\u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u6709\u54ea\u4e9b\u662f\u533b\u7597\u884c\u4e1a\u4ece\u4e1a\u8005\u3001\u5236\u9020\u5546\u4ee5\u53ca\u76f8\u5173\u6295\u8d44\u8005\u5fc5\u987b\u6df1\u5165\u4e86\u89e3\u7684\u6838\u5fc3\u8bae\u9898\u3002<\/p>\n<\/p>\n
\u5728\u5168\u7403\u8303\u56f4\u5185\uff0c\u4efb\u4f55\u533b\u7597\u8bbe\u5907\u5728\u4e0a\u5e02\u9500\u552e\u548c\u4e34\u5e8a\u4f7f\u7528\u524d\uff0c\u90fd\u5fc5\u987b\u7ecf\u8fc7\u4e25\u683c\u7684\u8bc4\u4f30\u548c\u5ba1\u6838\uff0c\u4ee5\u83b7\u5f97\u76f8\u5e94\u7684\u5e02\u573a\u51c6\u5165\u8bb8\u53ef\uff0c\u8fd9\u4e2a\u8fc7\u7a0b\u5c31\u662f\u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u3002<\/p>\n<\/p>\n
\u5b83\u4e0d\u4ec5\u662f\u4ea7\u54c1\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u201c\u901a\u884c\u8bc1\u201d\uff0c\u66f4\u662f\u4f01\u4e1a\u5408\u89c4\u7ecf\u8425\u3001\u89c4\u907f\u6cd5\u5f8b\u98ce\u9669\u3001\u8d62\u5f97\u5e02\u573a\u4fe1\u4efb\u7684\u57fa\u77f3\u3002<\/p>\n<\/p>\n
\u4e00\u3001\u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u7684\u6838\u5fc3\u6982\u5ff5\u4e0e\u91cd\u8981\u6027<\/strong><\/p>\n \u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u6709\u54ea\u4e9b\u9996\u5148\u9700\u8981\u4ece\u57fa\u672c\u6982\u5ff5\u5165\u624b\u3002<\/p>\n<\/p>\n \u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u662f\u6307\u7531\u6743\u5a01\u7684\u76d1\u7ba1\u673a\u6784\u6216\u6307\u5b9a\u7684\u7b2c\u4e09\u65b9\u673a\u6784\uff0c\u4f9d\u636e\u4e00\u7cfb\u5217\u6cd5\u89c4\u3001\u6807\u51c6\u548c\u6307\u5357\uff0c\u5bf9\u533b\u7597\u8bbe\u5907\u7684\u8bbe\u8ba1\u3001\u751f\u4ea7\u3001\u6027\u80fd\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8fdb\u884c\u7cfb\u7edf\u6027\u8bc4\u4ef7\uff0c\u5e76\u6700\u7ec8\u6279\u51c6\u5176\u8fdb\u5165\u76ee\u6807\u5e02\u573a\u7684\u8fc7\u7a0b\u3002<\/p>\n<\/p>\n \u5176\u91cd\u8981\u6027\u4e0d\u8a00\u800c\u55bb\uff1a\u5b83\u786e\u4fdd\u4e86\u60a3\u8005\u548c\u4f7f\u7528\u8005\u7684\u5b89\u5168\uff0c\u964d\u4f4e\u4e86\u533b\u7597\u98ce\u9669\uff1b\u5b83\u4fdd\u8bc1\u4e86\u8bbe\u5907\u80fd\u591f\u5b9e\u73b0\u5176\u9884\u671f\u7684\u533b\u7597\u76ee\u7684\uff1b\u540c\u65f6\uff0c\u5b83\u4e5f\u662f\u4ea7\u54c1\u5728\u5168\u7403\u5e02\u573a\u6d41\u901a\u7684\u5fc5\u5907\u6761\u4ef6\uff0c\u76f4\u63a5\u5173\u7cfb\u5230\u4f01\u4e1a\u7684\u5e02\u573a\u62d3\u5c55\u548c\u5546\u4e1a\u6210\u529f\u3002<\/p>\n<\/p>\n \u4e8c\u3001\u5168\u7403\u4e3b\u8981\u5e02\u573a\u7684\u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u4f53\u7cfb<\/strong><\/p>\n \u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u6709\u54ea\u4e9b\u5177\u4f53\u5185\u5bb9\uff0c\u5f88\u5927\u7a0b\u5ea6\u4e0a\u53d6\u51b3\u4e8e\u76ee\u6807\u5e02\u573a\u3002<\/p>\n<\/p>\n \u4e16\u754c\u4e0d\u540c\u56fd\u5bb6\u548c\u5730\u533a\u5efa\u7acb\u4e86\u5404\u81ea\u72ec\u7acb\u7684\u76d1\u7ba1\u4f53\u7cfb\uff0c\u5176\u4e2d\u4ee5\u7f8e\u56fd\u3001\u6b27\u76df\u548c\u4e2d\u56fd\u5e02\u573a\u7684\u8ba4\u8bc1\u6700\u4e3a\u91cd\u8981\u548c\u5178\u578b\u3002<\/p>\n<\/p>\n 1. \u7f8e\u56fdFDA\u8ba4\u8bc1<\/strong><\/p>\n \u7f8e\u56fd\u7684\u533b\u7597\u8bbe\u5907\u76d1\u7ba1\u7531\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u8d1f\u8d23\u3002<\/p>\n<\/p>\n \u5176\u8ba4\u8bc1\u4f53\u7cfb\u57fa\u4e8e\u8bbe\u5907\u7684\u98ce\u9669\u7b49\u7ea7\uff0c\u5c06\u8bbe\u5907\u5206\u4e3aI\u7c7b\u3001II\u7c7b\u548cIII\u7c7b\uff0c\u98ce\u9669\u9010\u7ea7\u589e\u9ad8\u3002<\/p>\n<\/p>\n I\u7c7b\u8bbe\u5907\u5927\u591a\u8c41\u514d\u4e0a\u5e02\u524d\u901a\u77e5\uff0c\u53ea\u9700\u8fdb\u884c\u673a\u6784\u6ce8\u518c\u548c\u4ea7\u54c1\u5217\u540d\uff1bII\u7c7b\u8bbe\u5907\u901a\u5e38\u9700\u8981\u7533\u8bf7510(k)\uff08\u4e0a\u5e02\u524d\u901a\u77e5\uff09\uff0c\u8bc1\u660e\u65b0\u4ea7\u54c1\u4e0e\u5df2\u5408\u6cd5\u4e0a\u5e02\u7684 predicate device\uff08\u8c13\u8bcd\u8bbe\u5907\uff09\u5b9e\u8d28\u7b49\u540c\uff1bIII\u7c7b\u8bbe\u5907\u98ce\u9669\u6700\u9ad8\uff0c\u901a\u5e38\u9700\u8981\u63d0\u4ea4PMA\uff08\u4e0a\u5e02\u524d\u6279\u51c6\uff09\u7533\u8bf7\uff0c\u63d0\u4f9b\u4e25\u683c\u7684\u79d1\u5b66\u8bc1\u636e\uff08\u5305\u62ec\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff09\u4ee5\u8bc1\u660e\u5176\u5b89\u5168\u6709\u6548\u6027\u3002<\/p>\n<\/p>\n 2. \u6b27\u76dfCE\u8ba4\u8bc1<\/strong><\/p>\n \u6b27\u76df\u5e02\u573a\u5b9e\u884cCE\u6807\u5fd7\u5236\u5ea6\u3002<\/p>\n<\/p>\n \u5236\u9020\u5546\u9700\u4f9d\u636e\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR, Regulation (EU) 2017\/745\uff09\u8bc1\u660e\u4ea7\u54c1\u7b26\u5408\u76f8\u5173\u8981\u6c42\u3002<\/p>\n<\/p>\n \u8fc7\u7a0b\u5305\u62ec\uff1a\u5bf9\u8bbe\u5907\u8fdb\u884c\u5206\u7c7b\uff08I\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u3001III\u7c7b\uff09\uff0c\u9009\u62e9\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84\uff0c\u901a\u5e38\u9700\u8981\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u7684\u5ba1\u6838\uff08\u9664\u5c11\u6570I\u7c7b\u8bbe\u5907\u5916\uff09\uff0c\u5efa\u7acb\u6280\u672f\u6587\u4ef6\u548c\u8d28\u91cf\u4f53\u7cfb\uff0c\u7b7e\u7f72\u7b26\u5408\u6027\u58f0\u660e\uff0c\u6700\u540e\u52a0\u8d34CE\u6807\u5fd7\u3002<\/p>\n<\/p>\n MDR\u76f8\u6bd4\u4e4b\u524d\u7684\u6307\u4ee4\uff08MDD\uff09\u8981\u6c42\u66f4\u4e3a\u4e25\u683c\uff0c\u7279\u522b\u5f3a\u8c03\u4e86\u4e34\u5e8a\u8bc4\u4ef7\u548c\u4e0a\u5e02\u540e\u76d1\u7763\u3002<\/p>\n<\/p>\n 3. \u4e2d\u56fdNMPA\u6ce8\u518c<\/strong><\/p>\n \u5728\u4e2d\u56fd\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u8d1f\u8d23\u533b\u7597\u8bbe\u5907\u7684\u6ce8\u518c\u7ba1\u7406\u3002<\/p>\n<\/p>\n \u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b\uff0c\u8bbe\u5907\u6309\u98ce\u9669\u5206\u4e3a\u7b2c\u4e00\u7c7b\u3001\u7b2c\u4e8c\u7c7b\u548c\u7b2c\u4e09\u7c7b\u3002<\/p>\n<\/p>\n \u7b2c\u4e00\u7c7b\u5b9e\u884c\u4ea7\u54c1\u5907\u6848\u7ba1\u7406\uff0c\u7b2c\u4e8c\u7c7b\u3001\u7b2c\u4e09\u7c7b\u5219\u9700\u8fdb\u884c\u4ea7\u54c1\u6ce8\u518c\u3002<\/p>\n<\/p>\n \u6ce8\u518c\u6d41\u7a0b\u5305\u62ec\uff1a\u4ea7\u54c1\u68c0\u9a8c\uff08\u5728\u5177\u6709\u8d44\u8d28\u7684\u68c0\u9a8c\u6240\u8fdb\u884c\uff09\u3001\u4e34\u5e8a\u8bc4\u4ef7\uff08\u63d0\u4ea4\u4e34\u5e8a\u8bd5\u9a8c\u62a5\u544a\u6216\u901a\u8fc7\u540c\u54c1\u79cd\u6bd4\u5bf9\u7b49\u65b9\u5f0f\u8c41\u514d\u8bd5\u9a8c\uff09\u3001\u6280\u672f\u5ba1\u8bc4\u3001\u4f53\u7cfb\u8003\u6838\uff08\u5bf9\u751f\u4ea7\u8d28\u91cf\u89c4\u8303\u8fdb\u884c\u6838\u67e5\uff09\u7b49\u73af\u8282\uff0c\u6700\u7ec8\u83b7\u5f97\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\u3002<\/p>\n<\/p>\n \u4e09\u3001\u5176\u4ed6\u91cd\u8981\u5e02\u573a\u7684\u8ba4\u8bc1<\/strong><\/p>\n \u9664\u4e86\u4e0a\u8ff0\u4e09\u5927\u5e02\u573a\uff0c\u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u6709\u54ea\u4e9b\u5176\u4ed6\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff1f<\/p>\n<\/p>\n \u65e5\u672c\u7531\u539a\u751f\u52b3\u52a8\u7701\uff08MHLW\uff09\u53ca\u5176\u4e0b\u5c5e\u7684\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u5c40\uff08PMDA\uff09\u76d1\u7ba1\uff0c\u9700\u8981\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\uff1b\u52a0\u62ff\u5927\u7531Health