{"id":7762,"date":"2026-09-22T11:12:47","date_gmt":"2026-09-22T04:12:47","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=7762"},"modified":"2026-09-22T11:13:10","modified_gmt":"2026-09-22T04:13:10","slug":"orthopaedic-implant-registration","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/orthopaedic-implant-registration\/","title":{"rendered":"\u5370\u5ea6\u5c3c\u897f\u4e9a\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\uff1aC\u7c7b\u548cD\u7c7b\u9014\u5f84"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u9acb\u5173\u8282\u5047\u4f53\u548c\u810a\u67f1\u56fa\u5b9a\u7cfb\u7edf\u53ef\u80fd\u653e\u5728\u540c\u4e00\u4e2a\u5de5\u4f5c\u53f0\u4e0a\uff0c\u4f46\u6700\u7ec8\u9001\u5230Kemenkes\uff08\u82f1\u56fd\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u673a\u6784\uff09\u540e\uff0c\u5374\u53ef\u80fd\u88ab\u5f52\u5165\u5b8c\u5168\u4e0d\u540c\u7684\u76d1\u7ba1\u7c7b\u522b\u3002\u800c\u8fd9\u6b63\u662f\u5927\u591a\u6570\u7533\u8bf7\u8005\u6ca1\u6709\u9884\u6599\u5230\u7684\u3002\u5236\u9020\u5546\u901a\u5e38\u4f1a\u6839\u636eC\u7c7b\u533b\u7597\u5668\u68b0\u7684\u7533\u8bf7\u6765\u5236\u5b9a\u65f6\u95f4\u8868\u548c\u5b9a\u4ef7\u7b56\u7565\uff0c\u4e00\u5207\u770b\u8d77\u6765\u90fd\u5f88\u987a\u5229\uff0c\u76f4\u5230\u6280\u672f\u6587\u4ef6\u9001\u5230\u8bc4\u4f30\u5458\u624b\u4e2d\uff0c\u5668\u68b0\u88ab\u91cd\u65b0\u5f52\u7c7b\u4e3aD\u7c7b\u3002\u5ba1\u67e5\u5468\u671f\u91cd\u65b0\u5f00\u59cb\uff0c\u653f\u5e9c\u6536\u8d39\u6807\u51c6\u4e5f\u968f\u4e4b\u63d0\u9ad8\uff0c\u8bc4\u4f30\u5458\u5f00\u59cb\u8981\u6c42\u63d0\u4f9b\u4e00\u4e9b\u4e8b\u5148\u6ca1\u6709\u51c6\u5907\u7684\u4e34\u5e8a\u8bc1\u636e\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u79cd\u60c5\u51b5\u6bd4\u6cd5\u89c4\u672c\u8eab\u6240\u6697\u793a\u7684\u66f4\u4e3a\u5e38\u89c1\uff0c\u56e0\u4e3a\u57282017\u5e74\u7b2c62\u53f7\u5370\u5c3c\u536b\u751f\u6761\u4f8b\uff08Permenkes No. 62 Tahun 2017\uff09\u4e2d\uff0c\u5e76\u6ca1\u6709\u5c06\u8fd9\u79cd\u91cd\u65b0\u5206\u7c7b\u4f5c\u4e3a\u4e00\u9879\u89c4\u5219\u660e\u786e\u89c4\u5b9a\u3002\u5b83\u53ea\u4f53\u73b0\u5728\u8bc4\u4f30\u4eba\u5458\u5bf9\u5668\u68b0\u9884\u671f\u7528\u9014\u7684\u89e3\u8bfb\u4e0a\uff0c\u800c\u8fd9\u6070\u6070\u662f\u90a3\u4e9b\u5728\u7533\u62a5\u8fc7\u7a0b\u4e2d\u5bb9\u6613\u8ba9\u56e2\u961f\u63aa\u624b\u4e0d\u53ca\u7684\u7ec6\u8282\u3002\u5982\u679c\u60a8\u662f\u76d1\u7ba1\u4e8b\u52a1\u56e2\u961f\u7684\u6210\u5458\uff0c\u8d1f\u8d23\u9aa8\u79d1\u54c1\u724c\u7684\u7ecf\u9500\uff0c\u6216\u8005\u751f\u4ea7\u690d\u5165\u7269\u5e76\u5c06\u5370\u5c3c\u89c6\u4e3a\u4e0b\u4e00\u4e2a\u5e02\u573a\uff0c\u90a3\u4e48\u5728\u5236\u5b9a\u65f6\u95f4\u8868\u4e4b\u524d\uff0c\u800c\u4e0d\u662f\u4e4b\u540e\uff0c\u4e86\u89e3\u8fd9\u4e00\u5224\u65ad\u81f3\u5173\u91cd\u8981\u3002\u4ee5\u4e0b\u5185\u5bb9\u5c06\u8be6\u7ec6\u4ecb\u7ecd\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u5982\u4f55\u533a\u5206C\u7c7b\u533b\u7597\u5668\u68b0\u548cD\u7c7b\u533b\u7597\u5668\u68b0\uff0c\u690d\u5165\u7269\u4f55\u65f6\u4f1a\u4eceC\u7c7b\u53d8\u4e3aD\u7c7b\uff0cRegalkes\u7533\u62a5\u6d41\u7a0b\u672c\u8eab\u662f\u5982\u4f55\u8fdb\u884c\u7684\uff0c\u4ee5\u53ca\u5728\u63d0\u4ea4\u7533\u62a5\u4e4b\u524d\uff0c\u60a8\u5e94\u8be5\u56f4\u7ed5\u54ea\u4e9b\u65f6\u95f4\u5b89\u6392\u3001\u6210\u672c\u548c\u5e02\u573a\u673a\u4f1a\u8fdb\u884c\u89c4\u5212\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4e3a\u4ec0\u4e48\u5927\u591a\u6570\u9aa8\u79d1\u690d\u5165\u7269\u5728\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u4e2d\u88ab\u5f52\u7c7b\u4e3aC\u7c7b\u533b\u7597\u5668\u68b0<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"667\" src=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Orthopaedic-Implant-Registration-in-Indonesia-2.webp\" alt=\"\u5370\u5ea6\u5c3c\u897f\u4e9a\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\" class=\"wp-image-7764\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Orthopaedic-Implant-Registration-in-Indonesia-2.webp 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Orthopaedic-Implant-Registration-in-Indonesia-2-300x200.