{"id":7707,"date":"2026-09-10T16:13:55","date_gmt":"2026-09-10T09:13:55","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-09-10T16:13:57","modified_gmt":"2026-09-10T09:13:57","slug":"radioactive-ivd-registration-in-indonesia-inside-the-ivd-radiation-regulatory-pathway","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/radioactive-ivd-registration-in-indonesia-inside-the-ivd-radiation-regulatory-pathway\/","title":{"rendered":"\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"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u6211\u4eec\u6700\u5e38\u9047\u5230\u7684\u9519\u8bef\u770b\u4f3c\u7b80\u5355\uff0c\u5b9e\u5219\u4e0d\u7136\u3002\u4e00\u5bb6\u516c\u53f8\u63d0\u4ea4\u653e\u5c04\u6027\u6807\u8bb0\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\uff08\u4f8b\u5982\u653e\u5c04\u514d\u75ab\u5206\u6790 (RIA) \u8bd5\u5242\uff09\u7533\u8bf7\u65f6\uff0c\u5b8c\u5168\u6309\u7167\u63d0\u4ea4\u666e\u901a\u8bca\u65ad\u8bd5\u5242\u7684\u65b9\u5f0f\u8fdb\u884c\uff0c\u4ec5\u4f7f\u7528\u4e86 Kemenkes \u6280\u672f\u6863\u6848\u3002Kemenkes \u5ba1\u67e5\u987a\u5229\u901a\u8fc7\uff0c\u5206\u7c7b\u7ed3\u679c\u4e5f\u7b26\u5408\u9884\u671f\u3002\u7136\u800c\uff0c\u8d27\u7269\u5230\u8fbe\u8fb9\u5883\u540e\uff0c\u5374\u53d1\u73b0\u8bd5\u5242\u76d2\u5185\u7684\u540c\u4f4d\u7d20\u9700\u8981\u5355\u72ec\u529e\u7406\u6e05\u5173\u624b\u7eed\uff0c\u800c\u6b64\u524d\u5374\u65e0\u4eba\u529e\u7406\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u95ee\u9898\u7684\u5173\u952e\u6839\u672c\u4e0d\u5728\u4e8e\u6587\u4e66\u5de5\u4f5c\uff0c\u800c\u5728\u4e8e\u6d41\u7a0b\u5b89\u6392\u3002\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u6700\u597d\u7406\u89e3\u4e3a\u4e24\u79cd\u4ea7\u54c1\u5171\u7528\u4e00\u4e2a\u6807\u7b7e\uff1a\u4e00\u662f\u8bca\u65ad\u8bd5\u5242\u672c\u8eab\uff08\u7531Kemenkes\u5ba1\u6838\uff09\uff0c\u4e8c\u662f\u8bd5\u5242\u76d2\u5185\u7684\u653e\u5c04\u6027\u7269\u8d28\uff08\u7531\u5b8c\u5168\u4e0d\u540c\u7684\u76d1\u7ba1\u673a\u6784\u8d1f\u8d23\uff09\u3002\u4ece\u4e00\u5f00\u59cb\u5c31\u51c6\u5907\u597d\u8fd9\u4e24\u4efd\u6587\u4ef6\uff0c\u65f6\u95f4\u5b89\u6392\u5c31\u80fd\u987a\u5229\u8fdb\u884c\u3002\u5982\u679c\u4e00\u4efd\u4e00\u4efd\u5730\u51c6\u5907\uff0c\u7b2c\u4e8c\u4efd\u6587\u4ef6\u51e0\u4e4e\u603b\u4f1a\u8ba9\u4f60\u63aa\u624b\u4e0d\u53ca\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u5c31\u662f\u5176\u80cc\u540e\u7684\u5168\u90e8\u903b\u8f91\u3002 <strong>IVD \u8f90\u5c04\u76d1\u7ba1\u9014\u5f84<\/strong> \u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u666e\u901a\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u53ea\u9700\u6ee1\u8db3\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u7684\u8981\u6c42\uff0c\u800c\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5219\u5fc5\u987b\u540c\u65f6\u6ee1\u8db3\u5370\u5c3c\u536b\u751f\u90e8\u548c\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u8981\u6c42\uff0c\u800c\u4e14\u5728\u4efb\u4f55\u4e00\u4e2a\u4ea7\u54c1\u80fd\u591f\u5408\u6cd5\u5730\u8fdb\u5165\u533b\u9662\u6216\u5b9e\u9a8c\u5ba4\u4e4b\u524d\uff0c\u90fd\u5fc5\u987b\u6ee1\u8db3\u8fd9\u4e9b\u8981\u6c42\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u6307\u5357\u5c06\u8be6\u7ec6\u4ecb\u7ecd\u76f8\u5173\u6d41\u7a0b\u3002\u5b83\u9762\u5411\u5373\u5c06\u628a\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u6295\u653e\u5370\u5c3c\u5e02\u573a\u7684\u76d1\u7ba1\u4e8b\u52a1\u7ecf\u7406\u3001\u5206\u9500\u5546\u548c\u8fdb\u53e3\u5546\uff0c\u65e0\u8bba\u8fd9\u662f\u4ed6\u4eec\u9996\u6b21\u7533\u62a5\u8fd8\u662f\u7b2c\u5341\u6b21\u7533\u62a5\uff0c\u6307\u5357\u90fd\u5c06\u6db5\u76d6\u5b9e\u9645\u6d89\u53ca\u7684\u4e24\u4e2a\u76d1\u7ba1\u673a\u6784\u3001\u4ed6\u4eec\u7684\u8981\u6c42\u4e0e\u666e\u901a\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7533\u62a5\u7684\u4e0d\u540c\u4e4b\u5904\uff0c\u4ee5\u53ca\u5728\u8d27\u7269\u5230\u8fbe\u6d77\u5173\u4e4b\u524d\u9700\u8981\u51c6\u5907\u7684\u4e8b\u9879\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f46\u662f\uff0c\u5982\u679c\u60a8\u7684\u4ea7\u54c1\u4e0d\u542b\u653e\u5c04\u6027\u793a\u8e2a\u5242\uff0c\u90a3\u4e48\u5bf9\u60a8\u6765\u8bf4\u66f4\u91cd\u8981\u7684\u9014\u5f84\u5c31\u662f\u6211\u4eec\u53e6\u4e00\u7bc7\u6587\u7ae0\u4e2d\u4ecb\u7ecd\u7684\u9014\u5f84\u3002, <a