{"id":7868,"date":"2026-10-06T11:24:08","date_gmt":"2026-10-06T04:24:08","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-10-06T11:28:47","modified_gmt":"2026-10-06T04:28:47","slug":"medical-device-risk-classification-indonesia","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/medical-device-risk-classification-indonesia\/","title":{"rendered":"A\u3001B\u3001C\u3001D \u7c7b\uff1a\u5370\u5c3c\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u5982\u4f55\u5f71\u54cd\u4e0b\u6e38\u4ea7\u4e1a\u94fe"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u5916\u56fd\u5236\u9020\u5546\u8fdb\u5165\u5370\u5c3c\u5e02\u573a\u65f6\u6700\u4e25\u91cd\u7684\u5931\u8bef\u4e4b\u4e00\u5c31\u662f\u5bf9\u5f85\u2026\u2026 <strong>\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b<\/strong> \u4ec5\u4ec5\u5c06\u5176\u89c6\u4e3a\u4e00\u9879\u884c\u653f\u624b\u7eed\u3002\u4ee4\u4eba\u60ca\u8bb6\u7684\u662f\uff0c\u5f88\u591a\u516c\u53f8\u76f4\u63a5\u7167\u642c\u56fd\u5916\u53c2\u8003\u5e02\u573a\u7684\u5206\u7c7b\uff0c\u60f3\u5f53\u7136\u5730\u8ba4\u4e3a\u6377\u514b\u836f\u54c1\u7ba1\u7406\u5c40\uff08Kemenkes\uff09\u4f1a\u7167\u642c\uff0c\u7ed3\u679c\u5f80\u5f80\u5728\u9884\u7b97\u548c\u4e0a\u5e02\u65e5\u671f\u90fd\u5df2\u786e\u5b9a\u4e4b\u540e\u624d\u610f\u8bc6\u5230\u81ea\u5df1\u7684\u9519\u8bef\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u533b\u7597\u5668\u68b0\u8fdb\u884c\u5206\u7c7b\u4e0d\u4ec5\u4ec5\u662f\u586b\u5199\u8868\u683c\u90a3\u4e48\u7b80\u5355\uff0c\u5b83\u51b3\u5b9a\u4e86\u60a8\u6240\u5728\u5730\u533a\u6d4b\u8bd5\u8981\u6c42\u7684\u4e25\u683c\u7a0b\u5ea6\uff0c\u4e0d\u540c\u98ce\u9669\u7b49\u7ea7\u4e4b\u95f4\u7684\u5dee\u8ddd\u53ef\u80fd\u975e\u5e38\u5de8\u5927\u3002\u6211\u4eec\u66fe\u4eb2\u8eab\u7ecf\u5386\u8fc7\u4e00\u4f4d\u5ba2\u6237\u6ce8\u518c\u7ed3\u6838\u75c5\uff08TB\uff09\u8bca\u65ad\u8bd5\u5242\u76d2\u7684\u6848\u4f8b\uff1a\u7531\u4e8e\u5176\u98ce\u9669\u7b49\u7ea7\uff0c\u8be5\u4ea7\u54c1\u9762\u4e34\u7684\u6d4b\u8bd5\u8303\u56f4\u6bd4\u4f4e\u98ce\u9669\u5668\u68b0\u8981\u4e25\u683c\u5f97\u591a\u3002\u63d0\u524d\u4e86\u89e3\u5982\u4f55\u5e94\u5bf9\u8fd9\u4e9b\u9650\u5236\uff0c\u5c06\u51b3\u5b9a\u60a8\u7684\u5ba1\u6279\u6d41\u7a0b\u662f\u5426\u4f1a\u65e0\u9650\u671f\u5ef6\u957f\uff0c\u4ee5\u53ca\u60a8\u7684\u56e2\u961f\u662f\u5426\u4f1a\u5728\u5370\u5c3c\u627f\u62c5\u5de8\u989d\u7684\u3001\u9884\u7b97\u5916\u7684\u5b9e\u9a8c\u5ba4\u8d39\u7528\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u6307\u5357\u8be6\u7ec6\u4ecb\u7ecd\u4e86\u5370\u5c3c A \u81f3 D \u7c7b\u8f66\u8f86\u7cfb\u7edf\u5728\u4e0b\u6e38\u7684\u5b9e\u9645\u8fd0\u4f5c\u65b9\u5f0f\u3001\u672c\u5730\u6d4b\u8bd5\u5982\u4f55\u8de8\u7c7b\u522b\u8fdb\u884c\u6269\u5c55\uff0c\u4ee5\u53ca\u5982\u4f55\u5c3d\u65e9\u6b63\u786e\u5206\u7c7b\u4ee5\u4fdd\u62a4\u60a8\u7684\u5e02\u573a\u8fdb\u5165\u65f6\u95f4\u8868\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"667\" src=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification.jpg\" alt=\"\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\" class=\"wp-image-7869\" srcset=\"https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification.jpg 