{"id":7767,"date":"2026-09-23T11:19:08","date_gmt":"2026-09-23T04:19:08","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=7767"},"modified":"2026-09-22T11:25:25","modified_gmt":"2026-09-22T04:25:25","slug":"samd-registration-indonesia","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/samd-registration-indonesia\/","title":{"rendered":"\u5370\u5c3cSaMD\u6ce8\u518c\uff1aKemenkes\u5982\u4f55\u5bf9\u57fa\u4e8e\u4eba\u5de5\u667a\u80fd\u7684\u8bca\u65ad\u8fdb\u884c\u5206\u7c7b"},"content":{"rendered":"<p class=\"wp-block-paragraph\">SaMD \u6307\u7684\u662f\u201c\u8f6f\u4ef6\u5373\u533b\u7597\u5668\u68b0\u201d\uff08Software as a Medical Device\uff09\uff0c\u5b83\u6307\u7684\u662f\u65e0\u9700\u96c6\u6210\u5230\u786c\u4ef6\u4e2d\uff0c\u5373\u53ef\u72ec\u7acb\u6267\u884c\u533b\u7597\u529f\u80fd\u7684\u8f6f\u4ef6\uff0c\u5305\u62ec\u57fa\u4e8e\u4eba\u5de5\u667a\u80fd\u7684\u8bca\u65ad\u5de5\u5177\u548c\u4e34\u5e8a\u51b3\u7b56\u652f\u6301\u7b97\u6cd5\u3002\u5b83\u4e5f\u6210\u4e3a\u4e86\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u4e2d\u6700\u4ee4\u4eba\u56f0\u60d1\u7684\u9886\u57df\u4e4b\u4e00\u3002\u6b64\u524d\uff0c\u65e0\u8bba\u662f\u63a8\u51fa\u5206\u8bca\u7b97\u6cd5\u7684\u533b\u7597\u79d1\u6280\u516c\u53f8\uff0c\u8fd8\u662f\u5ba1\u6838\u4f9b\u5e94\u5546\u4eba\u5de5\u667a\u80fd\u5de5\u5177\u7684\u533b\u9662IT\u56e2\u961f\uff0c\u90fd\u65e0\u6cd5\u53ef\u9760\u5730\u5224\u65ad\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u662f\u5426\u4f1a\u5c06\u5176\u89c6\u4e3a\u53d7\u76d1\u7ba1\u7684\u533b\u7597\u5668\u68b0\uff0c\u66f4\u9051\u8bba\u5176\u9700\u8981\u901a\u8fc7\u54ea\u4e2a\u7ea7\u522b\u7684\u5206\u7c7b\u3001\u6280\u672f\u6807\u51c6\u6216\u4e34\u5e8a\u8bc1\u636e\u8ba4\u8bc1\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/jdih.kemkes.go.id\/documents\/keputusan-menteri-kesehatan-republik-indonesia-nomor-hk0107menkes9512026\" target=\"_blank\" rel=\"noopener\">KMK \u53f7 HK.01.07\/MENKES\/951\/2026<\/a> \u60c5\u51b5\u53d1\u751f\u4e86\u6539\u53d8\u3002\u8fd9\u662f\u7b2c\u4e00\u90e8\u4e13\u95e8\u9488\u5bf9\u8f6f\u4ef6\u8bbe\u5907\u7f16\u5199\u7684Kemenkes\u6307\u5357\uff0c\u5b83\u6700\u7ec8\u5bf9\u8fc7\u53bb\u53ea\u80fd\u4e2a\u6848\u89e3\u51b3\u7684\u5206\u7c7b\u3001\u6807\u51c6\u548c\u8bc1\u636e\u95ee\u9898\u7ed9\u51fa\u4e86\u6b63\u5f0f\u7684\u7b54\u6848\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u6b63\u5728\u5f00\u53d1\u8bca\u65ad\u6216\u51b3\u7b56\u652f\u6301\u8f6f\u4ef6\u7684\u533b\u7597\u79d1\u6280\u516c\u53f8\u3001\u5728\u90e8\u7f72\u524d\u8bc4\u4f30\u4eba\u5de5\u667a\u80fd\u5de5\u5177\u7684\u533b\u9662IT\u56e2\u961f\uff0c\u4ee5\u53ca\u529b\u6c42\u51c6\u786e\u800c\u975e\u4ec5\u4ec5\u5feb\u901f\u505a\u51fa\u4ea7\u54c1\u5206\u7c7b\u7684\u76d1\u7ba1\u4e8b\u52a1\u4eba\u5458\u6765\u8bf4\uff0c\u672c\u6587\u6b63\u662f\u4e3a\u60a8\u800c\u5199\u3002\u6211\u4eec\u5c06\u4ecb\u7ecdKemenkes\u5982\u4f55\u533a\u5206\u8f6f\u4ef6\u5373\u533b\u7597\u5668\u68b0\uff08SaMD\uff09\u3001\u8f6f\u4ef6\u5373\u533b\u7597\u5668\u68b0\uff08SiMD\uff09\u548c\u4eba\u5de5\u667a\u80fd\u8d4b\u80fd\u533b\u7597\u5668\u68b0\uff08AIMD\/MLMD\uff09\uff0c\u8be6\u7ec6\u89e3\u8bfb\u8bc4\u4f30\u4eba\u5458\u7528\u4e8e\u4ea7\u54c1\u5206\u7c7b\u7684\u51b3\u7b56\u903b\u8f91\uff0c\u9610\u8ff0\u60a8\u63d0\u4ea4\u7533\u8bf7\u6240\u9700\u7684\u6280\u672f\u6807\u51c6\u548c\u4e34\u5e8a\u8bc1\u636e\uff0c\u89e3\u6790\u4e13\u4e3a\u4eba\u5de5\u667a\u80fd\u6784\u5efa\u7684\u6c99\u7bb1\u548c\u672c\u5730\u9a8c\u8bc1\u8def\u5f84\uff0c\u6700\u540e\u4e00\u6b65\u6b65\u4ecb\u7ecd\u6ce8\u518c\u6d41\u7a0b\u672c\u8eab\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5927\u591a\u6570\u5236\u9020\u5546\u5ffd\u7565\u7684\u4e00\u4e2a\u4e8b\u5b9e\u662f\uff1a\u5c3d\u7ba1\u5fb7\u56fd\u7535\u5b50\u548c\u82af\u7247\u5b89\u5168\u5c40 (Kemenkes) \u4e8e 2026 \u5e74 9 \u6708 7 \u65e5\u901a\u8fc7 KMK No. HK.01.07\/MENKES\/951\/2026 \u53d1\u5e03\u4e86\u6b63\u5f0f\u7684\u8f6f\u4ef6\u5206\u7c7b\u8def\u5f84\uff0c\u4f46\u5177\u4f53 SaMD \u4ea7\u54c1\u7684\u65e5\u5e38\u6ce8\u518c\u548c\u5206\u7c7b\u51b3\u5b9a\u4ecd\u7136\u9700\u8981 Kemenkes \u8fdb\u884c\u9010\u6848\u5ba1\u67e5\uff0c\u800c\u4e0d\u662f\u50cf\u5927\u591a\u6570\u786c\u4ef6\u8bbe\u5907\u90a3\u6837\u901a\u8fc7 Regalkes \u7cfb\u7edf\u81ea\u52a8\u63d0\u4ea4\u81ea\u6211\u58f0\u660e\u3002\u5b9e\u9645\u4e0a\uff0c\u5f00\u53d1\u4eba\u5458\u4ecd\u7136\u9700\u8981\u5c06\u5b9e\u9645\u4ea7\u54c1\u3001\u9884\u671f\u7528\u9014\u8bf4\u660e\u548c\u7b97\u6cd5\u6587\u6863\u4eb2\u81ea\u5e26\u5230 Kemenkes \u8bc4\u4f30\u4eba\u5458\u9762\u524d\uff0c\u624d\u80fd\u83b7\u5f97\u5177\u6709\u7ea6\u675f\u529b\u7684\u5206\u7c7b\u3002\u867d\u7136\u4e66\u9762\u6307\u5357\u5df2\u7ecf\u5b58\u5728\uff0c\u4f46\u56f4\u7ed5\u8be5\u6307\u5357\u7684\u5177\u4f53\u64cd\u4f5c\u6d41\u7a0b\u4ecd\u5728\u9010\u6848\u5236\u5b9a\u4e2d\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4e3a\u4ec0\u4e48\u5370\u5c3c\u7684SaMD\u6ce8\u518c\u6709\u4e86\u65b0\u7684\u89c4\u5219\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\/SaMD-Registration-in-Indonesia-Kemenkes-Guide-2.webp\" alt=\"SaMD \u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c Kemenkes \u6307\u5357\" class=\"wp-image-7769\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/SaMD-Registration-in-Indonesia-Kemenkes-Guide-2.webp 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/SaMD-Registration-in-Indonesia-Kemenkes-Guide-2-300x200.webp 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/09\/SaMD-Registration-in-Indonesia-Kemenkes-Guide-2-768x512.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u81ea\u90a3\u65f6\u8d77\uff0c\u8f6f\u4ef6\u5728\u6280\u672f\u4e0a\u5df2\u88ab\u7eb3\u5165\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u533b\u7597\u5668\u68b0\u5b9a\u4e49\u8303\u7574\u3002 <a href=\"https:\/\/www.kemkes.go.id\/id\/undang-undang-republik-indonesia-nomor-17-tahun-2023-tentang-kesehatan\" target=\"_blank\" rel=\"noopener\">\u4e91\u5f53-\u4e91\u5f53 No. 17 Tahun 2023 tentang Kesehatan<\/a>, \uff0c\u5176\u4e2d\u5b9a\u4e49 alat kesehatan \u5c06 perangkat lunak \u4e0e\u5668\u68b0\u548c\u690d\u5165\u7269\u4e00\u8d77\u5305\u62ec\u5728\u5185\uff0c\u53ca\u5176\u5b9e\u65bd\u6761\u4f8b <a href=\"https:\/\/kemkes.go.id\/id\/peraturan-pemerintah-ri-no-28-tahun-2024-tentang-peraturan-pelaksanaan-uu-kesehatan\" target=\"_blank\" rel=\"noopener\">PP No. 28 Tahun 2024<\/a>. \u4e0d\u8fc7\uff0c\u57282026\u5e749\u6708\u4e4b\u524d\uff0cKemenkes\u5bf9\u72ec\u7acb\u533b\u7597\u8f6f\u4ef6\u7684\u8bc4\u4f30\u91c7\u7528\u4e86\u4e0e\u786c\u4ef6\u76f8\u540c\u7684\u56db\u7ea7\u5206\u7c7b\u6807\u51c6\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>, \u4f46\u662f\uff0c\u76ee\u524d\u8fd8\u6ca1\u6709\u4e13\u95e8\u7684\u6280\u672f\u9014\u5f84\u6765\u533a\u5206\u8bca\u65ad\u7b97\u6cd5\u6216\u4eba\u5de5\u667a\u80fd\u5de5\u5177\u4e0e\u4e00\u822c\u7684\u5065\u5eb7\u5e94\u7528\u7a0b\u5e8f\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/jdih.kemkes.go.id\/documents\/keputusan-menteri-kesehatan-republik-indonesia-nomor-hk0107menkes9512026\" target=\"_blank\" rel=\"noopener\">KMK \u53f7 HK.01.07\/MENKES\/951\/2026<\/a> 2026\u5e749\u67087\u65e5\uff0c\u536b\u751f\u90e8\u957f\u53d1\u5e03\u7684\u300a\u5173\u4e8e\u533b\u7597\u5668\u68b0\u57fa\u7840\u6307\u5357\u300b\uff08tentang Pedoman Izin Edar Alat Kesehatan Berbasis Perangkat