href=\"https:\/\/productregistrationindonesia.com\/zh\/indonesia-ivd-registration-vs-medical-device\/\">\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<\/a>, \u8be5\u90e8\u5206\u8be6\u7ec6\u4ecb\u7ecd\u4e86\u98ce\u9669\u5206\u7c7b\u4ee5\u53caD\u7c7b\u4f20\u67d3\u75c5\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6240\u9700\u7684\u989d\u5916\u4e34\u5e8a\u8bc1\u636e\u6b65\u9aa4\u3002\u8fd9\u79cd\u533a\u522b\u5b8c\u5168\u7531Kemenkes\u8d1f\u8d23\u3002\u672c\u6587\u8ba8\u8bba\u7684\u8fd9\u4e00\u533a\u522b\u6d89\u53ca\u4e24\u4e2a\u4e0d\u540c\u7684\u76d1\u7ba1\u673a\u6784\uff0c\u4e5f\u662f\u540e\u7eed\u6240\u6709\u5185\u5bb9\u7684\u91cd\u70b9\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6838\u5fc3\u533a\u522b\uff1a\u4e00\u6b3e\u4ea7\u54c1\uff0c\u4e24\u4e2a\u5ba1\u6279\u5bf9\u8c61<\/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\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2.webp\" alt=\"\u5370\u5c3c\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u53cc\u76d1\u7ba1\u673a\u6784\u6307\u5357 \" class=\"wp-image-7709\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2.webp 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2-300x200.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2-18x12.webp 18w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/Radioactive-IVD-Registration-Indonesia-Dual-Regulator-Guide-2-768x512.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u76ee\u524d\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u9500\u552e\u7684\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u6280\u672f\u6bd4\u7b80\u5355\u7684\u4fa7\u5411\u6d41\u52a8\u8bd5\u7eb8\u6761\u79cd\u7c7b\u66f4\u591a\u3002\u4e00\u4e9b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u542b\u6709\u6d3b\u6027\u836f\u7269\u6210\u5206\uff0c\u800c\u8f83\u5c0f\u4f46\u6301\u7eed\u5b58\u5728\u7684\u4e00\u7c7b\u8bd5\u5242\u76d2\u5219\u542b\u6709\u653e\u5c04\u6027\u793a\u8e2a\u5242\uff0c\u6700\u5e38\u89c1\u7684\u662f\u7898-125\u7b49\u540c\u4f4d\u7d20\uff0c\u7528\u4e8e\u6fc0\u7d20\u6216\u80bf\u7624\u6807\u5fd7\u7269\u68c0\u6d4b\u7684\u653e\u5c04\u514d\u75ab\u5206\u6790\uff08RIA\uff09\u8bd5\u5242\u76d2\u4e2d\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u51c6\u5907\u6b64\u7c7b\u7533\u8bf7\u6750\u6599\u7684\u7ecf\u9a8c\uff0c\u82ac\u5170\u56fd\u5bb6\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u5c40 (Kemenkes) \u7684\u8bc4\u4f30\u4eba\u5458\u5728\u5ba1\u67e5\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u7684\u6280\u672f\u6587\u4ef6\u65f6\uff0c\u901a\u5e38\u4f1a\u5c06\u6587\u4ef6\u4fdd\u7559\u5728\u961f\u5217\u9636\u6bb5\uff0c\u76f4\u5230\u7533\u8bf7\u4eba\u80fd\u591f\u51fa\u793a\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u9881\u53d1\u7684\u6709\u6548\u6216\u6b63\u5728\u7533\u8bf7\u4e2d\u7684\u6388\u6743\u7f16\u53f7\uff0c\u5373\u4f7f\u2026\u2026 <a href=\"https:\/\/farmalkes.kemkes.go.id\/unduh\/permenkes-62-2017\/\" target=\"_blank\" rel=\"noopener\">2017\u5e74\u7b2c62\u53f7\u6cd5\u4ee4<\/a> \u6cd5\u89c4\u672c\u8eab\u5e76\u672a\u5c06\u6838\u5b89\u5168\u8bb8\u53ef\u5217\u4e3a\u660e\u786e\u7684\u6587\u4ef6\u8981\u6c42\u3002\u4ea4\u53c9\u6838\u67e5\u662f\u5ba1\u6838\u5458\u7684\u60ef\u4f8b\uff0c\u800c\u975e\u4e66\u9762\u6e05\u5355\u4e0a\u7684\u9879\u76ee\uff0c\u800c\u8fd9\u5e76\u975e\u9996\u6b21\u7533\u8bf7\u8005\u4ec5\u51ed\u6cd5\u89c4\u6587\u672c\u6240\u80fd\u9884\u6599\u5230\u7684\u7ec6\u8282\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u56e0\u6b64\uff0c\u653e\u5c04\u6027 