1000w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification-300x200.jpg 300w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification-768x512.jpg 768w, https:\/\/productregistrationindonesia.com\/wp-content\/uploads\/2026\/10\/Medical-device-risk-classification-18x12.jpg 18w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5370\u5c3c\u7684\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u662f\u4ec0\u4e48\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u7684\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u6839\u636e\u5668\u68b0\u5bf9\u60a3\u8005\u548c\u4f7f\u7528\u8005\u6784\u6210\u7684\u98ce\u9669\uff0c\u5c06\u6bcf\u79cd\u5668\u68b0\u5206\u4e3aA\u3001B\u3001C\u6216D\u7c7b\u3002A\u7c7b\u4e3a\u4f4e\u98ce\u9669\uff0cB\u7c7b\u4e3a\u4f4e\u81f3\u4e2d\u7b49\u98ce\u9669\uff0cC\u7c7b\u4e3a\u4e2d\u81f3\u9ad8\u98ce\u9669\uff0cD\u7c7b\u4e3a\u9ad8\u98ce\u9669\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u536b\u751f\u90e8\u9881\u5e03\u7684\u7b2c62\/2017\u53f7\u536b\u751f\u90e8\u957f\u6761\u4f8b\u89c4\u5b9a\u4e86\u8fd9\u79cd\u56db\u7ea7\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u3002 <a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/TataCaraKlasifikasi1.pdf\" target=\"_blank\" rel=\"noopener\">\u5206\u7c7b\u6307\u5357<\/a> \u5c06\u5176\u5e94\u7528\u4e8e\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u4ea7\u54c1\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u4f53\u5916\u8bca\u65ad\u4ea7\u54c1\uff0c\u98ce\u9669\u7b49\u7ea7\u7684\u5212\u5206\u7efc\u5408\u8003\u8651\u4e86\u4e2a\u4eba\u98ce\u9669\u548c\u516c\u5171\u536b\u751f\u98ce\u9669\u3002\u56e0\u6b64\uff0c\u4f20\u67d3\u75c5\u68c0\u6d4b\u4ea7\u54c1\u7684\u8bc4\u4f30\u65b9\u5f0f\u4e0e\u7b80\u5355\u7684\u4f4e\u98ce\u9669\u8f85\u52a9\u7528\u54c1\u4e0d\u540c\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u88681. \u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u6982\u89c8<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u73ed\u7ea7<\/strong><\/th><th><strong>\u98ce\u9669\u7b49\u7ea7\uff08Permenkes No. 62\/2017\uff09<\/strong><\/th><th><strong>\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5178\u578b\u7684\u4e0b\u6e38\u6548\u5e94<\/strong><\/th><\/tr><\/thead><tbody><tr><td>A<\/td><td>\u4f4e\u7684<\/td><td>\u6700\u7b80\u4fbf\u7684\u5ba1\u67e5\u65b9\u5f0f\uff0c\u5c3d\u7ba1\u8be5\u7c7b\u4ecd\u9700\u6839\u636e\u9884\u671f\u7528\u9014\u8fdb\u884c\u68c0\u67e5\u3002<\/td><\/tr><tr><td>B<\/td><td>\u4f4e\u81f3\u4e2d\u7b49<\/td><td>\u6587\u732e\u5ba1\u67e5\u5360\u636e\u4e3b\u5bfc\u5730\u4f4d\uff1b\u6d4b\u8bd5\u9700\u6c42\u53d6\u51b3\u4e8e\u8bbe\u5907\u7c7b\u578b<\/td><\/tr><tr><td>C<\/td><td>\u4e2d\u7b49\u81f3\u9ad8<\/td><td