{"id":7727,"date":"2026-09-14T15:40:07","date_gmt":"2026-09-14T08:40:07","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-09-14T15:40:10","modified_gmt":"2026-09-14T08:40:10","slug":"indonesia-ivd-registration-vs-medical-device","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/indonesia-ivd-registration-vs-medical-device\/","title":{"rendered":"\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff1a\u5176\u6d41\u7a0b\u4e0e\u533b\u7597\u5668\u68b0\u6709\u4f55\u4e0d\u540c"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u5370\u5c3c\u7684\u8bca\u65ad\u5e02\u573a\u53d1\u5c55\u8fc5\u731b\uff0c\u4ee5\u81f3\u4e8e\u8bb8\u591a\u5236\u9020\u5546\u73b0\u5728\u90fd\u8ba4\u4e3a\u4f53\u5916\u8bca\u65ad\u4ea7\u54c1\u53ef\u4ee5\u50cf\u6807\u51c6\u533b\u7597\u5668\u68b0\u4e00\u6837\u6ce8\u518c\uff0c\u4f7f\u7528\u76f8\u540c\u7684\u8d44\u6599\u3001\u76f8\u540c\u7684\u65f6\u95f4\u8868\u548c\u76f8\u540c\u7684\u9884\u671f\u7ed3\u679c\u3002\u5bf9\u4e8e\u5927\u591a\u6570\u98ce\u9669\u7b49\u7ea7\u7684\u4ea7\u54c1\u6765\u8bf4\uff0c\u8fd9\u79cd\u5047\u8bbe\u662f\u6210\u7acb\u7684\u3002\u4f46\u5bf9\u4e8e\u67d0\u4e00\u7279\u5b9a\u7c7b\u522b\u7684\u4f53\u5916\u8bca\u65ad\u4ea7\u54c1\u800c\u8a00\uff0c\u60c5\u51b5\u5e76\u975e\u5982\u6b64\u3002\u5728\u5370\u5c3c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08Kemenkes\uff09\u7684\u5ba1\u67e5\u8fc7\u7a0b\u4e2d\u624d\u53d1\u73b0\u8fd9\u4e00\u5dee\u8ddd\uff0c\u4ee3\u4ef7\u5c06\u975e\u5e38\u9ad8\u6602\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u6307\u5357\u9762\u5411\u51c6\u5907\u5411\u5370\u5c3c\u5e02\u573a\u63a8\u5e7f\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u4ea7\u54c1\u7684\u76d1\u7ba1\u7ecf\u7406\u3001\u5206\u9500\u5546\u548c\u5236\u9020\u5546\uff0c\u65e0\u8bba\u60a8\u662f\u7b2c\u4e00\u6b21\u8fd8\u662f\u7b2c\u5341\u6b21\u5411\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u63d0\u4ea4\u7533\u8bf7\u3002\u9605\u8bfb\u5b8c\u672c\u6307\u5357\u540e\uff0c\u60a8\u5c06\u4e86\u89e3\u5370\u5c3cIVD\u6ce8\u518c\u4e0e\u6807\u51c6\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6709\u4f55\u5f02\u540c\uff0c\u4e24\u8005\u7684\u771f\u6b63\u533a\u522b\u5728\u54ea\u91cc\uff0c\u98ce\u9669\u5206\u7c7b\u5982\u4f55\u5f71\u54cdKemenkes\u8981\u6c42\u7684\u6587\u6863\uff0c\u6700\u5e38\u5bfc\u81f4\u4f20\u67d3\u75c5IVD\u5ef6\u8bef\u7684\u9519\u8bef\uff0c\u4ee5\u53ca\u63d0\u4ea4\u8d44\u6599\u524d\u9700\u8981\u51c6\u5907\u54ea\u4e9b\u5185\u5bb9\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u662f\u5927\u591a\u6570\u6307\u5357\u90fd\u4f1a\u5ffd\u7565\u7684\u7ec6\u8282\u3002. <strong>\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c<\/strong> \u533b\u7597\u5668\u68b0\u6ce8\u518c\u5747\u901a\u8fc7\u540c\u4e00 izin edar \u7cfb\u7edf\u8fdb\u884c\uff0c\u4f9d\u636e\u662f Peraturan Menteri Kesehatan (Permenkes) No. 62 Tahun 2017\u3002\u4e24\u79cd\u4ea7\u54c1\u7c7b\u578b\u7684\u6863\u6848\u7ed3\u6784\u3001\u5ba1\u67e5\u90e8\u95e8\u548c\u7535\u5b50\u63d0\u4ea4\u6e20\u9053\u5747\u76f8\u540c\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u76d1\u7ba1\u56e2\u961f\u7684\u76f4\u63a5\u7533\u62a5\u7ecf\u9a8c\uff0c\u5305\u62ec\u6211\u4eec\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u8d1f\u8d23\u4eba Fahrurozi \u535a\u58eb\u7684\u610f\u89c1\uff0c\u53ea\u6709\u5f53\u4ea7\u54c1\u88ab\u5f52\u7c7b\u4e3a D \u7c7b\u98ce\u9669\u65f6\uff0c\u5ba1\u6279\u6d41\u7a0b\u624d\u4f1a\u6709\u6240\u4e0d\u540c\u3002D \u7c7b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u9700\u8981\u6709\u4e66\u9762\u4e34\u5e8a\u8bc1\u636e\uff0cKemenkes \u624d\u4f1a\u9881\u53d1 Nomor Izin Edar (NIE)\u3002. <strong>\u5b83\u8fd8\u53ef\u4ee5\u8fdb\u4e00\u6b65\u68c0\u6d4b\u5728\u5370\u5c3c\u793e\u4f1a\u5e7f\u6cdb\u4f20\u64ad\u7684\u75be\u75c5\uff0c\u4f8b\u5982\u827e\u6ecb\u75c5\u548c\u809d\u708e\u3002.