{"id":7771,"date":"2026-09-24T11:31:37","date_gmt":"2026-09-24T04:31:37","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=7771"},"modified":"2026-09-22T11:35:54","modified_gmt":"2026-09-22T04:35:54","slug":"registering-high-energy-therapeutic-equipment","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/registering-high-energy-therapeutic-equipment\/","title":{"rendered":"\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\uff1a\u8d28\u5b50\u6cbb\u7597\u3001\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\u548c\u76f4\u7ebf\u52a0\u901f\u5668"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u5927\u591a\u6570\u533b\u9662\u96c6\u56e2\u548c\u5236\u9020\u5546\u800c\u8a00\uff0c\u5c06\u8d28\u5b50\u6cbb\u7597\u3001\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\u6216\u76f4\u7ebf\u52a0\u901f\u5668\u7cfb\u7edf\u5f15\u5165\u5370\u5c3c\u6700\u56f0\u96be\u7684\u5e76\u975e\u7e41\u7410\u7684\u624b\u7eed\u672c\u8eab\uff0c\u800c\u662f\u672a\u80fd\u53ca\u65e9\u610f\u8bc6\u5230\uff0c\u5370\u5c3c\u7684\u4e24\u4e2a\u76d1\u7ba1\u673a\u6784\uff08\u5370\u5c3c\u56fd\u5bb6\u533b\u7597\u536b\u751f\u90e8\u548c\u8f90\u5c04\u5b89\u5168\u76d1\u7ba1\u673a\u6784\uff09\u9700\u8981\u4ece\u4e24\u4e2a\u622a\u7136\u4e0d\u540c\u7684\u89d2\u5ea6\u5ba1\u67e5\u540c\u4e00\u8bbe\u5907\uff1a\u4e00\u4e2a\u7528\u4e8e\u5e02\u573a\u51c6\u5165\u5ba1\u6279\uff0c\u4e00\u4e2a\u7528\u4e8e\u8f90\u5c04\u5b89\u5168\u8bc4\u4f30\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u79cd\u4fe1\u606f\u4e0d\u900f\u660e\u662f\u9020\u6210\u5927\u591a\u6570\u5ef6\u8bef\u7684\u6839\u6e90\u3002\u7533\u8bf7\u4eba\u5f80\u5f80\u5148\u83b7\u5f97\u4e86\u5fb7\u56fd\u6838\u80fd\u76d1\u7ba1\u673a\u6784\uff08Kemenkes\uff09\u7684\u4e0a\u5e02\u8bb8\u53ef\uff0c\u5374\u53d1\u73b0\u8f90\u5c04\u9632\u62a4\u7f69\u7684\u5efa\u9020\u8bb8\u53ef\u8bc1\u53d6\u51b3\u4e8e\u5c4f\u853d\u8ba1\u7b97\uff0c\u800c\u8fd9\u4e9b\u8ba1\u7b97\u53c8\u4e0e\u4ecd\u5728\u6700\u7ec8\u786e\u5b9a\u7684\u8bbe\u5907\u89c4\u683c\u76f8\u5173\u3002\u7b49\u5230\u53d1\u73b0\u8fd9\u79cd\u4e0d\u5339\u914d\u65f6\uff0c\u51e0\u4e2a\u6708\u7684\u5de5\u671f\u5c31\u5df2\u7ecf\u767d\u767d\u6d6a\u8d39\u4e86\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u6307\u5357\u4e13\u4e3a\u8ba1\u5212\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u8fdb\u53e3\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\u6216\u5efa\u8bbe\u76f8\u5173\u8bbe\u65bd\u7684\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u3001\u533b\u9662\u96c6\u56e2\u548c\u5206\u9500\u5546\u7f16\u5199\u3002\u6307\u5357\u9610\u8ff0\u4e86\u54ea\u4e9b\u673a\u6784\u8d1f\u8d23\u5ba1\u6279\u3001\u5206\u7c7b\u548c\u8f90\u5c04\u8bb8\u53ef\u5982\u4f55\u76f8\u4e92\u4f5c\u7528\uff0c\u4ee5\u53ca\u4e3a\u4ec0\u4e48\u771f\u6b63\u5e76\u884c\u63a8\u8fdb\u8fd9\u4e24\u9879\u5de5\u4f5c\uff08\u800c\u4e0d\u4ec5\u4ec5\u662f\u7eb8\u4e0a\u8c08\u5175\uff09\u624d\u80fd\u786e\u4fdd\u8bbe\u65bd\u6309\u8ba1\u5212\u5b8c\u6210\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u4e3a\u4ec0\u4e48\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\u662f\u5370\u5c3c\u6ce8\u518c\u96be\u5ea6\u6700\u9ad8\u7684\u7c7b\u522b\u4e4b\u4e00<\/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\/High-Energy-Therapeutic-Equipment-Registration-in-Indonesia-2.webp\" alt=\"\u5370\u5c3c\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\u6ce8\u518c\" class=\"wp-image-7773\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/High-Energy-Therapeutic-Equipment-Registration-in-Indonesia-2.webp 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/High-Energy-Therapeutic-Equipment-Registration-in-Indonesia-2-300x200.