>\u66f4\u6df1\u5165\u7684\u8bc1\u636e\u548c\u5728\u5f53\u5730\u8fdb\u884c\u6d4b\u8bd5\u7684\u771f\u6b63\u673a\u4f1a\u9700\u8981\u5c3d\u65e9\u8fdb\u884c\u8bc4\u4f30<\/td><\/tr><tr><td>D<\/td><td>\u9ad8\uff08\u4f8b\u5982\u5fc3\u810f\u652f\u67b6\u548c\u8d77\u640f\u5668\uff09<\/td><td>\u8bc1\u636e\u8981\u6c42\u6700\u9ad8\uff1b\u6d4b\u8bd5\u548c\u4e34\u5e8a\u8303\u56f4\u5fc5\u987b\u5728\u9884\u7b97\u7f16\u5236\u524d\u89c4\u5212\u597d\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u76ee\u524d\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u53d7\u54ea\u4e9b\u6cd5\u89c4\u7ba1\u8f96\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6cd5\u5f8b\u4f9d\u636e\u662f\u5370\u5ea6\u5c3c\u897f\u4e9a\u5171\u548c\u56fd\u9881\u5e03\u7684 2023 \u5e74\u7b2c 17 \u53f7\u536b\u751f\u6cd5\uff0c\u4ee5\u53ca\u603b\u7edf\u9881\u5e03\u7684 2024 \u5e74\u7b2c 28 \u53f7\u653f\u5e9c\u6761\u4f8b\uff08PP\uff09\uff0c\u8be5\u6761\u4f8b\u8d1f\u8d23\u5b9e\u65bd\u8be5\u6cd5\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/jdih.kemkes.go.id\/documents\/peraturan-menteri-kesehatan-nomor-5-tahun-2026\" target=\"_blank\" rel=\"noopener\">\u5173\u4e8e\u536b\u751f\u7528\u54c1\u7684\u7b2c5\/2026\u53f7\u6cd5\u4ee4<\/a>, \u8be5\u6761\u4f8b\u7531\u536b\u751f\u90e8\u4e8e 2026 \u5e74 4 \u6708 17 \u65e5\u5236\u5b9a\uff0c\u5e76\u4e8e 2026 \u5e74 5 \u6708 4 \u65e5\u9881\u5e03\uff0c\u73b0\u5bf9\u533b\u7597\u5668\u68b0\u7684\u6d41\u901a\u8fdb\u884c\u89c4\u8303\uff0c\u5e76\u53d6\u4ee3\u4e86 Permenkes No. 62\/2017\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b83\u8fd8\u63d0\u4f9b\u4e86\u63d0\u4ea4\u5206\u7c7b\u53d8\u66f4\u7684\u9014\u5f84\u3002\u7531\u4e8e\u8be5\u6cd5\u89c4\u51fa\u53f0\u65f6\u95f4\u8f83\u77ed\uff0c\u5728\u505a\u51fa\u4efb\u4f55\u63d0\u4ea4\u51b3\u5b9a\u4e4b\u524d\uff0c\u5e94\u7531\u5408\u683c\u7684\u6cd5\u89c4\u4e13\u5bb6\u786e\u8ba4\u5177\u4f53\u7684\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u89c4\u5b9a\u548c\u8fc7\u6e21\u89c4\u5219\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Permenkes No. 63\/2017 \u5173\u4e8e\u533b\u7597\u5668\u68b0\u826f\u597d\u4e34\u5e8a\u8bd5\u9a8c\u89c4\u8303\uff08CUKAKB\u3001Cara Uji Klinik Alat Kesehatan yang Baik\uff09\u94fe\u63a5 <a href=\"https:\/\/regulasi.bkpk.kemkes.go.id\/detail\/5b1b45eb-a075-4112-8401-fc42567fe927\/unduh\" target=\"_blank\" rel=\"noopener\">\u4e34\u5e8a\u7814\u7a76<\/a> \u9002\u7528\u4e8eC\u7c7b\u3001D\u7c7b\u53ca\u65b0\u578b\u533b\u7597\u5668\u68b0\u3002Permenkes\u7b2c5\/2026\u53f7\u6cd5\u4ee4\u64a4\u9500\u4e86\u5176\u5927\u90e8\u5206\u6761\u6b3e\u3002\u54ea\u4e9b\u6761\u6b3e\u4ecd\u7136\u6709\u6548\uff0c\u5c1a\u9700\u4e13\u5bb6\u786e\u8ba4\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u5982\u4f55\u9a71\u52a8\u6bcf\u4e2a\u4e0b\u6e38\u6b65\u9aa4<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b9e\u9645\u4e0a\uff0c\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u5c31\u50cf\u591a\u7c73\u8