 <em>\u901a\u77e5<\/em> \u6d41\u7a0b\u3002\u5ba1\u6838\u901a\u5e38\u975e\u5e38\u5feb\u2014\u2014A\u7c7b\u7533\u8bf7\u53ef\u4ee5\u5728\u77ed\u65f6\u95f4\u5185\u83b7\u5f97\u6279\u51c6 <strong>15\u4e2a\u5de5\u4f5c\u65e5<\/strong> \u5982\u679c\u6240\u6709\u6587\u4ef6\u90fd\u9f50\u5168\u3002<\/li>\n\n\n\n<li><strong>B \u7c7b\uff08\u4f4e\u81f3\u4e2d\u7b49\u98ce\u9669\uff09\uff1a<\/strong> \u4f8b\u5982\u8f93\u6db2\u6cf5\u3001\u75c5\u4eba\u76d1\u62a4\u4eea\u3002&nbsp;<\/li>\n\n\n\n<li><strong>C \u7c7b\uff08\u4e2d\u9ad8\u98ce\u9669\uff09\uff1a<\/strong> \u4f8b\u5982\u547c\u5438\u673a\u3001\u9aa8\u79d1\u690d\u5165\u7269\u3002<\/li>\n\n\n\n<li><strong>D\u7c7b\uff08\u9ad8\u98ce\u9669\uff09\uff1a<\/strong> \u4f8b\u5982\u5fc3\u810f\u8d77\u640f\u5668\u3001\u5fc3\u810f\u74e3\u819c\u3001\u827e\u6ecb\u75c5\u6bd2\u68c0\u6d4b\u8bd5\u5242\u76d2<\/li>\n<\/ul>\n\n\n\n<p>B\u3001C \u548c D \u7c7b\u533b\u7597\u5668\u68b0\u9700\u8981\u536b\u751f\u90e8\u8fdb\u884c\u5168\u9762\u8bc4\u4f30\uff0c\u8fd9\u610f\u5473\u7740\u9700\u8981\u63d0\u4ea4\u66f4\u8be6\u5c3d\u7684\u6587\u732e\u8d44\u6599\uff08\u91c7\u7528\u4e1c\u76df\u901a\u7528\u63d0\u4ea4\u6863\u6848\u6a21\u677f\u683c\u5f0f\u7684\u6280\u672f\u6863\u6848\uff09\uff0c\u5e76\u4e14\u5ba1\u6838\u65f6\u95f4\u66f4\u957f\u3002B \u7c7b\u548c C \u7c7b\u533b\u7597\u5668\u68b0\u7684\u5ba1\u6279\u5e73\u5747\u9700\u8981 1-2 \u4e2a\u6708\uff0c\u800c D \u7c7b\uff08\u98ce\u9669\u6700\u9ad8\uff09\u533b\u7597\u5668\u68b0\u7684\u5ba1\u6279\u5219\u53ef\u80fd\u9700\u8981\u957f\u8fbe 3 \u4e2a\u6708\u4ee5\u4e0a\uff0c\u56e0\u4e3a\u5176\u6280\u672f\u8bc4\u4f30\u975e\u5e38\u4e25\u683c\uff0c\u6709\u65f6\u8fd8\u9700\u8981\u4e34\u5e8a\u8bc4\u4f30\u3002<\/p>\n\n\n\n<p>\u9ad8\u98ce\u9669\u7c7b\u522b\u5fc5\u987b\u63d0\u4ea4\u8be6\u7ec6\u7684\u98ce\u9669\u5206\u6790\u3001\u5b89\u5168\u548c\u6027\u80fd\u6570\u636e\uff08\u4f8b\u5982\u7535\u6c14\u5b89\u5168\u3001\u751f\u7269\u76f8\u5bb9\u6027\u62a5\u544a\uff09\uff0c\u4ee5\u53caC\u7c7b\u548cD\u7c7b\u5668\u68b0\u7684\u4e34\u5e8a\u8bc1\u636e\uff0c\u4ee5\u8bc1\u660e\u5176\u6709\u6548\u6027\u3002\u98ce\u9669\u7b49\u7ea7\u4e0d\u4ec5\u51b3\u5b9a\u4e86\u5ba1\u67e5\u7ea7\u522b\uff0c\u8fd8\u51b3\u5b9a\u4e86 <em>\u6587\u6863<\/em> \u60a8\u5fc5\u987b\u63d0\u4f9b\u2014\u2014\u9519\u8bef\u5206\u7c7b\u6216\u9057\u6f0f\u6240\u9700\u6587\u4ef6\u53ef\u80fd\u4f1a\u5bfc\u81f4\u8017\u65f6\u7684\u66f4\u6b63\uff0c\u751a\u81f3\u88ab\u62d2\u7edd<\/p>\n\n\n\n<p>\u76d1\u7ba1\u673a\u6784\uff1a\u5370\u5c3c\u7684\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7531\u536b\u751f\u90e8\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u5c40\u8d1f\u8d23\u76d1\u7ba1\uff08\u901a\u5e38\u5728\u67d0\u4e9b\u65b9\u9762\u4e0e\u56fd\u5bb6\u836f\u54c1\u548c\u98df\u54c1\u7ba1\u7406\u5c40\u534f\u8c03\uff09\u3002\u6240\u6709\u63d0\u4ea4\u5747\u901a\u8fc7\u4e0e\u5370\u5c3cOSS\u7cfb\u7edf\u76f8\u8fde\u7684\u5728\u7ebf\u95e8\u6237\u7f51\u7ad9\uff08Regalkes\u7cfb\u7edf\uff09\u8fdb\u884c\u3002\u4f5c\u4e3a\u4e1c\u76df\u6210\u5458\u56fd\uff0c\u5370\u5c3c\u5df2\u5c06\u4e1c\u76dfCSDT\u683c\u5f0f\u6574\u5408\u5230\u5176\u5728\u7ebf\u6ce8\u518c\u6d41\u7a0b\u4e2d\uff0c\u8fd9\u610f\u5473\u7740\u5236\u9020\u5546\u53ef\u4ee5\u5927\u91cf\u91cd\u590d\u4f7f\u7528\u4e3a\u5176\u4ed6\u4e1c\u76df\u5e02\u573a\u51c6\u5907\u7684\u6863\u6848\u6750\u6599\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5f53\u5730\u4ee3\u8868\u548c IDAK \u8bb8\u53ef\u8bc1\u8981\u6c42<\/strong><\/h2>\n\n\n\n<p>\u5370\u5c3c\u4f53\u7cfb\u7684\u4e00\u4e2a\u5173\u952e\u65b9\u9762\u662f\uff0c\u53ea\u6709\u5370\u5c3c\u6cd5\u4eba\u5b9e\u4f53\u624d\u80fd\u6ce8\u518c\u533b\u7597\u5668\u68b0\u5e76\u6301\u6709NIE\u8bb8\u53ef\u8bc1\u3002\u5916\u56fd\u5236\u9020\u5546\u4e0d\u80fd\u76f4\u63a5\u81ea\u884c\u7533\u8bf7\u3002\u60a8\u5fc5\u987b\u901a\u8fc7\u4ee5\u4e0b\u9014\u5f84\u4e4b\u4e00\u8fdb\u884c\u8fd0\u8425\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6210\u7acb PT PMA \u5b50\u516c\u53f8<\/li>\n\n\n\n<li>\u4e0e IDAK \u6307\u5b9a\u672c\u5730\u7ecf\u9500\u5546<\/li>\n\n\n\n<li>\u8058\u8bf7\u72ec\u7acb\u7684\u7b2c\u4e09\u65b9\u8bb8\u53ef\u8bc1\u6301\u6709\u8005\u8fdb\u884c\u6ce8\u518c<\/li>\n<\/ul>\n\n\n\n<p>\u8bb8\u591a\u5916\u56fd\u5236\u9020\u5546\u9009\u62e9\u72ec\u7acb\u7684\u7b2c\u4e09\u65b9\u76d1\u7ba1\u516c\u53f8\uff08\u5f53\u5730\u6388\u6743\u4ee3\u8868\uff0cLAR\uff09\u4f5c\u4e3a\u4ea7\u54c1\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u3002\u4f8b\u5982\uff0c <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/\" data-type=\"link\" data-id=\"productregistrationindonesia.com\">ProductRegistrationIndonesia.com<\/a> \u6216\u5176\u4ed6\uff09\u6301\u6709\u81ea\u5df1\u7684\u5206\u9500\u5546\u8bb8\u53ef\u8bc1\uff08\u6709\u65f6\u79f0\u4e3a