IVD \u8bd5\u5242\u76d2\u88ab\u8bc4\u4f30\u4e3a\u7531\u4e24\u4e2a\u72ec\u7acb\u76d1\u7ba1\u673a\u6784\u6301\u6709\u7684\u4e24\u4e2a\u72ec\u7acb\u5ba1\u6279\u5bf9\u8c61\u3002 Kemenkes \u901a\u8fc7 Direktorat Jenderal Farmasi dan Alat Kesehatan (Ditjen Farmalkes) \u5bf9\u8be5\u5957\u4ef6\u4f5c\u4e3a\u4f53\u5916\u8bca\u65ad\u533b\u7597\u8bbe\u5907\u8fdb\u884c\u4e86\u8bc4\u4f30 <a href=\"https:\/\/farmalkes.kemkes.go.id\/unduh\/permenkes-62-2017\/\" target=\"_blank\" rel=\"noopener\">Peraturan Menteri Kesehatan (Permenkes) No. 62 Tahun 2017<\/a> Tentang Izin Edar Alat Kesehatan\u3001Alat Kesehatan \u4f53\u5916\u8bca\u65ad\u548c Perbekalan Kesehatan Rumah Tangga\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b64\u5916\uff0c\u5370\u5c3c\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u6839\u636e\u76f8\u5173\u89c4\u5b9a\uff0c\u5c06\u540c\u4e00\u8bd5\u5242\u76d2\u7684\u653e\u5c04\u6027\u542b\u91cf\u8bc4\u4f30\u4e3a\u53d7\u63a7\u653e\u5c04\u6027\u7269\u8d28\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/45931\" target=\"_blank\" rel=\"noopener\">\u6e29\u5f53-\u6e29\u5f53 No. 10 Tahun 1997<\/a> \u5173\u4e8e Ketenaganukliran \u53ca\u5176\u6267\u884c\u6761\u4f8b\u3002\u8fd9\u662f\u7b2c\u4e8c\u4e2a\u8f68\u9053\u3002 <strong>\u6838\u76d1\u7ba1\u5408\u89c4\u6027\u4f53\u5916\u8bca\u65ad<\/strong> \u7533\u8bf7\u4eba\u9700\u8981\u505a\u597d\u4ee5\u4e0b\u8be6\u7ec6\u8bf4\u660e\u7684\u51c6\u5907\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u82ac\u5170\u56fd\u5bb6\u836f\u54c1\u7ba1\u7406\u5c40 (Kemenkes) \u4e0b\u7684\u6807\u51c6\u4f53\u5916\u8bca\u65ad\u8bd5\u5242 (IVD) \u6ce8\u518c\u6d41\u7a0b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6240\u6709\u6295\u653e\u5370\u5c3c\u5e02\u573a\u7684\u4f53\u5916\u8bca\u65ad\u4ea7\u54c1\uff0c\u65e0\u8bba\u662f\u5426\u5177\u6709\u653e\u5c04\u6027\uff0c\u90fd\u5fc5\u987b\u9996\u5148\u7ecf\u8fc7\u4ee5\u4e0b\u6d41\u7a0b\uff1a <strong>\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c<\/strong> \u6839\u636e2017\u5e74\u7b2c62\u53f7\u653f\u5e9c\u6761\u4f8b\uff0c\u7533\u8bf7\u4eba\u901a\u8fc7\u4ee5\u4e0b\u65b9\u5f0f\u63d0\u4ea4\u6280\u672f\u6587\u4ef6\uff1a <a href=\"https:\/\/regalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\">\u96f7\u52a0\u5c14\u514b\u65af<\/a> \u7531\u7535\u5b50\u7cfb\u7edf\u7ba1\u7406 <a href=\"https:\/\/farmalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\">\u8fea\u7279\u5ef6\u00b7\u6cd5\u83ab\u5c14\u514b\u65af<\/a>, \u5176\u7ed3\u6784\u5927\u81f4\u6309\u7167\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4\u6210\u5458\u56fd\u4f7f\u7528\u7684\u4e1c\u76df\u901a\u7528\u7533\u62a5\u6587\u4ef6\u6a21\u677f\u5236\u5b9a\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u6863\u6848\u5c06\u6839\u636e\u4ea7\u54c1\u7684\u98ce\u9669\u7b49\u7ea7\u8fdb\u884c\u8bc4\u4f30\uff0c\u4ece\u98ce\u9669\u6700\u4f4e\u7684A\u7ea7\u5230\u98ce\u9669\u6700\u9ad8\u7684D\u7ea7\u3002\u8bc4\u4f30\u7ed3\u679c\u5c06\u83b7\u5f97Nomor Izin Edar (NIE)\uff0c\u5373\u6388\u6743\u8be5\u8bd5\u5242\u76d2\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u8fdb\u884c\u5e02\u573a\u63a8\u5e7f\u548c\u9500\u552e\u7684\u5206\u9500\u7f16\u53f7\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u65e0\u8bba\u8bd5\u5242\u76d2\u4e2d\u662f\u5426\u542b\u6709\u653e\u5c04\u6027\u793a\u8e2a\u5242\uff0c\u8fd9\u90e8\u5206\u6d41\u7a0b\u90fd\u76f8\u540c\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/medical-device-registration-indonesia\/\">\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c<\/a> \u670d\u52a1\u7ba1\u7406\u6b64 <a href=\"https:\/\/www.kemkes.go.id\/eng\/home\" target=\"_blank\" rel=\"noopener\">\u51ef\u95e8\u514b\u65af<\/a> \u4ece\u5934\u5230\u5c3e\u8ddf\u8e2a\u3002\u4e0d\u540c\u4e4b\u5904\u5728\u4e8e\uff0c\u5728\u6587\u4ef6\u80fd\u591f\u7ee7\u7eed\u63a8\u8fdb\u4e4b\u524d\uff0c\u5fc5\u987b\u4e0e