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/High-Energy-Therapeutic-Equipment-Registration-in-Indonesia-2-768x512.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u7684\u6240\u6709\u533b\u7597\u5668\u68b0\u7c7b\u522b\u4e2d\uff0c\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\u59cb\u7ec8\u662f\u6700\u5177\u6311\u6218\u6027\u7684\u4e0a\u5e02\u4ea7\u54c1\u4e4b\u4e00\u3002\u8d28\u5b50\u6cbb\u7597\u7cfb\u7edf\u3001\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\u540e\u88c5\u673a\u548c\u76f4\u7ebf\u52a0\u901f\u5668\u540c\u65f6\u6d89\u53ca\u4e24\u79cd\u76d1\u7ba1\u5236\u5ea6\uff1a\u533b\u7597\u5668\u68b0\u4e0a\u5e02\u8bb8\u53ef\u548c\u6838\u8f90\u5c04\u5b89\u5168\u8bb8\u53ef\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u5bf9\u8be5\u7c7b\u522b\u533b\u7597\u5668\u68b0\u7684\u6280\u672f\u5ba1\u67e5\u4e25\u683c\u7a0b\u5ea6\u4e0e\u6b27\u76df\u7684\u8bc4\u4f30\u6807\u51c6\u76f8\u5f53\uff0c\u5c3d\u7ba1\u4e24\u8005\u7684\u4f53\u7cfb\u5e76\u4e0d\u5b8c\u5168\u517c\u5bb9\u3002\u5370\u5c3c\u7684\u8bc4\u4f30\u6846\u67b6\u5efa\u7acb\u5728\u5168\u7403\u7edf\u4e00\u6807\u51c6\u4e4b\u4e0a\uff0c\u4e3b\u8981\u662f\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff0c\u800c\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4\u672c\u8eab\u53c8\u5927\u91cf\u501f\u9274\u4e86\u6b27\u76df\u548c\u56fd\u9645\u533b\u7597\u5668\u68b0\u98ce\u9669\u8bba\u575b\uff08IMDRF\uff09\u7684\u98ce\u9669\u5206\u7c7b\u6a21\u578b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\u9700\u8981\u54ea\u4e9b\u6761\u4ef6\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\u9700\u8981\u83b7\u5f97\u4e24\u9879\u4e0d\u540c\u7684\u653f\u5e9c\u8bb8\u53ef\u3002\u9996\u5148\u662f\u83b7\u5f97\u5370\u5c3c\u56fd\u5bb6\u536b\u751f\u90e8\uff08Kemenkes\uff09\u7684\u4e0a\u5e02\u8bb8\u53ef\uff0c\u5373Nomor Izin Edar (NIE)\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>, \u7531\u4e8e\u8fd9\u4e9b\u8bbe\u5907\u901a\u5e38\u4f1a\u88ab\u8bc4\u4f30\u4e3aC\u7c7b\u6216D\u7c7b\u8bbe\u5907\uff0c\u56e0\u4e3a\u5b83\u4eec\u6709\u53ef\u80fd\u5411\u4eba\u4f53\u4f20\u9012\u5305\u62ec\u7535\u79bb\u8f90\u5c04\u5728\u5185\u7684\u6709\u5bb3\u80fd\u91cf\u3002\u5176\u6b21\uff0c\u8fd8\u9700\u8981\u83b7\u5f97\u5370\u5ea6\u5c3c\u897f\u4e9a\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u9881\u53d1\u7684\u591a\u9636\u6bb5\u8f90\u5c04\u8bb8\u53ef\u8bc1\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/4842\/pp-no-29-tahun-2008\" target=\"_blank\" rel=\"noopener\">PP No. 29\/2008<\/a> \u548c <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/4755\/pp-no-33-tahun-2007\" target=\"_blank\" rel=\"noopener\">PP No. 