{"id":4026,"date":"2025-09-04T13:58:03","date_gmt":"2025-09-04T05:58:03","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4026"},"modified":"2025-09-04T13:58:03","modified_gmt":"2025-09-04T05:58:03","slug":"%e5%8c%bb%e9%99%a2mdr%e4%bb%80%e4%b9%88%e6%84%8f%e6%80%9d","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4026","title":{"rendered":"\u533b\u9662mdr\u4ec0\u4e48\u610f\u601d"},"content":{"rendered":"

\u4e00\u3001\u533b\u9662MDR\u662f\u4ec0\u4e48\u610f\u601d\uff1f\u6df1\u5165\u89e3\u6790\u533b\u7597\u8bbe\u5907\u62a5\u544a\u7cfb\u7edf<\/strong><\/p>\n

\u533b\u9662MDR\u662f\u4ec0\u4e48\u610f\u601d\uff1f\u8fd9\u662f\u8bb8\u591a\u533b\u7597\u4ece\u4e1a\u8005\u3001\u60a3\u8005\u6216\u76f8\u5173\u884c\u4e1a\u4eba\u58eb\u5e38\u9047\u5230\u7684\u7591\u95ee\u3002<\/p>\n

MDR\u662fMedical Device Reporting\u7684\u7f29\u5199\uff0c\u4e2d\u6587\u901a\u5e38\u7ffb\u8bd1\u4e3a\u201c\u533b\u7597\u8bbe\u5907\u62a5\u544a\u201d\u3002<\/p>\n

\u5b83\u6307\u7684\u662f\u4e00\u4e2a\u7531\u76d1\u7ba1\u673a\u6784\u5efa\u7acb\u7684\u7cfb\u7edf\u6027\u6d41\u7a0b\uff0c\u7528\u4e8e\u6536\u96c6\u3001\u8bc4\u4f30\u548c\u5b58\u6863\u533b\u7597\u8bbe\u5907\u5728\u4f7f\u7528\u8fc7\u7a0b\u4e2d\u53d1\u751f\u7684\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u3002<\/p>\n

\u5176\u6838\u5fc3\u76ee\u7684\u5728\u4e8e\u76d1\u6d4b\u533b\u7597\u8bbe\u5907\u7684\u5b89\u5168\u6027\uff0c\u53ca\u65f6\u53d1\u73b0\u6f5c\u5728\u98ce\u9669\uff0c\u4ece\u800c\u4fdd\u62a4\u60a3\u8005\u548c\u7528\u6237\u7684\u5065\u5eb7\u4e0e\u5b89\u5168\u3002<\/p>\n

\u7b80\u5355\u6765\u8bf4\uff0c\u5f53\u533b\u9662\u4f7f\u7528\u7684\u67d0\u4e00\u8bbe\u5907\u51fa\u73b0\u6545\u969c\u3001\u6027\u80fd\u4e0b\u964d\u6216\u5bfc\u81f4\u60a3\u8005\u4f24\u5bb3\u65f6\uff0c\u901a\u8fc7MDR\u7cfb\u7edf\u4e0a\u62a5\uff0c\u80fd\u591f\u4e3a\u76d1\u7ba1\u90e8\u95e8\u548c\u4f01\u4e1a\u63d0\u4f9b\u5173\u952e\u6570\u636e\uff0c\u4ee5\u4fbf\u91c7\u53d6\u6539\u8fdb\u548c\u9884\u9632\u63aa\u65bd\u3002<\/p>\n<\/p>\n

\u4e8c\u3001MDR\u7cfb\u7edf\u7684\u8d77\u6e90\u4e0e\u6cd5\u89c4\u80cc\u666f<\/strong><\/p>\n

\u8981\u7406\u89e3\u533b\u9662MDR\u662f\u4ec0\u4e48\u610f\u601d\uff0c\u79bb\u4e0d\u5f00\u5bf9\u5176\u6cd5\u89c4\u80cc\u666f\u7684\u4e86\u89e3\u3002<\/p>\n