bfa\u9aa8\u724c\u7684\u7b2c\u4e00\u5f20\u724c\u3002\u4e00\u65e6\u786e\u5b9a\u4e86\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\uff0c\u5ba1\u67e5\u6d41\u7a0b\u3001\u8bc1\u636e\u6587\u4ef6\u3001\u8d39\u7528\u548c\u6d4b\u8bd5\u8303\u56f4\u7b49\u90fd\u4f1a\u968f\u4e4b\u800c\u6765\uff0c\u56e0\u6b64\uff0c\u8fd9\u4e00\u9636\u6bb5\u7684\u4efb\u4f55\u9519\u8bef\u90fd\u4f1a\u5728\u540e\u7eed\u9636\u6bb5\u9020\u6210\u8fde\u9501\u53cd\u5e94\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u3001\u8bc1\u636e\u548c\u8d39\u7528<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u90e8\u59d4\u7684\u6307\u5bfc\u610f\u89c1\u6307\u51fa\uff0c\u975e\u7a0e\u56fd\u5bb6\u6536\u5165\uff08PNBP\uff09\u7684\u6536\u53d6\u53d6\u51b3\u4e8e\u7533\u8bf7\u4eba\u9009\u62e9\u7684\u98ce\u9669\u7b49\u7ea7\u548c\u7c7b\u522b\u3002\u56e0\u6b64\uff0c\u9519\u8bef\u7684\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u4f1a\u5728\u4efb\u4f55\u6d4b\u8bd5\u5f00\u59cb\u4e4b\u524d\u5c31\u5f71\u54cd\u6210\u672c\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u66f4\u9ad8\u7b49\u7ea7\u7684\u533b\u7597\u5668\u68b0\u4e5f\u9700\u8981\u66f4\u8be6\u5c3d\u7684\u6280\u672f\u8d44\u6599\uff0c\u5305\u62ec\u66f4\u5f3a\u6709\u529b\u7684\u6027\u80fd\u548c\u5b89\u5168\u6027\u8bc1\u636e\u3002\u5982\u679c\u56e2\u961f\u57fa\u4e8e\u9519\u8bef\u7684\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u8fdb\u884c\u89c4\u5212\uff0c\u4f8b\u5982\u7528B\u7ea7\u8bc1\u636e\u6765\u8bc1\u660eC\u7ea7\u5668\u68b0\uff0c\u901a\u5e38\u9700\u8981\u91cd\u65b0\u51c6\u5907\u90e8\u5206\u8d44\u6599\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u548c\u672c\u5730\u6d4b\u8bd5\u6210\u672c<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u4e00\u65e6\u5904\u7406\u4e0d\u5f53\uff0c\u5371\u5bb3\u6700\u5927\u4e4b\u5904\u5c31\u5728\u4e8e\u6b64\u3002\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u4e0d\u540c\u7c7b\u522b\u4ea7\u54c1\u5728\u672c\u5730\u6d4b\u8bd5\u65b9\u9762\u7684\u5dee\u5f02\u663e\u8457\uff0c\u800c\u524d\u6587\u63d0\u5230\u7684\u7ed3\u6838\u75c5\u4ea7\u54c1\u5c31\u662f\u6211\u4eec\u5904\u7406\u8fc7\u7684\u6700\u5178\u578b\u7684\u4f8b\u5b50\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u5ba2\u6237\u7684\u4ea7\u54c1\u9700\u8981\u6bd4\u4f4e\u7aef\u4ea7\u54c1\u66f4\u4e25\u683c\u7684\u672c\u5730\u6d4b\u8bd5\u3002\u7531\u4e8e\u5728\u5370\u5c3c\u8fdb\u884c\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u8d39\u7528\u6602\u8d35\uff0c\u5982\u679c\u540e\u671f\u624d\u53d1\u73b0\u68c0\u6d4b\u8303\u56f4\u8fc7\u5927\uff0c\u53ef\u80fd\u4f1a\u9020\u6210\u5de8\u5927\u7684\u8ba1\u5212\u5916\u6210\u672c\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bfc\u822a\u80fd\u529b\u662f\u9879\u76ee\u987a\u5229\u4e0e\u5426\u7684\u5173\u952e\uff1a\u7cbe\u51c6\u786e\u5b9a\u7c7b\u522b\uff0c\u7136\u540e\u7cbe\u51c6\u5b9a\u4e49\u6d4b\u8bd5\u8303\u56f4\u3002\u8fd9\u4e24\u9879\u5de5\u4f5c\u90fd\u57fa\u4e8e\u89c4\u8303\u5224