33\/2007<\/a>, \u6db5\u76d6\u7535\u79bb\u8f90\u5c04\u6e90\u7684\u8bbe\u65bd\u5efa\u8bbe\u548c\u4e34\u5e8a\u8fd0\u884c\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u8ffd\u8e2a<\/strong><\/td><td><strong>\u7ba1\u7406\u673a\u6784<\/strong><\/td><td><strong>\u6cd5\u5f8b\u4f9d\u636e<\/strong><\/td><td><strong>\u6db5\u76d6\u5185\u5bb9<\/strong><\/td><td><strong>\u5178\u578b\u8bbe\u5907<\/strong><\/td><\/tr><tr><td>Kemenkes \u8425\u9500\u6388\u6743<\/td><td>\u536b\u751f\u90e8\u533b\u7597\u5668\u68b0\u8bc4\u4f30\u5c40<\/td><td>2017\u5e74\u7b2c62\u53f7\u6cd5\u4ee4<\/td><td>\u4ea7\u54c1\u5b89\u5168\u3001\u8d28\u91cf\u548c\u6548\u76ca\u8bc4\u4f30\uff1b\u9881\u53d1Nomor Izin Edar (NIE)<\/td><td>\u76f4\u7ebf\u52a0\u901f\u5668\u3001\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\u540e\u88c5\u673a\u3001\u8d28\u5b50\u6cbb\u7597\u7cfb\u7edf<\/td><\/tr><tr><td>BAPETEN\u8f90\u5c04\u8bb8\u53ef\u8bc1<\/td><td>\u5df4\u4e39\u5f6d\u52a0\u74e6\u65af Tenaga Nuklir (BAPETEN)<\/td><td>PP \u53f7 29\/2008\uff1b PP \u53f7 33\/2007\uff1b\u4f69\u5361\u00b7\u5df4\u4f69\u6ed5 No. 3\/2013<\/td><td>\u8f90\u5c04\u5b89\u5168\u5ba1\u67e5\uff1b\u63a9\u4f53\u5efa\u9020\u8bb8\u53ef\u8bc1\uff1b\u8fd0\u884c\u8bb8\u53ef\u8bc1<\/td><td>\u76f8\u540c\u7684\u8bbe\u5907\uff0c\u88ab\u8bc4\u4f30\u4e3aA\u7ec4\u7535\u79bb\u8f90\u5c04\u6e90\u5229\u7528<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">Kemenkes\u5206\u7c7b\u548cNIE\u8def\u5f84<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u4e0e Permenkes No. 62\/2017 \u4e00\u8d77\u53d1\u5e03\u7684\u5206\u7c7b\u6307\u5357\uff0c\u4e0e\u4eba\u4f53\u8fdb\u884c\u80fd\u91cf\u4ea4\u6362\u7684\u4e3b\u52a8\u6cbb\u7597\u8bbe\u5907\u901a\u5e38\u5c5e\u4e8e B \u7c7b\u3002\u5982\u679c\u8003\u8651\u5230\u80fd\u91cf\u4ea4\u6362\u7684\u6027\u8d28\u3001\u5bc6\u5ea6\u548c\u5e94\u7528\u90e8\u4f4d\uff08\u5305\u62ec\u7535\u79bb\u8f90\u5c04\uff09\u800c\u5177\u6709\u6f5c\u5728\u5371\u9669\u6027\uff0c\u5219\u8be5\u8bbe\u5907\u5c06\u88ab\u63d0\u5347\u5230\u66f4\u9ad8\u7684\u7c7b\u522b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u56e0\u6b64\uff0c\u8d28\u5b50\u6cbb\u7597\u7cfb\u7edf\u3001\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\u540e\u88c5\u673a\u548c\u76f4\u7ebf\u52a0\u901f\u5668\u88ab\u8bc4\u4f30\u4e3a\u9ad8\u98ce\u9669\u8bbe\u5907\uff0c\u800c\u975e\u5e38\u89c4\u7684\u6cbb\u7597\u8bbe\u5907\u3002\u5728\u5f00\u59cb\u51c6\u5907\u7533\u62a5\u8d44\u6599\u4e4b\u524d\uff0c\u5e94\u4e0e\u6ce8\u518c\u76d1\u7ba1\u987e\u95ee\u786e\u8ba4\u786e\u5207\u7684\u5206\u7c7b\u548c\u4f50\u8bc1\u6750\u6599\uff0c\u56e0\u4e3a\u7533\u62a5\u9636\u6bb5\u7684\u9519\u8bef\u5206\u7c7b\u53ef\u80fd\u5bfc\u81f4\u9700\u8981\u91cd\u65b0\u63d0\u4ea4\u5168\u90e8\u8d44\u6599\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e2017\u5e74\u7b2c62\u53f7\u653f\u5e9c\u6cd5\u4ee4\uff0c\u8fdb\u53e3\u3001\u9500\u552e\u6216\u5206\u9500\u4efb\u4f55\u5546\u54c1\u524d\uff0c\u5fc5\u987b\u6301\u6709\u6709\u6548\u7684\u5916\u56fd\u4eba\u8eab\u4efd\u8bc1\u53f7\u7801\uff08NIE\uff09\uff0c\u8be5\u53f7\u7801\u81ea\u7b7e\u53d1\u4e4b\u65e5\u8d77\u6709\u6548\u671f\u6700\u957f\u4e3a\u4e94\u5e74\u3002\u65e0\u8eab\u4efd\u8bc1\u8fdb\u884c\u5206\u9500\u8fdd\u53cd\u4e862023\u5e74\u7b2c17\u53f7\u536b\u751f\u6cd5\u4ee4\u7b2c143\u6761\u7b2c\uff081\uff09\u6b3e\uff0c\u5e76\u5c06\u53d7\u5230\u884c\u653f\u5904\u7f5a\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u8f90\u5c04\u76d1\u7ba1\u5b89\u5168\u8bb8\u53ef\u8bc1<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u653e\u5c04\u6cbb\u7597\u6d3b\u52a8\uff0c\u5305\u62ec\u4f53\u5916\u653e\u5c04\u6cbb\u7597\u548c\u9065\u63a7\u540e\u88c5\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\uff0c\u88ab\u5f52\u7c7b\u4e3a <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/4842\/pp-no-29-tahun-2008\" target=\"_blank\" rel=\"noopener\">PP No. 29 Tahun 2008<\/a> Tentang Perizinan Pemanfaatan Sumber Radiasi Pengion dan Bahan Nuklir \u4f5c\u4e3a A \u7ec4\u7535\u79bb\u8f90\u5c04\u5229\u7528\u3002\u8fd9\u4f7f\u5176\u5904\u4e8e\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u6700\u4e25\u683c\u7684\u8bb8\u53ef\u7ea7\u522b\u4e4b\u4e0b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/jdih.bapeten.go.id\/id\/dokumen\/peraturan\/peraturan-kepala-badan-pengawas-tenaga-nuklir-nomor-3-tahun-2013-tentang-keselamatan-radiasi-dalam-penggunaan-radioterapi\" target=\"_blank\" rel=\"noopener\">\u4f69\u5361\u00b7\u5df4\u4f69\u6ed5 No.3 \u5854\u6d2a 2013<\/a> \u300a\u653e\u5c04\u6cbb\u7597\u8f90\u5c04\u5b89\u5168\u6761\u4f8b\u300b\uff08Tentang Keselamatan Radiasi Dalam Penggunaan Radioterapi\uff09\u89c4\u5b9a\u4e86\u653e\u5c04\u6cbb\u7597\u7279\u6709\u7684\u8f90\u5c04\u5b89\u5168\u8981\u6c42\u3001\u8bb8\u53ef\u6761\u4ef6\u548c\u62a5\u544a\u4e49\u52a1\u3002\u8bb8\u53ef\u5ba1\u6279\u5206\u9636\u6bb5\u8fdb\u884c\uff0c\u9996\u5148\u662f\u6cbb\u7597\u5ba4\u7684\u5efa\u9020\u8bb8\u53ef\u8bc1\uff0c\u5f85\u8bbe\u65bd\u901a\u8fc7\u73b0\u573a\u9a8c\u8bc1\u540e\uff0c\u518d\u9881\u53d1\u5355\u72ec\u7684\u8fd0\u884c\u8bb8\u53ef\u8bc1\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PP No. 33 Tahun 2007 tentang Keselamatan Radiasi Pengion dan Keamanan Sumber Radioaktif \u89c4\u5b9a\u4e86\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u5728\u65bd\u5de5\u548c\u8fd0\u8425\u5ba1\u67e5\u9636\u6bb5\u9002\u7528\u7684\u57fa\u672c\u8f90\u5c04\u5b89\u5168\u548c\u5b89\u4fdd\u6807\u51c6\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5982\u679c\u4e00\u6b3e\u8bbe\u5907\u5728\u6b27\u6d32\u83b7\u5f97\u6279\u51c6\uff0c\u5b83\u53ef\u4ee5\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u5417\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">CE\u6807\u5fd7\u6216\u5df2\u5728\u6b27\u76df\u83b7\u5f97\u7684\u8ba4\u8bc1\u5e76\u4e0d\u4f1a\u81ea\u52a8\u8f6c\u79fb\u3002\u5370\u5c3c\u7684\u5206\u7c7b\u4f53\u7cfb\u4e0e\u56fd\u9645\u6846\u67b6\u76f8\u534f\u8c03\uff0c\u56e0\u6b64\u62e5\u6709\u5b8c\u5584\u7684\u6b27\u76df\u6280\u672f\u6587\u4ef6\u7684\u8bbe\u5907\u5177\u6709\u660e\u663e\u7684\u4f18\u52bf\uff0c\u4f46\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u4ecd\u7136\u8981\u6c42\u63d0\u4f9b\u5b8c\u5168\u672c\u5730\u5316\u7684\u8d44\u6599\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u672c\u5730\u5316\u6587\u4ef6\u5305\u542b\u5370\u5c3c\u8bed\u6807\u7b7e\u3001\u6307\u5b9a\u7684\u672c\u5730\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\uff0c\u4ee5\u53ca\u6309\u7167\u5370\u5c3c\u81ea\u8eab\u6a21\u677f\u800c\u975e\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u683c\u5f0f\u7f16\u5199\u7684\u6587\u4ef6\u3002\u5370\u5c3c\