{"id":6185,"date":"2026-05-18T08:44:00","date_gmt":"2026-05-18T01:44:00","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-07-15T21:25:17","modified_gmt":"2026-07-15T14:25:17","slug":"fast-track-medical-device-registration-process-in-indonesia","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/fast-track-medical-device-registration-process-in-indonesia\/","title":{"rendered":"\u901a\u8fc7\u5f53\u5730\u6388\u6743\u4ee3\u8868\u4e86\u89e3\u5370\u5c3c\u533b\u7597\u5668\u68b0\u5feb\u901f\u6ce8\u518c\u6d41\u7a0b"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u5370\u5c3c\u533b\u7597\u4fdd\u5065\u5e02\u573a\u4e0d\u4e4f\u673a\u9047\uff0c\u4f46\u5bf9\u4e8e\u6ca1\u6709\u6218\u7565\u5c31\u8fdb\u5165\u8be5\u5e02\u573a\u7684\u5916\u56fd\u51fa\u53e3\u5546\u6765\u8bf4\uff0c\u65f6\u95f4\u5374\u975e\u5e38\u7d27\u8feb\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u5bf9\u533b\u7597\u6280\u672f\u7684\u9700\u6c42\u6b63\u5728\u6fc0\u589e\u3002\u56fd\u5bb6\u5065\u5eb7\u4fdd\u9669\u8ba1\u5212\uff08JKN\uff09\u76ee\u524d\u8986\u76d6\u4e86\u7ea690%\u7684\u4eba\u53e3\uff0c\u800c\u653f\u5e9c\u7684\u514d\u8d39\u5065\u5eb7\u7b5b\u67e5\u8ba1\u5212\uff08CKG\uff09\u7684\u76ee\u6807\u662f\u4ec5\u57282026\u5e74\u5c31\u8986\u76d61.3\u4ebf\u4eba\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u5916\u56fd\u533b\u7597\u5668\u68b0\u51fa\u53e3\u5546\u800c\u8a00\uff0c\u8fd9\u662f\u4e00\u4e2a\u660e\u786e\u7684\u5e02\u573a\u4fe1\u53f7\u3002\u8bca\u65ad\u8bbe\u5907\u3001\u5b9e\u9a8c\u5ba4\u8bbe\u5907\u3001\u624b\u672f\u5668\u68b0\u548c\u75c5\u4eba\u76d1\u62a4\u7cfb\u7edf\u5728\u653f\u5e9c\u7684\u652f\u6301\u4e0b\uff0c\u9700\u6c42\u65fa\u76db\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7136\u800c\uff0c\u5982\u679c\u76d1\u7ba1\u5ba1\u6279\u51fa\u73b0\u5ef6\u8bef\uff0c\u8fd9\u4e00\u673a\u4f1a\u7a97\u53e3\u5f88\u5feb\u5c31\u4f1a\u5173\u95ed\u3002\u5982\u679c\u6ca1\u6709\u505a\u597d\u5145\u5206\u51c6\u5907\uff0c\u4e2d\u9ad8\u98ce\u9669\u533b\u7597\u5668\u68b0\u7684\u6807\u51c6AKL\u6ce8\u518c\u6d41\u7a0b\u53ef\u80fd\u9700\u89816\u523018\u4e2a\u6708\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e3a\u4e86\u5feb\u901f\u63a8\u8fdb\uff0c\u5145\u5206\u5229\u7528\u536b\u751f\u90e8 (MoH) \u7684\u533b\u7597\u5668\u68b0\u5feb\u901f\u6ce8\u518c\u6d41\u7a0b\u81f3\u5173\u91cd\u8981\u3002\u5982\u679c\u60a8\u4ece\u4e00\u5f00\u59cb\u5c31\u80fd\u627e\u5230\u5408\u9002\u7684\u672c\u5730\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\uff0c\u8fd9\u6761\u7ed3\u6784\u5316\u7684\u5feb\u6377\u9014\u5f84\u53ef\u4ee5\u4e3a\u60a8\u8282\u7701\u6570\u6708\u7684\u65f6\u95f4\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u6307\u5357\u8be6\u7ec6\u4ecb\u7ecd\u4e86\u54ea\u4e9b\u4eba\u7b26\u5408\u8d44\u683c\u3001\u54ea\u4e9b\u8bbe\u5907\u7c7b\u522b\u4f18\u5148\u8003\u8651\uff0c\u4ee5\u53ca\u8bb8\u53ef\u8bc1\u6301\u6709\u8005\u8ba1\u5212\u5728\u5b9e\u8df5\u4e2d\u5982\u4f55\u8fd0\u4f5c\u4ee5\u52a0\u901f\u60a8\u8fdb\u5165\u5e02\u573a\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u5feb\u901f\u901a\u9053\u662f\u4ec0\u4e48\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5feb\u901f\u901a\u9053\u662f\u5370\u5ea6\u5c3c\u897f\u4e9a\u536b\u751f\u90e8\u6839\u636e