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Orthopaedic-Implant-Registration-in-Indonesia-2-768x512.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112243\/permenkes-no-62-tahun-2017\" target=\"_blank\" rel=\"noopener\">2017\u5e74\u7b2c62\u53f7\u6cd5\u4ee4<\/a> tentang Izin Edar Alat Kesehatan\u3001Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga\uff0c\u7531 <a href=\"https:\/\/kemkes.go.id\/eng\/home\" target=\"_blank\" rel=\"noopener\">\u536b\u751f\u90e8\uff08Kemenkes\uff09<\/a>, \u5236\u5b9a\u4e86\u5370\u5c3c\u6240\u6709\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4e2d\u4f7f\u7528\u7684\u56db\u7ea7\u98ce\u9669\u5206\u7c7b\uff1aA \u7c7b\uff08\u4f4e\u98ce\u9669\uff09\u3001B \u7c7b\uff08\u4f4e\u81f3\u4e2d\u7b49\u98ce\u9669\uff09\u3001C \u7c7b\uff08\u4e2d\u7b49\u81f3\u9ad8\u98ce\u9669\uff09\u548c D \u7c7b\uff08\u9ad8\u98ce\u9669\uff09\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9aa8\u79d1\u690d\u5165\u7269\uff0c\u4f8b\u5982\u94a2\u677f\u3001\u87ba\u9489\u3001\u9ad3\u5185\u9489\u548c\u5355\u5173\u8282\u5047\u4f53\uff0c\u5c5e\u4e8e\u4fb5\u5165\u6027\u3001\u957f\u671f\u63a5\u89e6\u5f0f\u5668\u68b0\u3002\u6839\u636e2017\u5e74\u7b2c62\u53f7\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Permenkes No. 62 Tahun 2017\uff09\u7684\u5206\u7c7b\u9644\u4ef6\uff0c\u6b64\u7c7b\u690d\u5165\u7269\u901a\u5e38\u88ab\u5f52\u5165\u5370\u5c3c\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\u7684C\u7c7b\u533b\u7597\u5668\u68b0\u7c7b\u522b\u3002C\u7c7b\u533b\u7597\u5668\u68b0\u5c5e\u4e8e\u4e2d\u7b49\u7ea7\u522b\uff0c\u9700\u8981\u8fdb\u884c\u5168\u9762\u7684\u6280\u672f\u8bc4\u4f30\uff0c\u4f46\u5176\u516c\u5f00\u5ba1\u67e5\u76ee\u6807\u6bd4D\u7c7b\u533b\u7597\u5668\u68b0\u7684\u5ba1\u67e5\u76ee\u6807\u66f4\u77ed\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5f53\u9aa8\u79d1\u690d\u5165\u7269\u5728\u5370\u5c3c\u88ab\u8ba4\u5b9a\u4e3aD\u7c7b\u533b\u7597\u5668\u68b0\u65f6<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u591a\u7528\u9014\u9aa8\u79d1\u690d\u5165\u7269\uff0c\u5373\u83b7\u51c6\u7528\u4e8e\u591a\u4e2a\u5173\u8282\u3001\u591a\u79cd\u624b\u672f\u65b9\u5f0f\u6216\u4e0e\u5176\u4ed6\u690d\u5165\u7cfb\u7edf\u8054\u5408\u4f7f\u7528\u7684\u5668\u68b0\uff0c\u662f\u6211\u4eec\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\u8fc7\u7a0b\u4e2d\u6700\u5e38\u88ab\u91cd\u65b0\u5f52\u7c7b\u4e3aD\u7c7b\u7684\u5668\u68b0\u7c7b\u522b\u3002\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u8fd9\u79cd\u60c5\u51b5\u7684\u53d1\u751f\u662f\u56e0\u4e3a\u66f4\u5e7f\u6cdb\u7684\u9884\u671f\u7528\u9014\u58f0\u660e\u4f1a\u63d0\u9ad8\u8bc4\u4f30\u4eba\u5458\u9700\u8981\u8bc4\u4f30\u7684\u98ce\u9669\u7b49\u7ea7\uff0c\u5373\u4f7f\u5668\u68b0\u7684\u7269\u7406\u7ed3\u6784\u548c\u6750\u6599\u4e0e\u5df2\u5728\u5176\u4ed6\u5730\u65b9\u5907\u6848\u7684\u5370\u5c3cC\u7c7b\u533b\u7597\u5668\u68b0\u76f8\u540c\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2017\u5e74\u7b2c62\u53f7\u536b\u751f\u90e8\u6cd5\u4ee4\u7b2c7\u6761\u5c06D\u7c7b\u533b\u7597\u5668\u68b0\u5b9a\u4e49\u4e3a\u5bf9\u60a3\u8005\u6784\u6210\u9ad8\u98ce\u9669\u7684\u5668\u68b0\uff0c\u4f46\u536b\u751f\u90e8\u7684\u5206\u7c7b\u6307\u5357\u5e76\u672a\u91c7\u7528\u56fa\u5b9a\u516c\u5f0f\uff0c\u800c\u662f\u5c06\u4e34\u754c\u3001\u7ec4\u5408\u548c\u591a\u9002\u5e94\u75c7\u690d\u5165\u7269\u7684\u6cbb\u7597\u4ea4\u7531\u8bc4\u4f30\u4eba\u5458\u81ea\u884c\u5224\u65ad\u3002\u6b63\u662f\u8fd9\u79cd\u5224\u65ad\u4e0a\u7684\u5dee\u5f02\uff0c\u4f7f\u5f97\u690d\u5165\u7269\u5236\u9020\u5546\u7684\u5206\u7c7b\u5047\u8bbe\u4e0e\u536b\u751f\u90e8\u7684\u5b9e\u9645\u5224\u5b9a\u53ef\u80fd\u51fa\u73b0\u5206\u6b67\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u9aa8\u79d1\u690d\u5165\u7269\u88ab\u5f52\u7c7b\u4e3a C \u7c7b\u8fd8\u662f D \u7c7b\uff0c\u53d6\u51b3\u4e8e\u4ec0\u4e48\u56e0\u7d20\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u9aa8\u79d1\u690d\u5165\u7269\u7684\u5206\u7c7b\u53d6\u51b3\u4e8e\u5176\u9884\u671f\u7528\u9014\u3001\u4fb5\u5165\u6027\u548c\u4e0e\u8eab\u4f53\u63a5\u89e6\u7684\u6301\u7eed\u65f6\u95f4\uff0c\u7531\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u6839\u636e\u56db\u7ea7\u7cfb\u7edf\u8fdb\u884c\u8bc4\u4f30\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112243\/permenkes-no-62-tahun-2017\" target=\"_blank\" rel=\"noopener\">2017\u5e74\u7b2c62\u53f7\u6cd5\u4ee4<\/a>. \u5355\u4e00\u9002\u5e94\u75c7\u3001\u5355\u5173\u8282\u690d\u5165\u7269\u901a\u5e38\u6ce8\u518c\u4e3a C \u7c7b\u3002\u7528\u4e8e\u591a\u4e2a\u5173\u8282\u3001\u591a\u79cd\u624b\u672f\u6280\u672f\u6216\u4e0e\u5176\u4ed6\u690d\u5165\u7cfb\u7edf\u8054\u5408\u4f7f\u7528\u7684\u690d\u5165\u7269\u901a\u5e38\u88ab\u5f52\u7c7b\u4e3a D \u7c7b\uff0c\u8fd9\u4f1a\u589e\u52a0\u5ba1\u67e5\u65f6\u95f4\u3001\u989d\u5916\u7684\u4e34\u5e8a\u8bc1\u636e\u548c\u66f4\u9ad8\u7684 PNBP \u8d39\u7528\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kemenkes \u7684\u5206\u7c7b\u6307\u5357\u5217\u51fa\u4e86\u8bc4\u4f30\u4eba\u5458\u5bf9\u6bcf\u79cd\u5668\u68b0\uff08\u4e0d\u4ec5\u9650\u4e8e\u690d\u5165\u7269\uff09\u8fdb\u884c\u8bc4\u4f30\u7684\u5177\u4f53\u56e0\u7d20\uff1a\u4e0e\u8eab\u4f53\u63a5\u89e6\u7684\u6301\u7eed\u65f6\u95f4\u3001\u4fb5\u5165\u7a0b\u5ea6\u548c\u9014\u5f84\u3001\u5668\u68b0\u662f\u5426\u4e0e\u5176\u4ed6\u533b\u7597\u5668\u68b0\u8054\u5408\u4f7f\u7528\u3001\u9884\u671f\u7528\u9014\u3001\u4f5c\u7528\u662f\u5c40\u90e8\u8fd8\u662f\u5168\u8eab\u6027\u7684\u3001\u5728\u4f53\u5185\u7684\u4f5c\u7528\u673a\u5236\uff0c\u4ee5\u53ca\uff08\u5982\u9002\u7528\uff09\u5176\u751f\u7269\u5b66\u6548\u5e94\u3002\u5bf9\u4e8e\u9aa8\u79d1\u690d\u5165\u7269\u800c\u8a00\uff0c\u8054\u5408\u4f7f\u7528\u548c\u591a\u9002\u5e94\u75c7\u56e0\u7d20\u901a\u5e38\u662f\u5bfc\u81f4\u5176\u4ece C \u7c7b\u964d\u81f3 D \u7c7b\u7684\u539f\u56e0\u3002\u5236\u9020\u5546\u5e94\u5728\u63d0\u4ea4\u7533\u8bf7\u524d\u901a\u8fc7 Regalkes \u7cfb\u7edf\u8fdb\u884c\u81ea\u6211\u8bc4\u4f30\u4ee5\u786e\u8ba4\u5176\u5206\u7c7b\uff0c\u56e0\u4e3a\u9519\u8bef\u7684\u81ea\u6211\u7533\u62a5\u5206\u7c7b\u662f\u5bfc\u81f4\u884c\u653f\u9a73\u56de\u7684\u5e38\u89c1\u539f\u56e0\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>C\u7c7b\u4e0eD\u7c7b\u9aa8\u79d1\u690d\u5165\u7269\u767b\u8bb0\u6982\u89c8<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e0b\u8868\u603b\u7ed3\u4e86 C \u7c7b\u548c D \u7c7b\u9aa8\u79d1\u690d\u5165\u7269\u6587\u4ef6\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8fc7\u7a0b\u4e2d\u4f1a\u9047\u5230\u7684\u5b9e\u9645\u5dee\u5f02\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u6807\u51c6<\/strong><\/th><th><strong>C\u7c7b<\/strong><\/th><th><strong>D\u7c7b<\/strong><\/th><\/tr><\/thead><tbody><tr><td>\u98ce\u9669\u7b49\u7ea7\uff08Permenkes No. 62\/2017\uff09<\/td><td>\u4e2d\u5ea6\u81f3\u9ad8\u5ea6\u98ce\u9669<\/td><td>\u9ad8\u98ce\u9669<\/td><\/tr><tr><td>\u5178\u578b\u7684\u9aa8\u79d1\u6848\u4f8b<\/td><td>\u94a2\u677f\u3001\u87ba\u9489\u3001\u9ad3\u5185\u9489\u3001\u5355\u5173\u8282\u5047\u4f53<\/td><td>\u591a\u9002\u5e94\u75c7\u5173\u8282\u7cfb\u7edf\u3001\u591a\u4e34\u5e8a\u810a\u67f1\u690d\u5165\u7269\u3001\u7ec4\u5408\u690d\u5165\u7cfb\u7edf<\/td><\/tr><tr><td>\u8bc4\u6d4b\u76ee\u6807\uff0c\u56fd\u5185\u8bbe\u5907<\/td><td>30\u4e2a\u5de5\u4f5c\u65e5<\/td><td>40\u4e2a\u5de5\u4f5c\u65e5<\/td><\/tr><tr><td>\u5ba1\u67e5\u76ee\u6807\uff0c\u8fdb\u53e3\u8bbe\u5907<\/td><td>40\u4e2a\u5de5\u4f5c\u65e5<\/td><td>55\u4e2a\u5de5\u4f5c\u65e5<\/td><\/tr><tr><td>\u4e34\u5e8a\u8bc1\u636e\u6807\u51c6<\/td><td>\u6587\u732e\u8bc4\u4ef7\u901a\u5e38\u88ab\u63a5\u53d7<\/td><td>\u6839\u636e2017\u5e74\u7b2c63\u53f7\u8054\u90a6\u6761\u4f8b\u8fdb\u884c\u5168\u9762\u8bc4\u4f30\uff0c\u901a\u5e38\u91c7\u7528\u5730\u65b9\u6570\u636e\u3002<\/td><\/tr><tr><td>PNBP\u653f\u5e9c\u8d39\u7528<\/td><td>\u8f83\u4f4e\u5173\u7a0e\u7b49\u7ea7<\/td><td>\u8f83\u9ad8\u5173\u7a0e\u7b49\u7ea7\uff08PP No. 64\/2019\uff09<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u5ba1\u6838\u65e5\u76ee\u6807\u53cd\u6620\u4e86\u6839\u636e2017\u5e74\u7b2c62\u53f7\u653f\u5e9c\u6761\u4f8b\u53d1\u5e03\u7684\u670d\u52a1\u6807\u51c6\uff0c\u5e76\u4ece\u56fa\u5b9a\u6536\u636e\u65e5\u671f\uff08tanda