{"id":4224,"date":"2025-09-04T13:58:15","date_gmt":"2025-09-04T05:58:15","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4224"},"modified":"2025-09-04T13:58:15","modified_gmt":"2025-09-04T05:58:15","slug":"%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e5%87%ba%e5%8f%a3%e7%be%8e%e5%9b%bd%e9%9c%80%e8%a6%81%e4%bb%80%e4%b9%88%e8%ae%a4%e8%af%81","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4224","title":{"rendered":"\u533b\u7597\u5668\u68b0\u51fa\u53e3\u7f8e\u56fd\u9700\u8981\u4ec0\u4e48\u8ba4\u8bc1"},"content":{"rendered":"<p><strong>\u4e00\u3001\u533b\u7597\u5668\u68b0\u51fa\u53e3\u7f8e\u56fd\u9700\u8981\u4ec0\u4e48\u8ba4\u8bc1\uff1f\u5168\u9762\u89e3\u6790FDA\u8ba4\u8bc1\u6d41\u7a0b\u4e0e\u8981\u6c42<\/strong><\/p>\n<p>\u533b\u7597\u5668\u68b0\u51fa\u53e3\u7f8e\u56fd\u5e02\u573a\u662f\u8bb8\u591a\u4f01\u4e1a\u5168\u7403\u5316\u6218\u7565\u7684\u91cd\u8981\u73af\u8282\uff0c\u7136\u800c\u8fd9\u4e00\u8fc7\u7a0b\u6d89\u53ca\u4e25\u683c\u7684\u6cd5\u89c4\u548c\u8ba4\u8bc1\u8981\u6c42\uff0c\u5176\u4e2d\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u76d1\u7ba1\u662f\u6838\u5fc3\u73af\u8282\u3002\u4f01\u4e1a\u9700\u6df1\u5165\u4e86\u89e3FDA\u7684\u5206\u7c7b\u4f53\u7cfb\u3001\u6ce8\u518c\u6d41\u7a0b\u4ee5\u53ca\u5408\u89c4\u6807\u51c6\uff0c\u5426\u5219\u53ef\u80fd\u9762\u4e34\u4ea7\u54c1\u88ab\u6263\u7559\u3001\u7f5a\u6b3e\u751a\u81f3\u5e02\u573a\u7981\u5165\u7684\u98ce\u9669\u3002\u672c\u6587\u5c06\u7cfb\u7edf\u4ecb\u7ecd\u533b\u7597\u5668\u68b0\u51fa\u53e3\u7f8e\u56fd\u6240\u9700\u7684\u5173\u952e\u8ba4\u8bc1\uff0c\u5305\u62ecFDA\u6ce8\u518c\u3001510(k)\u6216PMA\u7533\u8bf7\u3001QSR\u8d28\u91cf\u4f53\u7cfb\u8981\u6c42\u7b49\uff0c\u5e76\u63d0\u4f9b\u5b9e\u7528\u6307\u5357\u5e2e\u52a9\u4e2d\u56fd\u4f01\u4e1a\u987a\u5229\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u3002<\/p>\n<\/p>\n<p><strong>\u4e8c\u3001FDA\u533b\u7597\u5668\u68b0\u5206\u7c7b\uff1a\u786e\u5b9a\u4ea7\u54c1\u5408\u89c4\u8def\u5f84\u7684\u57fa\u7840<\/strong><\/p>\n<p>FDA\u6839\u636e\u98ce\u9669\u7b49\u7ea7\u5c06\u533b\u7597\u5668\u68b0\u5206\u4e3a\u4e09\u7c7b\uff08Class 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Approval\uff09\u5ba1\u6279\uff0c\u5305\u62ec\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u548c\u5b89\u5168\u6709\u6548\u6027\u8bc1\u660e\u3002\u4f01\u4e1a\u9996\u5148\u9700\u901a\u8fc7FDA\u6570\u636e\u5e93\u6216\u4e13\u4e1a\u54a8\u8be2\u786e\u5b9a\u4ea7\u54c1\u5206\u7c7b\uff0c\u9519\u8bef\u5206\u7c7b\u53ef\u80fd\u5bfc\u81f4\u7533\u8bf7\u88ab\u62d2\u6216\u65f6\u95f4\u6210\u672c\u589e\u52a0\u3002<\/p>\n<\/p>\n<p><strong>\u4e09\u3001FDA\u6