IDAK \u6216\u4ee5\u524d\u79f0\u4e3a IPAK 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https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2025\/08\/medical-device-registration-300x200.png 300w, https:\/\/stage-main-2025.productregistrationindonesia.com\/wp-content\/uploads\/2025\/08\/medical-device-registration-768x512.png 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u60a8\u9700\u8981\u4e86\u89e3\u7684\u76d1\u7ba1\u8981\u70b9<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u5916\u5546\u6240\u6709\u6743\u53ca\u6295\u8d44\u89c4\u5219<\/strong><\/h3>\n\n\n\n<p>\u968f\u7740\u7b2c10\/2021\u53f7\u603b\u7edf\u6761\u4f8b\u7684\u5b9e\u65bd\uff0c\u5916\u56fd\u6295\u8d44\u8005\u73b0\u5728\u6709\u673a\u4f1a\u5168\u8d44\u62e5\u6709\u5728\u5370\u5c3c\u4ece\u4e8b\u533b\u7597\u5668\u68b0\u8fdb\u53e3\u548c\u6ce8\u518c\u7684\u516c\u53f8\u3002\u4f46\u524d\u63d0\u662f\u6ee1\u8db3\u5fc5\u8981\u7684\u8bb8\u53ef\u8981\u6c42\u3002<\/p>\n\n\n\n<p>\u8fd9\u9879\u6cd5\u89c4\u5bf9\u4e8e\u5e0c\u671b\u5728\u5370\u5c3c\u5e02\u573a\u5efa\u7acb\u672c\u5730\u63a7\u5236\u6743\u7684\u8de8\u56fd\u5065\u5eb7\u54c1\u724c\u6765\u8bf4\u5177\u6709\u663e\u8457\u4f18\u52bf\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u672c\u5730\u5185\u5bb9\u8981\u6c42 (TKDN)<\/strong><\/h3>\n\n\n\n<p>\u6839\u636e\u5de5\u4e1a\u90e8\u7b2c31\/2022\u53f7\u6761\u4f8b\uff0c\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u73b0\u5728\u5fc5\u987b\u62a5\u544a\u672c\u5730\u6210\u5206\uff0c\u6839\u636e\u4ea7\u54c1\u7c7b\u578b\uff0c\u76ee\u6807\u6700\u9ad8\u53ef\u8fbe80%\u3002\u8fd9\u9879\u6cd5\u89c4\u5bf9\u4e8e\u516c\u5171\u91c7\u8d2d\u8d44\u683c\u7684\u5ba1\u6838\u5c24\u4e3a\u91cd\u8981\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u4e0a\u5e02\u540e\u76d1\u7763\u4e0e\u66f4\u65b0<\/strong><\/h3>\n\n\n\n<p>\u4ea7\u54c1\u5728\u4fdd\u6301\u6ce8\u518c\u72b6\u6001\u7684\u540c\u65f6\uff0c\u9700\u63a5\u53d7\u6301\u7eed\u76d1\u7ba1\uff0c\u5305\u62ec\u4ea7\u54c1\u7eed\u671f\u3001\u4ea7\u54c1\u53d8\u66f4\u4ee5\u53ca\u4e0a\u5e02\u540e\u62a5\u544a\u3002NIE\u8bb8\u53ef\u8bc1\u7684\u6709\u6548\u671f\u901a\u5e38\u4e3a2\u81f35\u5e74\uff0c\u5177\u4f53\u53d6\u51b3\u4e8e\u5176\u5206\u7c7b\u3002\u5982\u679c\u51fa\u73b0\u4e0d\u5408\u89c4\u6216\u5b89\u5168\