Regalkes \u7cfb\u7edf\u63d0\u4f9b\u7684\u533b\u7597\u5668\u68b0\u5feb\u901f\u5ba1\u6279\u673a\u5236\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u6761\u9014\u5f84\u5e76\u975e\u4eba\u4eba\u9002\u7528\u3002\u5b83\u9700\u5728\u7279\u5b9a\u7684\u76d1\u7ba1\u6761\u4ef6\u4e0b\u624d\u80fd\u83b7\u5f97\u6279\u51c6\uff0c\u8fd9\u4e9b\u6761\u4ef6\u65e8\u5728\u6ee1\u8db3\u7d27\u8feb\u7684\u516c\u5171\u536b\u751f\u9700\u6c42\u3001\u56fd\u5bb6\u536b\u751f\u8ba1\u5212\u7684\u4f18\u5148\u4e8b\u9879\u4ee5\u53ca\u653f\u5e9c\u91c7\u8d2d\u76ee\u6807\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e Peraturan Menteri Kesehatan No. 62 Tahun 2017 (<a href=\"https:\/\/farmalkes.kemkes.go.id\/unduh\/permenkes-62-2017\/\" target=\"_blank\" rel=\"noopener\">2017\u5e74\u536b\u751f\u90e8\u957f\u7b2c62\u53f7\u6761\u4f8b<\/a>\uff09\uff0c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7684\u6cd5\u5f8b\u57fa\u7840\u7531\u6b64\u786e\u7acb\u3002\u5728\u6b64\u6846\u67b6\u4e0b\uff0c\u536b\u751f\u90e8\u6709\u6743\u52a0\u5feb\u5bf9\u88ab\u8ba4\u4e3a\u81f3\u5173\u91cd\u8981\u6216\u5177\u6709\u6218\u7565\u610f\u4e49\u7684\u5668\u68b0\u7684\u5ba1\u67e5\u65f6\u9650\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u968f\u540e\u536b\u751f\u90e8\u53d1\u5e03\u7684\u901a\u544a\u548c\u6280\u672f\u6307\u5357\u8fdb\u4e00\u6b65\u660e\u786e\u4e86\u54ea\u4e9b\u7c7b\u522b\u548c\u6761\u4ef6\u7b26\u5408\u6761\u4ef6\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5feb\u901f\u901a\u9053\u63d0\u4ea4\u7684\u7533\u8bf7\u65e0\u9700\u7ecf\u8fc7\u6807\u51c6\u7684\u6863\u6848\u961f\u5217\uff0c\u800c\u662f\u4f1a\u4f18\u5148\u5206\u914d\u5ba1\u7a3f\u4eba\u5e76\u7f29\u77ed\u6f84\u6e05\u65f6\u95f4\uff0c\u524d\u63d0\u662f\u6240\u6709\u6587\u4ef6\u5b8c\u6574\u3001\u683c\u5f0f\u6b63\u786e\uff0c\u5e76\u6309\u65f6\u63d0\u4ea4\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/license-holder-service-in-indonesia\/\">\u8ba4\u53ef\u7684\u672c\u5730\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u536b\u751f\u90e8\u7684\u7279\u6b8a\u51c6\u5165\u8981\u6c42<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u536b\u751f\u90e8\u4e0d\u4f1a\u81ea\u52a8\u6388\u4e88\u5feb\u901f\u901a\u9053\u8d44\u683c\u3002\u7533\u8bf7\u5fc5\u987b\u6ee1\u8db3\u82e5\u5e72\u6761\u4ef6\u624d\u80fd\u83b7\u5f97\u6279\u51c6\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u4e9b\u8981\u6c42\u65e2\u9002\u7528\u4e8e\u6b63\u5728\u6ce8\u518c\u7684\u4ea7\u54c1\uff0c\u4e5f\u9002\u7528\u4e8e\u6301\u6709\u8bb8\u53ef\u8bc1\u7684\u5f53\u5730\u5b9e\u4f53\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. \u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u5fc5\u987b\u5b8c\u5168\u9075\u5b88\u89c4\u5b9a<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u81ea2024\u5e747\u67081\u65e5\u8d77\uff0c\u536b\u751f\u90e8\u5f3a\u5236\u6267\u884c\u4e00\u9879\u89c4\u5b9a\uff1a\u4efb\u4f55\u63d0\u4ea4\u65b0\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7533\u8bf7\u7684\u516c\u53f8\u5fc5\u987b\u6301\u6709\u6709\u6548\u7684CDAKB\uff08Cara