ce8\u518c\u4e0e\u4ea7\u54c1\u5217\u540d\uff1a\u5f3a\u5236\u6027\u57fa\u7840\u8981\u6c42<\/strong><\/p>\n<p>\u6240\u6709\u51fa\u53e3\u7f8e\u56fd\u7684\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u5b8c\u6210FDA\u673a\u6784\u6ce8\u518c\u548c\u4ea7\u54c1\u5217\u540d\uff0c\u8fd9\u662f\u5e02\u573a\u51c6\u5165\u7684\u524d\u63d0\u3002\u6ce8\u518c\u9700\u901a\u8fc7FDA\u7684FURLS\u7cfb\u7edf\u8fdb\u884c\uff0c\u4f01\u4e1a\u9700\u7533\u8bf7\u9093\u767d\u6c0f\u7f16\u7801\uff08DUNS Number\uff09\u4f5c\u4e3a\u552f\u4e00\u6807\u8bc6\uff0c\u5e76\u652f\u4ed8\u5e74\u8d39\uff082023\u5e74\u7ea6\u4e3a$6,493\uff09\u3002\u6ce8\u518c\u540e\uff0c\u4f01\u4e1a\u9700\u5c06\u6bcf\u4e2a\u4ea7\u54c1\u8fdb\u884c\u5217\u540d\uff0c\u63d0\u4f9b\u578b\u53f7\u3001\u7528\u9014\u7b49\u4fe1\u606f\u3002\u6b64\u8fc7\u7a0b\u65e0\u9700FDA\u5ba1\u6838\u6279\u51c6\uff0c\u4f46\u4fe1\u606f\u5fc5\u987b\u51c6\u786e\uff0c\u5426\u5219\u53ef\u80fd\u88ab\u89c6\u4e3a\u6b3a\u8bc8\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u6ce8\u518c\u548c\u5217\u540d\u6bcf\u5e74\u9700\u66f4\u65b0\uff0c\u4e14\u5de5\u5382\u5730\u5740\u53d8\u66f4\u6216\u4ea7\u54c1\u505c\u4ea7\u65f6\u9700\u53ca\u65f6\u66f4\u65b0\u4fe1\u606f\u3002<\/p>\n<\/p>\n<p><strong>\u56db\u3001510(k)\u9884\u5e02\u901a\u77e5\uff1a\u4e2d\u4f4e\u98ce\u9669\u8bbe\u5907\u7684\u5173\u952e\u8ba4\u8bc1<\/strong><\/p>\n<p>\u5bf9\u4e8eClass II\u548c\u90e8\u5206Class I\u8bbe\u5907\uff0c510(k)\u7533\u8bf7\u662f\u5e38\u89c1\u7684\u8ba4\u8bc1\u65b9\u5f0f\u3002\u4f01\u4e1a\u9700\u5411FDA\u8bc1\u660e\u65b0\u4ea7\u54c1\u4e0e\u5df2\u4e0a\u5e02\u7684\u5408\u6cd5\u8bbe\u5907\uff08\u8c13\u8bcd\u8bbe\u5907\uff09\u5728\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u4e0a\u5b9e\u8d28\u6027\u7b49\u6548\u3002\u7533\u8bf7\u6750\u6599\u5305\u62ec\u6280\u672f\u6587\u4ef6\u3001\u6d4b\u8bd5\u62a5\u544a\uff08\u5982\u751f\u7269\u76f8\u5bb9\u6027\u3001\u7535\u6c14\u5b89\u5168\u3001\u8f6f\u4ef6\u9a8c\u8bc1\uff09\u3001\u6027\u80fd\u5bf9\u6bd4\u6570\u636e\u53ca\u6807\u7b7e\u6837\u672c\u3002FDA\u5ba1\u6838\u5468\u671f\u901a\u5e38\u4e3a90\u5929\uff0c\u4f46\u53ef\u80fd\u8981\u6c42\u8865\u5145\u8d44\u6599\u5ef6\u957f\u6d41\u7a0b\u3002510(k)\u83b7\u6279\u540e\uff0c\u4f01\u4e1a\u83b7\u5f97K\u53f7\uff0c\u65b9\u53ef\u51fa\u53e3\u4ea7\u54c1\u3002\u636e\u7edf\u8ba1\uff0c\u7ea680%\u7684\u533b\u7597\u5668\u68b0\u901a\u8fc7\u6b64\u9014\u5f84\u4e0a\u5e02\uff0c\u4f46\u8fd1\u5e74\u6765FDA\u52a0\u5f3a\u4e86\u5ba1\u6838\u4e25\u683c\u5ea6\uff0c\u5efa\u8bae\u4f01\u4e1a\u63d0\u524d\u89c4\u5212\u3002<\/p>\n<\/p>\n<p><strong>\u4e94\u3001PMA\u5e02\u573a\u524d\u6279\u51c6\uff1a\u9ad8\u98ce\u9669\u8bbe\u5907\u7684\u5168\u9762\u8bc4\u4f30<\/strong><\/p>\n<p>Class