Kemenkes \u6863\u6848\u4e00\u8d77\u63d0\u4ea4\u7684\u6750\u6599\uff0c\u5373\u4e0b\u6587\u6240\u8ff0\u7684\u7b2c\u4e8c\u90e8\u5206\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u7b2c\u4e8c\u6761\u8f68\u9053\uff1a\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7684\u6838\u76d1\u7ba1\u5408\u89c4\u6027<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4f53\u5916\u8bca\u65ad\u7684\u6838\u76d1\u7ba1\u5408\u89c4\u6027<\/strong> \u542b\u6709\u653e\u5c04\u6027\u7269\u8d28\u7684\u8bd5\u5242\u76d2\u7531\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u800c\u975e\u5370\u5c3c\u73af\u5883\u3001\u5de5\u4e1a\u548c\u80fd\u6e90\u90e8\uff08Kemenkes\uff09\u4fdd\u7ba1\uff0c\u5e76\u4f9d\u636e\u5355\u72ec\u7684\u6cd5\u5f8b\u89c4\u5b9a\u8fdb\u884c\u7ba1\u7406\u3002\u5728\u5370\u5c3c\u4f7f\u7528\u653e\u5c04\u6027\u7269\u8d28\uff0c\u5305\u62ec\u8fdb\u53e3\u653e\u5c04\u6027\u7269\u8d28\uff0c\u5747\u9700\u6839\u636e\u300a\u5370\u5c3c\u6cd5\u300b\u7b2c17\u6761\u7b2c\uff081\uff09\u6b3e\u7684\u89c4\u5b9a\uff0c\u83b7\u5f97\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u8bb8\u53ef\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/45931\" target=\"_blank\" rel=\"noopener\">\u6e29\u5f53-\u6e29\u5f53 No. 10 Tahun 199<\/a>7 tentang Ketenaganukliran.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7535\u79bb\u8f90\u5c04\u6e90\u548c\u6838\u6750\u6599\u7684\u4f7f\u7528\u8bb8\u53ef\u7a0b\u5e8f\u5982\u4e0b <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/4842\/pp-no-29-tahun-2008\" target=\"_blank\" rel=\"noopener\">Peraturan Pemerintah No. 29 Tahun 2008<\/a> Tentang Perizinan Pemanfaatan Sumber Radiasi Pengion dan Bahan Nuklir\u3002\u8f90\u5c04\u5b89\u5168\u548c\u653e\u5c04\u6e90\u5b89\u5168\u8981\u6c42\u8f7d\u4e8e <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/265188\/pp-no-45-tahun-2023\" target=\"_blank\" rel=\"noopener\">Peraturan Pemerintah No. 45 \u5854\u6d2a 2023<\/a> tentang Keselamatan Radiasi Pengion dan Keamanan Zat Radioaktif\uff0c\u53d6\u4ee3\u4e86\u65e9\u671f\u7684 <a href=\"https:\/\/jdih.bapeten.go.id\/id\/dokumen\/peraturan\/peraturan-pemerintah-no-33-tahun-2007-tentang-keselamatan-radiasi-pengion-dan-keamanan-zat-radioaktif\" target=\"_blank\" rel=\"noopener\">Peraturan Pemerintah No. 33 Tahun 2007<\/a> \u5173\u4e8e\u540c\u4e00\u4e3b\u9898\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7b80\u800c\u8a00\u4e4b\uff1a\u4ec5\u51ed\u5370\u5c3c\u56fd\u5bb6\u836f\u54c1\u7ba1\u7406\u5c40\uff08Kemenkes izin edar\uff09\u7684\u8fdb\u53e3\u8bb8\u53ef\uff0c\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u65e0\u6cd5\u5408\u6cd5\u8fdb\u5165\u5370\u5c3c\u3002\u8fdb\u53e3\u5546\u6216\u5176\u6307\u5b9a\u7684\u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u8fd8\u5fc5\u987b\u83b7\u5f97\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u6388\u6743\uff0c\u8be5\u6388\u6743\u6db5\u76d6\u653e\u5c04\u6027\u7269\u8d28\u672c\u8eab\u3002\u8be5\u6388\u6743\u901a\u8fc7\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u5728\u7ebf\u8bb8\u53ef\u7cfb\u7edf\u8fdb\u884c\u5ba1\u6279\uff0c\u8be5\u7cfb\u7edf\u73b0\u5df2\u4e0e\u5370\u5c3c\u57fa\u4e8e\u98ce\u9669\u7684\u5ba1\u6279\u7cfb\u7edf\u6574\u5408\u3002 <a href=\"https:\/\/oss.go.id\/en\" target=\"_blank\" rel=\"noopener\">\u5728\u7ebf\u5355\u4e00\u63d0\u4ea4\uff08OSS\uff09<\/a> \u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u5e73\u53f0 <a href=\"https:\/\/jdih.bapeten.go.id\/id\/dokumen\/peraturan\/peraturan-kepala-badan-no-3-tahun-2021-tentang-standar-kegiatan-usaha-dan-standar-produk-pada-penyelenggaraan-perizinan-berusaha-berbasis-risiko-sektor-ketenaganukliran\" target=\"_blank\" rel=\"noopener\">2021\u5e74\u7b2c3\u53f7\u6761\u4f8b<\/a> \u7ecf\u5e38\u4f7f\u7528\u6807\u51c6\u4ea7\u54c1\u548c\u6807\u51c6\u4ea7\u54c1\u6765\u751f\u4ea7 Penyelenggaraan Perizinan