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u4e5f\u9075\u5faa\u540c\u6837\u7684\u539f\u5219\uff0c\u65e0\u8bba\u662f\u5426\u4e8b\u5148\u83b7\u5f97\u6b27\u76df\u6216\u65e5\u672c\u7684\u6279\u51c6\uff0c\u90fd\u4f1a\u6839\u636e\u5370\u5c3c\u7684\u5b89\u5168\u6cd5\u89c4\u8bc4\u4f30\u8f90\u5c04\u6e90\u548c\u5c4f\u853d\u8bbe\u8ba1\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5370\u5c3c\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\u5e02\u573a\u89c4\u6a21\u6709\u591a\u5927\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u5bf9\u5148\u8fdb\u653e\u5c04\u6cbb\u7597\u80fd\u529b\u7684\u9700\u6c42\u5de8\u5927\uff0c\u4e14\u4ecd\u5728\u4e0d\u65ad\u53d1\u5c55\u3002\u636e\u57c3\u5361\u533b\u9662\u7684\u57c3\u5361\u00b7\u8482\u666e\u5854\u00b7\u7ef4\u8d3e\u4e9a\u764c\u75c7\u4e2d\u5fc3\u79f0\uff0c\u622a\u81f32025\u5e7412\u6708\uff0c\u5370\u5c3c\u5883\u5185\u5c1a\u65e0\u4efb\u4f55\u8d28\u5b50\u6cbb\u7597\u6280\u672f\u6295\u5165\u4e34\u5e8a\u5e94\u7528\u3002\u8be5\u4e2d\u5fc3\u8ba1\u5212\u4e8e2027\u5e74\u5efa\u6210\u5370\u5c3c\u9996\u4e2a\u6295\u5165\u8fd0\u8425\u7684\u8d28\u5b50\u6cbb\u7597\u4e2d\u5fc3\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b64\u5916\uff0cRS Kanker Dharmais \u8fd8\u4e0e\u65e5\u672c Medipolis \u8d28\u5b50\u6cbb\u7597\u7814\u7a76\u4e2d\u5fc3\u5f00\u5c55\u4e86\u6280\u672f\u8f6c\u8ba9\u5408\u4f5c\uff0c\u65e8\u5728\u5efa\u7acb\u672c\u5730\u8d28\u5b50\u675f\u6cbb\u7597\u80fd\u529b\u3002\u8fd9\u4e24\u9879\u4e3e\u63aa\u90fd\u6307\u5411\u540c\u4e00\u4e2a\u6839\u672c\u539f\u56e0\uff1a\u5927\u91cf\u764c\u75c7\u60a3\u8005\u76ee\u524d\u4e0d\u5f97\u4e0d\u524d\u5f80\u56fd\u5916\uff08\u4e3b\u8981\u524d\u5f80\u65e5\u672c\u3001\u65b0\u52a0\u5761\u548c\u9a6c\u6765\u897f\u4e9a\uff09\u63a5\u53d7\u672c\u56fd\u65e0\u6cd5\u63d0\u4f9b\u7684\u6cbb\u7597\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5177\u4f53\u800c\u8a00\uff0c\u76f4\u7ebf\u52a0\u901f\u5668\u548c\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\u540e\u88c5\u673a\u7684\u9700\u6c42\u66f4\u4e3a\u7a33\u5b9a\uff0c\u56e0\u4e3a\u5b83\u4eec\u5df2\u6210\u4e3a\u5370\u5c3c\u65e5\u76ca\u58ee\u5927\u7684\u764c\u75c7\u4e2d\u5fc3\u7f51\u7edc\u4e2d\u7684\u6807\u51c6\u6cbb\u7597\u8bbe\u5907\u3002\u8fdb\u5165\u8fd9\u4e00\u9886\u57df\u7684\u5236\u9020\u5546\u548c\u5206\u9500\u5546\u5e76\u975e\u5728\u5f00\u62d3\u65b0\u7684\u5e02\u573a\u7c7b\u522b\uff0c\u800c\u662f\u5728\u4e00\u4e2a\u6d3b\u8dc3\u4e14\u76d1\u7ba1\u4e25\u683c\u7684\u5e02\u573a\u4e2d\u4e89\u593a\u4efd\u989d\u3002\u5728\u8fd9\u4e2a\u5e02\u573a\u4e2d\uff0c\u6bcf\u53f0\u552e\u51fa\u7684\u8bbe\u5907\u90fd\u9700\u8981\u83b7\u5f97\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u7684\u8bb8\u53ef\u548c\u8f90\u5c04\u8bb8\u53ef\u8bc1\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u6ce8\u518c\u65f6\u95f4\u8868\uff1a\u9020\u6210\u5ef6\u8bef\u7684\u771f\u6b63\u539f\u56e0\u662f\u4ec0\u4e48\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u4ee5\u4e0b\u4e09\u4e2a\u56e0\u7d20\u901a\u5e38\u51b3\u5b9a\u6b64\u7c7b\u60a3\u8005\u63a5\u53d7 Kemenkes \u548c\u653e\u5c04\u6cbb\u7597\u540e\u9700\u8981\u591a\u957f\u65f6\u95f4\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Kemenkes NIE\u6863\u6848\u548c\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u65bd\u5de5\u8bb8\u53ef\u8bc1\u662f\u5e76\u884c\u63d0\u4ea4\u8fd8\u662f\u5148\u540e\u63d0\u4ea4<\/li>\n\n\n\n<li>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\uff08\u5982\u8d28\u5b50\u6cbb\u7597\u3001\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\u548c\u76f4\u7ebf\u52a0\u901f\u5668\uff09\u65f6\uff0c\u5730\u70b9\u4e0d\u7b26\u5408\u5176\u9884\u671f\u7684\u533a\u57df\u5212\u5206\u3002.