III\u8bbe\u5907\u6216\u65e0\u6cd5\u627e\u5230\u8c13\u8bcd\u8bbe\u5907\u7684\u4ea7\u54c1\u9700\u8fdb\u884cPMA\u7533\u8bf7\uff0c\u8fd9\u662fFDA\u6700\u4e25\u683c\u7684\u5ba1\u6279\u8def\u5f84\u3002\u4f01\u4e1a\u9700\u63d0\u4ea4\u79d1\u5b66\u8bc1\u636e\uff0c\u5305\u62ec\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u3001\u5236\u9020\u8fc7\u7a0b\u63cf\u8ff0\u3001\u98ce\u9669\u5206\u6790\u53ca\u957f\u671f\u968f\u8bbf\u62a5\u544a\u3002PMA\u6d41\u7a0b\u8017\u65f6\u8f83\u957f\uff08\u5e73\u57471-3\u5e74\uff09\uff0c\u8d39\u7528\u9ad8\u6602\uff08\u7533\u8bf7\u8d39\u7ea6$20,000\uff09\uff0c\u4e14\u9700\u63a5\u53d7FDA\u5de5\u5382\u73b0\u573a\u5ba1\u6838\u3002\u901a\u8fc7\u540e\uff0c\u4f01\u4e1a\u83b7\u5f97PMA\u7f16\u53f7\uff0c\u4ea7\u54c1\u65b9\u53ef\u4e0a\u5e02\u3002\u7531\u4e8e\u590d\u6742\u5ea6\u9ad8\uff0c\u8bb8\u591a\u4f01\u4e1a\u9009\u62e9\u4e0e\u4e13\u4e1a\u6cd5\u89c4\u987e\u95ee\u5408\u4f5c\uff0c\u4ee5\u786e\u4fdd\u6570\u636e\u7b26\u540821 CFR 814\u8981\u6c42\u3002<\/p>\n<\/p>\n<p><strong>\u516d\u3001QSR\u8d28\u91cf\u4f53\u7cfb\u89c4\u8303\uff1a\u7b26\u540821 CFR Part 820\u8981\u6c42<\/strong><\/p>\n<p>FDA\u8981\u6c42\u6240\u6709\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5efa\u7acb\u5e76\u7ef4\u62a4\u8d28\u91cf\u4f53\u7cfb\uff0c\u7b26\u5408QSR\uff08Quality System Regulation\uff09\/cGMP\uff08current Good Manufacturing Practice\uff09\u6807\u51c6\uff0c\u537321 CFR Part 820\u3002\u8be5\u89c4\u8303\u8986\u76d6\u8bbe\u8ba1\u63a7\u5236\u3001\u6587\u4ef6\u7ba1\u7406\u3001\u751f\u4ea7\u8fc7\u7a0b\u3001\u68c0\u9a8c\u6d4b\u8bd5\u3001\u7ea0\u6b63\u9884\u9632\u63aa\u65bd\uff08CAPA\uff09\u53ca\u4f9b\u5e94\u5546\u5ba1\u6838\u7b49\u65b9\u9762\u3002\u4f01\u4e1a\u9700\u51c6\u5907\u8d28\u91cf\u624b\u518c\u3001\u7a0b\u5e8f\u6587\u4ef6\u548c\u8d28\u91cf\u8bb0\u5f55\uff0c\u5e76\u63a5\u53d7FDA\u4e0d\u5b9a\u671f\u73b0\u573a\u68c0\u67e5\u3002\u672a\u901a\u8fc7\u68c0\u67e5\u53ef\u80fd\u5bfc\u81f4\u8b66\u544a\u4fe1\u3001\u8fdb\u53e3\u7981\u4ee4\u6216\u5211\u4e8b\u5904\u7f5a\u3002\u5efa\u8bae\u4f01\u4e1a\u53c2\u8003ISO 13485\u6807\u51c6\uff0c\u56e0\u5176\u4e0eQSR\u9ad8\u5ea6\u517c\u5bb9\uff0c\u53ef\u7b80\u5316\u5408\u89c4\u5de5\u4f5c\u3002<\/p>\n<\/p>\n<p><strong>\u4e03\u3001\u5176\u4ed6\u5173\u952e\u8ba4\u8bc1\u4e0e\u8981\u6c42\uff1a\u6807\u7b7e\u3001UDI\u548c\u6d77\u5173\u5408\u89c4<\/strong><\/p>\n<p>\u9664\u4e86\u4e3b\u8981\u8ba4\u8bc1\uff0c\u4f01\u4e1a\u8fd8\u9700\u5173\u6ce8\u6807\u7b7e\u8981\u6c42\uff0821 CFR Part 801\uff09\u3001UDI\uff08Unique Device 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