Lunak\uff09\u586b\u8865\u4e86\u8fd9\u4e00\u7a7a\u767d\u3002\u8fd9\u6b63\u662f\u81ea2024\u5e74\u4ee5\u6765\uff0c\u4e1a\u754c\u4e00\u76f4\u52aa\u529b\u6784\u5efa\u7684\u76d1\u7ba1\u53d1\u5c55\u65b9\u5411\u3002\u5f53\u65f6\uff0c\u536b\u751f\u90e8\u548c\u56fd\u9645\u673a\u6784\u9996\u6b21\u5f00\u59cb\u5206\u53d1\u533b\u7597\u5668\u68b0\u6846\u67b6\u63d0\u6848\uff1b2026\u5e74\u7684\u536b\u751f\u90e8\u6307\u5357\u6807\u5fd7\u7740\u8fd9\u4e9b\u57fa\u7840\u5de5\u4f5c\u8f6c\u5316\u4e3a\u73b0\u884c\u6709\u6548\u7684\u6307\u5bfc\u65b9\u9488\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u54ea\u4e9b\u8bbe\u5907\u5c5e\u4e8eSaMD\u3001SiMD\u6216AI\u533b\u7597\u8bbe\u5907\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636eKMK No. HK.01.07\/MENKES\/951\/2026\u53f7\u6587\u4ef6\uff0c\u6377\u514b\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u5c40\uff08Kemenkes\uff09\u5c06\u57fa\u4e8e\u8f6f\u4ef6\u7684\u533b\u7597\u4ea7\u54c1\u5206\u4e3a\u4e09\u7c7b\u3002\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u662f\u6307\u8fd0\u884c\u5728\u901a\u7528\u786c\u4ef6\u4e0a\u7684\u72ec\u7acb\u8f6f\u4ef6\uff0c\u5b83\u5e76\u975e\u7279\u5b9a\u7269\u7406\u8bbe\u5907\u7684\u4e00\u90e8\u5206\u3002\u533b\u7597\u5668\u68b0\u5185\u7f6e\u8f6f\u4ef6\uff08SiMD\uff09\u662f\u6307\u5d4c\u5165\u7269\u7406\u8bbe\u5907\u5e76\u63a7\u5236\u5176\u6027\u80fd\u7684\u8f6f\u4ef6\uff0c\u56e0\u6b64\u5b83\u9075\u5faa\u8be5\u8bbe\u5907\u81ea\u8eab\u7684\u98ce\u9669\u7b49\u7ea7\uff0c\u800c\u975e\u5355\u72ec\u5206\u7c7b\u3002\u4f7f\u7528\u4eba\u5de5\u667a\u80fd\u6216\u673a\u5668\u5b66\u4e60\u7684\u8bbe\u5907\uff0c\u5305\u62ecAIMD\uff08\u4eba\u5de5\u667a\u80fd\u533b\u7597\u8bbe\u5907\uff09\u548cMLMD\uff08\u673a\u5668\u5b66\u4e60\u533b\u7597\u8bbe\u5907\uff09\uff0c\u88ab\u89c6\u4e3a\u7b2c\u4e09\u7c7b\uff0c\u5176\u5728SaMD\u6216SiMD\u7c7b\u522b\u7684\u57fa\u7840\u4e0a\u589e\u52a0\u4e86\u989d\u5916\u7684\u6280\u672f\u548c\u4e34\u5e8a\u8981\u6c42\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u7c7b\u522b<\/strong><\/td><td><strong>\u5b9a\u4e49<\/strong><\/td><td><strong>\u4f8b\u5b50<\/strong><\/td><\/tr><tr><td>SaMD<\/td><td>\u72ec\u7acb\u8f6f\u4ef6\uff0c\u53ef\u5728\u666e\u901a\u8ba1\u7b97\u673a\u3001\u5e73\u677f\u7535\u8111\u6216\u667a\u80fd\u624b\u673a\u4e0a\u8fd0\u884c\uff0c\u65e0\u9700\u96c6\u6210\u5230\u7279\u5b9a\u786c\u4ef6\u8bbe\u5907\u4e2d\u3002<\/td><td>\u8fde\u7eed\u8840\u7cd6\u76d1\u6d4b\u5e94\u7528\u7a0b\u5e8f\uff0c\u6570\u5b57\u5fc3\u7535\u56fe\u8bfb\u53d6\u7b97\u6cd5<\/td><\/tr><tr><td>SiMD<\/td><td>\u5d4c\u5165\u7269\u7406\u533b\u7597\u8bbe\u5907\u5e76\u63a7\u5236\u5176\u6027\u80fd\u7684\u8f6f\u4ef6<\/td><td>\u78c1\u5171\u632f\u6210\u50cf\u4eea\u4e0a\u7684\u4fe1\u53f7\u5904\u7406\u6a21\u5757\uff0c\u547c\u5438\u673a\u81ea\u52a8\u5316\u8f6f\u4ef6<\/td><\/tr><tr><td>AIMD \/ MLMD<\/td><td>\u4f7f\u7528\u4eba\u5de5\u667a\u80fd\u6216\u673a\u5668\u5b66\u4e60\uff08\u5305\u62ec\u751f\u6210\u6a21\u578b\u548c\u673a\u5668\u5b66\u4e60\u7b97\u6cd5\uff09\u7684\u72ec\u7acb\u5f0f\u6216\u5d4c\u5165\u5f0f\u533b\u7597\u8bbe\u5907<\/td><td>AI\u8f85\u52a9\u653e\u5c04\u79d1\u5206\u8bca\u5de5\u5177\uff0c\u751f\u6210\u5f0f\u4e34\u5e8a\u51b3\u7b56\u652f\u6301\u52a9\u624b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3cSaMD\u5206\u7c7b\uff1aKemenkes\u51b3\u7b56\u903b\u8f91<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">KMK No. HK.01.07\/MENKES\/951\/2026 \u89c4\u5b9a\u4e86 Kemenkes \u8bc4\u4f30\u4eba\u5458\u7528\u4e8e\u5bf9\u4ea7\u54c1\u8fdb\u884c\u5206\u7c7b\u7684\u9010\u6b65\u51b3\u7b56\u6d41\u7a0b\u3002\u7b80\u800c\u8a00\u4e4b\uff0c\u8be5\u903b\u8f91\u6309\u4ee5\u4e0b\u987a\u5e8f\u7ecf\u8fc7\u4ee5\u4e0b\u68c0\u67e5\u70b9\uff1a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1. \u8be5\u8f6f\u4ef6\u662f\u5426\u63a7\u5236\u7279\u5b9a\u7269\u7406\u533b\u7597\u8bbe\u5907\u7684\u6027\u80fd\u6216\u4e3a\u5176\u63d0\u4f9b\u529f\u80fd\uff1f\u5982\u679c\u662f\uff0c\u5219\u8be5\u8f6f\u4ef6\u5c5e\u4e8eSiMD\uff0c\u5e76\u627f\u62c5\u8be5\u8bbe\u5907\u73b0\u6709\u7684\u98ce\u9669\u7b49\u7ea7\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2. \u5982\u679c\u4e0d\u662f\uff0c\u5b83\u662f\u5426\u4f1a\u5bf9\u60a3\u8005\u7279\u5b9a\u6570\u636e\u8fdb\u884c\u9664\u7b80\u5355\u5b58\u50a8\u3001\u5f52\u6863\u6216\u68c0\u7d22\u4e4b\u5916\u7684\u64cd\u4f5c\uff1f\u5982\u679c\u5426\uff0c\u5219\u5b83\u5b8c\u5168\u4e0d\u7b26\u5408\u533b\u7597\u5668\u68b0\u7684\u5b9a\u4e49\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. \u5b83\u662f\u5426\u91c7\u96c6\u3001\u5904\u7406\u6216\u5206\u6790\u6765\u81ea\u7279\u5b9a\u6765\u6e90\u7684\u4fe1\u53f7\u6216\u6570\u636e\uff0c\u4f8b\u5982\u4f53\u5916\u8bca\u65ad\u7ed3\u679c\u3001MRI \u8f93\u51fa\u3001\u4e0b\u4e00\u4ee3\u6d4b\u5e8f\u6216\u8fde\u7eed\u8840\u7cd6\u76d1\u6d4b\uff1f\u5982\u679c\u662f\uff0c\u5219\u5b83\u662f SaMD\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. \u5982\u679c\u4e0d\u662f\uff0c\u5b83\u662f\u5426\u663e\u793a\u3001\u5206\u6790\u6216\u6253\u5370\u8fde\u7eed\u4fe1\u53f7\u3001\u533b\u5b66\u56fe\u50cf\u3001\u6ce2\u5f62\uff08\u4f8b\u5982\u5fc3\u7535\u56fe\uff09\u6216\u8fde\u7eed\u91c7\u6837\u6570\u636e\uff1f\u5982\u679c\u662f\uff0c\u90a3\u4e48\u5b83\u5c31\u662fSaMD\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">5. \u5982\u679c\u4e0d\u662f\uff0c\u5b83\u662f\u5426\u751f\u6210\u75be\u75c5\u98ce\u9669\u8bc4\u5206\u3001\u60a3\u75c5\u6982\u7387\u6216\u65f6\u95f4\u7d27\u8feb\u7684\u8f93\u51fa\uff1f\u5982\u679c\u662f\uff0c\u5219\u5c5e\u4e8e\u8f6f\u4ef6\u533b\u7597\u5668\u68b0 (SaMD)\uff1b\u5982\u679c\u4e0d\u662f\uff0c\u5219\u4e0d\u5c5e\u4e8e Kemenkes \u8f6f\u4ef6\u533b\u7597\u5668\u68b0\u7684\u8303\u7574\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u6d41\u7a0b\u51b3\u5b9a\u4e86\u4ea7\u54c1\u5728\u5370\u5c3c\u4e0a\u5e02\u7528\u4e8e\u4e34\u5e8a\u4e4b\u524d\u662f\u5426\u9700\u8981 Izin Edar\uff0c\u56e0\u6b64\u6211\u4eec\u5efa\u8bae\u5728\u76d1\u7ba1\u987e\u95ee\u7684\u6307\u5bfc\u4e0b\u5bf9\u5019\u9009\u4ea7\u54c1\u8fdb\u884c\u5ba1\u6838\uff0c\u800c\u4e0d\u662f\u60f3\u5f53\u7136\u5730\u8ba4\u4e3a\u5065\u5eb7\u5e94\u7528\u7a0b\u5e8f\u53ef\u4ee5\u8c41\u514d\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>IEC 62304 \u5370\u5ea6\u5c3c\u897f\u4e9a\u533b\u7597\u8f6f\u4ef6\uff1a\u6807\u51c6 KMK No. HK.01.07\/MENKES\/951\/2026 \u6307\u5411<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">KMK No. HK.01.07\/MENKES\/951\/2026 \u5e76\u672a\u5236\u5b9a\u65b0\u7684\u6280\u672f\u6807\u51c6\uff0c\u800c\u662f\u5c06\u8d28\u91cf\u548c\u5b89\u5168\u8981\u6c42\u5efa\u7acb\u5728\u56fd\u9645\u516c\u8ba4\u7684\u6807\u51c6\u4e4b\u4e0a\u3002\u5bf9\u4e8e SaMD\u3001SiMD \u548c AI \u8bbe\u5907\uff0c\u8be5\u6307\u5357\u53c2\u8003\u4e86\u4ee5\u4e0b\u6807\u51c6\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 13485 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6db5\u76d6\u8f6f\u4ef6\u7684\u8bbe\u8ba1\u548c\u7ef4\u62a4\u3002.<\/li>\n\n\n\n<li>ISO 14971 \u7528\u4e8e\u8f6f\u4ef6\u751f\u547d\u5468\u671f\u5185\u7684\u98ce\u9669\u7ba1\u7406\u3002.<\/li>\n\n\n\n<li>IEC 62304 \u662f\u533b\u7597\u8f6f\u4ef6\u5f00\u53d1\u751f\u547d\u5468\u671f\u7684\u6807\u51c6\uff0c\u4e0e IEC 62304 \u533b\u7597\u8f6f\u4ef6\u5370\u5c3c\u5408\u89c4\u6027\u5de5\u4f5c\u6700\u76f4\u63a5\u76f8\u5173\uff0c\u6db5\u76d6\u4e86\u8f6f\u4ef6\u7684\u8bbe\u8ba1\u3001\u9a8c\u8bc1\u548c\u7ef4\u62a4\u65b9\u5f0f\u3002.<\/li>\n\n\n\n<li>IEC 82304 \u9002\u7528\u4e8e\u5df2\u90e8\u7f72\u7684\u6700\u7ec8\u5065\u5eb7\u8f6f\u4ef6\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u3002.<\/li>\n\n\n\n<li>IEC 63450 \u662f\u4e00\u4e2a\u8f83\u65b0\u7684\u6807\u51c6\uff0c\u4e13\u95e8\u7528\u4e8e\u4eba\u5de5\u667a\u80fd\u533b\u7597\u8bbe\u5907 (AIMD) \u7684\u6280\u672f\u9a8c\u8bc1\u3002.