MDR\u7cfb\u7edf\u5e76\u975e\u533b\u9662\u81ea\u53d1\u521b\u5efa\uff0c\u800c\u662f\u6e90\u4e8e\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u7684\u5f3a\u5236\u6027\u8981\u6c42\u3002<\/p>\n

\u4ee5\u7f8e\u56fd\u4e3a\u4f8b\uff0c\u5176\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u65e9\u57281984\u5e74\u5c31\u5efa\u7acb\u4e86MDR\u6cd5\u89c4\uff0821 CFR Part 803\uff09\uff0c\u8981\u6c42\u8bbe\u5907\u5236\u9020\u5546\u3001\u8fdb\u53e3\u5546\u3001\u5206\u9500\u5546\u548c\u4f7f\u7528\u5355\u4f4d\uff08\u5982\u533b\u9662\uff09\u62a5\u544a\u533b\u7597\u8bbe\u5907\u76f8\u5173\u7684\u4e0d\u826f\u4e8b\u4ef6\u3002<\/p>\n

\u5728\u4e2d\u56fd\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u53d1\u5e03\u7684\u300a\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u548c\u518d\u8bc4\u4ef7\u7ba1\u7406\u529e\u6cd5\u300b\u4e5f\u6784\u5efa\u4e86\u7c7b\u4f3c\u7684\u76d1\u7ba1\u4f53\u7cfb\u3002<\/p>\n

\u533b\u9662\u4f5c\u4e3a\u533b\u7597\u8bbe\u5907\u7684\u6700\u7ec8\u4f7f\u7528\u5355\u4f4d\uff0c\u662f\u53d1\u73b0\u4e0d\u826f\u4e8b\u4ef6\u7684\u7b2c\u4e00\u7ebf\uff0c\u56e0\u6b64\u5176\u5728MDR\u4f53\u7cfb\u4e2d\u626e\u6f14\u7740\u81f3\u5173\u91cd\u8981\u7684\u89d2\u8272\u3002<\/p>\n<\/p>\n

\u4e09\u3001\u533b\u9662MDR\u7684\u5177\u4f53\u5185\u5bb9\u4e0e\u62a5\u544a\u8303\u56f4<\/strong><\/p>\n

\u533b\u9662MDR\u5177\u4f53\u62a5\u544a\u4ec0\u4e48\u5462\uff1f\u5e76\u4e0d\u662f\u6240\u6709\u8bbe\u5907\u95ee\u9898\u90fd\u9700\u8981\u4e0a\u62a5\u3002<\/p>\n

\u901a\u5e38\uff0c\u62a5\u544a\u8303\u56f4\u5305\u62ec\u53ef\u80fd\u5bfc\u81f4\u6216\u5df2\u7ecf\u5bfc\u81f4\u6b7b\u4ea1\u3001\u4e25\u91cd\u4f24\u5bb3\u6216\u91cd\u5927\u516c\u5171\u536b\u751f\u98ce\u9669\u7684\u8bbe\u5907\u76f8\u5173\u4e8b\u4ef6\u3002<\/p>\n

\u4f8b\u5982\uff0c\u5fc3\u810f\u8d77\u640f\u5668\u610f\u5916\u65ad\u7535\u3001\u8f93\u6db2\u6cf5\u7ed9\u836f\u5242\u91cf\u9519\u8bef\u3001\u4eba\u5de5\u5173\u8282\u8fc7\u65e9\u5931\u6548\u7b49\u3002<\/p>\n

\u62a5\u544a\u5185\u5bb9\u9700\u8be6\u7ec6\u8bb0\u5f55\u4e8b\u4ef6\u53d1\u751f\u65f6\u95f4\u3001\u5730\u70b9\u3001\u6d89\u53ca\u8bbe\u5907\u578b\u53f7\u548c\u5e8f\u5217\u53f7\u3001\u60a3\u8005\u60c5\u51b5\u3001\u4e8b\u4ef6\u521d\u6b65\u5206\u6790\u4ee5\u53ca\u5df2\u91c7\u53d6\u7684\u63aa\u65bd\u3002<\/p>\n