Berusaha Berbasis Risiko Sektor Ketenaganukliran\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u8fdb\u53e3\u987b\u9075\u5b88\u6838\u76d1\u7ba1\u673a\u6784\u7684\u8981\u6c42<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u653e\u5c04\u6027\u7269\u8d28\u7684\u8fdb\u53e3\u5728\u6bcf\u4e2a\u9636\u6bb5\u90fd\u5fc5\u987b\u9075\u5faa\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u6d41\u7a0b\u8981\u6c42\uff0c\u800c\u975e\u8fdb\u53e3\u5546\u81ea\u884c\u8bbe\u5b9a\u7684\u901a\u7528\u6d77\u5173\u65f6\u95f4\u8868\u3002\u8d27\u7269\u63cf\u8ff0\u3001\u5305\u88c5\u3001\u73b0\u573a\u8f90\u5c04\u9632\u62a4\u8bbe\u5907\u4ee5\u53ca\u653e\u5c04\u6027\u7269\u8d28\u7684\u50a8\u5b58\u8bbe\u65bd\u7b49\u6240\u6709\u4fe1\u606f\u90fd\u5fc5\u987b\u7ecf\u8fc7\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u5ba1\u6838\uff0c\u65b9\u53ef\u83b7\u51c6\u5165\u5883\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b64\u6b65\u9aa4\u72ec\u7acb\u4e8e\u975e\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242 (IVD) \u8d27\u7269\u7684\u6d77\u5173\u6e05\u5173\u6d41\u7a0b\uff0c\u4e14\u662f\u5bf9\u5176\u7684\u8865\u5145\u3002\u8fdb\u53e3\u5546\u4e0d\u80fd\u4f7f\u7528\u666e\u901a\u8bd5\u5242\u8d27\u7269\u7684\u76f8\u540c\u6587\u4ef6\u6765\u542f\u52a8\u6b64\u6b65\u9aa4\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=\"KqX6cAX3RK\"><a href=\"https:\/\/productregistrationindonesia.com\/zh\/bapeten-import-license-amendment\/\">BAPETEN\u8fdb\u53e3\u8bb8\u53ef\u8bc1\u4fee\u8ba2\uff1a\u4e3a\u4f55\u65b0\u589e\u4e00\u79cd\u8f90\u5c04\u8bbe\u5907\u578b\u53f7\u4f1a\u5bfc\u81f4\u60a8\u7684\u8d27\u7269\u8fd0\u8f93\u5ef6\u8bef<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u5370\u5c3c\u56fd\u5bb6\u836f\u54c1\u548c\u6d88\u8d39\u54c1\u7ba1\u7406\u5c40\uff08BAPETEN\uff09\u8fdb\u53e3\u8bb8\u53ef\u8bc1\u4fee\u8ba2\uff1a\u4e3a\u4f55\u65b0\u589e\u4e00\u79cd\u8f90\u5c04\u8bbe\u5907\u578b\u53f7\u4f1a\u5bfc\u81f4\u60a8\u7684\u8d27\u7269\u8fd0\u8f93\u53d7\u963b\u201d\u2014\u2014\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\" src=\"https:\/\/productregistrationindonesia.com\/bapeten-import-license-amendment\/embed\/#?secret=EzG7wV98Gp#?secret=KqX6cAX3RK\" data-secret=\"KqX6cAX3RK\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u8fd9\u4e24\u6761\u8f68\u9053\u4e0d\u53ef\u4e92\u6362\u3002<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u6301\u6709Kemenkes izin edar\u8bc1\u4e66\u5e76\u4e0d\u4ee3\u8868\u6709\u6743\u8fdb\u53e3\u653e\u5c04\u6027\u793a\u8e2a\u5242\uff0c\u6301\u6709\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u9881\u53d1\u7684\u8fdb\u53e3\u8bb8\u53ef\u8bc1\u4e5f\u4e0d\u4ee3\u8868\u6709\u6743\u5546\u4e1a\u5206\u9500\u6210\u54c1\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u3002\u53ea\u6709\u540c\u65f6\u6301\u6709\u6709\u6548\u8bc1\u4e66\u548c\u8fdb\u53e3\u8bb8\u53ef\u8bc1\uff0c\u4e14\u8bc1\u4e66\u4e0a\u7684\u4fe1\u606f\u4e0e\u540c\u4e00\u4ea7\u54c1\u548c\u540c\u4e00\u6cd5\u5f8b\u5b9e\u4f53\u7684\u4fe1\u606f\u76f8\u7b26\uff0c\u8be5\u6279\u8d27\u7269\u7684\u8fd0\u8f93\u624d\u5408\u6cd5\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=\"5PtkY4eHzq\"><a href=\"https:\/\/productregistrationindonesia.com\/zh\/radiation-medical-device-distributor\/\">\u5370\u5c3c\u653e\u5c04\u533b\u7597\u5668\u68b0\u5206\u9500\u5546\uff1a\u5408\u683c\u4f9b\u5e94\u5546\u7684\u8303\u56f4\u6bd4\u4f60\u60f3\u8c61\u7684\u8981\u5c0f\u3002<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u5370\u5c3c\u653e\u5c04\u533b\u7597\u5668\u68b0\u5206\u9500\u5546\uff1a\u5408\u683c\u5206\u9500\u5546\u7684\u8303\u56f4\u6bd4\u60a8\u60f3\u8c61\u7684\u8981\u5c0f\u201d\u2014\u2014\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\" src=\"https:\/\/productregistrationindonesia.com\/radiation-medical-device-distributor\/embed\/#?secret=KPmk8UiKKM#?secret=5PtkY4eHzq\" data-secret=\"5PtkY4eHzq\" 