<\/li>\n\n\n\n<li>IEC 63521 \u662f\u673a\u5668\u5b66\u4e60\u533b\u7597\u8bbe\u5907 (MLMD) \u6027\u80fd\u8bc4\u4f30\u7684\u65b0\u6807\u51c6\u3002.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 60601-1\uff08\u533b\u7528\u7535\u6c14\u8bbe\u5907\u2014\u901a\u7528\u8981\u6c42\uff09<\/li>\n\n\n\n<li>IEC 61010-1\uff08\u901a\u7528\u5b89\u5168\u8981\u6c42\uff09<\/li>\n\n\n\n<li>IEC 62366-1\uff08\u53ef\u7528\u6027\u5de5\u7a0b\uff09<\/li>\n\n\n\n<li><strong>ISO 27001<\/strong> \uff08\u4fe1\u606f\u5b89\u5168\u7ba1\u7406\u7cfb\u7edf\uff09\u2014 ini relevan sekali mengingat artikel sudah membahas keamanan siber\/data AI\uff0csebaiknya ditambahkan\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0cIEC 62304 \u751f\u547d\u5468\u671f\u6587\u6863\u662f\u56fd\u9645 SaMD \u5f00\u53d1\u4eba\u5458\u5728\u5411\u5370\u5c3c\u63d0\u4ea4\u7533\u8bf7\u65f6\u9996\u5148\u9047\u5230\u7684\u95ee\u9898\uff0c\u56e0\u4e3a\u5168\u7403\u56e2\u961f\u901a\u5e38\u5c06\u8fd9\u4e9b\u8bc1\u636e\u4fdd\u5b58\u5728\u5185\u90e8\u5de5\u7a0b\u7ef4\u57fa\u4e2d\uff0c\u800c\u4e0d\u662f\u50cf\u5370\u5c3c\u56fd\u5bb6\u8bc4\u4f30\u673a\u6784 (Kemenkes) \u8bc4\u4f30\u4eba\u5458\u6240\u671f\u671b\u7684\u90a3\u6837\uff0c\u4ee5\u6253\u5305\u597d\u7684\u3001\u53ef\u76f4\u63a5\u63d0\u4ea4\u7684\u6587\u4ef6\u5f62\u5f0f\u4fdd\u5b58\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>SaMD\u6ce8\u518c\u7684\u4e34\u5e8a\u8bc1\u636e\u9884\u671f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">KMK No. HK.01.07\/MENKES\/951\/2026 \u5c06\u4e34\u5e8a\u8bc1\u636e\u7684\u8861\u91cf\u6807\u51c6\u653e\u5728\u8f6f\u4ef6\u5b9e\u9645\u4e3a\u4e34\u5e8a\u533b\u751f\u63d0\u4f9b\u7684\u670d\u52a1\u4e0a\uff0c\u800c\u4e0d\u4ec5\u4ec5\u662f\u6f5c\u5728\u75be\u75c5\u7684\u4e25\u91cd\u7a0b\u5ea6\u3002\u6700\u6e05\u6670\u7684\u7ed3\u8bba\uff0c\u4e5f\u662f\u5bf9\u4e00\u4e2a\u5e38\u89c1\u95ee\u9898\u7684\u72ec\u7acb\u89e3\u7b54\uff0c\u662f\uff1a\u65e0\u8bba\u8f6f\u4ef6\u76f4\u63a5\u7528\u4e8e\u6cbb\u7597\u6216\u8bca\u65ad\uff0c\u65e0\u8bba\u75be\u75c5\u4e25\u91cd\u7a0b\u5ea6\u5982\u4f55\uff0c\u90fd\u9700\u8981\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff1b\u800c\u4ec5\u63d0\u4f9b\u4fe1\u606f\u6216\u652f\u6301\u4e34\u5e8a\u7ba1\u7406\u7684\u8f6f\u4ef6\uff0c\u901a\u5e38\u53ef\u4ee5\u4f9d\u8d56\u6587\u732e\u7efc\u8ff0\u548c\u5df2\u8bb0\u5f55\u7684\u4e34\u5e8a\u7ecf\u9a8c\uff0c\u9664\u975e\u75c5\u60c5\u5371\u91cd\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u8f6f\u4ef6\u7684\u529f\u80fd<\/strong><\/td><td><strong>\u5178\u578b\u7684\u4e34\u5e8a\u8bc1\u636e\u9884\u671f<\/strong><\/td><\/tr><tr><td>\u4ec5\u63d0\u4f9b\u4fe1\u606f<\/td><td>\u6587\u732e\u7efc\u8ff0\u53ca\u4e34\u5e8a\u7ecf\u9a8c\u8bb0\u5f55<\/td><\/tr><tr><td>\u6307\u5bfc\u6216\u5f71\u54cd\u4e34\u5e8a\u7ba1\u7406<\/td><td>\u6587\u732e\u56de\u987e\u52a0\u4e0a\u4e34\u5e8a\u7ecf\u9a8c\uff1b\u5f53\u75c5\u60c5\u5371\u91cd\u6216\u7ed3\u679c\u4e0e\u8bca\u65ad\u5bc6\u5207\u76f8\u5173\u65f6\uff0c\u5219\u9700\u5f00\u5c55\u4e13\u95e8\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/td><\/tr><tr><td>\u76f4\u63a5\u6cbb\u7597\u6216\u8bca\u65ad<\/td><td>\u65e0\u8bba\u6f5c\u5728\u75be\u75c5\u7684\u4e25\u91cd\u7a0b\u5ea6\u5982\u4f55\uff0c\u6587\u732e\u7efc\u8ff0\u3001\u4e34\u5e8a\u7ecf\u9a8c\u548c\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u90fd\u81f3\u5173\u91cd\u8981\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>AI \u533b\u7597\u5668\u68b0 Kemenkes \u6ce8\u518c\uff1a\u6c99\u76d2\u548c\u672c\u5730\u4e34\u5e8a\u9a8c\u8bc1<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u4eba\u5de5\u667a\u80fd\u533b\u7597\u8bbe\u5907\uff0c\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\u7684\u6ce8\u518c\u6587\u4ef6\uff08KMK