\u65ad\uff0c\u800c\u975e\u5916\u6765\u8bc1\u4e66\u4e0a\u7684\u6807\u7b7e\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u548c\u65f6\u95f4\u7ebf\u98ce\u9669<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u6211\u4eec\u4e0d\u63d0\u4f9b\u56fa\u5b9a\u7684\u5de5\u671f\uff0c\u56e0\u4e3a\u5de5\u671f\u4f1a\u56e0\u4ea7\u54c1\u548c\u5ba1\u6838\u6d41\u7a0b\u800c\u5f02\u3002\u4f46\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5982\u679c\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u5728\u5ba1\u6838\u8fc7\u7a0b\u4e2d\u53d7\u5230\u8d28\u7591\uff0c\u9879\u76ee\u8fdb\u5ea6\u5f80\u5f80\u4f1a\u5927\u5e45\u653e\u7f13\uff0c\u56e0\u4e3a\u8bc1\u636e\u6587\u4ef6\u548c\u6d4b\u8bd5\u8ba1\u5212\u53ef\u80fd\u9700\u8981\u91cd\u65b0\u51c6\u5907\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff1a\u5206\u7c7b\u9002\u7528\u8303\u56f4<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5c3c\uff0c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u9996\u5148\u8981\u786e\u5b9a\u9884\u671f\u7528\u9014\uff0c\u7136\u540e\u662f\u4ea7\u54c1\u7c7b\u522b\uff0c\u6700\u540e\u662f\u4e0e\u8be5\u7c7b\u522b\u76f8\u7b26\u7684\u8bc1\u636e\u6587\u4ef6\u548c\u6d4b\u8bd5\u8ba1\u5212\u3002\u4ed3\u4fc3\u8fdb\u884c\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u662f\u5bfc\u81f4\u8fd4\u5de5\u7684\u6700\u5e38\u89c1\u539f\u56e0\u3002.<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u660e\u786e\u8bbe\u5907\u540d\u79f0\u3001\u9884\u671f\u7528\u9014\u4ee5\u53ca\u4efb\u4f55\u4f53\u5916\u8bca\u65ad\u529f\u80fd\u3002.<\/li>\n\n\n\n<li>\u6839\u636e\u9002\u7528\u7684 Kemenkes \u89c4\u5219\uff0c\u901a\u8fc7\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u786e\u5b9a\u7c7b\u522b\u3002.<\/li>\n\n\n\n<li>\u5c06\u6280\u672f\u6587\u4ef6\u548c\u6d4b\u8bd5\u8ba1\u5212\u4e0e\u76f8\u5e94\u7684\u7c7b\u522b\u5339\u914d\u3002.<\/li>\n\n\n\n<li>\u901a\u8fc7 Kemenkes \u6ce8\u518c\u7cfb\u7edf\u63d0\u4ea4\u3002.<\/li>\n\n\n\n<li>\u505a\u597d\u5206\u9500\u548c\u4e0a\u5e02\u540e\u4e49\u52a1\u7684\u51c6\u5907\u3002.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\u6bcf\u4e00\u6b65\u90fd\u6d89\u53ca\u5224\u65ad\uff0c\u800c\u6e05\u5355\u65e0\u6cd5\u89e3\u51b3\u8fd9\u4e9b\u95ee\u9898\u3002\u6211\u4eec\u7684\u6307\u5357\u5c06\u6307\u5bfc\u60a8\u5982\u4f55\u64cd\u4f5c\u3002 <strong>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6d41\u7a0b<\/strong> \u6db5\u76d6\u6574\u4e2a\u65c5\u7a0b\uff0c\u4ee5\u53ca Product Registration Indonesia \u7684 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/medical-device-registration-indonesia\/\">\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1<\/a> \u652f\u6301\u6bcf\u4e2a\u9636\u6bb5\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=\"tR6QTMBbLx\"><a