Distribusi Alat Kesehatan yang Baik\uff0c\u826f\u597d\u533b\u7597\u5668\u68b0\u5206\u9500\u6307\u5357\uff09\u8bc1\u4e66\u3002\u65e0\u8bba\u5668\u68b0\u7684\u7d27\u8feb\u6027\u6216\u5e02\u573a\u5730\u4f4d\u5982\u4f55\uff0c\u672a\u6301\u6709\u6709\u6548CDAKB\u8ba4\u8bc1\u7684\u516c\u53f8\u5747\u65e0\u8d44\u683c\u6ce8\u518c\u4ea7\u54c1\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u5916\u56fd\u51fa\u53e3\u5546\u800c\u8a00\uff0c\u8fd9\u610f\u5473\u7740\u4ed6\u4eec\u9009\u62e9\u7684\u5f53\u5730\u5408\u4f5c\u4f19\u4f34\u5fc5\u987b\u5728\u63d0\u4ea4\u7533\u8bf7\u524d\u5df2\u83b7\u5f97\u6b64\u9879\u8ba4\u8bc1\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. \u9996\u6b21\u63d0\u4ea4\u65f6\u9700\u63d0\u4ea4\u5b8c\u6574\u8d44\u6599<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u63d0\u4ea4\u7684\u6750\u6599\u4e0d\u5b8c\u6574\uff0c\u5219\u65e0\u6cd5\u4eab\u53d7\u5feb\u901f\u5ba1\u6838\u670d\u52a1\u3002\u536b\u751f\u90e8\u4e0d\u4f1a\u4e3a\u9700\u8981\u53cd\u590d\u6f84\u6e05\u7684\u6587\u4ef6\u9884\u7559\u52a0\u6025\u5ba1\u6838\u540d\u989d\u3002\u6240\u9700\u6587\u4ef6\u901a\u5e38\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u539f\u5236\u9020\u5546\u51fa\u5177\u7684\u6388\u6743\u4e66\uff08LoA\uff09<\/li>\n\n\n\n<li>\u539f\u4ea7\u56fd\u51fa\u5177\u7684\u81ea\u7531\u9500\u552e\u8bc1\u660e\uff08CFS\uff09<\/li>\n\n\n\n<li>ISO 13485\u8ba4\u8bc1<\/li>\n\n\n\n<li>\u7b26\u5408\u4e1c\u76df\u901a\u7528\u7533\u62a5\u6587\u4ef6\u6a21\u677f\uff08CSDT\uff09\u7684\u6280\u672f\u6587\u4ef6<\/li>\n\n\n\n<li>\u5370\u5ea6\u5c3c\u897f\u4e9a\u8bed\u6807\u7b7e\u548c\u4f7f\u7528\u8bf4\u660e (IFU)<\/li>\n\n\n\n<li>\u9002\u7528\u4e8e\u8be5\u8bbe\u5907\u7c7b\u522b\u7684\u98ce\u9669\u5206\u6790\u6587\u6863<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. \u7ecf\u8ba4\u8bc1\u7684\u8bc1\u660e\u6587\u4ef6<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6240\u6709\u5916\u56fd\u76d1\u7ba1\u6587\u4ef6\uff0c\u5305\u62ecCFS\u3001GMP\u8bc1\u4e66\u548cLoA\uff0c\u90fd\u5fc5\u987b\u7ecf\u8fc7\u516c\u8bc1\uff0c\u5e76\u901a\u8fc7\u5370\u5c3c\u5927\u4f7f\u9986\u8fdb\u884c\u5408\u6cd5\u5316\u8ba4\u8bc1\uff0c\u6216\u52a0\u76d6\u6d77\u7259\u8ba4\u8bc1\uff0c\u624d\u80fd\u88abRegalkes\u95e8\u6237\u7f51\u7ad9\u63a5\u53d7\u3002\u5982\u679c\u542f\u52a8\u8f83\u665a\uff0c\u4ec5\u6b64\u6b65\u9aa4\u5c31\u53ef\u80fd\u9700\u8981\u6570\u6708\u65f6\u95f4\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. \u8bbe\u5907\u5206\u7c7b\u51c6\u786e\u7387<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9519\u8bef\u5206\u7c7b\u662f\u5bfc\u81f4\u4efb\u4f55\u6ce8\u518c\u6d41\u7a0b\uff08\u5305\u62ec\u5feb\u901f\u901a\u9053\u548c\u5176\u4ed6\u6d41\u7a0b\uff09\u5ef6\u8bef\u7684\u6700\u5e38\u89c1\u539f\u56e0\u4e4b\u4e00\u3002\u5370\u5c3c\u91c7\u7528\u57fa\u4e8e\u98ce\u9669\u7684\u5206\u7c7b\u7cfb\u7edf\uff0c\u8be5\u7cfb\u7edf\u4e0e\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4 (AMDD) \u76f8\u4e00\u81f4\uff0c\u5c06\u533b\u7597\u5668\u68b0\u5206\u4e3a A \u7c7b\uff08\u4f4e\u98ce\u9669\uff09\u81f3 D \u7c7b\uff08\u9ad8\u98ce\u9669\uff09\u3002A \u7c7b\u548c B \u7c7b\u5668\u68b0\u7684\u5feb\u901f\u901a\u9053\u533b\u7597\u5668\u68b0\u8bb8\u53ef\u5ba1\u67e5\u66f4\u4e3a\u4fbf\u6377\uff0c\u800c C \u7c7b\u548c D \u7c7b\u5668\u68b0\u7684\u7533\u8bf7\u5219\u9700\u8981\u66f4\u5f3a\u6709\u529b\u7684\u4e34\u5e8a\u548c\u6280\u672f\u8bc1\u636e\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4f18\u5148\u7c7b\u522b\uff1a\u54ea\u4e9b\u533b\u7597\u5668\u68b0\u7b26\u5408\u5feb\u901f\u901a\u9053\u6761\u4ef6\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u536b\u751f\u90e8\u4f18\u5148\u5173\u6ce8\u7b26\u5408\u56fd\u5bb6\u536b\u751f\u8ba1\u5212\u76ee\u6807\u7684\u8bbe\u5907\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u536b\u751f\u90e8\u76ee\u524d\u7684\u4f18\u5148\u4e8b\u9879\u548c\u91c7\u8d2d\u9700\u6c42\uff0c\u4ee5\u4e0b\u7c7b\u522b\u901a\u5e38\u7b26\u5408\u52a0\u5feb\u5ba1\u67e5\u7684\u6761\u4ef6\uff1a<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u8bca\u65ad\u548c\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u8bbe\u5907<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5373\u65f6\u68c0\u6d4b\u8bd5\u5242\u76d2\u3001\u8840\u6db2\u5206\u6790\u4eea\u548c\u75c5\u7406\u8bbe\u5907\u76f4\u63a5\u652f\u6301CKG\u548cJKN\u9879\u76ee\u3002\u8fd9\u4e9b\u4ea7\u54c1\u662f\u653f\u5e9c\u533b\u9662\u548c\u793e\u533a\u536b\u751f\u4e2d\u5fc3\uff08Puskesmas\uff09\u7684\u91cd\u70b9\u9700\u6c42\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u6210\u50cf\u8bbe\u5907<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u653f\u5e9c\u5728\u6269\u5efa\u5fc3\u810f\u75c5\u5b66\u3001\u80bf\u7624\u5b66\u548c\u91cd\u75c7\u76d1\u62a4\u57fa\u7840\u8bbe\u65bd\u65f6\uff0c\u4f18\u5148\u8003\u8651 X \u5c04\u7ebf\u7cfb\u7edf\u3001\u8d85\u58f0\u6ce2\u673a\u5668\u548c CT\/MRI \u76f8\u5173\u8bbe\u5907\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u60a3\u8005\u76d1\u62a4\u7cfb\u7edf<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u968f\u7740\u722a\u54c7\u5c9b\u4ee5\u5916\u5404\u7701\u65b0\u5efa\u7684\u516c\u7acb\u533b\u9662\u6295\u5165\u4f7f\u7528\uff0c\u751f\u547d\u4f53\u5f81\u76d1\u62a4\u4eea\u3001\u5fc3\u7535\u56fe\u8bbe\u5907\u548cICU\u76d1\u62a4\u8bbe\u5907\u7684\u9700\u6c42\u6301\u7eed\u589e\u957f\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u611f\u67d3\u63a7\u5236\u548c\u6d88\u6bd2\u8bbe\u5907<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u9274\u4e8e\u75ab\u60c5\u540e\u536b\u751f\u6539\u9769\u7684\u4f18\u5148\u4e8b\u9879\uff0c\u652f\u6301\u536b\u751f\u3001\u6d88\u6bd2\u548c\u9884\u9632\u611f\u67d3\u7684\u8bbe\u5907\u5728\u536b\u751f\u90e8\u7684\u5ba1\u67e5\u4f18\u5148\u4e8b\u9879\u6e05\u5355\u4e2d\u4ecd\u7136\u5360\u636e\u91cd\u8981\u4f4d\u7f6e\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u5916\u79d1\u548c\u690d\u5165\u5f0f\u5668\u68b0\uff08C\/D\u7c7b\uff09<\/strong>&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u867d\u7136\u8fd9\u4e9b\u9700\u8981\u66f4\u4e25\u683c\u7684\u6587\u4ef6\u8bb0\u5f55\uff0c\u4f46\u5b83\u4eec\u5177\u6709\u6218\u7565\u610f\u4e49\uff0c\u5982\u679c\u63d0\u4ea4\u8bb8\u53ef\u8bc1\u7684\u6301\u6709\u4eba\u5728\u536b\u751