No. HK.01.07\/MENKES\/951\/2026\uff09\u5f15\u5165\u4e86\u4e24\u9879\u673a\u5236\uff0c\u65e8\u5728\u5e73\u8861\u521b\u65b0\u4e0e\u60a3\u8005\u5b89\u5168\u3002\u9996\u5148\uff0c\u76d1\u7ba1\u6c99\u76d2\u5141\u8bb8\u5728\u53d7\u63a7\u73af\u5883\u4e0b\u6d4b\u8bd5\u9488\u5bf9\u5370\u5c3c\u4eba\u7fa4\u4e34\u5e8a\u8bc1\u636e\u6709\u9650\u7684\u6570\u5b57\u533b\u7597\u521b\u65b0\u4ea7\u54c1\uff0c\u524d\u63d0\u662f\u8be5\u4ea7\u54c1\u5df2\u8fbe\u5230\u6280\u672f\u6210\u719f\u5ea69\u7ea7\uff08TRL 9\uff09\uff0c\u8fd9\u610f\u5473\u7740\u5b83\u5df2\u5728\u5176\u4ed6\u5730\u533a\u7684\u5b9e\u9645\u8fd0\u884c\u6761\u4ef6\u4e0b\u88ab\u8bc1\u660e\u80fd\u591f\u6210\u529f\u8fd0\u884c\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5176\u6b21\uff0c\u8fdb\u53e3\u7684\u3001\u4f7f\u7528\u4eba\u5de5\u667a\u80fd\u8fdb\u884c\u4e2d\u9ad8\u98ce\u9669\u7528\u9014\uff08\u4f8b\u5982\u8bca\u65ad\u3001\u7b5b\u67e5\u6216\u4e34\u5e8a\u51b3\u7b56\uff09\u7684\u8f6f\u4ef6\u578b\u533b\u7597\u5668\u68b0\uff0c\u5fc5\u987b\u5728\u5370\u5c3c\u8fdb\u884c\u672c\u5730\u4e34\u5e8a\u9a8c\u8bc1\uff0c\u5e76\u5c06\u9a8c\u8bc1\u7ed3\u679c\u63d0\u4ea4\u7ed9\u5370\u5c3c\u536b\u751f\u90e8\uff08Kemenkes\uff09\uff0c\u6700\u8fdf\u4e0d\u5f97\u665a\u4e8e\u4ea7\u54c1\u8bb8\u53ef\u8bc1\uff08Izin Edar\uff09\u9881\u53d1\u540e\u4e00\u5e74\u3002\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u90a3\u4e9b\u8ba4\u4e3a\u6d77\u5916\u9a8c\u8bc1\u6570\u636e\u5c31\u8db3\u591f\u5145\u5206\u7684\u5236\u9020\u5546\uff0c\u4e8b\u540e\u6700\u6709\u53ef\u80fd\u88ab\u8981\u6c42\u8fdb\u884c\u672c\u5730\u9a8c\u8bc1\u3002\u56e0\u6b64\uff0c\u6211\u4eec\u5efa\u8bae\u5236\u9020\u5546\u5728\u63d0\u4ea4\u7533\u8bf7\u524d\u5c31\u505a\u597d\u9a8c\u8bc1\u51c6\u5907\uff0c\u800c\u4e0d\u662f\u5728\u88ab\u8be2\u95ee\u540e\u624d\u8fdb\u884c\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u8fde\u7eed\u673a\u5668\u5b66\u4e60\u548c\u57fa\u4e8eLLM\u7684SaMD<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">KMK No. HK.01.07\/MENKES\/951\/2026 \u4e5f\u6d89\u53ca\u4e0a\u5e02\u540e\u4ecd\u6301\u7eed\u5b66\u4e60\u7684\u6a21\u578b\u3002\u4f01\u4e1a\u8fd0\u8425\u8005\u5fc5\u987b\u63d0\u4ea4\u5176\u6301\u7eed\u673a\u5668\u5b66\u4e60\u63a7\u5236\u673a\u5236\u7684\u6587\u6863\uff0c\u6db5\u76d6\u5f02\u5e38\u68c0\u6d4b\u548c\u7f13\u89e3\u3001\u771f\u5b9e\u4e16\u754c\u6570\u636e\u7ba1\u7406\u3001\u5b66\u4e60\u8fc7\u7a0b\u7684\u53ef\u8ffd\u6eaf\u6027\u4ee5\u53ca\u6301\u7eed\u9a8c\u8bc1\u7b56\u7565\u3002\u5bf9\u4e8e\u57fa\u4e8e\u751f\u6210\u6a21\u578b\u6216\u5927\u578b\u8bed\u8a00\u6a21\u578b\u6784\u5efa\u7684\u8bbe\u5907\uff0c\u8be5\u6307\u5357\u7279\u522b\u8981\u6c42\u5236\u5b9a\u7f13\u89e3\u201c\u5e7b\u89c9\u201d\u7684\u65b9\u6848\uff0c\u5373\u6a21\u578b\u503e\u5411\u4e8e\u4ea7\u751f\u542c\u8d77\u6765\u81ea\u4fe1\u4f46\u5b9e\u9645\u4e0a\u9519\u8bef\u7684\u8f93\u51fa\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u6307\u5357\u533a\u5206\u4e86\u9700\u8981\u63d0\u4ea4\u65b0\u7684 Izin Edar \u7533\u8bf7\u7684\u91cd\u5927\u53d8\u66f4\u548c\u53ea\u9700\u66f4\u65b0\u73b0\u6709\u6ce8\u518c\u6570\u636e\u7684\u8f83\u5c0f\u53d8\u66f4\u3002\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5bf9\u4e8e\u53c2\u6570\u9010\u6e10\u53d8\u5316\u7684\u6a21\u578b\uff0c\u8fd9\u6761\u754c\u9650\u5728\u5b9e\u8df5\u4e2d\u5e76\u4e0d\u603b\u662f\u90a3\u4e48\u6e05\u6670\uff0c\u56e0\u6b64\uff0c\u5728 Kemenkes \u786e\u8ba4\u4e4b\u524d\uff0c\u6211\u4eec\u5c06\u4efb\u4f55\u8bca\u65ad\u6216\u5206\u8bca\u903b\u8f91\u7684\u53d8\u66f4\u90fd\u89c6\u4e3a\u65b0\u7684\u7533\u8bf7\u95ee\u9898\uff0c\u800c\u4e0d\u662f\u9ed8\u8ba4\u91c7\u7528\u8f83\u7b80\u5355\u7684\u62a5\u544a\u65b9\u5f0f\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6d41\u7a0b\u4e2d\uff0c\u8f6f\u4ef6\u5373\u533b\u7597\u5668\u68b0\uff08SaMD\uff09\u6709\u4f55\u4e0d\u540c\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u786c\u4ef6\u533b\u7597\u5668\u68b0\u7684\u6ce8\u518c\u6d41\u7a0b\u901a\u5e38\u9075\u5faaRegalkes\u7684\u65e2\u5b9a\u7a0b\u5e8f\uff1a\u81ea\u6211\u58f0\u660e\u5206\u7c7b\u3001\u63d0\u4ea4\u4e1c\u76dfCSDT\u6587\u4ef6\u3001\u652f\u4ed8PNBP\u8d39\u7528\u3001\u6280\u672f\u5ba1\u67e5\u4ee5\u53caNIE\u7b7e\u53d1\u3002\u8f6f\u4ef6\u5373\u533b\u7597\u5668\u68b0\uff08SaMD\uff09\u7684\u6ce8\u518c\u6d41\u7a0b\u4e0e\u786c\u4ef6\u7c7b\u4f3c\uff0c\u5747\u9075\u5faaPermenkes 2017\u5e74\u7b2c62\u53f7\u6cd5\u4ee4\u89c4\u5b9a\u7684\u6cd5\u5f8b\u6846\u67b6\uff0c\u4f46KMK No. HK.01.07\/MENKES\/951\/2026\u589e\u52a0\u4e86\u8f6f\u4ef6\u7279\u5b9a\u7684\u5206\u7c7b\u5224\u5b9a\u3001IEC 62304\u548c\u4eba\u5de5\u667a\u80fd\u7279\u5b9a\u6807\u51c6\u7684\u8bc1\u636e\uff0c\u4ee5\u53ca\uff08\u5982\u9002\u7528\uff09\u4e0a\u8ff0\u6c99\u7bb1\u548c\u672c\u5730\u9a8c\u8bc1\u6b65\u9aa4\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5bf9\u9879\u76ee\u8fdb\u5ea6\u5f71\u54cd\u6700\u5927\u7684\u5b9e\u9645\u533a\u522b\u5728\u4e8e\uff0c\u786c\u4ef6\u6587\u4ef6\u901a\u5e38\u53ef\u4ee5\u4e3b\u8981\u901a\u8fc7\u7eb8\u8d28\u6587\u4ef6\u5728 Regalkes \u7cfb\u7edf\u4e2d\u6d41\u8f6c\uff0c\u800c SaMD \u6216 AI \u542f\u7528\u7684\u6587\u4ef6\u901a\u5e38\u4ecd\u7136\u9700\u8981\u4e0e Kemenkes \u8bc4\u4f30\u4eba\u5458\u8fdb\u884c\u76f4\u63a5\u7684\u4f1a\u9762\u6216\u5de5\u4f5c\u4f1a\u8bae\uff0c\u4ee5\u786e\u8ba4\u5206\u7c7b\u5e76\u4e86\u89e3\u7b97\u6cd5\u7684\u9884\u671f\u7528\u9014\uff0c\u8fd9\u4ec5\u4ec5\u662f\u56e0\u4e3a\u65b0\u7684 pedoman \u51fa\u73b0\u65f6\u95f4\u592a\u77ed\uff0c\u5c1a\u672a\u5efa\u7acb\u5b8c\u5168\u6807\u51c6\u5316\u7684\u3001\u72ec\u7acb\u7684\u5ba1\u67e5\u6d41\u7a0b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3cSaMD\u6ce8\u518c\u6d41\u7a0b\u8be6\u89e3<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. \u786e\u8ba4\u4ea7\u54c1\u662fSaMD\u3001SiMD\u8fd8\u662f\u8d85\u51fa\u8303\u56f4<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5c06\u4ea7\u54c1\u7684\u9884\u671f\u7528\u9014\u58f0\u660e\u6309\u7167\u4e0a\u8ff0\u5206\u7c7b\u51b3\u7b56\u6d41\u7a0b\u8fdb\u884c\u5904\u7406\uff0c\u5e76\u8bb0\u5f55\u7406\u7531\uff0c\u56e0\u4e3a Kemenkes \u4f1a\u5728\u5ba1\u67e5\u671f\u95f4\u8981\u6c42\u63d0\u4f9b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. \u786e\u4fdd\u672c\u5730\u5b9e\u4f53\u3001IDAK \u548c CDAKB \u7684\u5b89\u5168<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e0e\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\u4efb\u4f55\u533b\u7597\u5668\u68b0\u4e00\u6837\uff0c\u5916\u56fd SaMD \u5f00\u53d1\u5546\u9700\u8981\u4e00\u5bb6\u5728\u5f53\u5730\u6ce8\u518c\u7684\u5b9e\u4f53\uff0c\u8be5\u5b9e\u4f53\u6301\u6709\u6709\u6548\u7684 IDAK \u548c CDAKB \u8bc1\u4e66\uff0c\u4f5c\u4e3a Izin Edar \u8bb8\u53ef\u8bc1\u6301\u6709\u4eba\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3. \u6574\u7406\u6280\u672f\u548c\u4e34\u5e8a\u6863\u6848<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5c06 ISO 13485\u3001ISO 14971\u3001IEC 62304 \u4ee5\u53ca\uff08\u5982\u9002\u7528\uff09IEC 82304\u3001IEC 63450 \u548c IEC 63521 \u8bc1\u636e\u4e0e\u4ea7\u54c1\u529f\u80fd\u7ea7\u522b\u8981\u6c42\u7684\u4e34\u5e8a\u8bc1\u636e\u7ea7\u522b\u4e00\u8d77\u7f16\u5236\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>4. \u76f4\u63a5\u5c06\u5206\u7c7b\u7ed3\u679c\u63d0\u4ea4\u7ed9 Kemenkes<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u7531\u4e8e\u8f6f\u4ef6\u7279\u5b9a\u9014\u5f84\u662f\u65b0\u7684\uff0c\u56e0\u6b64\u9884\u8ba1\u4f1a\u7531 Kemenkes \u8bc4\u4f30\u4eba\u5458\u8fdb\u884c\u76f4\u63a5\u5206\u7c7b\u68c0\u67e5\uff0c\u800c\u4e0d\u662f\u7eaf\u7cb9\u7684\u81ea\u6211\u58f0\u660e\u7c7b\u522b\uff0c\u7279\u522b\u662f\u5bf9\u4e8e\u4efb\u4f55\u6d89\u53ca\u8bca\u65ad\u3001\u5206\u8bca\u6216 