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>\u6807\u51c6\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u4e0e\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\uff1a\u5e76\u6392\u6bd4\u8f83<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e0b\u8868\u5217\u51fa\u4e86\u4e24\u6761\u9014\u5f84\u5e76\u884c\u8fd0\u884c\u7684\u60c5\u51b5\uff0c\u4ee5\u53ca\u653e\u5c04\u6027 IVD \u8bd5\u5242\u76d2\u9700\u8981\u989d\u5916\u6ee1\u8db3\u7684\u8981\u6c42\u7684\u60c5\u51b5\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u65b9\u9762<\/strong><\/td><td><strong>\u6807\u51c6\u4f53\u5916\u8bca\u65ad<\/strong><\/td><td><strong>\u653e\u5c04\u6027 IVD<\/strong><\/td><\/tr><tr><td>\u4e3b\u8981\u76d1\u7ba1\u673a\u6784<\/td><td>Kemenkes (Ditjen Farmalkes)<\/td><td>Kemenkes \u548c\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784<\/td><\/tr><tr><td>\u6cd5\u5f8b\u4f9d\u636e<\/td><td>2017\u5e74\u7b2c62\u53f7\u6cd5\u4ee4<\/td><td>Permenkes \u7b2c 62\/2017 \u53f7\u52a0\u4e0a UU \u7b2c 10\/1997 \u53f7\u3001PP \u7b2c 29\/2008 \u53f7\u3001PP \u7b2c 45\/2023 \u53f7<\/td><\/tr><tr><td>\u5ba1\u6279\u5bf9\u8c61<\/td><td>\u6574\u4e2a\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2<\/td><td>\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\uff08Kemenkes\uff09\u53ca\u5176\u6240\u542b\u653e\u5c04\u6027\u7269\u8d28\uff0c\u5747\u7531\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u5355\u72ec\u8bc4\u4f30\u3002<\/td><\/tr><tr><td>\u63d0\u4ea4\u7cfb\u7edf<\/td><td>REGALKES \u548c BALIS \u7cfb\u7edf<\/td><td>\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u5728\u7ebf\u7cfb\u7edf REGALKES\uff08Kemenkes\uff09\u548c BALIS SYSTEM \u4e0e OSS-RBA \u96c6\u6210<\/td><\/tr><tr><td>\u5bfc\u5165\u6b65\u9aa4<\/td><td>\u6807\u51c6\u6d77\u5173\u548c\u8fdb\u53e3\u6587\u4ef6<\/td><td>\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u9881\u53d1\u7684\u6db5\u76d6\u653e\u5c04\u6027\u7269\u8d28\u7684\u989d\u5916\u8fdb\u53e3\u8bb8\u53ef\u8bc1<\/td><\/tr><tr><td>\u8bbe\u65bd\u8981\u6c42<\/td><td>\u6839\u636e Permenkes \u7b2c 62\/2017 \u53f7\u6761\u4f8b\u8fdb\u884c\u4e00\u822c\u5b58\u50a8<\/td><td>\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u5ba1\u67e5\u7684\u8f90\u5c04\u9632\u62a4\u50a8\u5b58\u548c\u5b89\u5168\u6587\u4ef6\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6ce8\u518c\u8fc7\u7a0b\u4e2d\u4e24\u6761\u8def\u5f84\u7684\u4ea4\u6c47\u70b9<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u7b80\u77ed\u7684\u5e8f\u5217\u8bf4\u660e\u4e86\u7279\u5b9a\u4ea7\u54c1\u9075\u5faa\u7684\u8def\u5f84\u4ee5\u53ca\u4e24\u4e2a\u76d1\u7ba1\u673a\u6784\u7684\u8981\u6c42\u5728\u54ea\u91cc\u76f8\u4ea4\u3002.<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u662f\u5426\u542b\u6709\u4efb\u4f55\u653e\u5c04\u6027\u540c\u4f4d\u7d20\u6216\u793a\u8e2a\u5242\uff1f\u5982\u679c\u6ca1\u6709\uff0c\u5219\u9075\u5faa2017\u5e74\u7b2c62\u53f7\u653f\u5e9c\u6761\u4f8b\u89c4\u5b9a\u7684\u4ec5\u9650Kemenkes\u7684\u6807\u51c6\u6d41\u7a0b\u3002.<\/li>\n\n\n\n<li>\u5982\u679c\u7b54\u6848\u662f\u80af\u5b9a\u7684\uff0c\u7533\u8bf7\u4eba\u662f\u5426\u5df2\u660e\u786e\u6307\u51fa\u540c\u4f4d\u7d20\u7c7b\u578b\u548c\u6d3b\u5ea6\u6c34\u5e73\uff1f\u8fd9\u4e00\u7ec6\u8282\u51b3\u5b9a\u4e86\u8be5\u8bd5\u5242\u76d2\u6240\u5c5e\u7684\u5177\u4f53\u8c03\u8282\u5668\u7c7b\u522b\u3002.<\/li>\n\n\n\n<li>\u4e0e\u82ac\u5170\u56fd\u5bb6\u6838\u5b89\u5168\u5c40\uff08Kemenkes\uff09\u7684\u7533\u8bf7\u6587\u4ef6\u540c\u6b65\uff0c\u662f\u5426\u5df2\u83b7\u5f97\u6216\u81f3\u5c11\u542f\u52a8\u4e86\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u5bf9\u653e\u5c04\u6027\u7269\u8d28\u7684\u6388\u6743\u7a0b\u5e8f\uff1f\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5373\u4f7f\u6280\u672f\u6587\u4ef6\u672c\u8eab\u5b8c\u6574\uff0c\u5982\u679c\u6ca1\u6709\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u76f8\u5e94\u6388\u6743\u6587\u4ef6\uff0c\u6587\u4ef6\u901a\u5e38\u4f1a\u5728\u82ac\u5170\u56fd\u5bb6\u6838\u5b89\u5168\u5c40\u7684\u5ba1\u67e5\u9636\u6bb5\u88ab\u6401\u7f6e\u3002.