<\/strong> \u9664\u4e86D\u7c7b\u9aa8\u79d1\u690d\u5165\u7269\u6240\u9700\u7684\u6807\u51c6\u4e34\u5e8a\u8bc1\u636e\u5305\u4e4b\u5916\uff0c\u8bc4\u4f30\u4eba\u5458\u901a\u5e38\u8fd8\u4f1a\u8981\u6c42\u5bf9\u8fd9\u4e9b\u7279\u5b9a\u4ea7\u54c1\u8fdb\u884c\u989d\u5916\u7684\u7597\u6548\u6d4b\u8bd5\u3002\u6cd5\u89c4\u6587\u672c\u4e2d\u5e76\u672a\u660e\u786e\u89c4\u5b9a\u8fd9\u4e00\u533a\u522b\u3002\u8bc4\u4f30\u56e2\u961f\u5728\u5b9e\u8df5\u4e2d\u5982\u4f55\u5e94\u7528\u8fd9\u4e00\u89c4\u5b9a\uff0c\u624d\u662f\u5f71\u54cd\u4f20\u67d3\u75c5\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5b9e\u9645\u4e0a\u5e02\u65f6\u95f4\u7684\u5173\u952e\u6240\u5728\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff08IVD\uff09\u6ce8\u518c\u548c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6709\u4ec0\u4e48\u533a\u522b\uff1f<\/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\/Indonesia-IVD-Registration-How-It-Differs-2.webp\" alt=\"\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u6709\u4f55\u4e0d\u540c\uff1f\" class=\"wp-image-7729\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Indonesia-IVD-Registration-How-It-Differs-2.webp 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Indonesia-IVD-Registration-How-It-Differs-2-300x200.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Indonesia-IVD-Registration-How-It-Differs-2-768x512.webp 768w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Indonesia-IVD-Registration-How-It-Differs-2-18x12.webp 18w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u4e24\u4e2a\u4ea7\u54c1\u7c7b\u522b\u5747\u6839\u636e\u540c\u4e00\u6587\u4e66\u8fdb\u884c\u5b9a\u4e49\u548c\u8bb8\u53ef\uff1aPermenkes No. 62 Tahun 2017 tentang Izin Edar Alat Kesehatan\u3001Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga\u3002\u5728\u6d41\u901a\u4efb\u4e00\u4ea7\u54c1\u7c7b\u578b\u4e4b\u524d\u6301\u6709\u5206\u9500\u8bb8\u53ef\u8bc1\u7684\u4e49\u52a1\u4e5f\u53ef\u4ee5\u8ffd\u6eaf\u5230 Undang-Undang No. 17 Tahun 2023 tentang Kesehatan, Pasal 143\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5916\u56fd\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u751f\u4ea7\u5546\u4e0d\u80fd\u76f4\u63a5\u6ce8\u518c\u3002\u6ce8\u518c\u5fc5\u987b\u901a\u8fc7\u5370\u5c3c\u6cd5\u5f8b\u5b9e\u4f53\u8fdb\u884c\uff0c\u8be5\u5b9e\u4f53\u53ef\u4ee5\u662fPT PMA\uff08\u5370\u5c3c\u836f\u54c1\u5236\u9020\u5546\u534f\u4f1a\uff09\u6216\u4f5c\u4e3a\u5f53\u5730\u6388\u6743\u4ee3\u8868\u7684\u5f53\u5730\u6301\u724c\u5206\u9500\u5546\uff0c\u8fd9\u4e0e\u4f20\u7edf\u533b\u7597\u5668\u68b0\u7684\u6ce8\u518c\u8981\u6c42\u5b8c\u5168\u76f8\u540c\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7b80\u800c\u8a00\u4e4b\uff0c\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\uff08IVD\uff09\u4e0e\u533b\u7597\u5668\u68b0\u7684\u6ce8\u518c\u5e76\u975e\u4e24\u4e2a\u72ec\u7acb\u5e76\u884c\u7684\u7cfb\u7edf\uff0c\u800c\u662f\u540c\u4e00\u6761\u5ba1\u6279\u8def\u5f84\uff0c\u7531\u540c\u4e00\u536b\u751f\u90e8\uff08Kemenkes\uff09\u5ba1\u6838\uff0c\u5e76\u901a\u8fc7\u540c\u4e00\u95e8\u6237\u7f51\u7ad9\u63d0\u4ea4\u3002\u4e24\u8005\u7684\u771f\u6b63\u533a\u522b\u5728\u4e8eD\u7c7b\u4ea7\u54c1\uff0c\u6b64\u7c7b\u4ea7\u54c1\u5fc5\u987b\u63d0\u4f9b\u4e34\u5e8a\u8bc1\u636e\uff0c\u5e76\u4e14\u7528\u4e8e\u6cbb\u7597\u827e\u6ecb\u75c5\u548c\u809d\u708e\u7b49\u4f20\u67d3\u75c5\u7684\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u8fd8\u9700\u8fdb\u884c\u989d\u5916\u7684\u7597\u6548\u6d4b\u8bd5\uff0c\u800cD\u7c7b\u9aa8\u79d1\u690d\u5165\u7269\u6216\u5fc3\u810f\u5668\u68b0\u5219\u65e0\u9700\u8fdb\u884c\u6b64\u9879\u6d4b\u8bd5\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u5143\u7d20<\/strong><\/td><td><strong>\u533b\u7597\u5668\u68b0\uff08A-C\u7c7b\uff09<\/strong><\/td><td><strong>IVD\uff08D\u7c7b\uff0c\u4f20\u67d3\u75c5\uff09<\/strong><\/td><\/tr><tr><td>\u7ba1\u7406\u89c4\u5219<\/td><td>Permenkes 62\/2017<\/td><td>Permenkes 62\/2017 + \u8bc4\u4f30\u5458\u5e94\u7528\u7684\u6548\u679c\u6b65\u9aa4<\/td><\/tr><tr><td>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u7684\u6cd5\u4eba\u5b9e\u4f53<\/td><td>\u5fc5\u9700\uff08PT PMA \u6216 LAR\uff09<\/td><td>\u5fc5\u9700\uff08PT PMA \u6216 LAR\uff09<\/td><\/tr><tr><td>\u63d0\u4ea4\u6e20\u9053<\/td><td>OSS-RBA \u548c regalkes.kemkes.go.id<\/td><td>OSS-RBA \u548c regalkes.kemkes.go.id<\/td><\/tr><tr><td>\u4e34\u5e8a\u8bc1\u636e<\/td><td>A-C \u7c7b\u65e0\u9700\u6b64\u9879\u8981\u6c42<\/td><td>\u9700\u8981\u63d0\u4f9b\u4f20\u67d3\u75c5\u68c0\u6d4b\u7684\u989d\u5916\u6709\u6548\u6027\u6570\u636e<\/td><\/tr><tr><td>\u5370\u5c3c\u5e02\u573a\u524d\u8bc4\u4f30<\/td><td>A-C \u7c7b\u65e0\u9700\u6b64\u9879\u8981\u6c42<\/td><td>\u5c24\u5176\u5bf9\u4e8e\u827e\u6ecb\u75c5\u548c\u809d\u708e\u68c0\u6d4b\u8bd5\u5242\u76d2\u800c\u8a00\uff0c\u8fd9\u662f\u5fc5\u9700\u7684\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u98ce\u9669\u7b49\u7ea7\u5206\u7c7b\uff1aA\u7ea7\u81f3D\u7ea7<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\u5206\u7c7b\u9075\u5faa\u4e0e\u533b\u7597\u5668\u68b0\u76f8\u540c\u7684\u56db\u7ea7\u5206\u7c7b\u4f53\u7cfb\uff0c\u8be5\u4f53\u7cfb\u4e0e\u4e1c\u76df\u6807\u51c6\u4e00\u81f4\uff0c\u8be6\u89c1\u5370\u5c3c\u536b\u751f\u90e82017\u5e74\u7b2c62\u53f7\u6cd5\u4ee4\u3002\u5206\u7c7b\u5e76\u975e\u4ec5\u4ec5\u662f\u4ea7\u54c1\u5907\u6848\u65f6\u8d34\u4e0a\u7684\u6807\u7b7e\uff0c\u5b83\u51b3\u5b9a\u4e86\u6280\u672f\u6587\u4ef6\u7684\u539a\u5ea6\u3001\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u62a5\u544a\u662f\u5426\u8db3\u591f\u6216\u662f\u5426\u9700\u8981\u5b8c\u6574\u7684\u4e34\u5e8a\u7814\u7a76\u3001\u5370\u5c3c\u536b\u751f\u90e8\u5ba1\u6838\u7533\u8bf7\u7684\u5927\u81f4\u65f6\u95f4\uff0c\u4ee5\u53ca\u5982\u679c\u4ea7\u54c1\u6700\u521d\u5206\u7c7b\u9519\u8bef\uff0c\u540e\u7eed\u7684\u5904\u7406\u6d41\u7a0b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5206\u7c7b\u4f9d\u636e\u7684\u662f\u9884\u671f\u7528\u9014\u548c\u9519\u8bef\u7ed3\u679c\u7684\u540e\u679c\uff0c\u800c\u4e0d\u662f\u8bbe\u5907\u5728\u8d27\u67b6\u4e0a\u770b\u8d77\u6765\u6709\u591a\u590d\u6742\u3002\u5373\u4f7f\u662f\u7b80\u5355\u7684\u4fa7\u5411\u5c42\u6790\u68c0\u6d4b\u76d2\uff0c\u5982\u679c\u5047\u9634\u6027\u6216\u5047\u9633\u6027\u7ed3\u679c\u4f1a\u9020\u6210\u4e25\u91cd\u7684\u4e34\u5e8a\u540e\u679c\uff0c\u4f8b\u5982\u6f0f\u8bca\u6d3b\u52a8\u6027HIV\u6216\u809d\u708e\u611f\u67d3\uff0c\u4e5f\u53ef\u80fd\u88ab\u5f52\u4e3aD\u7c7b\u3002\u5982\u679c\u5236\u9020\u5546\u6839\u636e\u8bbe\u5907\u5f62\u5f0f\u800c\u975e\u4e34\u5e8a\u540e\u679c\u8fdb\u884c\u5206\u7c7b\uff0c\u90a3\u4e48\u4ed6\u4eec\u6700\u6709\u53ef\u80fd\u5728Kemenkes\u5ba1\u67e5\u9636\u6bb5\u53d7\u5230\u5206\u7c7b\u8d28\u7591\uff0c\u800c\u4e14\u6b64\u65f6\u7684\u8d28\u7591\u4f1a\u91cd\u7f6e\u8bc4\u4f30\u5468\u671f\uff0c\u800c\u4e0d\u662f\u7b80\u5355\u5730\u8c03\u6574\u5468\u671f\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u73ed\u7ea7<\/strong><\/td><td><strong>\u98ce\u9669\u7b49\u7ea7<\/strong><\/td><td><strong>\u5178\u578b\u7684\u4f53\u5916\u8bca\u65ad\u793a\u4f8b<\/strong><\/td><td><strong>\u4e34\u5e8a\u8bc1\u636e<\/strong><\/td><\/tr><tr><td>A<\/td><td>\u4f4e\u7684<\/td><td>\u5e38\u7528\u5b9e\u9a8c\u5ba4\u8bd5\u5242\u3001\u57fa\u672c\u6807\u672c\u91c7\u96c6\u88c5\u7f6e<\/td><td>\u65e0\u9700<\/td><\/tr><tr><td>B<\/td><td>\u4f4e\u81f3\u4e2d\u7b49<\/td><td>\u598a\u5a20\u548c\u6392\u5375\u81ea\u6d4b\u8bd5\u5242\u76d2\uff0c\u57fa\u7840\u8840\u7cd6\u8bd5\u7eb8<\/td><td>\u65e0\u9700<\/td><\/tr><tr><td>C<\/td><td>\u4e2d\u7b49\u81f3\u9ad8<\/td><td>\u80bf\u7624\u6807\u5fd7\u7269\u68c0\u6d4b\u3001\u6fc0\u7d20\u68c0\u6d4b\u3001\u4e34\u5e8a\u5316\u5b66\u5206\u6790\u4eea<\/td><td>\u5177\u4f53\u60c5\u51b5\u5177\u4f53\u5206\u6790<\/td><\/tr><tr><td>D<\/td><td>\u9ad8\u7684<\/td><td>\u8840\u6db2\u4f20\u64ad\u75c5\u539f\u4f53\u68c0\u6d4b\uff0c\u5305\u62ec\u827e\u6ecb\u75c5\u6bd2\u548c\u809d\u708e\u68c0\u6d4b\u8bd5\u5242\u76d2\u3001\u8840\u6db2\u7b5b\u67e5\u8bd5\u5242<\/td><td>\u9700\u8981\u63d0\u4f9b\u4f20\u67d3\u75c5\u68c0\u6d4b\u7684\u6709\u6548\u6027\u6570\u636e<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Kemenkes\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5ba1\u6279\u6d41\u7a0b\u8be6\u89e3<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u82ac\u5170\u56fd\u5bb6\u836f\u54c1\u7ba1\u7406\u5c40 (Kemenkes) \u7684\u4f53\u5916\u8bca\u65ad (IVD) \u5ba1\u6279\u6d41\u7a0b\u5728\u884c\u653f\u4e0a\u4e0e\u533b\u7597\u5668\u68b0\u5ba1\u6279\u6d41\u7a0b\u7c7b\u4f3c\u3002\u4ee5\u4e0b\u6b65\u9aa4\u53cd\u6620\u4e86\u6587\u4ef6\u5728\u82ac\u5170\u56fd\u5bb6\u836f\u54c1\u7ba1\u7406\u5c40 (Kemenkes) \u7684\u5ba1\u6279\u6d41\u7a0b\uff0c\u8be5\u6d41\u7a0b\u53c2\u8003\u4e86\u82ac\u5170\u56fd\u5bb6\u836f\u54c1\u7ba1\u7406\u5c40 (Permenkes) \u7b2c 62\/2017 \u53f7\u6761\u4f8b\u4ee5\u53ca\u6211\u4eec\u56e2\u961f\u7684\u7533\u8bf7\u7ecf\u9a8c\u3002.<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u786e\u8ba4\u6cd5\u5f8b\u5b9e\u4f53\u5730\u4f4d\uff1a\u6307\u5b9a\u5f53\u5730\u6388\u6743\u4ee3\u8868\u6216\u8bbe\u7acbPT PMA\u4ee5\u6301\u6709NIE\u3002.<\/li>\n\n\n\n<li>\u5728\u7f16\u5236\u6280\u672f\u6587\u4ef6\u4e4b\u524d\uff0c\u786e\u5b9a\u98ce\u9669\u5206\u7c7b\uff08A \u7c7b\u81f3 D \u7c7b\uff09\uff0c\u56e0\u4e3a\u5206\u7c7b\u51b3\u5b9a\u4e86\u6587\u6863\u7684\u6df1\u5ea6\u3002.<\/li>\n\n\n\n<li>\u51c6\u5907\u4e1c\u76df\u5171\u540c\u7533\u62a5\u6587\u4ef6\u6a21\u677f\uff0c\u5305\u62ec\u5370\u5c3c\u8bed\u6807\u7b7e\u548c\u8d28\u91cf\u4f53\u7cfb\u8bc1\u660e\uff0c\u4f8b\u5982 ISO 13485\u3002.<\/li>\n\n\n\n<li>\u901a\u8fc7 regalkes.kemkes.go.id \u63d0\u4ea4\uff0c\u4ee5\u4fbf Direktorat Jenderal Kefarmasian dan Alat Kesehatan \u8fdb\u884c\u884c\u653f\u548c\u6280\u672f\u9a8c\u8bc1\u3002.<\/li>\n\n\n\n<li>\u5bf9\u4e8e D \u7c7b IVD\uff0c\u8bf7\u63d0\u4ea4\u4e0e Permenkes No. 63 Tahun 2017 tentang Cara Uji Klinik Alat Kesehatan yang Baik \u4e00\u81f4\u7684\u4e34\u5e8a\u8bc1\u636e\u3002.<\/li>\n\n\n\n<li>\u5bf9\u4e8e\u4f20\u67d3\u75c5\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff0c\u5e94\u56de\u5e94\u8bc4\u4f30\u4eba\u5458\u63d0\u51fa\u7684\u8865\u5145\u7597\u6548\u6570\u636e\u8981\u6c42\uff0c\u6211\u4eec\u7684\u56e2\u961f\u53d1\u73b0\u8fd9\u4e00\u6b65\u9aa4\u5c24\u5176\u9002\u7528\u4e8e HIV \u548c\u809d\u708e\u8bca\u65ad\u3002.<\/li>\n\n\n\n<li>\u6536\u5230 Nomor Izin Edar \u5e76\u5c65\u884c\u4e0a\u5e02\u540e\u4e49\u52a1\uff0c\u5305\u62ec\u5728\u5230\u671f\u524d\u63d0\u4ea4\u4efb\u4f55\u7eed\u671f\u7533\u8bf7\u3002.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u8bc4\u4f30\u65f6\u95f4\u548c\u9002\u7528\u7684\u653f\u5e9c\u8d39\u7528\u56e0\u4ea7\u54c1\u7c7b\u522b\u3001\u65b0\u9896\u6027\u4ee5\u53ca\u9996\u6b21\u63d0\u4ea4\u6750\u6599\u7684\u5b8c\u6574\u6027\u800c\u5f02\uff0c\u56e0\u6b64\u6211\u4eec\u5728\u6b64\u4e0d\u63d0\u4f9b\u56fa\u5b9a\u6570\u5b57\u3002\u8bf7\u8054\u7cfb\u6211\u4eec\u7684\u56e2\u961f\uff0c\u83b7\u53d6\u9488\u5bf9\u60a8\u4ea7\u54c1\u7684\u5177\u4f53\u65f6\u95f4\u9884\u4f30\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u7533\u8bf7\u901a\u5e38\u51fa\u9519\u7684\u5730\u65b9<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6211\u4eec\u770b\u5230\u7684\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u5ef6\u8bef\u5927\u591a\u5e76\u975e\u7531\u4e8e\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u529e\u4e8b\u6548\u7387\u4f4e\u4e0b\u6240\u81f4\uff0c\u800c\u662f\u6e90\u4e8e\u7533\u8bf7\u521d\u671f\u505a\u51fa\u7684\u51b3\u5b9a\uff0c\u5f80\u5f80\u662f\u5728\u7533\u8bf7\u6750\u6599\u9001\u8fbe\u5ba1\u6838\u4eba\u5458\u4e4b\u524d\u5c31\u5df2\u505a\u51fa\u3002\u4ee5\u4e0b\u6a21\u5f0f\u5728\u4e0d\u540c\u7684\u5ba2\u6237\u548c\u4ea7\u54c1\u7c7b\u578b\u4e2d\u53cd\u590d\u51fa\u73b0\uff0c\u56e0\u6b64\u503c\u5f97\u660e\u786e\u5217\u51fa\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u6211\u4eec\u6700\u5e38\u89c1\u7684\u9519\u8bef<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6309\u8bbe\u5907\u5f62\u5f0f\u800c\u975e\u4e34\u5e8a\u540e\u679c\u5bf9\u4ea7\u54c1\u8fdb\u884c\u5206\u7c7b\uff0c\u7136\u540e\u5728\u5ba1\u67e5\u8fc7\u7a0b\u4e2d\u53d1\u73b0\u5feb\u901f\u6d4b\u8bd5\u5b9e\u9645\u4e0a\u5c5e\u4e8e D \u7c7b\u3002.