\u00a0<\/li>\n\n\n\n<li>\u65e0\u8bba\u5c4f\u853d\u548c\u63a9\u4f53\u8bbe\u8ba1\u662f\u5728\u4e4b\u524d\u8fd8\u662f\u4e4b\u540e\u6700\u7ec8\u786e\u5b9a\uff0c\u8bbe\u5907\u89c4\u683c\u90fd\u5df2\u4e0e\u5236\u9020\u5546\u9501\u5b9a\u3002<\/li>\n\n\n\n<li>\u65e0\u8bba\u7533\u8bf7\u4eba\u662f\u5426\u5df2\u5177\u5907\u7ecf\u8ba4\u53ef\u7684\u672c\u5730\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u548c\u8f90\u5c04\u9632\u62a4\u5b98\u5b89\u6392\uff0c\u6216\u8005\u9700\u8981\u5efa\u7acb\u6b64\u7c7b\u5b89\u6392\uff0c\u90fd\u5e94\u8003\u8651\u5728\u5185\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u4e9b\u56e0\u7d20\u5e76\u975e\u4ec5\u9760\u6cd5\u89c4\u5c31\u80fd\u89e3\u51b3\u3002\u5b83\u4eec\u53d6\u51b3\u4e8e\u7533\u8bf7\u7b56\u7565\u4ece\u4e00\u5f00\u59cb\u5c31\u5982\u4f55\u6784\u5efa\uff0c\u56e0\u6b64\uff0c\u6b64\u7c7b\u7533\u8bf7\u7684\u65f6\u95f4\u89c4\u5212\u5e94\u4e0e\u76d1\u7ba1\u5408\u4f5c\u4f19\u4f34\u5171\u540c\u5236\u5b9a\uff0c\u800c\u975e\u5b64\u7acb\u5730\u8fdb\u884c\u4f30\u7b97\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u6b64\u7c7b\u5e38\u89c1\u9677\u9631<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5c06Kemenkes\u548c\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u7533\u8bf7\u89c6\u4e3a\u4e00\u4e2a\u5408\u5e76\u6d41\u7a0b\uff0c\u800c\u5b9e\u9645\u4e0a\u5b83\u4eec\u5728\u6cd5\u5f8b\u548c\u7a0b\u5e8f\u4e0a\u662f\u72ec\u7acb\u7684\u7533\u8bf7\uff0c\u7531\u4e0d\u540c\u7684\u5ba1\u67e5\u5458\u8fdb\u884c\u5ba1\u67e5\u3002<\/li>\n\n\n\n<li>\u5047\u8bbe\u5e26\u6709 CE \u6807\u5fd7\u7684\u8bbe\u5907\u53ea\u9700\u8981\u7ffb\u8bd1\uff0c\u4f46\u5370\u5c3c\u7684\u7533\u62a5\u6587\u4ef6\u7ed3\u6784\u672c\u8eab\u4e0e\u6b27\u76df MDR \u6280\u672f\u6587\u4ef6\u683c\u5f0f\u4e0d\u540c\u3002<\/li>\n\n\n\n<li>\u6700\u7ec8\u786e\u5b9a\u7b26\u5408\u5206\u533a\u89c4\u5b9a\u7684\u9ad8\u80fd\u6cbb\u7597\u8bbe\u5907\uff08\u4f8b\u5982\u8d28\u5b50\u6cbb\u7597\u3001\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\u548c\u76f4\u7ebf\u52a0\u901f\u5668\uff09\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u7684\u573a\u5730\u3002\u00a0<\/li>\n\n\n\n<li>\u5728\u4e0e\u8bbe\u5907\u5236\u9020\u5546\u786e\u8ba4\u6700\u7ec8\u675f\u6d41\u80fd\u91cf\u548c\u6e90\u89c4\u683c\u4e4b\u524d\uff0c\u786e\u5b9a\u63a9\u4f53\u7ed3\u6784\u3002<\/li>\n\n\n\n<li>\u4f4e\u4f30\u4e86\u5730\u65b9\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u5728NIE\u548c\u8f90\u5c04\u8bb8\u53ef\u8bc1\u9881\u53d1\u540e\u6301\u7eed\u7684\u62a5\u544a\u4e49\u52a1\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u6b63\u786e\u7406\u89e3 