f\u90e8\u6709\u826f\u597d\u7684\u8bb0\u5f55\uff0c\u5219\u53ef\u4ee5\u4eab\u53d7\u52a0\u5feb\u5904\u7406\u670d\u52a1\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5ea6\u5c3c\u897f\u4e9a\u533b\u7597\u5668\u68b0\u672c\u5730\u6388\u6743\u4ee3\u8868\u5236\u5ea6<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u662f\u5927\u591a\u6570\u9996\u6b21\u8fdb\u5165\u5370\u5c3c\u5e02\u573a\u7684\u5916\u56fd\u51fa\u53e3\u5546\u5bb9\u6613\u72af\u7684\u9519\u8bef\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u6cd5\u5f8b\u660e\u786e\u89c4\u5b9a\uff1a\u5916\u56fd\u5236\u9020\u5546\u4e0d\u5f97\u4ee5\u81ea\u8eab\u540d\u4e49\u6ce8\u518c\u533b\u7597\u5668\u68b0\u3002\u6ce8\u518c\u5fc5\u987b\u7531\u5370\u5c3c\u6cd5\u4eba\u5b9e\u4f53\u6301\u6709\u3002\u8be5\u5b9e\u4f53\u8d1f\u8d23\u4ea7\u54c1\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u7684\u76d1\u7ba1\u5408\u89c4\u3001\u4e0a\u5e02\u540e\u4e49\u52a1\u4ee5\u53ca\u4e0e\u536b\u751f\u90e8\u7684\u6c9f\u901a\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5386\u53f2\u4e0a\uff0c\u5927\u591a\u6570\u51fa\u53e3\u5546\u901a\u8fc7\u6307\u5b9a\u5176\u5370\u5c3c\u5206\u9500\u5546\u4e3a\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u6765\u89e3\u51b3\u8fd9\u4e2a\u95ee\u9898\u3002\u8fd9\u79cd\u505a\u6cd5\u81f3\u4eca\u4ecd\u7136\u5f88\u5e38\u89c1\uff0c\u4f46\u5b83\u4f1a\u9020\u6210\u4e25\u91cd\u7684\u5546\u4e1a\u98ce\u9669\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u4e0e\u5206\u9500\u5546\u7684\u5173\u7cfb\u6076\u5316\uff0c\u6216\u8005\u5236\u9020\u5546\u60f3\u8981\u62d3\u5c55\u5176\u4ed6\u5206\u9500\u6e20\u9053\uff0c\u5219\u6ce8\u518c\u8bb8\u53ef\u8bc1\u7684\u6240\u6709\u6743\u5f52\u5206\u9500\u5546\u6240\u6709\u3002\u66f4\u6362\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u9700\u8981\u91cd\u65b0\u7533\u8bf7\uff0c\u8fd9\u5c06\u4f7fAKL\u6ce8\u518c\u6d41\u7a0b\u4ece\u5934\u5f00\u59cb\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u5f53\u5730\u6388\u6743\u4ee3\u8868\u5982\u4f55\u8fd0\u4f5c\uff1f<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f5c\u4e3a\u4e00\u5bb6\u72ec\u7acb\u7684\u672c\u5730\u6388\u6743\u4ee3\u8868\u6216\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\uff0c\u6211\u4eec\u662f\u4e00\u5bb6\u672c\u5730\u6ce8\u518c\u516c\u53f8\uff0c\u62e5\u6709 IDAK\uff08<em>\u4f0a\u8f9b\u5206\u9500\u963f\u62c9\u7279\u00b7\u514b\u585e\u54c8\u5766<\/em>\uff09\u548c CDAKB \u8ba4\u8bc1\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b83\u4f5c\u4e3a\u5916\u56fd\u5236\u9020\u5546\u4ea7\u54c1\u7684\u5b98\u65b9\u6ce8\u518c\u5b9e\u4f53\uff0c\u4f46\u4e0d\u53c2\u4e0e\u9500\u552e\u3001\u5206\u9500\u6216\u5546\u4e1a\u8c08\u5224\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u79cd\u5206\u79bb\u662f\u5176\u5173\u952e\u4f18\u52bf\u3002\u5916\u56fd\u5236\u9020\u5546\u53ef\u4ee5\u6307\u5b9a\u591a\u5bb6\u5206\u9500\u5546\uff0c\u81ea\u7531\u8c08\u5224\uff0c\u751a\u81f3\u65e5\u540e\u8fc7\u6e21\u5230\u81ea\u5df1\u7684\u5370\u5c3c\u5b9e\u4f53\uff0c\u6240\u6709\u8fd9\u4e9b\u90fd\u4e0d\u4f1a\u5f71\u54cd\u4ea7\u54c1\u7684\u6ce8\u518c\u72b6\u6001\