u95ee\u9898\uff0c\u53ef\u80fd\u4f1a\u88ab\u64a4\u9500\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4e3a\u4f55\u91cd\u8981\uff1a\u8d85\u8d8a\u5408\u89c4\uff0c\u8d70\u5411\u5e02\u573a\u6218\u7565<\/strong><\/h2>\n\n\n\n<p>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u83b7\u5f97\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u5ba1\u6279\u662f\u4e00\u4e2a\u590d\u6742\u7684\u8fc7\u7a0b\uff0c\u8fdc\u4e0d\u6b62\u7b80\u5355\u7684\u6838\u5bf9\u6e05\u5355\u90a3\u4e48\u7b80\u5355\u3002\u672c\u8d28\u4e0a\uff0c\u8981\u4e86\u89e3\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u73af\u5883\uff0c\u4e0d\u4ec5\u9700\u8981\u6df1\u5165\u4e86\u89e3\u6280\u672f\u8981\u6c42\uff0c\u8fd8\u9700\u8981\u6df1\u5165\u4e86\u89e3\u5176\u57fa\u672c\u539f\u5219\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u4fdd\u6301\u5bf9\u4ea7\u54c1\u7684\u63a7\u5236\uff1a<\/strong> \u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u76d1\u7ba1\u5ba1\u6279\u4e0d\u80fd\u5728\u5b9e\u4f53\u4e4b\u95f4\u8f6c\u79fb\u3002\u5982\u679c\u60a8\u8ba9\u5f53\u5730\u5206\u9500\u5546\u6ce8\u518c\u60a8\u7684\u4ea7\u54c1\uff08\u5e76\u56e0\u6b64\u6301\u6709 NIE\uff09\uff0c\u8be5\u5206\u9500\u5546\u5b9e\u9645\u4e0a\u5c31\u201c\u62e5\u6709\u201d\u4e86\u60a8\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u4ea7\u54c1\u8bb8\u53ef\u8bc1\u3002\u8fd9\u4f1a\u4e25\u91cd\u9650\u5236\u60a8\u7684\u7075\u6d3b\u6027\uff0c\u56e0\u4e3a\u66f4\u6362\u5206\u9500\u5546\u6216\u91cd\u5851\u4ea7\u54c1\u54c1\u724c\u90fd\u9700\u8981\u91cd\u65b0\u5f00\u59cb\u6ce8\u518c\u6d41\u7a0b\u3002\u4e3a\u4e86\u907f\u514d\u88ab\u9501\u5b9a\u6216\u5931\u53bb\u5e02\u573a\u8fde\u7eed\u6027\uff0c\u8bb8\u591a\u5916\u56fd\u5236\u9020\u5546\u66f4\u503e\u5411\u4e8e\u5c06 NIE \u4ea4\u7ed9\u5176\u5b50\u516c\u53f8\u6216\u4e2d\u7acb\u7684\u7b2c\u4e09\u65b9 LAR \u6301\u6709\u3002\u7ba1\u7406\u60a8\u7684\u8bb8\u53ef\u8bc1\u53ef\u4ee5\u786e\u4fdd\u60a8\u83b7\u5f97\u957f\u671f\u63a7\u5236\u6743\uff0c\u4ee5\u4fbf\u60a8\u53ef\u4ee5\u6839\u636e\u81ea\u5df1\u7684\u60c5\u51b5\u66f4\u65b0\u4ea7\u54c1\u6807\u7b7e\u3001\u6dfb\u52a0\u65b0\u7684\u4ea7\u54c1\u53d8\u4f53\u6216\u91cd\u65b0\u8c03\u6574\u5206\u9500\u7f51\u7edc\u3002<br><\/li>\n\n\n\n<li><strong>\u6218\u7565\u76d1\u7ba1\u89c4\u5212\uff1a<\/strong> \u5982\u4f55\u5bf9\u5668\u68b0\u8fdb\u884c\u5206\u7c