<\/li>\n\n\n\n<li>\u5c06 D \u7c7b\u4e34\u5e8a\u8bc1\u636e\u8981\u6c42\u89c6\u4e3a\u4e00\u9879\u52fe\u9009\u6846\uff0c\u63d0\u4ea4\u7684\u662f\u901a\u7528\u6587\u732e\u6458\u8981\uff0c\u800c\u4e0d\u662f\u4e0e\u9884\u671f\u7528\u9014\u548c\u76ee\u6807\u4eba\u7fa4\u76f8\u5339\u914d\u7684\u6570\u636e\u3002.<\/li>\n\n\n\n<li>\u5047\u8bbe\u4f20\u67d3\u75c5\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u53ea\u9700\u8981\u6807\u51c6\u7684 D \u7c7b\u5305\u88c5\uff0c\u90a3\u4e48\u5374\u56e0\u4e3a\u8981\u6c42\u63d0\u4f9b\u539f\u672c\u53ef\u4ee5\u9884\u5148\u51c6\u5907\u597d\u7684\u989d\u5916\u7597\u6548\u6570\u636e\u800c\u6d6a\u8d39\u4e86\u6570\u5468\u65f6\u95f4\u3002.<\/li>\n\n\n\n<li>\u5728\u6280\u672f\u6587\u4ef6\u5df2\u7ecf\u5b8c\u6210\u4e4b\u540e\u624d\u4efb\u547d\u5f53\u5730\u6388\u6743\u4ee3\u8868\uff0c\u8fd9\u5bfc\u81f4\u5373\u4f7f\u4ea7\u54c1\u6587\u4ef6\u672c\u8eab\u5df2\u7ecf\u51c6\u5907\u5c31\u7eea\uff0c\u63d0\u4ea4\u5de5\u4f5c\u4e5f\u4f1a\u88ab\u803d\u6401\u3002.<\/li>\n\n\n\n<li>\u76f4\u63a5\u7ffb\u8bd1\u6807\u7b7e\u548c\u4f7f\u7528\u8bf4\u660e\u4e66\u7684\u5185\u5bb9\uff0c\u800c\u4e0d\u662f\u6309\u7167 Kemenkes \u8981\u6c42\u7684\u683c\u5f0f\u8fdb\u884c\u8c03\u6574\uff0c\u8fd9\u5bfc\u81f4\u5728\u6280\u672f\u5ba1\u67e5\u5f00\u59cb\u4e4b\u524d\u5c31\u88ab\u884c\u653f\u9a73\u56de\u3002.<\/li>\n\n\n\n<li>\u9519\u8fc7\u4e86 izin edar \u7eed\u671f\u7a97\u53e3\u671f\uff0c\u5728 Kemenkes \u9884\u671f\u7684\u63d0\u524d\u671f\u8fc7\u540e\u63d0\u4ea4\u4e86\u7533\u8bf7\u3002.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u8fd1\u671f\u6587\u4ef6\u4e2d\u7684\u4e24\u4e2a\u4f8b\u5b50<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u4ee5\u4e0b\u793a\u4f8b\u662f\u4ece\u6211\u4eec\u5728\u591a\u4e2a\u6587\u4ef6\u4e2d\u770b\u5230\u7684\u91cd\u590d\u6a21\u5f0f\u4e2d\u63d0\u53d6\u51fa\u6765\u7684\u7efc\u5408\u793a\u4f8b\uff0c\u800c\u4e0d\u662f\u4ece\u5355\u4e2a\u6307\u5b9a\u5ba2\u6237\u4e2d\u63d0\u53d6\u7684\u793a\u4f8b\uff0c\u4ee5\u4fdd\u62a4\u673a\u5bc6\u6027\u3002.<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e00\u5bb6\u4e59\u809d\u5feb\u901f\u68c0\u6d4b\u8bd5\u5242\u751f\u4ea7\u5546\u524d\u6765\u54a8\u8be2\uff0c\u4ed6\u4eec\u4ee5\u4e3a\u8be5\u4ea7\u54c1\u7684\u5ba1\u6279\u6d41\u7a0b\u4f1a\u4e0e\u4e4b\u524d\u5728\u5370\u5c3c\u6ce8\u518c\u7684\u4e00\u6b3e\u5916\u89c2\u76f8\u4f3c\u7684\u8461\u8404\u7cd6\u68c0\u6d4b\u8bd5\u5242\u76f8\u540c\u3002\u8fd9\u4e24\u6b3e\u8bd5\u5242\u5747\u4e3a\u4fa7\u5411\u5c42\u6790\u6cd5\u68c0\u6d4b\u76d2\uff0c\u4e14\u7533\u8bf7\u6750\u6599\u4e5f\u4e0e\u4e4b\u524d\u6ce8\u518c\u7684\u4f4e\u98ce\u9669\u4ea7\u54c1\u4e00\u6837\u8be6\u5c3d\u3002\u5370\u5c3c\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08Kemenkes\uff09\u5ba1\u67e5\u4e86\u8be5\u8bd5\u5242\u7684\u9884\u671f\u7528\u9014\u540e\uff0c\u5c06\u5176\u5f52\u7c7b\u4e3aD\u7c7b\uff0c\u5e76\u8981\u6c42\u63d0\u4f9b\u4e34\u5e8a\u8bc1\u636e\u548c\u8865\u5145\u7684\u3001\u9488\u5bf9\u4e59\u809d\u68c0\u6d4b\u7684\u7597\u6548\u6570\u636e\u3002\u5982\u679c\u5728\u9996\u6b21\u63d0\u4ea4\u524d\u5c31\u786e\u8ba4\u4e86\u5206\u7c7b\uff0c\u90a3\u4e48\u91cd\u65b0\u51c6\u5907\u7533\u8bf7\u6750\u6599\u6240\u9700\u7684\u65f6\u95f4\u5c06\u4f1a\u5927\u5927\u7f29\u77ed\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u53e6\u4e00\u4f4d\u5ba2\u6237\u662f\u4e00\u5bb6\u827e\u6ecb\u75c5\u6bd2\u81ea\u68c0\u8bd5\u5242\u76d2\u8fdb\u53e3\u5546\uff0c\u4ed6\u5df2\u51c6\u5907\u597d\u4e34\u5e8a\u7814\u7a76\u6570\u636e\uff0c\u4f46\u5374\u6ca1\u6709\u9884\u7559\u65f6\u95f4\u8fdb\u884c\u7597\u6548\u6d4b\u8bd5\u2014\u2014\u8fd9\u662f\u8bc4\u4f30\u4eba\u5458\u4e13\u95e8\u9488\u5bf9\u4f20\u67d3\u75c5\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff08IVD\uff09\u7684\u8981\u6c42\u3002\u4e34\u5e8a\u8d44\u6599\u5305\u672c\u8eab\u987a\u5229\u901a\u8fc7\u3002\u4f46\u968f\u540e\u8981\u6c42\u63d0\u4f9b\u7597\u6548\u6570\u636e\uff0c\u5374\u5bfc\u81f4\u5ba2\u6237\u989d\u5916\u589e\u52a0\u4e86\u4e00\u4e2a\u5ba1\u6838\u5468\u671f\uff0c\u800c\u5ba2\u6237\u5e76\u672a\u9884\u6599\u5230\u8fd9\u4e00\u70b9\uff0c\u8fd9\u4f7f\u5f97\u4ea7\u54c1\u4e0a\u5e02\u65f6\u95f4\u63a8\u8fdf\u4e86\u4e00\u4e2a\u5b63\u5ea6\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u7528\u4e8e\u4f20\u67d3\u75c5\u68c0\u6d4b\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u7528\u4e8e\u4f20\u67d3\u75c5\u68c0\u6d4b\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\uff0c\u5c5e\u4e8e\u4e00\u4e2a\u89c4\u6a21\u5e9e\u5927\u4e14\u4ecd\u5728\u589e\u957f\u7684\u5e02\u573a\u3002\u6839\u636e\u76f8\u5173\u6570\u636e\uff0c\u4e59\u578b\u809d\u708e\u7684\u60a3\u75c5\u7387\u5df2\u4ece2013\u5e74\u76847.1%\u4e0b\u964d\u52302023\u5e74\u76842.4%\u3002 <a href=\"https:\/\/kemkes.go.id\/id\/angka-hepatitis-b-dan-c-di-indonesia-turun\" target=\"_blank\" rel=\"noopener\">Kemenkes \u5f15\u7528\u7684 Riskesdas \u6570\u636e<\/a>, \u7136\u800c\uff0c\u536b\u751f\u90e8\u4ecd\u7136\u5c06\u5370\u5ea6\u5c3c\u897f\u4e9a\u5217\u4e3a\u4e1c\u5357\u4e9a\u809d\u75c5\u8d1f\u62c5\u8f83\u91cd\u7684\u56fd\u5bb6\u4e4b\u4e00\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b63\u662f\u7531\u4e8e\u5982\u6b64\u5e9e\u5927\u7684\u68c0\u6d4b\u9700\u6c42\uff0cD\u7c7b\u4f20\u67d3\u75c5\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7684\u989d\u5916\u6709\u6548\u6027\u68c0\u6d4b\u6b65\u9aa4\u624d\u663e\u5f97\u5c24\u4e3a\u91cd\u8981\uff0c\u5176\u610f\u4e49\u4e0d\u4ec5\u5728\u4e8e\u7a0b\u5e8f\u5c42\u9762\uff0c\u66f4\u5728\u4e8e\u5546\u4e1a\u5c42\u9762\u3002\u90a3\u4e9b\u63d0\u524d\u901a\u8fc7\u8fd9\u4e00\u6b65\u9aa4\u7684\u4ea7\u54c1\uff0c\u80fd\u591f\u6bd4\u4ecd\u5728\u6536\u96c6\u6570\u636e\u7684\u7ade\u4e89\u5bf9\u624b\u66f4\u5feb\u5730\u8fdb\u5165\u533b\u9662\u3001\u5b9e\u9a8c\u5ba4\u548c\u56fd\u5bb6\u7b5b\u67e5\u9879\u76ee\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7531\u4e8e\u9700\u6c42\u96c6\u4e2d\u5728\u7279\u5b9a\u7701\u4efd\u3001\u75be\u75c5\u9879\u76ee\u548c\u91c7\u8d2d\u6e20\u9053\uff0c\u6211\u4eec\u8fd8\u5e2e\u52a9\u5ba2\u6237\u91cf\u5316\u5b9e\u9645\u53ef\u89e6\u8fbe\u7684\u9700\u6c42\u548c\u4e70\u5bb6\u7fa4\u4f53\uff0c\u4ee5\u53ca\u76d1\u7ba1\u6587\u4ef6\uff0c\u56e0\u6b64 D \u7c7b\u4f53\u5916\u8bca\u65ad\u4ea7\u54c1\u7684\u4e0a\u5e02\u65e2\u6709\u5546\u4e1a\u6570\u636e\u652f\u6301\uff0c\u4e5f\u6709\u5df2\u6279\u51c6\u7684\u8bb8\u53ef\u8bc1\u652f\u6301\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4e3a\u4ec0\u4e48\u4f01\u4e1a\u9009\u62e9\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u8fdb\u884c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5c3c\uff0c\u9996\u6b21\u6b63\u786e\u63d0\u4ea4\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u4ea7\u54c1\u7533\u62a5\u8d44\u6599\u4ec5\u4ec5\u662f\u51b3\u5b9a\u4ea7\u54c1\u80fd\u5426\u6210\u529f\u7684\u4e00\u534a\u3002\u53e6\u4e00\u534a\u5728\u4e8e\u4e86\u89e3\u5e02\u573a\u662f\u5426\u5b58\u5728\uff0c\u4ee5\u53ca\u5e02\u573a\u5728\u54ea\u91cc\u3002\u5982\u679c\u4f01\u4e1a\u5c06\u8fd9\u4e24\u8005\u89c6\u4e3a\u4e24\u4e2a\u72ec\u7acb\u7684\u5de5\u4f5c\u6d41\u7a0b\u2014\u2014\u4e00\u65b9\u9762\u662f\u76d1\u7ba1\uff0c\u53e6\u4e00\u65b9\u9762\u662f\u5546\u4e1a\u7814\u7a76\u2014\u2014\u6700\u7ec8\u5f80\u5f80\u4f1a\u5bfc\u81f4\u4ea7\u54c1\u83b7\u5f97\u56fd\u5bb6\u8fdb\u53e3\u8bb8\u53ef\uff08NIE\uff09\uff0c\u4f46\u5374\u59cb\u7ec8\u627e\u4e0d\u5230\u4e70\u5bb6\uff1b\u6216\u8005\u5728\u4ea7\u54c1\u5206\u7c7b\u5c1a\u672a\u5f97\u5230\u786e\u8ba4\u7684\u60c5\u51b5\u4e0b\u5c31\u5236\u5b9a\u4e86\u5546\u4e1a\u8ba1\u5212\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ea7\u54c1\u6ce8\u518c\u5370\u5c3c\u516c\u53f8\u65e8\u5728\u5f25\u5408\u8fd9\u4e00\u5dee\u8ddd\u3002\u6211\u4eec\u7684\u76d1\u7ba1\u56e2\u961f\u8d1f\u8d23\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7684\u5206\u7c7b\u3001\u4e1c\u76df\u7efc\u5408\u6807\u51c6\u8bca\u65ad\u5de5\u5177 (CSDT) \u7684\u51c6\u5907\u5de5\u4f5c\u4ee5\u53ca\u4e0e\u5370\u5c3c\u536b\u751f\u90e8 (Kemenkes) \u7684\u6c9f\u901a\uff0c\u5305\u62ecD\u7c7b\u4f20\u67d3\u75c5\u8bca\u65ad\u8bd5\u5242\u901a\u5e38\u9700\u8981\u8fdb\u884c\u7684\u989d\u5916\u6709\u6548\u6027\u6d4b\u8bd5\u6b65\u9aa4\u3002\u6b64\u5916\uff0c\u6211\u4eec\u8fd8\u80fd\u63d0\u4f9b\u5e02\u573a\u60c5\u62a5\uff0c\u5373\u5ba2\u6237\u62df\u8fdb\u5165\u7684\u7279\u5b9a\u75be\u75c5\u9886\u57df\u4e2d\u5173\u4e8e\u68c0\u6d4b\u9700\u6c42\u3001\u91c7\u8d2d\u6e20\u9053\u548c\u4e70\u5bb6\u7fa4\u4f53\u7684\u771f\u5b9e\u6570\u636e\uff0c\u4ece\u800c\u786e\u4fdd\u6ce8\u518c\u51b3\u7b56\u548c\u5546\u4e1a\u51b3\u7b56\u57fa\u4e8e\u540c\u4e00\u5957\u4fe1\u606f\uff0c\u800c\u975e\u5404\u81ea\u72ec\u7acb\u7684\u731c\u6d4b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u809d\u708e\u6216\u827e\u6ecb\u75c5\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u800c\u8a00\uff0c\u8fd9\u79cd\u7ec4\u5408\u5f80\u5f80\u6bd4\u5176\u4ed6\u8bd5\u5242\u66f4\u4e3a\u91cd\u8981\u3002\u9700\u6c42\u771f\u5b9e\u5b58\u5728\u4e14\u6709\u636e\u53ef\u67e5\uff0c\u4f46\u4e3b\u8981\u96c6\u4e2d\u5728\u7279\u5b9a\u7701\u4efd\u3001\u56fd\u5bb6\u7b5b\u67e5\u9879\u76ee\u4ee5\u53ca\u533b\u9662\u6216\u5b9e\u9a8c\u5ba4\u7684\u91c7\u8d2d\u6e20\u9053\uff0c\u800c\u5bf9\u4eff\u5236\u836f\u5e02\u573a\u7684\u5047\u8bbe\u5f80\u5f80\u7ecf\u4e0d\u8d77\u63a8\u6572\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u60a8\u6b63\u5728\u51c6\u5907\u63d0\u4ea4\u6587\u4ef6\uff0c\u6211\u4eec\u7684 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/medical-device-registration-indonesia\/\">\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u670d\u52a1<\/a> \u6211\u4eec\u5168\u7a0b\u8d1f\u8d23\u5904\u7406\u6863\u6848\u548c\u51ef\u95e8\u514b\u65af\u7684\u6765\u5f80\u4fe1\u51fd\uff0c\u4ee5\u53ca\u6211\u4eec\u7684 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/license-holder-service-in-indonesia\/\">\u5370\u5c3c\u6301\u724c\u670d\u52a1<\/a> \u5982\u679c\u60a8\u8fd8\u6ca1\u6709\u7b26\u5408\u89c4\u5b9a\u7684\u672c\u5730\u5b9e\u4f53\uff0c\u5219\u53ef\u4ee5\u6301\u6709 NIE\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f53\u5e02\u573a\u89c4\u6a21\u4e0e\u5206\u7c7b\u672c\u8eab\u540c\u6837\u91cd\u8981\u65f6\uff0c\u6211\u4eec\u7684 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/local-distributor-selection-indonesia\/\">\u5370\u5c3c\u5206\u9500\u5546\u7504\u9009\u670d\u52a1<\/a> \u5c06\u76d1\u7ba1\u7b56\u7565\u4e0e\u4f20\u67d3\u75c5\u548c\u5176\u4ed6\u9ad8\u98ce\u9669\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7684\u9700\u6c42\u3001\u5b9a\u4ef7\u548c\u5206\u9500\u8303\u56f4\u7684\u5546\u4e1a\u6570\u636e\u76f8\u7ed3\u5408\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u9700\u4e86\u89e3 Kemenkes \u5982\u4f55\u5728\u5b9e\u8df5\u4e2d\u5e94\u7528\u57fa\u4e8e\u98ce\u9669\u7684\u89c4\u5219\uff0c\u8bf7\u53c2\u9605\u6211\u4eec\u5173\u4e8e\u6b64\u4e3b\u9898\u7684\u6587\u7ae0\u3002 <strong>\u5370\u5c3c\u7ffb\u65b0\u533b\u7597\u5668\u68b0\uff1a\u65b0\u8fdb\u53e3\u89c4\u5219\u7a76\u7adf\u5141\u8bb8\u4e86\u4ec0\u4e48<\/strong><strong>.