\u8fd9\u4e9b\u4fe1\u606f\u6c47\u805a\u6210\u5e9e\u5927\u7684\u5b89\u5168\u6570\u636e\u5e93\uff0c\u4e3a\u76d1\u7ba1\u51b3\u7b56\u548c\u4ea7\u54c1\u8fed\u4ee3\u63d0\u4f9b\u8bc1\u636e\u652f\u6301\u3002<\/p>\n<\/p>\n

\u56db\u3001MDR\u5728\u533b\u9662\u7ba1\u7406\u4e2d\u7684\u8fd0\u4f5c\u6d41\u7a0b<\/strong><\/p>\n

\u533b\u9662\u5185\u90e8\u5982\u4f55\u8fd0\u4f5cMDR\uff1f\u8fd9\u901a\u5e38\u662f\u4e00\u4e2a\u591a\u90e8\u95e8\u534f\u4f5c\u7684\u6807\u51c6\u5316\u6d41\u7a0b\u3002<\/p>\n

\u5f53\u4e34\u5e8a\u79d1\u5ba4\u53d1\u73b0\u53ef\u80fd\u4e0e\u8bbe\u5907\u76f8\u5173\u7684\u5f02\u5e38\u4e8b\u4ef6\u65f6\uff0c\u9700\u7b2c\u4e00\u65f6\u95f4\u5411\u533b\u9662\u7684\u533b\u7597\u5668\u68b0\u7ba1\u7406\u90e8\u95e8\u6216\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u4e13\u5458\u62a5\u544a\u3002<\/p>\n

\u968f\u540e\uff0c\u4e13\u5458\u4f1a\u521d\u6b65\u8bc4\u4f30\u4e8b\u4ef6\u662f\u5426\u5c5e\u4e8e\u5e94\u62a5\u8303\u7574\uff0c\u5e76\u6536\u96c6\u6574\u7406\u8be6\u7ec6\u4fe1\u606f\u3002<\/p>\n

\u786e\u8ba4\u9700\u8981\u4e0a\u62a5\u540e\uff0c\u533b\u9662\u4f1a\u901a\u8fc7\u56fd\u5bb6\u6307\u5b9a\u7684\u76d1\u6d4b\u7f51\u7edc\u5e73\u53f0\uff08\u5982\u4e2d\u56fd\u7684\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u4fe1\u606f\u7cfb\u7edf\uff09\u63d0\u4ea4\u62a5\u544a\u3002<\/p>\n

\u540c\u65f6\uff0c\u533b\u9662\u4e5f\u5e94\u53ca\u65f6\u4e0e\u8bbe\u5907\u751f\u4ea7\u5546\u6216\u4f9b\u5e94\u5546\u6c9f\u901a\uff0c\u534f\u540c\u8c03\u67e5\u6839\u672c\u539f\u56e0\u3002<\/p>\n<\/p>\n

\u4e94\u3001MDR\u5bf9\u60a3\u8005\u5b89\u5168\u4e0e\u533b\u7597\u8d28\u91cf\u7684\u6df1\u8fdc\u5f71\u54cd<\/strong><\/p>\n

\u7406\u89e3\u533b\u9662MDR\u662f\u4ec0\u4e48\u610f\u601d\uff0c\u6700\u5173\u952e\u7684\u662f\u8ba4\u8bc6\u5230\u5176\u5bf9\u60a3\u8005\u5b89\u5168\u7684\u5de8\u5927\u4ef7\u503c\u3002<\/p>\n

\u4e00\u4e2a\u9ad8\u6548\u3001\u900f\u660e\u7684MDR\u7cfb\u7edf\u662f\u4fdd\u969c\u60a3\u8005\u5b89\u5168\u7684\u201c\u54e8\u5175\u201d\u3002<\/p>\n