AI \u9a71\u52a8\u7684\u51b3\u7b56\u652f\u6301\u7684\u5185\u5bb9\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>5. \u5982\u9002\u7528\uff0c\u89e3\u51b3\u6c99\u7bb1\u6216\u672c\u5730\u9a8c\u8bc1\u8981\u6c42<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5c3d\u65e9\u786e\u8ba4\u4ea7\u54c1\u662f\u5426\u9700\u8981\u6c99\u7bb1\u6d4b\u8bd5\u6216\u83b7\u6279\u540e\u7684\u672c\u5730\u4e34\u5e8a\u9a8c\u8bc1\uff0c\u56e0\u4e3a\u8fd9\u4e24\u8005\u90fd\u4f1a\u5f71\u54cd\u5b9e\u9645\u7684\u4e0a\u5e02\u65f6\u95f4\u8868\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6. \u4f7f\u7528 Komdigi \u5b9e\u73b0\u5b89\u5168\u7684\u65e0\u7ebf\u5408\u89c4\u6027\uff08\u9002\u7528\u4e8e\u84dd\u7259\u3001RFID \u6216 Wi-Fi\uff09<\/strong>&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u8bbe\u5907\u4f7f\u7528\u65e0\u7ebf\u8fde\u63a5\uff08\u4f8b\u5982\u84dd\u7259\u3001\u5c04\u9891\u8bc6\u522b\/RFID \u6216 Wi-Fi\uff09\uff0c\u5219\u5fc5\u987b\u4ece\u901a\u4fe1\u548c\u6570\u7801\u90e8\u83b7\u5f97\u7535\u4fe1\u8bbe\u5907\u8ba4\u8bc1\uff08<em>Kementerian Komunikasi \u548c Digital<\/em> \/ Komdigi\uff09\u3002.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3cSaMD\u6ce8\u518c\u80cc\u540e\u7684\u5e02\u573a\u673a\u9047<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5c3d\u7ba1\u4e0a\u8ff0\u5408\u89c4\u7ec6\u8282\u7e41\u591a\uff0c\u4f46\u5c31\u5546\u4e1a\u89d2\u5ea6\u800c\u8a00\uff0c\u65f6\u673a\u786e\u5b9e\u975e\u5e38\u6709\u5229\u3002\u4e0d\u540c\u7814\u7a76\u673a\u6784\u5bf9\u201c\u6570\u5b57\u5065\u5eb7\u201d\u7684\u5b9a\u4e49\u5404\u4e0d\u76f8\u540c\uff0c\u56e0\u6b64\u7ed9\u51fa\u7684\u4f30\u7b97\u4e5f\u7565\u6709\u5dee\u5f02\uff0c\u4f46\u90fd\u6307\u5411\u540c\u4e00\u4e2a\u65b9\u5411\uff1a\u636e Ken Research \u9884\u6d4b\uff0c\u5370\u5c3c\u6570\u5b57\u5065\u5eb7\u5e02\u573a\u5728 2023 \u5e74\u7684\u4f30\u503c\u5df2\u7ea6\u4e3a 21 \u4ebf\u7f8e\u5143\uff1b\u800c\u5370\u5c3c\u4eba\u5de5\u667a\u80fd\u533b\u7597\u9886\u57df\u7684\u5e02\u573a\u89c4\u6a21\u9884\u8ba1\u5c06\u4ece 2022 \u5e74\u7684\u4e0d\u8db3 1 \u4ebf\u7f8e\u5143\u589e\u957f\u5230 2030 \u5e74\u7684\u7ea6 8.2 \u4ebf\u7f8e\u5143\uff0c\u590d\u5408\u5e74\u589e\u957f\u7387\u8d85\u8fc7 40%\uff08Insights10\uff09\u3002Mordor Intelligence \u5bf9\u66f4\u5e7f\u6cdb\u7684\u4e92\u8054\u533b\u7597\u9886\u57df\u7684\u9884\u6d4b\u5219\u8ba4\u4e3a\uff0c\u8be5\u9886\u57df\u7684\u89c4\u6a21\u66f4\u5927\uff0c\u5e76\u4e14\u5230 2030 \u5e74\u4ee3\u521d\u4ecd\u5c06\u4fdd\u6301\u7c7b\u4f3c\u7684\u5feb\u901f\u589e\u957f\u3002.<\/p>\n\n\n\n<p 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algorithms, that performs a medical function entirely on its own, without being built into a piece of hardware. It has also become one of the most confusing corners of Indonesia&#8217;s device rules. Until now, a health-tech company launching [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":7768,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7767","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\/7767","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\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/comments?post=7767"}],"version-history":[{"count":1,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7767\/revisions"}],"predecessor-version":[{"id":7770,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7767\/revisions\/7770"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/7768"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=7767"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=7767"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=7767"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=7767"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}