7b\u548c\u51c6\u5907\u5c06\u76f4\u63a5\u5f71\u54cd\u4e1a\u52a1\u3002\u7cbe\u5fc3\u51c6\u5907\u7684\u3001\u7b26\u5408\u6b63\u786e\u98ce\u9669\u7b49\u7ea7\u7684\u7533\u62a5\u6750\u6599\u53ef\u4ee5\u52a0\u5feb\u4e0a\u5e02\u65f6\u95f4\uff0c\u800c\u9519\u8bef\uff08\u4f8b\u5982\u4f4e\u4f30\u98ce\u9669\u7b49\u7ea7\u6216\u63d0\u4ea4\u4e0d\u5b8c\u6574\u7684\u6570\u636e\uff09\u5219\u53ef\u80fd\u5bfc\u81f4\u7533\u8bf7\u88ab\u62d2\u548c\u4e25\u91cd\u7684\u5ef6\u8bef\u3002\u5c3d\u65e9\u6295\u8d44\u4e8e\u6cd5\u89c4\u4e13\u4e1a\u77e5\u8bc6\u662f\u503c\u5f97\u7684\u2014\u2014\u4f8b\u5982\uff0c\u6839\u636e\u5370\u5c3c\u6cd5\u89c4\u8981\u6c42\u8fdb\u884c\u5dee\u8ddd\u5206\u6790\uff08\u60a8\u7684\u4f7f\u7528\u8bf4\u660e\u4e66 (IFU) \u7ffb\u8bd1\u3001\u6d4b\u8bd5\u62a5\u544a\u548c\u8bc1\u4e66\u662f\u5426\u9f50\u5168\uff1f\uff09\uff0c\u5e76\u4e3b\u52a8\u89e3\u51b3\u8fd9\u4e9b\u95ee\u9898\u3002\u8fd9\u53ef\u4ee5\u964d\u4f4e\u536b\u751f\u90e8 (MoH) \u9700\u8981\u8865\u5145\u4fe1\u606f\u7684\u53ef\u80fd\u6027\uff0c\u4ece\u800c\u907f\u514d\u5ba1\u6279\u6d41\u7a0b\u51fa\u73b0\u5ef6\u8bef\u3002\u66f4\u5feb\u7684\u5ba1\u6279\u610f\u5473\u7740\u60a8\u53ef\u4ee5\u66f4\u5feb\u5730\u5f00\u59cb\u9500\u552e\uff0c\u62a2\u5360\u5e02\u573a\u5148\u673a\uff0c\u9886\u5148\u4e8e\u7ade\u4e89\u5bf9\u624b\u3002<br><\/li>\n\n\n\n<li><strong>\u540c\u6b65\u76d1\u7ba1\u548c\u5e02\u573a\u51c6\u5165\uff1a<\/strong> 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\u4e0e\u5176\u5c06TKDN\u6216\u6e05\u771f\u8ba4\u8bc1\u7b49\u6cd5\u89c4\u89c6\u4e3a\u8d1f\u62c5\uff0c\u4e0d\u5982\u5c06\u5176\u7eb3\u5165\u4f60\u7684\u5e02\u573a\u6218\u7565\u3002\u5982\u679c\u4f60\u7684\u8bbe\u5907\u80fd\u591f\u91c7\u7528\u672c\u5730\u7ec4\u4ef6\u6216\u7ec4\u88c5\uff0c\u8fd9\u6837\u505a\u4e0d\u4ec5\u6709\u52a9\u4e8e\u5408\u89c4\uff0c\u8fd8\u80fd\u8ba9\u4f60\u7684\u4ea7\u54c1\u5728\u516c\u4f17\u5e02\u573a\u66f4\u5177\u7ade\u4e89\u529b\u3002 <span style=\"box-sizing: border-box; margin: 0px; padding: 0px;\">\u5408\u540c<\/span>\u540c\u6837\uff0c\u4e86\u89e3\u5373\u5c06\u51fa\u53f0\u7684\u6cd5\u89c4\uff08\u4f8b\u5982\u6e05\u771f\u8ba4\u8bc1\u622a\u6b62\u65e5\u671f\u6216\u65b0\u6807\u51c6\uff09\u53ef\u4ee5\u5e2e\u52a9\u60a8\u63d0\u524d\u89c4\u5212\u4ea7\u54c1\u4fee\u6539\u6216\u83b7\u5f97\u5fc5\u8981\u7684\u8ba4\u8bc1\u3002\u90a3\u4e9b\u9886\u5148