<\/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=\"3kRhuas9OG\"><a href=\"https:\/\/productregistrationindonesia.com\/zh\/refurbished-medical-devices-indonesia-import-guide\/\">\u5370\u5c3c\u7ffb\u65b0\u533b\u7597\u5668\u68b0\uff1a\u65b0\u8fdb\u53e3\u89c4\u5219\u7a76\u7adf\u5141\u8bb8\u4e86\u4ec0\u4e48<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u5370\u5c3c\u7ffb\u65b0\u533b\u7597\u5668\u68b0\uff1a\u65b0\u8fdb\u53e3\u89c4\u5219\u7684\u5b9e\u9645\u5141\u8bb8\u8303\u56f4\u201d\u2014\u2014\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\" src=\"https:\/\/productregistrationindonesia.com\/refurbished-medical-devices-indonesia-import-guide\/embed\/#?secret=4zdmbIEzYj#?secret=3kRhuas9OG\" data-secret=\"3kRhuas9OG\" 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>\u8054\u7cfb\u6211\u4eec\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u56e2\u961f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5c3c\uff0c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff08IVD\uff09\u4e0a\u5e02\u5931\u8d25\u5f88\u5c11\u662f\u56e0\u4e3a\u6587\u4ef6\u51c6\u5907\u56f0\u96be\u3002\u901a\u5e38\u5931\u8d25\u7684\u539f\u56e0\u5728\u4e8e\uff0c\u5206\u7c7b\u3001\u4e34\u5e8a\u8bc1\u636e\u6216\u5e02\u573a\u89c4\u6a21\u7684\u786e\u5b9a\u4e3a\u65f6\u5df2\u665a\uff0c\u65e0\u6cd5\u53ca\u65f6\u8c03\u6574\u3002\u8fd9\u4e9b\u90fd\u4e0d\u8db3\u4e3a\u5947\u3002\u5982\u679c\u60a8\u7684\u4ea7\u54c1\u63a5\u8fd1D\u7c7b\uff0c\u6216\u8005\u7528\u4e8e\u8bca\u65ad\u827e\u6ecb\u75c5\u6216\u809d\u708e\u7b49\u4f20\u67d3\u75c5\uff0c\u90a3\u4e48\u5728\u63d0\u4ea4\u7533\u8bf7\u524d\u786e\u4fdd\u5206\u7c7b\u548c\u8bc1\u636e\u8ba1\u5212\u7684\u6b63\u786e\u6027\uff0c\u662f\u4fdd\u969c\u60a8\u6309\u65f6\u4e0a\u5e02\u7684\u6700\u5173\u952e\u56e0\u7d20\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6211\u4eec\u7684\u56e2\u961f\u5df2\u7ecf\u591a\u6b21\u7ecf\u5386\u8fc7\u7c7b\u4f3c\u7684\u6289\u62e9\u9636\u6bb5\uff0c\u6df1\u77e5\u901a\u5e38\u4f1a\u5728\u54ea\u4e9b\u65b9\u9762\u51fa\u9519\uff0c\u4ee5\u53ca\u5982\u4f55\u4ece\u4e00\u5f00\u59cb\u5c31\u89c4\u907f\u8fd9\u4e9b\u95ee\u9898\u3002\u65e0\u8bba\u60a8\u662f\u5728\u786e\u5b9a\u4ea7\u54c1\u5206\u7c7b\u3001\u6536\u96c6\u4e34\u5e8a\u8bc1\u636e\uff0c\u8fd8\u662f\u5728\u6295\u5165\u9884\u7b97\u524d\u8bd5\u56fe\u4e86\u89e3\u771f\u5b9e\u7684\u5e02\u573a\u89c4\u6a21\uff0c\u6211\u4eec\u90fd\u4e50\u610f\u8bc4\u4f30\u60a8\u7684\u4ea7\u54c1\uff0c\u5e76\u5766\u8bda\u5730\u544a\u8bc9\u60a8\u9884\u671f\u7ed3\u679c\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bf7\u901a\u8fc7\u6211\u4eec\u7684\u8054\u7cfb\u65b9\u5f0f\u8054\u7cfb\u6211\u4eec <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/medical-device-registration-indonesia\/\">\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u670d\u52a1\u9875\u9762<\/a>, \u6216\u8005\uff0c\u60a8\u4e5f\u53ef\u4ee5\u901a\u8fc7\u4e0b\u9762\u7684\u8868\u683c\u63d0\u4ea4\u60a8\u7684\u8bf7\u6c42\uff0c\u6211\u4eec\u7684\u76d1\u7ba1\u56e2\u961f\u5c06\u8ddf\u8fdb\u60a8\u7279\u5b9a\u4ea7\u54c1\u548c\u7c7b\u522b\u7684\u540e\u7eed\u6b65\u9aa4\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>Indonesia&#8217;s diagnostics market has grown fast enough that many manufacturers now assume an in vitro diagnostic product can be registered exactly the way a standard medical device is, using the same dossier, the same timeline, and the same expectations. For most risk classes, that assumption holds up fine. For one specific group of IVDs, it [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":7728,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7727","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\/7727","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=7727"}],"version-history":[{"count":1,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7727\/revisions"}],"predecessor-version":[{"id":7731,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7727\/revisions\/7731"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/7728"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=7727"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=7727"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=7727"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=7727"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}