href=\"https:\/\/productregistrationindonesia.com\/zh\/the-process-of-registering-medical-devices-in-indonesia\/\">\u5370\u5ea6\u5c3c\u897f\u4e9a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6d41\u7a0b<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u5370\u5c3c\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6d41\u7a0b\u201d\u2014\u2014\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\" src=\"https:\/\/productregistrationindonesia.com\/the-process-of-registering-medical-devices-in-indonesia\/embed\/#?secret=o0tazzfkSu#?secret=tR6QTMBbLx\" data-secret=\"tR6QTMBbLx\" 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>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u5e02\u573a\u51c6\u5165\u7b56\u7565\uff1a\u9884\u7b97\u7f16\u5236\u524d\u5148\u8fdb\u884c\u5206\u7c7b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u533b\u7597\u5668\u68b0\u5e02\u573a\u51c6\u5165\u7b56\u7565\u5e94\u4ece\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u5165\u624b\uff0c\u800c\u975e\u4ef7\u683c\u6e05\u5355\u6216\u4e0e\u5206\u9500\u5546\u8c08\u5224\u3002\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u786e\u7acb\u4e86\u6240\u6709\u5546\u4e1a\u5047\u8bbe\u6240\u4f9d\u8d56\u7684\u8bc1\u636e\u3001\u6d4b\u8bd5\u548c\u6536\u8d39\u6807\u51c6\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u88682. \u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u51b3\u7b56\u6307\u5357<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u60c5\u51b5<\/strong><\/th><th><strong>\u5904\u7406\u4e0d\u5f53\u7684\u98ce\u9669<\/strong><\/th><th><strong>\u660e\u667a\u7684\u4e0b\u4e00\u6b65<\/strong><\/th><\/tr><\/thead><tbody><tr><td>\u5916\u7c4d\u4eba\u58eb\u5c5e\u4e8eC\u7c7b\u6216D\u7c7b\u3002<\/td><td>\u672c\u5730\u68c0\u6d4b\u548c\u8bc1\u636e\u53ef\u80fd\u6bd4\u8ba1\u5212\u7684\u66f4\u7e41\u91cd<\/td><td>\u5728\u7f16\u5236\u9884\u7b97\u524d\uff0c\u8bf7\u8981\u6c42\u8fdb\u884c\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u5ba1\u67e5\u3002<\/td><\/tr><tr><td>\u8be5\u4ea7\u54c1\u662f\u4e00\u79cd\u7528\u4e8e\u6cbb\u7597\u7ed3\u6838\u75c5\u7b49\u4f20\u67d3\u75c5\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u3002<\/td><td>\u6d4b\u8bd5\u8303\u56f4\u53ef\u80fd\u6bd4\u9884\u671f\u7684\u8981\u91cd\u5f97\u591a\u3002<\/td><td>\u5c3d\u65e9\u4e0e\u4e13\u5bb6\u4e00\u8d77\u8fdb\u884c\u672c\u5730\u8303\u56f4\u6d4b\u8bd5<\/td><\/tr><tr><td>\u8be5\u4ea7\u54c1\u4ecb\u4e8e\u4e24\u7c7b\u4ea7\u54c1\u4e4b\u95f4<\/td><td>\u8bfe\u5802\u5728\u590d\u4e60\u4e2d\u53d7\u5230\u6311\u6218<\/td><td>\u63d0\u4ea4\u7533\u8bf7\u524d\uff0c\u8bf7\u5bfb\u6c42\u4e13\u5bb6\u5206\u7c7b\u610f\u89c1\u3002<\/td><\/tr><tr><td>\u7531\u4e8e\u8be5\u8bbe\u5907\u770b\u8d77\u6765\u5f88\u7b80\u5355\uff0c\u56e0\u6b64\u5047\u5b9a\u4e3aA\u7c7b\u3002<\/td><td>\u9884\u671f\u7528\u9014\u7684\u63aa\u8f9e\u53ef\u80fd\u4f1a\u63d0\u9ad8\u9636\u7ea7<\/td><td>\u9996\u5148\u5ba1\u67e5\u58f0\u660e\u548c\u9884\u671f\u7528\u9014\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u9ad8\u98ce\u9669\u533b\u7597\u5668\u68b0\u662f\u4e00\u79cd\u7279\u6b8a\u60c5\u51b5\u3002\u8bf7\u53c2\u9605\u6211\u4eec\u7