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6211\u4eec\u7ba1\u7406\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6863\u6848\u51c6\u5907\u548cRegalkes\u63d0\u4ea4<\/li>\n\n\n\n<li>\u653f\u5e9c\u8d39\u7528\uff08PNBP\uff09\u652f\u4ed8\u548c\u8ddf\u8e2a<\/li>\n\n\n\n<li>\u536b\u751f\u90e8\u6f84\u6e05\u56de\u590d\u548c\u5ba1\u7a3f\u4eba\u6c9f\u901a<\/li>\n\n\n\n<li>\u4e0a\u5e02\u540e\u76d1\u6d4b\u62a5\u544a<\/li>\n\n\n\n<li>\u8bb8\u53ef\u8bc1\u7eed\u671f\uff08\u6bcf5\u5e74\u4e00\u6b21\uff09<\/li>\n\n\n\n<li>\u51c6\u5907\u5c31\u7eea\u540e\uff0c\u8bb8\u53ef\u8bc1\u5c06\u8f6c\u8ba9\u7ed9\u5236\u9020\u5546\u81ea\u5df1\u7684\u5b9e\u4f53\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5feb\u901f\u901a\u9053\u5236\u5ea6\u80cc\u540e\u7684\u76d1\u7ba1\u6846\u67b6<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e86\u89e3\u6cd5\u5f8b\u4f9d\u636e\u6709\u52a9\u4e8e\u51fa\u53e3\u5546\u66f4\u6709\u4fe1\u5fc3\u5730\u505a\u597d\u51c6\u5907\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2017 \u5e74\u7b2c 62 \u53f7\u90e8\u957f\u4ee4<\/strong> \u4ecd\u7136\u662f\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7684\u4e3b\u8981\u6cd5\u5f8b\u4f9d\u636e\u3002\u5b83\u89c4\u5b9a\uff0c\u5728\u8fdb\u53e3\u3001\u9500\u552e\u6216\u63a8\u5e7f\u4efb\u4f55\u533b\u7597\u5668\u68b0\u4e4b\u524d\uff0c\u5fc5\u987b\u83b7\u5f97NIE\uff08Nomor Izin Edar\uff09\u6279\u51c6\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2021\u5e74\u7b2c10\u53f7\u603b\u7edf\u4ee4<\/strong> \u8fd9\u4e3a\u5916\u56fd\u6295\u8d44\u8005\u6301\u6709\u4ece\u4e8b\u533b\u7597\u5668\u68b0\u8fdb\u53e3\u548c\u6ce8\u518c\u516c\u53f8\u7684\u591a\u6570\u80a1\u6743\u6216\u5168\u90e8\u80a1\u6743\u6253\u5f00\u4e86\u5927\u95e8\u3002\u8fd9\u4f7f\u5f97PT PMA\uff08\u5916\u8d44\u63a7\u80a1\u672c\u5730\u5b9e\u4f53\uff09\u6210\u4e3a\u4e00\u79cd\u66f4\u53ef\u884c\u7684\u957f\u671f\u5e02\u573a\u8fdb\u5165\u9014\u5f84\uff0c\u800c\u72ec\u7acb\u7684\u672c\u5730\u6388\u6743\u4ee3\u8868\u5219\u5728\u8bbe\u7acb\u9636\u6bb5\u53d1\u6325\u4e86\u6865\u6881\u4f5c\u7528\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AMDD\uff09<\/strong> \u7b26\u5408\u89c4\u5b9a\u610f\u5473\u7740\u62e5\u6709CE\u6807\u5fd7\u6216FDA\u8ba4\u8bc1\u7684\u5236\u9020\u5546\u5df2\u7ecf\u5177\u5907\u4e86\u76f8\u5173\u7684\u6587\u6863\u57fa\u7840\uff0c\u4f46\u4ecd\u9700\u5b8c\u6210\u5370\u5c3c\u7684\u5168\u9762\u6ce8\u518c\u3002\u4ec5\u83b7\u5f97CE\u6216FDA\u8ba4\u8bc1\u5e76\u4e0d\u80fd\u4fdd\u8bc1\u83b7\u5f97\u5e02\u573a\u51c6\u5165\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>CDAKB \u6267\u884c\uff082024 \u5e74\u66f4\u65b0\uff09\uff1a<\/strong> \u81ea2024\u5e74\u4e2d\u671f\u4ee5\u6765\uff0c\u536b\u751f\u90e8\u5bf9\u6240\u6709\u65b0\u6ce8\u518c\u4f01\u4e1a\u5f3a\u5236\u6267\u884c\u4e25\u683c\u7684CDAKB\u9884\u8ba4\u8bc1\u3002\u8fd1\u671f\u52a0\u5f3a\u7684\u76d1\u7ba1\u63aa\u65bd\u675c\u7edd\u4e86\u4f7f\u7528\u672a\u7ecf\u5ba1\u6838\u7684\u672c\u5730\u5206\u9500\u5546\u4f5c\u4e3a\u8bb8\u53ef\u8bc1\u6301\u6709\u8005\u7684\u53ef\u80fd\u6027\uff0c\u4ece\u800c\u63d0\u5347\u4e86\u4e13\u4e1a\u8bb8\u53ef\u8bc1\u6301\u6709\u4f01\u4e1a\u7684