terima tetap\uff09\u5f00\u59cb\u8ba1\u7b97\uff0c\u800c\u975e\u4ece\u9996\u6b21\u4e0a\u4f20\u65e5\u671f\u5f00\u59cb\u8ba1\u7b97\u3002\u5ba1\u6838\u65e5\u76ee\u6807\u4e0d\u5305\u62ec\u56de\u590d\u6280\u672f\u54a8\u8be2\u6240\u82b1\u8d39\u7684\u65f6\u95f4\u3002\u670d\u52a1\u6807\u51c6\u548c\u6536\u8d39\u6807\u51c6\u4f1a\u5b9a\u671f\u901a\u8fc7\u76f8\u5173\u5de5\u5177\u8fdb\u884c\u66f4\u65b0\uff0c\u4f8b\u5982\uff1a <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/335213\/permenkes-no-11-tahun-2025\" target=\"_blank\" rel=\"noopener\">2025\u5e74\u7b2c11\u53f7\u6cd5\u4ee4<\/a>, \u56e0\u6b64\uff0c\u5728\u5236\u5b9a\u9762\u5411\u5ba2\u6237\u7684\u65f6\u95f4\u8868\u4e4b\u524d\uff0c\u8bf7\u786e\u8ba4\u5f53\u524d\u7684 SLA\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5ea6\u5c3c\u897f\u4e9a\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\u7684\u6cd5\u5f8b\u4f9d\u636e<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u6587\u4ef6\u89c4\u8303\u4e86\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\uff0c\u662f\u4e2d\u5c0f\u4f01\u4e1a\u5ba1\u7a3f\u4eba\u5728\u53d1\u8868\u6587\u7ae0\u524d\u5e94\u91cd\u70b9\u53c2\u8003\u7684\u6587\u4ef6\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.kemkes.go.id\/id\/undang-undang-republik-indonesia-nomor-17-tahun-2023-tentang-kesehatan\" target=\"_blank\" rel=\"noopener\"><strong>\u6e29\u5f53-\u6e29\u5f53 No. 17 Tahun 2023<\/strong><\/a> <strong>tentang Kesehatan\uff08\u5370\u5ea6\u5c3c\u897f\u4e9a Pemerintah Republik\uff09\uff1a<\/strong> \u7b2c 143 \u53f7\u6cd5\u4ee4\u8981\u6c42\u4efb\u4f55\u751f\u4ea7\u6216\u5206\u9500\u533b\u7597\u5668\u68b0\u7684\u4eba\u6301\u6709\u4e2d\u592e\u6216\u5730\u65b9\u653f\u5e9c\u9881\u53d1\u7684\u76f8\u5173 izin edar\uff0c\u8fd9\u662f\u672c\u6587\u6240\u8ff0\u7684 izin edar \u8981\u6c42\u7684\u603b\u4f53\u6cd5\u5f8b\u4f9d\u636e\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112243\/permenkes-no-62-tahun-2017\" target=\"_blank\" rel=\"noopener\"><strong>2017\u5e74\u7b2c62\u53f7\u6cd5\u4ee4<\/strong><\/a> <strong>\uff08\u536b\u751f\u90e8\uff09\uff1a<\/strong> Izin Edar Alat Kesehatan\u3001Alat Kesehatan \u4f53\u5916\u8bca\u65ad\u548c Perbekalan Kesehatan Rumah Tangga\uff1b\u57fa\u672c\u5206\u7c7b\u548c\u8bb8\u53ef\u89c4\u5b9a\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/112244\/permenkes-no-63-tahun-2017\" target=\"_blank\" rel=\"noopener\"><strong>2017\u5e74\u7b2c63\u53f7\u6cd5\u4ee4<\/strong><\/a> <strong>\uff08\u536b\u751f\u90e8\uff09\uff1a<\/strong> Cara Uji Klinik Alat Kesehatan yang Baik\uff1b\u7ba1\u7406\u5e94\u7528\u4e8e\u79cd\u690d\u4f53\u7684\u4e34\u5e8a\u8bc1\u636e\u548c\u826f\u597d\u4e34\u5e8a\u5b9e\u8df5\u6807\u51c6\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/335213\/permenkes-no-11-tahun-2025\" target=\"_blank\" rel=\"noopener\"><strong>2025\u5e74\u7b2c11\u53f7\u6cd5\u4ee4<\/strong><\/a> <strong>\uff08Kementerian Kesehatan\uff09\uff0c2025 \u5e74 10 \u6708 3 \u65e5\u751f\u6548\uff1a<\/strong> \u6807\u51c6\u4ea7\u54c1\u548c\u6807\u51c6\u4ea7\u54c1\/Jasa pada Penyelenggaraan Perizinan Berusaha Berbasis Risiko Subsektor Kesehatan\uff1b\u5f53\u524d\u57fa\u4e8e\u98ce\u9669\u7684\u8bb8\u53ef\u6807\u51c6\u6db5\u76d6\u901a\u8fc7 Regalkes \u5904\u7406\u7684 Izin Edar \u7a0b\u5e8f\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/peraturan.bpk.go.id\/Details\/120630\/pp-no-64-tahun-2019\" target=\"_blank\" rel=\"noopener\"><strong>PP No. 64 Tahun 2019<\/strong><\/a> <strong>\uff08\u5370\u5ea6\u5c3c\u897f\u4e9a\u5171\u548c\u56fd\uff09\uff1a<\/strong> Jenis dan Tarif atas Penerimaan Negara Bukan Pajak yang Berlaku pada Kementerian Kesehatan\uff1b\u8bbe\u7f6e\u8bbe\u5907\u7c7b\u522b\u5f15\u7528\u7684 PNBP \u8d39\u7528\u7ed3\u6784\u3002.<\/li>\n\n\n\n<li><a href=\"https:\/\/asean.org\/book\/asean-medical-device-directive\/\" target=\"_blank\" rel=\"noopener\"><strong>\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4<\/strong><\/a> <strong>\uff08AMDD\uff09\uff0c\u9644\u4ef6 4\uff1a<\/strong> \u4e1c\u76df\u5171\u540c\u7533\u62a5\u6587\u4ef6\u6a21\u677f\uff08CSDT\uff09\uff0c\u5373\u5370\u5ea6\u5c3c\u897f\u4e9a\u63d0\u4ea4 Regalkes \u7533\u62a5\u6587\u4ef6\u6240\u9700\u7684\u6587\u4ef6\u683c\u5f0f\u3002.