684\u5206\u6790\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/zh\/navigating-high-risk-medical-device-registration-indonesias-class-3-d-vs-global-standards\/\">\u5370\u5c3c3\/D\u7ea7\u8981\u6c42\u4e0e\u5168\u7403\u6807\u51c6\u7684\u6bd4\u8f83<\/a> \u66f4\u591a\u8be6\u60c5\u8bf7\u89c1\u4e0b\u6587\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u533b\u7597\u5668\u68b0\u83b7\u6279\u540e\u7684\u76d1\u7ba1\u5408\u89c4\u6027<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5c3c\uff0c\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u5408\u89c4\u6027\u5728\u83b7\u5f97\u6279\u51c6\u540e\u4ecd\u7136\u6301\u7eed\u3002Permenkes No. 5\/2026\u53f7\u6cd5\u4ee4\u4e5f\u6db5\u76d6\u4e86\u533b\u7597\u7528\u54c1\u7684\u63a7\u5236\u548c\u76d1\u7763\uff0c\u56e0\u6b64\uff0c\u6ce8\u518c\u6301\u6709\u4eba\u5728\u4ea7\u54c1\u4e0a\u5e02\u540e\u4ecd\u9700\u627f\u62c5\u8d23\u4efb\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u536b\u751f\u5b50\u884c\u4e1a\u7684\u8425\u4e1a\u6267\u7167\u53d1\u653e\u9075\u5faa\u536b\u751f\u90e8\u7b2c11\/2025\u53f7\u6cd5\u4ee4\u4e2d\u57fa\u4e8e\u98ce\u9669\u7684\u6807\u51c6\uff0c\u5e76\u901a\u8fc7\u4ee5\u4e0b\u9014\u5f84\u8fdb\u884c\u5ba1\u6279\uff1a <a href=\"https:\/\/oss.go.id\/\" target=\"_blank\" rel=\"noopener\">\u5728\u7ebf\u5355\u4e00\u63d0\u4ea4\uff08OSS\uff09<\/a> \u7cfb\u7edf\u3002\u5206\u9500\u5546\u901a\u5e38\u8fd8\u9700\u8981\u533b\u7597\u5668\u68b0\u5206\u9500\u8bb8\u53ef\u8bc1\uff08IDAK\u3001Izin Distribusi Alat Kesehatan\uff09\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u6279\u51c6\u540e\u7684\u5408\u89c4\u6027\u5931\u8d25\u5f80\u5f80\u53ef\u4ee5\u8ffd\u6eaf\u5230\u6700\u521d\u7684\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\uff0c\u56e0\u4e3a\u6807\u7b7e\u3001\u5206\u9500\u548c\u8b66\u6212\u804c\u8d23\u662f\u6839\u636e\u9519\u8bef\u7684\u98ce\u9669\u7ea7\u522b\u5236\u5b9a\u7684\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u4e2d\u7684\u4e94\u4e2a\u5e38\u89c1\u9519\u8bef<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u672a\u7ecf\u672c\u5730\u6838\u67e5\uff0c\u76f4\u63a5\u7167\u642c\u5176\u4ed6\u56fd\u5bb6\u7684\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u8bc1\u4e66\u3002.<\/li>\n\n\n\n<li>\u9009\u62e9\u8f83\u4f4e\u7b49\u7ea7\u4ee5\u51cf\u5c11\u8d39\u7528\u6216\u8003\u8bd5\uff0c\u7136\u540e\u9762\u4e34\u91cd\u65b0\u8bc4\u4f30\u3002.<\/li>\n\n\n\n<li>\u4ec5\u5728\u63d0\u4ea4\u7533\u8bf7\u6750\u6599\u540e\u624d\u8fdb\u884c\u672c\u5730\u6d4b\u8bd5\u3002.<\/li>\n\n\n\n<li>\u64b0\u5199\u9884\u671f\u7528\u9014\u58f0\u660e\u65f6\uff0c\u5176\u8303\u56f4\u6bd4\u8bc1\u636e\u652f\u6301\u7684\u8303\u56f4\u66f4\u5e7f\u3002.