Kemenkes-\u8f90\u5c04\u8c03\u8282\u5668\u5e8f\u5217<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5c3c\uff0c\u80fd\u5426\u6210\u529f\u7533\u8bf7\u6b64\u7c7b\u7b7e\u8bc1\uff0c\u4e0e\u5176\u8bf4\u662f\u53d6\u51b3\u4e8e\u5355\u4e00\u8868\u683c\uff0c\u4e0d\u5982\u8bf4\u662f\u53d6\u51b3\u4e8e\u5370\u5c3c\u73af\u5883\u3001\u5de5\u4e1a\u548c\u80fd\u6e90\u90e8\uff08Kemenkes\uff09\u548c\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u7b56\u7565\u80fd\u5426\u53ca\u65f6\u534f\u8c03\u4e00\u81f4\u3002\u4ece\u4e00\u5f00\u59cb\u5c31\u5c06\u4e24\u6761\u9014\u5f84\u7ed3\u5408\u8d77\u6765\uff0c\u800c\u4e0d\u662f\u5c06\u5176\u89c6\u4e3a\u5faa\u5e8f\u6e10\u8fdb\u7684\u6b65\u9aa4\u7684\u7533\u8bf7\u4eba\uff0c\u901a\u5e38\u6bd4\u90a3\u4e9b\u5148\u63d0\u4ea4\u7533\u8bf7\u540e\u518d\u8fdb\u884c\u8c03\u6574\u7684\u7533\u8bf7\u4eba\u901f\u5ea6\u66f4\u5feb\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u79cd\u6d41\u7a0b\u5b89\u6392\u4e0d\u4ec5\u4ec5\u6db5\u76d6\u6587\u4e66\u5de5\u4f5c\u3002\u5b83\u610f\u5473\u7740\u5728\u6700\u7ec8\u786e\u5b9a\u63a9\u4f53\u7ed3\u6784\u4e4b\u524d\uff0c\u9700\u8981\u4e0e\u5236\u9020\u5546\u786e\u8ba4\u675f\u6d41\u80fd\u91cf\u548c\u653e\u5c04\u6e90\u89c4\u683c\uff1b\u5c3d\u65e9\u5b89\u6392\u597d\u7ecf\u8ba4\u53ef\u7684\u5f53\u5730\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u548c\u8f90\u5c04\u9632\u62a4\u5b98\u5458\uff1b\u5e76\u5c06Kemenkes\u6863\u6848\u548c\u8f90\u5c04\u8bb8\u53ef\u8bc1\u7533\u8bf7\u4f5c\u4e3a\u4e00\u4e2a\u534f\u8c03\u7684\u7b56\u7565\u6765\u51c6\u5907\uff0c\u800c\u4e0d\u662f\u4e24\u4e2a\u4e92\u4e0d\u76f8\u5173\u7684\u7533\u8bf7\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9274\u4e8e\u6392\u5e8f\u6b63\u786e\u81f3\u5173\u91cd\u8981\uff0c\u6700\u7a33\u59a5\u7684\u505a\u6cd5\u662f\u5728\u63d0\u4ea4\u4efb\u4f55\u6587\u4ef6\u4e4b\u524d\u5c31\u89c4\u5212\u597d\u4e24\u6761\u8def\u5f84\uff0c\u800c\u4e0d\u662f\u5728\u5ba1\u67e5\u8fc7\u7a0b\u4e2d\u51fa\u73b0\u95ee\u9898\u4e4b\u540e\u518d\u505a\u51b3\u5b9a\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u79cd\u6d4b\u5e8f\u65b9\u5f0f\u6b63\u662f\u6211\u4eec\u6240\u9700\u8981\u7684 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/radiation-medical-device-registration-in-indonesia\/\">\u653e\u5c04\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1<\/a> \u65e8\u5728\u63d0\u4f9b\u652f\u6301\uff0c\u5c24\u5176\u4fa7\u91cd\u4e8e\u9ad8\u80fd\u548c\u8f90\u5c04\u53d1\u5c04\u8bbe\u5907\u3002\u6b63\u5728\u901a\u8fc7\u66f4\u5e7f\u6cdb\u7684C\u7c7b\u548cD\u7c7b\u8bbe\u5907\u9014\u5f84\u4ee5\u53ca\u8f90\u5c04\u8bb8\u53ef\u6d41\u7a0b\u5f00\u5c55\u5de5\u4f5c\u7684\u5236\u9020\u5546\u4f1a\u53d1\u73b0\uff0c\u6211\u4eec\u7684\u89e3\u51b3\u65b9\u6848\u6db5\u76d6\u4e86\u4ed6\u4eec\u6240\u9700\u7684\u4e00\u5207\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/medical-device-registration-indonesia\/\">\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1<\/a>, \u8be5\u673a\u6784\u8d1f\u8d23\u5904\u7406\u4ece\u5206\u7c7b\u5230\u4e0a\u5e02\u540e\u62a5\u544a\u7684\u6574\u4e2aKemenkes\u6d41\u7a0b\u3002\u5982\u9700\u66f4\u8be6\u7ec6\u5730\u4e86\u89e3\u4e0d\u540c\u8bbe\u5907\u7c7b\u578b\u8f90\u5c04\u76f8\u5173\u9014\u5f84\u7684\u6bd4\u8f83\uff0c\u8bf7\u53c2\u9605\u6211\u4eec\u5173\u4e8e[\u6b64\u5904\u5e94\u63d2\u5165\u76f8\u5173\u6587\u7ae0\u94fe\u63a5]\u7684\u76f8\u5173\u6587\u7ae0\u3002 <strong>\u5370\u5ea6\u5c3c\u897f\u4e9a\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u6ce8\u518c<\/strong> \u4e5f\u503c\u5f97\u4e00\u8bfb\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=\"zdg3a7VGcc\"><a href=\"https:\/\/productregistrationindonesia.com\/zh\/radioactive-ivd-registration-in-indonesia-inside-the-ivd-radiation-regulatory-pathway\/\">\u5370\u5ea6\u5c3c\u897f\u4e9a\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\uff1a\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u8f90\u5c04\u76d1\u7ba1\u8def\u5f84\u5185\u5e55<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u5370\u5c3c\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\uff1a\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u8f90\u5c04\u76d1\u7ba1\u8def\u5f84\u5185\u5e55\u201d\u2014\u2014\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\" src=\"https:\/\/productregistrationindonesia.com\/radioactive-ivd-registration-in-indonesia-inside-the-ivd-radiation-regulatory-pathway\/embed\/#?secret=4JEe1A0LLB#?secret=zdg3a7VGcc\" data-secret=\"zdg3a7VGcc\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u51c6\u5907\u597d\u5f00\u59cb\u6ce8\u518c\u4e86\u5417\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8ba1\u5212\u5c06\u8d28\u5b50\u6cbb\u7597\u3001\u8fd1\u8ddd\u79bb\u653e\u5c04\u6cbb\u7597\u6216\u76f4\u7ebf\u52a0\u901f\u5668\u8bbe\u5907\u5f15\u5165\u5370\u5ea6\u5c3c\u897f\u4e9a\uff1f\u4ece\u4e00\u5f00\u59cb\u5c31\u6b63\u786e\u529e\u7406\u5370\u5c3c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (Kemenkes) \u7684\u5ba1\u6279\u548c\u8f90\u5c04\u8bb8\u53ef\u8bc1\uff0c\u53ef\u4ee5\u907f\u514d\u6570\u6708\u4e0d\u5fc5\u8981\u7684\u5ef6\u8bef\u3002\u8bf7\u4f7f\u7528\u4e0b\u65b9\u8868\u683c\u8054\u7cfb\u6211\u4eec\u7684\u56e2\u961f\uff0c\u6211\u4eec\u5c06\u5e2e\u52a9\u60a8\u5236\u5b9a\u5408\u9002\u7684\u8bbe\u5907\u5f15\u8fdb\u7b56\u7565\uff0c\u4ee5\u4fbf\u60a8\u5728\u786e\u5b9a\u7533\u8bf7\u65f6\u95f4\u8868\u6216\u8bbe\u8ba1\u9632\u62a4\u7f69\u4e4b\u524d\u505a\u597d\u51c6\u5907\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>For most hospital groups and manufacturers, the hardest part of bringing proton therapy, brachytherapy, or linear accelerator systems into Indonesia is not the paperwork itself. It is not knowing, early enough, that two separate regulators (Kemenkes and the Radiation Regulator) will need to review the same equipment through two very different lenses: one for market [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":7772,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7771","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\/7771","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=7771"}],"version-history":[{"count":1,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7771\/revisions"}],"predecessor-version":[{"id":7775,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7771\/revisions\/7775"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/7772"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=7771"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=7771"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=7771"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=7771"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}