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u96f7\u683c\u5c14\u514b\u65af\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\u63d0\u4ea4\u6d41\u7a0b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Regalkes \u63d0\u4ea4\u6d41\u7a0b\u662f\u5370\u5ea6\u5c3c\u897f\u4e9a\u6240\u6709\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7684\u6570\u5b57\u5316\u652f\u67f1\uff0c\u9aa8\u79d1\u690d\u5165\u7269\u8981\u7ecf\u8fc7\u4e94\u4e2a\u9636\u6bb5\u624d\u80fd\u5b8c\u6210\u6ce8\u518c\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. \u672c\u5730\u5b9e\u4f53\u3001IDAK \u548c CDAKB<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5916\u56fd\u9aa8\u79d1\u5236\u9020\u5546\u4e0d\u80fd\u81ea\u884c\u6301\u6709Izin Edar\u8bc1\u4e66\u3002\u5fc5\u987b\u7531\u6301\u6709\u6709\u6548IDAK\uff08\u533b\u7597\u5668\u68b0\u5206\u9500\u5546\uff09\u548cCDAKB\uff08\u826f\u597d\u533b\u7597\u5668\u68b0\u5206\u9500\u65b9\u5f0f\uff09\u8bc1\u4e66\u7684\u672c\u5730\u7ecf\u9500\u5546\u4f5c\u4e3a\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u3002\u7531\u4e8e\u690d\u5165\u7269\u5c5e\u4e8eC\u7c7b\u6216D\u7c7b\uff0cKemenkes\u4f1a\u5728\u6280\u672f\u6587\u4ef6\u5f00\u542f\u5ba1\u6838\u524d\u6838\u5b9e\u672c\u5730\u5b9e\u4f53\u7684CDAKB\u8d44\u8d28\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. \u4e1c\u76df\u533b\u7597\u5668\u68b0\u5370\u5c3c\u6ce8\u518c\u7ba1\u7406\u59d4\u5458\u4f1a\uff08CSDT\uff09\u533b\u7597\u5668\u68b0\u6587\u4ef6\u51c6\u5907<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u7533\u62a5\u8d44\u6599\u9075\u5faa\u4e1c\u76df\u901a\u7528\u7533\u62a5\u8d44\u6599\u6a21\u677f\uff08ASEAN CSDT\uff09\u5370\u5c3c\u533b\u7597\u5668\u68b0\u683c\u5f0f\uff0c\u5177\u4f53\u5185\u5bb9\u89c1\u300a\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4\u300b\uff08AMDD\uff09\u9644\u4ef64\uff1a\u5305\u62ec\u884c\u653f\u6570\u636e\u3001\u5668\u68b0\u63cf\u8ff0\u548c\u5206\u7c7b\u3001\u6280\u672f\u6587\u6863\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8bc1\u660e\uff08\u4f8b\u5982ISO 13485\u8bc1\u4e66\uff09\u3001\u6027\u80fd\u548c\u5b89\u5168\u6570\u636e\u4ee5\u53ca\u6807\u7b7e\u548c\u4f7f\u7528\u8bf4\u660e\u4e66\u3002\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u690d\u5165\u7269\u7533\u62a5\u8d44\u6599\u7684\u6280\u672f\u6587\u6863\u90e8\u5206\u9700\u8981\u4fee\u6539\u6700\u591a\uff0c\u56e0\u4e3a\u5168\u7403\u7533\u62a5\u8d44\u6599\u5f88\u5c11\u5305\u542b\u5370\u5c3c\u8bed\u6807\u7b7e\u548c\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u8981\u6c42\u7684\u672c\u5730\u98ce\u9669\u7ba1\u7406\u9644\u5f55\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3. \u63d0\u4ea4\u548cPNBP\u4ed8\u6b3e<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b8c\u6574\u7684CSDT\u6587\u4ef6\u901a\u8fc7Regalkes\u63d0\u4ea4\u6d41\u7a0b\u4e0a\u4f20\u81f3regalkes.kemkes.go.id\u3002\u4e00\u65e6\u81ea\u6211\u7533\u62a5\u7684\u7c7b\u522b\u5f97\u5230\u6838\u5b9e\uff0c\u7533\u8bf7\u4eba\u9700\u5728\u7cfb\u7edf\u8bbe\u5b9a\u7684\u4ed8\u6b3e\u671f\u9650\u5185\u7f34\u7eb3PNBP\u8d39\u7528\uff0c\u4e4b\u540e\u7cfb\u7edf\u5c06\u51fa\u5177\u56fa\u5b9a\u6536\u636e\uff0c\u6280\u672f\u8bc4\u4f30\u6d41\u7a0b\u968f\u5373\u5f00\u59cb\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>4. \u6280\u672f\u8bc4\u4f30\u548c\u54a8\u8be2<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5177\u4f53\u5230\u9aa8\u79d1\u690d\u5165\u7269\uff0c\u8bc4\u4f30\u4eba\u5458\u901a\u5e38\u4f1a\u5bf9\u751f\u7269\u76f8\u5bb9\u6027\u6d4b\u8bd5\u8303\u56f4\u3001\u706d\u83cc\u9a8c\u8bc1\u4ee5\u53ca\uff08\u5bf9\u4e8e D \u7c7b\u6587\u4ef6\uff09\u6839\u636e 2017 \u5e74\u7b2c 63 \u53f7 Permenkes \u53f7\u6cd5\u4ee4\u63d0\u4ea4\u7684\u4e34\u5e8a\u8bc1\u636e\u7684\u6df1\u5ea6\u63d0\u51fa\u7591\u95ee\u3002\u6bcf\u6b21\u56de\u590d\u90fd\u4f1a\u91cd\u7f6e\u90e8\u5206\u5ba1\u67e5\u65f6\u95f4\uff0c\u56e0\u6b64\u56de\u590d\u901f\u5ea6\u4e0e\u521d\u59cb\u6863\u6848\u8d28\u91cf\u540c\u6837\u91cd\u8981\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>5. NIE \u7684\u7b7e\u53d1\u548c\u6709\u6548\u671f<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bc4\u4f30\u5b8c\u6210\u540e\uff0c\u82ac\u5170\u56fd\u5bb6\u536b\u751f\u90e8\uff08Kemenkes\uff09\u5c06\u9881\u53d1\u4ea7\u54c1\u8bb8\u53ef\u8bc1\uff08Nomor Izin Edar\uff0c\u7b80\u79f0NIE\uff09\u3002\u8be5\u8bb8\u53ef\u8bc1\u81ea\u9881\u53d1\u4e4b\u65e5\u8d77\u6709\u6548\u671f\u4e3a\u4e94\u5e74\uff0c\u671f\u6ee1\u540e\uff0c\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u5fc5\u987b\u5728\u6709\u6548\u671f\u5c4a\u6ee1\u524d\u7eed\u671f\uff0c\u65b9\u53ef\u7ee7\u7eed\u5728\u5e02\u573a\u4e0a\u9500\u552e\u8be5\u690d\u5165\u7269\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u9aa8\u79d1\u690d\u5165\u7269\u4e34\u5e8a\u6570\u636e\u8981\u6c42<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u5bf9\u9aa8\u79d1\u690d\u5165\u7269\u4e34\u5e8a\u6570\u636e\u7684\u671f\u671b\u56e0\u7c7b\u522b\u800c\u5f02\u3002C\u7c7b\u9aa8\u79d1\u690d\u5165\u7269\u901a\u5e38\u53ef\u4f9d\u636e\u6587\u732e\u652f\u6301\u7684\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\uff0c\u5e76\u8f85\u4ee5\u4f53\u5916\u8bd5\u9a8c\u548c\u751f\u7269\u76f8\u5bb9\u6027\u6d4b\u8bd5\uff0c\u524d\u63d0\u662f\u8be5\u690d\u5165\u7269\u4e0e\u5177\u6709\u826f\u597d\u5b89\u5168\u8bb0\u5f55\u7684\u690d\u5165\u7269\u5b9e\u8d28\u7b49\u6548\u3002D\u7c7b\u690d\u5165\u7269\uff0c\u5c24\u5176\u662f\u591a\u4e34\u5e8a\u7cfb\u7edf\uff0c\u5219\u9700\u6839\u636e2017\u5e74\u7b2c63\u53f7\u5370\u5c3c\u536b\u751f\u90e8\uff08Permenkes No. 63 Tahun 2017\uff09\u7684\u826f\u597d\u4e34\u5e8a\u5b9e\u8df5\u6807\u51c6\u8fdb\u884c\u8bc4\u4f30\uff0c\u8bc4\u4f30\u4eba\u5458\u901a\u5e38\u66f4\u503e\u5411\u4e8e\u63d0\u4f9b\u53cd\u6620\u5370\u5c3c\u60a3\u8005\u5b9e\u9645\u4f7f\u7528\u60c5\u51b5\u7684\u4e34\u5e8a\u6570\u636e\uff0c\u800c\u975e\u4ec5\u6765\u81ea\u5176\u4ed6\u5e02\u573a\u7684\u6570\u636e\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5236\u9020\u5546\u5728\u63d0\u4ea4\u4e4b\u524d\u51c6\u5907\u4e00\u4efd\u9488\u5bf9\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\u9644\u5f55\uff0c\u800c\u4e0d\u662f\u7b49\u5230\u88ab\u95ee\u8be2\u65f6\u624d\u8981\u6c42\u63d0\u4f9b\uff0c\u53ef\u4ee5\u7f29\u77ed D \u7c7b\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\u65f6\u95f4\u7ebf\u7684\u4e00\u5230\u4e24\u4e2a\u5ba1\u67e5\u5468\u671f\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u9aa8\u79d1\u690d\u5165\u7269\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8d39\u7528<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8d39\u7528\u9996\u5148\u662f\u653f\u5e9c\u5f81\u6536\u7684\u201cIzin Edar\u201d\u8d39\u7528\uff0c\u5373\u56fd\u5bb6\u975e\u8425\u5229\u6027\u91c7\u8d2d\u7a0e\uff08PNBP\uff09\uff0c\u8be5\u7a0e\u9879\u89c4\u5b9a\u4e8e2019\u5e74\u7b2c64\u53f7\u603b\u7edf\u4ee4\u4e2d\u3002\u8d39\u7528\u6839\u636e\u5668\u68b0\u7c7b\u522b\u800c\u5b9a\uff0cD\u7c7b\u533b\u7597\u5668\u68b0\u7684\u5370\u5c3c\u5173\u7a0e\u9ad8\u4e8eC\u7c7b\u533b\u7597\u5668\u68b0\u3002PNBP\u8d39\u7528\u53ea\u662f\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\u9884\u7b97\u4e2d\u7684\u4e00\u4e2a\u9879\u76ee\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5728\u5370\u5c3c\u6ce8\u518c\u533b\u7597\u5668\u68b0\u7684\u4e3b\u8981\u6210\u672c\u56e0\u7d20\uff08\u4f8b\u5982\u9aa8\u79d1\u690d\u5165\u7269\uff09\u5305\u62ec\uff1a\u672c\u5730\u68c0\u6d4b\uff08\u5982\u9700SNI\u6216KAN\u8ba4\u8bc1\u7684\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\uff09\u3001\u6280\u672f\u6587\u4ef6\u7684\u5370\u5c3c\u8bed\u7ffb\u8bd1\u3001\u5f53\u5730IDAK\/CDAKB\u4ee3\u7406\u673a\u6784\u7684\u670d\u52a1\u8d39\uff0c\u4ee5\u53ca\u5bf9\u4e8eD\u7c7b\u591a\u4e34\u5e8a\u5668\u68b0\u800c\u8a00\uff0c\u51c6\u5907\u672c\u5730\u4e34\u5e8a\u6570\u636e\u7684\u989d\u5916\u6210\u672c\u3002\u7531\u4e8e\u8fd9\u4e9b\u8d39\u7528\u56e0\u5668\u68b0\u914d\u7f6e\u800c\u5f02\uff0c\u6211\u4eec\u5efa\u8bae\u60a8\u9488\u5bf9\u5177\u4f53\u690d\u5165\u7269\u7d22\u53d6\u8be6\u7ec6\u7684\u8d39\u7528\u6e05\u5355\uff0c\u800c\u4e0d\