Canada\u76d1\u7ba1\uff0c\u9700\u8981\u83b7\u5f97\u533b\u7597\u5668\u68b0\u8bb8\u53ef\u8bc1\uff08MDL\uff09\uff1b\u5176\u4ed6\u5982\u6fb3\u5927\u5229\u4e9a\uff08TGA\uff09\u3001\u97e9\u56fd\uff08MFDS\uff09\u3001\u5df4\u897f\uff08ANVISA\uff09\u7b49\u56fd\u5bb6\u4e5f\u90fd\u6709\u5176\u72ec\u7279\u7684\u8ba4\u8bc1\u6d41\u7a0b\u548c\u8981\u6c42\u3002<\/p>\n<\/p>\n \u56db\u3001\u8ba4\u8bc1\u8fc7\u7a0b\u4e2d\u7684\u901a\u7528\u6838\u5fc3\u8981\u7d20<\/strong><\/p>\n \u5c3d\u7ba1\u5404\u56fd\u6d41\u7a0b\u5404\u5f02\uff0c\u4f46\u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u6709\u54ea\u4e9b\u5171\u901a\u7684\u5173\u952e\u8981\u7d20\uff1f<\/p>\n<\/p>\n \u9996\u5148\uff0c\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\u662f\u57fa\u7840\uff0c\u5c24\u5176\u662f\u4f9d\u636eISO 13485\u6807\u51c6\u5efa\u7acb\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u5b83\u662f\u5168\u7403\u591a\u6570\u76d1\u7ba1\u673a\u6784\u5171\u540c\u8ba4\u53ef\u7684\u57fa\u7840\u8981\u6c42\u3002<\/p>\n<\/p>\n \u5176\u6b21\uff0c\u6280\u672f\u6587\u4ef6\u662f\u6838\u5fc3\uff0c\u5b83\u6c47\u96c6\u4e86\u6240\u6709\u8bc1\u660e\u4ea7\u54c1\u5b89\u5168\u6709\u6548\u7684\u8bc1\u636e\uff0c\u5305\u62ec\u4ea7\u54c1\u8bf4\u660e\u4e66\u3001\u6807\u7b7e\u3001\u8bbe\u8ba1\u6587\u4ef6\u3001\u6027\u80fd\u6d4b\u8bd5\u62a5\u544a\u3001\u751f\u7269\u76f8\u5bb9\u6027\u62a5\u544a\u3001\u706d\u83cc\u9a8c\u8bc1\u62a5\u544a\u7b49\u3002<\/p>\n<\/p>\n \u6700\u540e\uff0c\u4e34\u5e8a\u8bc4\u4ef7\u662f\u91cd\u4e2d\u4e4b\u91cd\uff0c\u9700\u8981\u901a\u8fc7\u4e34\u5e8a\u8bd5\u9a8c\u6216\u73b0\u6709\u4e34\u5e8a\u6570\u636e\u7684\u7efc\u5408\u5206\u6790\uff0c\u6301\u7eed\u8bc1\u660e\u4ea7\u54c1\u7684\u4e34\u5e8a\u5b89\u5168\u548c\u6027\u80fd\u3002<\/p>\n<\/p>\n \u4e94\u3001\u4f01\u4e1a\u5982\u4f55\u5e94\u5bf9\u590d\u6742\u7684\u8ba4\u8bc1\u6311\u6218\uff1f<\/strong><\/p>\n \u9762\u5bf9\u201c\u533b\u7597\u8bbe\u5907\u8ba4\u8bc1\u6709\u54ea\u4e9b\u201d\u7684\u590d\u6742\u6027\u95ee\u9898\uff0c\u4f01\u4e1a\u9700\u8981\u4e00\u4e2a\u7cfb\u7edf\u6027\u7684\u7b56\u7565\u3002<\/p>\n<\/p>\n \u9996\u5148\uff0c\u5e94\u8fdb\u884c\u65e9\u671f\u89c4\u5212\uff0c\u5728\u4ea7\u54c1\u7814\u53d1\u7acb\u9879\u9636\u6bb5\u5c31\u660e\u786e\u76ee\u6807\u5e02\u573a\u53ca\u5176\u6cd5\u89c4\u8981\u6c42\u3002<\/p>\n<\/p>\n 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