<\/li>\n\n\n\n<li>\u8fdb\u53e3\u5546\u767b\u8bb0\u4fe1\u606f\u662f\u5426\u4e0e\u6377\u514b\u6d77\u5173\u603b\u7f72\uff08Kemenkes izin edar\uff09\u548c\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u8bb8\u53ef\u8bc1\u4e0a\u6240\u5217\u7684\u6cd5\u5f8b\u5b9e\u4f53\u4e00\u81f4\uff1f\u4e24\u4efd\u6587\u4ef6\u4e0d\u7b26\u662f\u5bfc\u81f4\u8d27\u7269\u88ab\u6263\u7559\u7684\u5e38\u89c1\u539f\u56e0\u4e4b\u4e00\u3002.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u7b80\u800c\u8a00\u4e4b\uff1a\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u9700\u8981\u6839\u636e Permenkes No. 62 Tahun 2017 \u83b7\u5f97 Kemenkes izin edar \u8ba4\u8bc1\uff0c\u4ee5\u53ca\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u76f8\u5e94\u6388\u6743\u3002<\/em> <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/45931\" target=\"_blank\" rel=\"noopener\"><em>UU No. 10 Tahun 1997<\/em><\/a><em>, \u5fc5\u987b\u7531\u540c\u4e00\u6cd5\u5f8b\u5b9e\u4f53\u6301\u6709\uff0c\u624d\u80fd\u5408\u6cd5\u8fdb\u53e3\u5230\u5370\u5ea6\u5c3c\u897f\u4e9a\u5e76\u8fdb\u884c\u5206\u9500\u3002.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6211\u4eec\u5728\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u8fc7\u7a0b\u4e2d\u5e38\u89c1\u7684\u9519\u8bef<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5c06\u83b7\u5f97\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u8bb8\u53ef\u89c6\u4e3a\u5728\u9881\u53d1 Kemenkes izin edar \u8bc1\u4e66\u540e\u5b89\u6392\u7684\u4e00\u79cd\u5f62\u5f0f\uff0c\u800c\u4e0d\u662f\u4ece\u4e00\u5f00\u59cb\u5c31\u5e76\u884c\u8fdb\u884c\u3002.<\/li>\n\n\n\n<li>\u5047\u8bbe\u5df2\u7528\u4e8e\u8fdb\u53e3\u975e\u653e\u5c04\u6027\u4ea7\u54c1\u7684\u8fdb\u53e3\u5546\u81ea\u52a8\u5177\u5907\u8fdb\u53e3\u653e\u5c04\u6027\u7269\u8d28\u7684\u8d44\u683c\u3002.<\/li>\n\n\n\n<li>\u4f4e\u4f30\u4e86\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u5bf9\u653e\u5c04\u6027\u7269\u8d28\u50a8\u5b58\u8bbe\u65bd\u6587\u4ef6\u7684\u8981\u6c42\uff0c\u8fd9\u4e0e\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u6839\u636e\u826f\u597d\u5206\u9500\u89c4\u8303\u5bf9\u4e00\u822c\u4ed3\u5e93\u5408\u89c4\u6027\u7684\u8981\u6c42\u4e0d\u540c\u3002.<\/li>\n\n\n\n<li>\u5c06\u201c\u8bd5\u5242\u76d2\u5185\u542b\u6709\u653e\u5c04\u6027\u6210\u5206\u201d\u89c6\u4e3a\u8db3\u591f\u7684\u7ec6\u8282\uff0c\u800c\u5b9e\u9645\u4e0a\u51b3\u5b9a\u9002\u7528\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u54ea\u4e9b\u8981\u6c42\u7684\uff0c\u662f\u540c\u4f4d\u7d20\u7c7b\u578b\u548c\u653e\u5c04\u6027\u6c34\u5e73\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u7531\u4e8e\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u786e\u5207\u5206\u7c7b\u548c\u6240\u9700\u53c2\u8003\u56e0\u540c\u4f4d\u7d20\u3001\u6d3b\u6027\u6c34\u5e73\u548c\u9884\u671f\u7528\u9014\u800c\u5f02\uff0c\u56e0\u6b64\u5728\u786e\u5b9a\u63d0\u4ea4\u65f6\u95f4\u8868\u4e4b\u524d\uff0c\u901a\u5e38\u503c\u5f97\u4e0e\u76d1\u7ba1\u5408\u4f5c\u4f19\u4f34\u8fdb\u884c\u78cb\u5546\uff0c\u800c\u4e0d\u662f\u5728 Kemenkes \u5907\u6848\u4e4b\u5916\u5355\u72ec\u89e3\u51b3\u6b64\u95ee\u9898\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u653e\u5c04\u6027\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1\uff1a\u6211\u4eec\u5982\u4f55\u652f\u6301\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u7684\u5907\u6848<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/radiation-medical-device-registration-in-indonesia\/\"><strong>\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u653e\u5c04\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1<\/strong><\/a> \u6db5\u76d6\u6807\u51c6\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u6d41\u7a0b\u548c\u65b0\u589e\u6d41\u7a0b\u3002 <strong>\u6838\u76d1\u7ba1\u5408\u89c4\u6027\u4f53\u5916\u8bca\u65ad<\/strong> \u7533\u8bf7\u4eba\u4f1a\u9047\u5230\u8bd5\u5242\u76d2\u5185\u542b\u6709\u653e\u5c04\u6027\u793a\u8e2a\u5242\u7684\u60c5\u51b5\u3002\u6211\u4eec\u5c06\u82ac\u5170\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08Kemenkes\uff09\u7684\u6280\u672f\u6587\u4ef6\u548c\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u7684\u6388\u6743\u7533\u8bf7\u6574\u5408\u5230\u4e00\u4e2a\u9879\u76ee\u65f6\u95f4\u8868\u4e2d\uff0c\u800c\u4e0d\u662f\u7531\u4e24\u4e2a\u4e0d\u540c\u7684\u56e2\u961f\u5206\u522b\u5904\u7406\u4e24\u4e2a\u4e92\u4e0d\u5173\u8054\u7684\u7533\u8bf7\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u90a3\u4e9b\u4ea7\u54c1\u7ec4\u5408\u4e2d\u8fd8\u5305\u62ec\u4e0e\u8fd9\u4e9b\u5957\u4ef6\u4e00\u8d77\u4f7f\u7528\u7684\u8f90\u5c04\u53d1\u5c04\u4eea\u5668\uff08\u4f8b\u5982\u4f3d\u9a6c\u8ba1\u6570\u5668\uff09\u7684\u5236\u9020\u5546\uff0c\u6211\u4eec\u7684 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/radiation-medical-device-registration-in-indonesia\/\">\u8f90\u5c04\u533b\u7597\u5668\u68b0\u6ce8\u518c<\/a> \u8be5\u670d\u52a1\u8d1f\u8d23\u5904\u7406\u540c\u4e00\u6279\u6b21\u8d27\u7269\u7684\u8bbe\u5907\u90e8\u5206\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u9700\u66f4\u5168\u9762\u5730\u4e86\u89e3\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u548c Kemenkes \u5bf9\u8f90\u5c04\u76f8\u5173\u533b\u7597\u4ea7\u54c1\u7684\u5ba1\u6279\u6d41\u7a0b\uff0c\u8bf7\u53c2\u9605\u6211\u4eec\u5173\u4e8e\u6b64\u4e3b\u9898\u7684\u76f8\u5173\u6587\u7ae0\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/radiation-emitting-medical-device-registration-indonesia\/\">\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u8f90\u5c04\u53d1\u5c04\u533b\u7597\u5668\u68b0\u6ce8\u518c<\/a>. \u5bf9\u4e8e\u9002\u7528\u4e8e\u975e\u653e\u5c04\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7684\u5206\u7c7b\u5dee\u5f02\uff0c\u5305\u62ecD\u7c7b\u4f20\u67d3\u75c5\u7597\u6548\u8bc4\u4f30\u6b65\u9aa4\uff0c\u8bf7\u53c2\u89c1 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/indonesia-ivd-registration-vs-medical-device\/\">\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<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u9884\u7ea6\u54a8\u8be2<\/strong> \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<\/a> \u5728\u60a8\u786e\u5b9a\u8fdb\u53e3\u6216\u4e0a\u5e02\u65e5\u671f\u4e4b\u524d\uff0c\u56e2\u961f\u5c06\u4e86\u89e3 Kemenkes \u548c\u56fd\u5bb6\u8f90\u5c04\u76d1\u7ba1\u673a\u6784\u5bf9\u60a8\u7279\u5b9a\u653e\u5c04\u6027 IVD \u8bd5\u5242\u76d2\u7684\u8981\u6c42\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>The mistake we run into most often is deceptively simple. A company files a radiolabeled IVD kit, a radioimmunoassay (RIA) reagent, say, exactly the way it would file an ordinary diagnostic, using nothing but a Kemenkes technical dossier. The Kemenkes review goes fine. The classification lands where expected. Then the shipment reaches the border, and [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":7708,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7707","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\/7707","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=7707"}],"version-history":[{"count":1,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7707\/revisions"}],"predecessor-version":[{"id":7712,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7707\/revisions\/7712"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/7708"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=7707"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=7707"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=7707"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=7707"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}