\u91cd\u8981\u6027\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>AKL\u6ce8\u518c\u65f6\u95f4\u8868\u7684\u5b9e\u9645\u60c5\u51b5<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bb8\u591a\u5916\u56fd\u51fa\u53e3\u5546\u4f4e\u4f30\u4e86\u76d1\u7ba1\u6d41\u7a0b\u542f\u52a8\u7684\u5fc5\u8981\u6027\u3002AKL\u6ce8\u518c\u6d41\u7a0b\u5e76\u975e\u4ece\u5236\u9020\u5546\u51c6\u5907\u9500\u552e\u4ea7\u54c1\u4e4b\u65f6\u5f00\u59cb\uff0c\u800c\u662f\u4ece\u51b3\u5b9a\u8fdb\u5165\u5370\u5c3c\u5e02\u573a\u4e4b\u65f6\uff0c\u751a\u81f3\u66f4\u65e9\u7684\u65f6\u5019\u5c31\u5f00\u59cb\u4e86\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u539f\u56e0\u5982\u4e0b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5927\u4f7f\u9986\u8ba4\u8bc1\u548c\u6587\u4ef6\u6d77\u7259\u8ba4\u8bc1\u53ef\u80fd\u9700\u89812\u52306\u4e2a\u6708\uff0c\u5177\u4f53\u65f6\u95f4\u53d6\u51b3\u4e8e\u539f\u7c4d\u56fd\u3002<\/li>\n\n\n\n<li>ISO 13485 \u8bc1\u4e66\u9a8c\u8bc1\u9700\u8981\u989d\u5916\u7684\u8ba4\u8bc1\u65f6\u95f4<\/li>\n\n\n\n<li>\u6388\u6743\u4e66\u6709\u6548\u671f\u5fc5\u987b\u6db5\u76d6\u5b8c\u6574\u76845\u5e74\uff0c\u4ee5\u4e0eNIE\u6ce8\u518c\u6709\u6548\u671f\u4fdd\u6301\u4e00\u81f4\u3002<\/li>\n\n\n\n<li>C\u7c7b\u548cD\u7c7b\u5668\u68b0\u53ef\u80fd\u9700\u8981\u5f53\u5730\u4e34\u5e8a\u8bc1\u636e\u6216\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\uff0c\u8fd9\u5c06\u589e\u52a03\u81f36\u4e2a\u6708\u7684\u5ba1\u6279\u65f6\u95f4\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u76ee\u6807\u91c7\u8d2d\u653f\u5e9c\u6216LKPP\u7535\u5b50\u76ee\u5f55\u7684\u51fa\u53e3\u5546\u800c\u8a00\uff0c\u6ce8\u518cNIE\u662f\u5148\u51b3\u6761\u4ef6\uff0c\u6ca1\u6709\u6377\u5f84\u53ef\u8d70\u3002\u552f\u4e00\u771f\u6b63\u6709\u6548\u7684\u52a0\u901f\u65b9\u6cd5\u662f\u5c3d\u65e9\u542f\u52a8\uff0c\u5e76\u786e\u4fdd\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u51c6\u5907\u5c31\u7eea\u3001\u8d44\u8d28\u9f50\u5168\u4e14\u7ecf\u9a8c\u4e30\u5bcc\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-product-registration-indonesia wp-block-embed-product-registration-indonesia\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"wZbjztJhXa\"><a href=\"https:\/\/productregistrationindonesia.com\/zh\/the-process-of-registering-medical-devices-in-indonesia\/\">\u5370\u5ea6\u5c3c\u897f\u4e9a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6d41\u7a0b<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6d41\u7a0b\u201d\u2014\u2014\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\" src=\"https:\/\/productregistrationindonesia.com\/the-process-of-registering-medical-devices-in-indonesia\/embed\/#?secret=P4BhycHHv9#?secret=wZbjztJhXa\" data-secret=\"wZbjztJhXa\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\u5982\u4f55\u652f\u6301\u5feb\u901f\u901a\u9053\u63d0\u4ea4\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Product Registration Indonesia 