\u5b83\u80fd\u591f\u65e9\u671f\u9884\u8b66\u6709\u7f3a\u9677\u6216\u9ad8\u98ce\u9669\u7684\u4ea7\u54c1\uff0c\u907f\u514d\u540c\u7c7b\u4e8b\u4ef6\u5728\u4e0d\u540c\u533b\u9662\u91cd\u590d\u53d1\u751f\u3002<\/p>\n

\u901a\u8fc7\u5206\u6790\u4e0a\u62a5\u7684\u6570\u636e\uff0c\u76d1\u7ba1\u673a\u6784\u53ef\u4ee5\u8d23\u4ee4\u751f\u4ea7\u4f01\u4e1a\u53ec\u56de\u4ea7\u54c1\u3001\u4fee\u6539\u8bbe\u8ba1\u6216\u66f4\u65b0\u4f7f\u7528\u8bf4\u660e\uff0c\u4ece\u6e90\u5934\u6d88\u9664\u9690\u60a3\u3002<\/p>\n

\u5bf9\u4e8e\u533b\u9662\u800c\u8a00\uff0c\u79ef\u6781\u53c2\u4e0eMDR\u4e0d\u4ec5\u662f\u5c65\u884c\u6cd5\u5f8b\u4e49\u52a1\uff0c\u66f4\u662f\u63d0\u5347\u533b\u7597\u8d28\u91cf\u3001\u6784\u5efa\u5b89\u5168\u6587\u5316\u3001\u9632\u8303\u533b\u7597\u98ce\u9669\u7684\u91cd\u8981\u4e3e\u63aa\u3002<\/p>\n<\/p>\n

\u516d\u3001\u533b\u9662\u5b9e\u65bdMDR\u9762\u4e34\u7684\u6311\u6218\u4e0e\u5bf9\u7b56<\/strong><\/p>\n

\u5c3d\u7ba1MDR\u7684\u91cd\u8981\u6027\u6bcb\u5eb8\u7f6e\u7591\uff0c\u4f46\u533b\u9662\u5728\u5b9e\u8df5\u4e2d\u5e38\u9762\u4e34\u8bf8\u591a\u6311\u6218\u3002<\/p>\n

\u4e3b\u8981\u5305\u62ec\uff1a\u4e34\u5e8a\u533b\u62a4\u4eba\u5458\u62a5\u544a\u610f\u8bc6\u4e0d\u8db3\u3001\u5bb3\u6015\u627f\u62c5\u8d23\u4efb\u800c\u9009\u62e9\u9690\u7792\u3001\u62a5\u544a\u6d41\u7a0b\u590d\u6742\u8017\u65f6\u3001\u4ee5\u53ca\u540e\u7eed\u7684\u53cd\u9988\u673a\u5236\u4e0d\u5065\u5168\u7b49\u3002<\/p>\n

\u4e3a\u89e3\u51b3\u8fd9\u4e9b\u95ee\u9898\uff0c\u533b\u9662\u9700\u8981\u52a0\u5f3a\u57f9\u8bad\uff0c\u8425\u9020\u201c\u975e\u60e9\u7f5a\u6027\u201d\u7684\u62a5\u544a\u6587\u5316\uff0c\u8ba9\u5458\u5de5\u660e\u767d\u62a5\u544a\u7684\u76ee\u7684\u662f\u6539\u8fdb\u7cfb\u7edf\u800c\u975e\u8ffd\u7a76\u4e2a\u4eba\u8d23\u4efb\u3002<\/p>\n

\u540c\u65f6\uff0c\u7b80\u5316\u62a5\u544a\u6d41\u7a0b\uff0c\u5229\u7528\u4fe1\u606f\u5316\u624b\u6bb5\u63d0\u9ad8\u6548\u7387\uff0c\u5e76\u5efa\u7acb\u5185\u90e8\u53cd\u9988\u673a\u5236\uff0c\u8ba9\u62a5\u544a\u8005\u80fd\u770b\u5230\u5176\u884c\u52a8\u5e26\u6765\u7684\u79ef\u6781\u6539\u53d8\uff0c\u4ece\u800c\u63d0\u5347\u6301\u7eed\u53c2\u4e0e\u7684\u79ef\u6781\u6027\u3002<\/p>\n<\/p>\n