u662f\u6839\u636e\u884c\u4e1a\u901a\u7528\u6570\u636e\u8fdb\u884c\u9884\u7b97\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u79cd\u690d\u4f53\u7279\u5b9a\u8c03\u6574\u5982\u4f55\u5f71\u54cd\u5de5\u671f\u548c\u6210\u672c<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5373\u4f7f\u57fa\u672c\u5206\u7c7b\u4fdd\u6301\u4e0d\u53d8\uff0c\u690d\u5165\u7269\u4e5f\u4f1a\u6539\u53d8\u6587\u4ef6\u5185\u5bb9\u3002\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5ba1\u6838\u4eba\u5458\u7ecf\u5e38\u8981\u6c42\u5bf9\u975e\u690d\u5165\u5f0fC\u7c7b\u5668\u68b0\u8fdb\u884c\u4e00\u4e9b\u8c03\u6574\uff0c\u800c\u8fd9\u4e9b\u8c03\u6574\u901a\u5e38\u4e0d\u9700\u8981\uff1a\u4f8b\u5982\uff0c\u4e0e\u786e\u5207\u5305\u88c5\u914d\u7f6e\u76f8\u5173\u7684\u706d\u83cc\u6709\u6548\u671f\u6570\u636e\u3001\u6240\u7528\u91d1\u5c5e\u6216\u805a\u5408\u7269\u7684\u6750\u6599\u53ef\u8ffd\u6eaf\u6027\u6587\u4ef6\uff0c\u4ee5\u53ca\u6839\u636eISO 14971\u6807\u51c6\u9488\u5bf9\u5370\u5ea6\u5c3c\u897f\u4e9a\u5236\u5b9a\u7684\u3001\u65e8\u5728\u89e3\u51b3\u957f\u671f\u690d\u5165\u98ce\u9669\u7684\u98ce\u9669\u7ba1\u7406\u9644\u5f55\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u4e9b\u8c03\u6574\uff0c\u518d\u52a0\u4e0a\u524d\u9762\u8ba8\u8bba\u8fc7\u7684 C \u7c7b\u5230 D \u7c7b\u7684\u91cd\u65b0\u5206\u7c7b\u98ce\u9669\uff0c\u5c31\u662f\u4e3a\u4ec0\u4e48\u4e24\u4e2a\u5728\u540c\u4e00\u540d\u4e49\u7c7b\u522b\u4e0b\u63d0\u4ea4\u7684\u9aa8\u79d1\u690d\u5165\u7269\u6700\u7ec8\u53ef\u80fd\u4f1a\u5728\u73b0\u5b9e\u4e16\u754c\u7684\u65f6\u95f4\u8868\u4e0a\u51fa\u73b0\u5f88\u5927\u7684\u5dee\u5f02\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u9aa8\u79d1\u690d\u5165\u7269\u5e02\u573a\u6f5c\u529b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b63\u786e\u7684\u5206\u7c7b\u548c\u6863\u6848\u51c6\u5907\u5de5\u4f5c\u4e0d\u4ec5\u5728\u884c\u653f\u4e0a\u81f3\u5173\u91cd\u8981\uff0c\u5728\u5546\u4e1a\u4e0a\u4e5f\u540c\u6837\u91cd\u8981\u30022024\u5e74\uff0c\u5370\u5c3c\u9aa8\u79d1\u5668\u68b0\u5e02\u573a\u4ef7\u503c\u7ea6\u4e3a100\u4e07\u4ebf\u81f32.069\u4ebf\u7f8e\u5143\uff0c\u9884\u8ba1\u52302029\u5e74\u5c06\u4ee5\u7ea66.61\u4e07\u4ebf\u81f33\u4e07\u4ebf\u7f8e\u5143\u7684\u590d\u5408\u5e74\u589e\u957f\u7387\u589e\u957f\uff0c\u8fbe\u5230\u7ea6100\u4e07\u4ebf\u81f32.845\u4ebf\u7f8e\u5143\u3002\u63a8\u52a8\u8fd9\u4e00\u589e\u957f\u7684\u56e0\u7d20\u5305\u62ec\u533b\u7597\u4fdd\u5065\u652f\u51fa\u589e\u52a0\u3001\u4e2d\u4ea7\u9636\u7ea7\u58ee\u5927\u4ee5\u53ca\u4e3b\u8981\u57ce\u5e02\u4ee5\u5916\u5730\u533a\u9aa8\u79d1\u624b\u672f\u670d\u52a1\u53ef\u53ca\u6027\u7684\u63d0\u9ad8\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u5236\u9020\u5546\u548c\u5206\u9500\u5546\u800c\u8a00\uff0c\u8fd9\u79cd\u589e\u957f\u7a97\u53e3\u671f\u5f88\u77ed\u6682\uff0c\u5e76\u975e\u6c38\u4e45\u6709\u6548\uff1a\u6bcf\u56e0\u5206\u7c7b\u9519\u8bef\u3001\u8d44\u6599\u4e0d\u5b8c\u6574\u6216\u53ef\u907f\u514d\u7684\u95ee\u8be2\u800c\u635f\u5931\u4e00\u4e2a\u6708\uff0c\u7ade\u4e89\u5bf9\u624b\u7684\u4ea7\u54c1\u5c31\u6bd4\u4f60\u7684\u4ea7\u54c1\u591a\u4e00\u4e2a\u6708\u5360\u636e\u836f\u54c1\u76ee\u5f55\u548c\u624b\u672f\u5ba4\u3002\u8fd9\u6b63\u662f\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\u7684\u5546\u4e1a\u548c\u76d1\u7ba1\u5c42\u9762\u4ea4\u6c47\u4e4b\u5904\uff0c\u56e0\u4e3a\u4e00\u4efd\u5207\u5b9e\u53ef\u884c\u3001\u6761\u7406\u6e05\u6670\u7684\u7533\u8bf7\u624d\u662f\u771f\u6b63\u51b3\u5b9a\u4ea7\u54c1\u4f55\u65f6\u80fd\u5728\u5370\u5c3c\u5e02\u573a\u5f00\u59cb\u76c8\u5229\u7684\u5173\u952e\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\u4e2d\u5fc3\u4ece\u5546\u4e1a\u548c\u76d1\u7ba1\u4e24\u4e2a\u65b9\u9762\u63d0\u4f9b\u652f\u6301\uff1a\u6211\u4eec\u7684\u9884\u63d0\u4ea4\u5206\u7c7b\u5ba1\u67e5\u65e8\u5728\u9632\u60a3\u4e8e\u672a\u7136\uff0c\u907f\u514d\u4ea7\u54c1\u88ab\u91cd\u65b0\u5206\u7c7b\u4e3aD\u7c7b\uff0c\u4ece\u800c\u5f71\u54cd\u4e0a\u5e02\u65e5\u671f\uff1b\u6211\u4eec\u63d0\u4f9b\u7684\u8be6\u7ec6\u6210\u672c\u4f30\u7b97\uff0c\u8ba9\u5236\u9020\u5546\u7684\u8d22\u52a1\u548c\u4e1a\u52a1\u62d3\u5c55\u56e2\u961f\u80fd\u591f\u7528\u5b9e\u9645\u6570\u636e\u800c\u975e\u884c\u4e1a\u5e73\u5747\u503c\u6765\u6a21\u62df\u5370\u5c3c\u5e02\u573a\u7684\u673a\u9047\u3002\u5b9e\u9645\u4e0a\uff0c\u4e00\u6b21\u6027\u63d0\u4ea4\u6b63\u786e\u7684\u6587\u4ef6\uff0c\u4e0d\u4ec5\u5173\u4e4e\u5408\u89c4\uff0c\u66f4\u5173\u4e4e\u5e02\u573a\u51c6\u5165\u7684\u901f\u5ea6\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\u5982\u4f55\u5e2e\u52a9\u60a8\u8fdb\u884c\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6211\u4eec\u7684 