\u4e8e\u76d1\u7ba1\u53d8\u5316\u7684\u516c\u53f8\u901a\u5e38\u4f1a\u5c06\u8fd9\u4e9b\u53d8\u5316\u8f6c\u5316\u4e3a\u5356\u70b9\uff08\u201c\u7b26\u5408\u653f\u5e9c\u89c4\u5b9a\u201d\u3001\u201c\u672c\u5730\u652f\u6301\u201d\uff09\uff0c\u4ece\u800c\u5f15\u8d77\u5370\u5c3c\u4e70\u5bb6\u7684\u5171\u9e23\u3002<br><\/li>\n<\/ul>\n\n\n\n<p>\u672c\u8d28\u4e0a\uff0c <strong>\u4e49\u52a1 <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/medical-device-registration-indonesia\/\">\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u533b\u7597\u5668\u68b0<\/a> \u4e0d\u4ec5\u4ec5\u662f\u6587\u4e66\u5de5\u4f5c\u2014\u2014\u5b83\u662f\u5546\u4e1a\u6218\u7565\u7684\u5173\u952e\u90e8\u5206<\/strong>. \u5c3d\u65e9\u5e76\u660e\u667a\u5730\u6ee1\u8db3\u8fd9\u4e9b\u8981\u6c42\u5c06\u4f7f\u60a8\u5728\u8fd9\u4e2a\u5feb\u901f\u589e\u957f\u7684\u533b\u7597\u4fdd\u5065\u5e02\u573a\u4e2d\u83b7\u5f97\u7ade\u4e89\u4f18\u52bf\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4e3a\u4ec0\u4e48\u8981\u4e0e ProductRegistrationIndonesia.com \u5408\u4f5c\uff1f<\/strong><\/h2>\n\n\n\n<p>\u968f\u7740\u536b\u751f\u90e8\u6cd5\u89c4\u7684\u4e0d\u65ad\u6f14\u53d8\u4ee5\u53ca\u5370\u5ea6\u5c3c\u897f\u4e9a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6280\u672f\u6587\u4ef6\u8981\u6c42\u7684\u65e5\u76ca\u590d\u6742\uff0c\u6211\u4eec\u7684\u4e13\u5bb6\u56e2\u961f\u786e\u4fdd\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e13\u5bb6\u6307\u5bfc\uff0c\u7cbe\u51c6\u5206\u7c7b<\/li>\n\n\n\n<li>\u901a\u8fc7\u503c\u5f97\u4fe1\u8d56\u7684 LAR \u6216 PT PMA \u8bbe\u7f6e\u8fdb\u884c\u672c\u5730\u4ee3\u8868<\/li>\n\n\n\n<li>\u65e0\u7f1d\u6ce8\u518c\u6d41\u7a0b<\/li>\n\n\n\n<li>\u6279\u51c6\u540e\u5408\u89c4\u652f\u6301\uff1aTKDN \u62a5\u544a\u3001\u7eed\u8ba2\u63d0\u9192\u548c\u53d8\u66f4\u7ba1\u7406<\/li>\n<\/ul>\n\n\n\n<p>\u8fdb\u5165\u5370\u5c3c\u533b\u7597\u5668\u68b0\u5e02\u573a\u65e0\u7591\u5145\u6ee1\u6311\u6218\uff0c\u4f46\u53ea\u8981\u627e\u5230\u5408\u9002\u7684\u5408\u4f5c\u4f19\u4f34\uff0c\u5c31\u80fd\u7b80\u5316\u6d41\u7a0b\u3002ProductRegistrationIndonesia.com \u7684\u56e2\u961f\u5728\u5e2e\u52a9\u533b\u7597\u5668\u68b0\u54c1\u724c\u5b9e\u73b0\u5408\u89c4\u6027\u7684\u540c\u65f6\uff0c\u6ee1\u8db3\u5176\u4e1a\u52a1\u65f6\u95f4\u8868\u65b9\u9762\u62e5\u6709\u4e30\u5bcc\u7684\u7ecf\u9a8c\u3002\u6211\u4eec\u7ed3\u5408\u5b9e\u5730\u6d1e\u5bdf\u3001\u76d1\u7ba1\u4e13\u4e1a\u77e5\u8bc6\u548c\u6218\u7565\u773c\u5149\uff0c\u786e\u4fdd\u60a8\u7684\u5668\u68b0\u4e0d\u4ec5\u7b26\u5408\u6240\u6709\u6cd5\u5f8b\u8981\u6c42\uff0c\u8fd8\u80fd\u83b7\u5f97\u5546\u4e1a\u6210\u529f\u3002<\/p>\n\n\n\n<p>\u8ba9\u6211\u4eec\u5e2e\u60a8\u5904\u7406\u7e41\u91cd\u7684\u76d1\u7ba1\u4e8b\u52a1\uff0c\u8ba9\u60a8\u4e13\u6ce8\u4e8e\u81ea\u5df1\u7684\u5f3a\u9879\u2014\u2014\u4e3a\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u548c\u60a3\u8005\u63d0\u4f9b\u521b\u65b0\u7684\u533b\u7597\u89e3\u51b3\u65b9\u6848\u3002\u5728\u6211\u4eec\u7684\u652f\u6301\u4e0b\uff0c\u60a8\u5c06\u62e5\u6709\u4ece\u521d\u59cb\u6ce8\u518c\u5230\u6301\u7eed\u5e02\u573a\u589e\u957f\u7684\u6e05\u6670\u8def\u7ebf\u56fe\uff0c\u5c06\u5370\u5ea6\u5c3c\u897f\u4e9a\u9519\u7efc\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u8f6c\u5316\u4e3a\u60a8\u4e1a\u52a1\u53d1\u5c55\u7684\u575a\u5b9e\u4e4b\u8def\u3002<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>In Indonesia, the Ministry of Health mandates that all medical devices, including IVDs and household health supplies, must acquire an official registration number known as Nomor Izin Edar (NIE). This requirement is anchored in MoH Regulation No.\u202f62 of 2017, and aligns with the ASEAN Medical Device Directive (AMDD) framework. Before medical devices can be legally [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":2108,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-2104","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-articles"],"acf":[],"_links":{"self":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/2104","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/comments?post=2104"}],"version-history":[{"count":4,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/2104\/revisions"}],"predecessor-version":[{"id":4103,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/2104\/revisions\/4103"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/2108"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=2104"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=2104"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=2104"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=2104"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}