<\/li>\n\n\n\n<li>\u5ffd\u7565\u76d1\u7ba1\u53d8\u5316\uff0c\u5305\u62ec\u5bf9 Permenkes No. 62\/2017 \u7684\u66ff\u6362\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u5c06\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u89c6\u4e3a\u4e00\u9879\u6218\u7565\u51b3\u7b56\uff0c\u5e76\u5c3d\u65e9\u505a\u51fa\u51b3\u5b9a\u4e14\u7531\u4e13\u5bb6\u8fdb\u884c\u5ba1\u6838\uff0c\u90a3\u4e48\u6bcf\u4e00\u4e2a\u9519\u8bef\u90fd\u662f\u53ef\u4ee5\u907f\u514d\u7684\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u7ed3\u8bba\uff1a\u4ece\u4e00\u5f00\u59cb\u5c31\u6b63\u786e\u8fdb\u884c\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7597\u5668\u68b0\u98ce\u9669\u5206\u7c7b\u4f1a\u5f71\u54cd\u60a8\u8fdb\u5165\u5370\u5c3c\u5e02\u573a\u7684\u65b9\u5f0f\uff0c\u5305\u62ec\u6d4b\u8bd5\u8303\u56f4\u3001\u6210\u672c\u548c\u65f6\u95f4\u5b89\u6392\u3002\u597d\u6d88\u606f\u662f\uff0c\u98ce\u9669\u662f\u53ef\u63a7\u7684\uff1a\u901a\u8fc7\u65e9\u671f\u4e13\u5bb6\u5ba1\u67e5\uff0c\u5927\u591a\u6570\u610f\u5916\u60c5\u51b5\u90fd\u80fd\u5728\u9020\u6210\u9ad8\u6602\u6210\u672c\u4e4b\u524d\u88ab\u53d1\u73b0\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Product Registration Indonesia (PRI) \u5e2e\u52a9\u5236\u9020\u5546\u548c\u8fdb\u53e3\u5546\u786e\u8ba4\u533b\u7597\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\uff0c\u786e\u5b9a\u672c\u5730\u6d4b\u8bd5\u8303\u56f4\uff0c\u5e76\u5efa\u7acb\u4e0e\u98ce\u9669\u7b49\u7ea7\u76f8\u7b26\u7684\u6ce8\u518c\u6587\u4ef6\u3002\u6211\u4eec\u5f88\u4e50\u610f\u4e0e\u60a8\u4e00\u8d77\u5ba1\u6838\u60a8\u7684\u5668\u68b0\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u60f3\u5728\u4ed8\u8d39\u524d\u786e\u8ba4\u60a8\u7684\u7c7b\u522b\u5417\uff1f\u8bf7\u586b\u5199\u4e0b\u65b9\u7684\u8054\u7cfb\u8868\u683c\uff0c\u6211\u4eec\u7684\u76d1\u7ba1\u56e2\u961f\u5c06\u4e0e\u60a8\u8054\u7cfb\uff0c\u786e\u5b9a\u60a8\u7684\u7c7b\u522b\u548c\u6d4b\u8bd5\u8303\u56f4\u3002.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>One of the most critical missteps foreign manufacturers make when entering Indonesia is treating medical device risk classification as a mere administrative box to tick. It is surprisingly common for companies to copy a classification directly from a foreign reference market, assume Kemenkes will simply align, and only realize their mistake after budgets and launch [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":7870,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[57],"class_list":["post-7868","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\/7868","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=7868"}],"version-history":[{"count":2,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7868\/revisions"}],"predecessor-version":[{"id":7873,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/7868\/revisions\/7873"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/7870"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=7868"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=7868"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=7868"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=7868"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}