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/medical-device-registration-indonesia\/\">\u533b\u7597\u5668\u68b0\u6ce8\u518c<\/a> \u670d\u52a1\u6db5\u76d6\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4 (CSDT) \u6587\u4ef6\u51c6\u5907\u3001Regalkes \u7533\u62a5\u4ee5\u53ca A \u7c7b\u81f3 D \u7c7b\u533b\u7597\u5668\u68b0\uff08\u5305\u62ec\u9aa8\u79d1\u690d\u5165\u7269\uff09\u7684\u6280\u672f\u54a8\u8be2\u7ba1\u7406\u3002\u5bf9\u4e8e\u5728\u5370\u5c3c\u6ca1\u6709\u8bbe\u7acb\u5b9e\u4f53\u7684\u5236\u9020\u5546\uff0c\u6211\u4eec\u7684 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/license-holder-service-in-indonesia\/\">\u6267\u7167\u6301\u6709\u4eba\u670d\u52a1<\/a> \u8ba9\u6211\u4eec\u4f5c\u4e3a\u60a8\u5f53\u5730\u7684 IDAK\/CDAKB \u6301\u6709\u4eba\u4ee3\u8868\u548c Izin Edar \u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u60a8\u7684\u690d\u5165\u7269\u53ef\u80fd\u5c5e\u4e8e\u4e0a\u6587\u6240\u8ff0\u7684D\u7c7b\u591a\u4e34\u5e8a\u7c7b\u522b\uff0c\u6211\u4eec\u7684\u56e2\u961f\u53ef\u4ee5\u5728\u60a8\u786e\u5b9a\u63d0\u4ea4\u65f6\u95f4\u8868\u4e4b\u524d\uff0c\u6309\u7167\u6211\u4eec\u6587\u4ef6\u4e2d\u6982\u8ff0\u7684\u76f8\u540c\u7684\u6863\u6848\u89c4\u8303\uff0c\u8fdb\u884c\u9884\u63d0\u4ea4\u5206\u7c7b\u5ba1\u67e5\u3002 <strong>\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6ce8\u518cCSDT\u7b80\u660e\u6307\u5357<\/strong>.<\/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=\"vsVsUtu4we\"><a 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\u56e2\u961f\u6bcf\u5929\u90fd\u4e0e\u5236\u9020\u5546\u548c\u5206\u9500\u5546\u5408\u4f5c\uff0c\u4ee5\u786e\u8ba4\u8bbe\u5907\u7684\u7c7b\u522b\uff0c\u5236\u5b9a\u6863\u6848\u8981\u6c42\uff0c\u5e76\u5728\u5411 Regalkes \u63d0\u4ea4\u4efb\u4f55\u6587\u4ef6\u4e4b\u524d\u8bbe\u5b9a\u4e00\u4e2a\u73b0\u5b9e\u7684\u65f6\u95f4\u8868\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u51c6\u5907\u597d\u7ee7\u7eed\u4e86\u5417\uff1f\u8bf7\u586b\u5199\u4e0b\u9762\u7684\u8868\u683c\u4e0e\u6211\u4eec\u7684\u56e2\u961f\u8054\u7cfb\uff0c\u6211\u4eec\u7684\u76d1\u7ba1\u4e13\u5bb6\u5c06\u4e0e\u60a8\u8054\u7cfb\uff0c\u544a\u77e5\u60a8\u9aa8\u79d1\u690d\u5165\u7269\u6ce8\u518c\u7684\u540e\u7eed\u6b65\u9aa4\u3002.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>A hip prosthesis and a spinal fixation system can sit on the same workbench and still land in two completely different regulatory categories once they reach Kemenkes. That&#8217;s the part most filings don&#8217;t budget for. A manufacturer builds its timeline and pricing around a Class C submission, and everything looks routine, until the technical file [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":7763,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7762","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-articles","country-indonesia"],"acf":[],"_links":{"self":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7762","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=7762"}],"version-history":[{"count":1,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7762\/revisions"}],"predecessor-version":[{"id":7766,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7762\/revisions\/7766"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/7763"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=7762"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=7762"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=7762"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=7762"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}