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class=\"wp-block-paragraph\">\u5370\u5c3c\u7684\u533b\u7597\u4fdd\u5065\u5e02\u573a\u662f\u4e9a\u6d32\u6700\u5177\u6d3b\u529b\u7684\u5e02\u573a\u4e4b\u4e00\u3002\u653f\u5e9c\u5bf9\u516c\u5171\u536b\u751f\u57fa\u7840\u8bbe\u65bd\u7684\u6295\u8d44\u3001\u5168\u6c11\u533b\u4fdd\u8986\u76d6\u4ee5\u53ca\u8be5\u56fd\u4e0d\u65ad\u6269\u5927\u7684\u533b\u9662\u548c\u8bca\u65ad\u4e2d\u5fc3\u7f51\u7edc\uff0c\u4f7f\u5f97\u8fd9\u4e2a\u5e02\u573a\u6210\u4e3a\u5177\u6709\u524d\u77bb\u6027\u7684\u5236\u9020\u5546\u4e0d\u5bb9\u9519\u8fc7\u7684\u5e02\u573a\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f46\u662f <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/medical-device-registration-indonesia\/\">\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6d41\u7a0b<\/a> \u5bf9\u4e8e\u542f\u52a8\u665a\u3001\u8d44\u6599\u4e0d\u5168\u6216\u9009\u62e9\u9519\u8bef\u7684\u5f53\u5730\u5408\u4f5c\u4f19\u4f34\uff0c\u6211\u4eec\u7edd\u4e0d\u5bbd\u5bb9\u3002\u6211\u4eec\u63d0\u4f9b\u5feb\u901f\u901a\u9053\u3002\u8bb8\u53ef\u8bc1\u6301\u6709\u8005\u6a21\u5f0f\u884c\u4e4b\u6709\u6548\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u95ee\u9898\u662f\u51fa\u53e3\u5546\u662f\u5426\u80fd\u6b63\u786e\u5229\u7528\u8fd9\u4e9b\u4fe1\u606f\uff0c\u8fd8\u662f\u8981\u82b1\u8d39 12 \u5230 18 \u4e2a\u6708\u7684\u65f6\u95f4\u6765\u5f04\u6e05\u695a\u4ed6\u4eec\u5f53\u521d\u5e94\u8be5\u91c7\u53d6\u54ea\u4e9b\u4e0d\u540c\u7684\u505a\u6cd5\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u5e0c\u671b\u5145\u6ee1\u4fe1\u5fc3\u3001\u6e05\u6670\u660e\u4e86\u3001\u5feb\u901f\u63a8\u8fdb\u4e1a\u52a1\u7684\u5916\u56fd\u51fa\u53e3\u5546\uff0c\u6211\u4eec\u5df2\u505a\u597d\u51c6\u5907\uff0c\u4ece\u4e00\u5f00\u59cb\u5c31\u4e3a\u4ed6\u4eec\u7684\u8bbe\u5907\u7ec4\u5408\u89c4\u5212\u6b63\u786e\u7684\u53d1\u5c55\u8def\u5f84\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>There is no shortage of opportunity in Indonesia\u2019s healthcare market, but there is a very real shortage of time for foreign exporters entering without a strategy.&nbsp; Indonesia\u2019s demand for medical technology is surging. The national health insurance program (JKN) now covers approximately 90% of the population, and the government\u2019s Cek Kesehatan Gratis (CKG) health screening [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":6186,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-6185","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-articles"],"acf":[],"_links":{"self":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/6185","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\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/comments?post=6185"}],"version-history":[{"count":4,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/6185\/revisions"}],"predecessor-version":[{"id":6485,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/6185\/revisions\/6485"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/6186"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=6185"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=6185"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=6185"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=6185"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}