\u4e03\u3001MDR\u4e0e\u6700\u65b0\u6280\u672f\u53d1\u5c55\u7684\u878d\u5408<\/strong><\/p>\n

\u968f\u7740\u6280\u672f\u7684\u53d1\u5c55\uff0cMDR\u7cfb\u7edf\u4e5f\u5728\u4e0d\u65ad\u8fdb\u5316\u3002<\/p>\n

\u7269\u8054\u7f51\uff08IoT\uff09\u6280\u672f\u4f7f\u5f97\u533b\u7597\u8bbe\u5907\u80fd\u591f\u81ea\u52a8\u8bb0\u5f55\u8fd0\u884c\u72b6\u6001\u548c\u5f02\u5e38\u65e5\u5fd7\uff0c\u5e76\u5b9e\u65f6\u4f20\u8f93\u6570\u636e\uff0c\u4e3a\u5b9e\u73b0\u81ea\u52a8\u9884\u8b66\u548c\u4e0a\u62a5\u63d0\u4f9b\u4e86\u53ef\u80fd\u3002<\/p>\n

\u4eba\u5de5\u667a\u80fd\uff08AI\uff09\u6280\u672f\u5219\u53ef\u7528\u4e8e\u6d77\u91cf\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u7684\u6570\u636e\u6316\u6398\uff0c\u5feb\u901f\u8bc6\u522b\u9690\u85cf\u7684\u98ce\u9669\u6a21\u5f0f\u548c\u4fe1\u53f7\uff0c\u63d0\u9ad8\u98ce\u9669\u8bc6\u522b\u7684\u6548\u7387\u548c\u51c6\u786e\u6027\u3002<\/p>\n

\u533a\u5757\u94fe\u6280\u672f\u56e0\u5176\u4e0d\u53ef\u7be1\u6539\u7684\u7279\u6027\uff0c\u4e5f\u53ef\u7528\u4e8e\u786e\u4fdd\u4e0a\u62a5\u6570\u636e\u7684\u771f\u5b9e\u6027\u548c\u5b8c\u6574\u6027\uff0c\u589e\u5f3a\u6574\u4e2a\u76d1\u6d4b\u7cfb\u7edf\u7684\u516c\u4fe1\u529b\u3002<\/p>\n

\u8fd9\u4e9b\u6280\u672f\u7684\u878d\u5408\uff0c\u6b63\u5728\u8ba9\u201c\u533b\u9662MDR\u662f\u4ec0\u4e48\u610f\u601d\u201d\u7684\u7b54\u6848\u53d8\u5f97\u66f4\u52a0\u667a\u80fd\u548c\u9ad8\u6548\u3002<\/p>\n<\/p>\n

\u516b\u3001\u603b\u7ed3\uff1aMDR\u662f\u73b0\u4ee3\u533b\u7597\u5b89\u5168\u7684\u57fa\u77f3<\/strong><\/p>\n

\u7efc\u4e0a\u6240\u8ff0\uff0c\u533b\u9662MDR\u662f\u4e00\u4e2a\u81f3\u5173\u91cd\u8981\u7684\u533b\u7597\u8bbe\u5907\u5b89\u5168\u76d1\u6d4b\u4e0e\u62a5\u544a\u7cfb\u7edf\u3002<\/p>\n

\u5b83\u8fde\u63a5\u4e86\u533b\u9662\u3001\u751f\u4ea7\u4f01\u4e1a\u3001\u76d1\u7ba1\u673a\u6784\u548c\u60a3\u8005\uff0c\u5171\u540c\u6784\u5efa\u4e86\u4e00\u5f20\u5b88\u62a4\u751f\u547d\u7684\u5b89\u5168\u7f51\u3002<\/p>\n

\u5bf9\u4e8e\u533b\u7597\u884c\u4e1a\u800c\u8a00\uff0c\u6df1\u5165\u7406\u89e3\u5e76\u6709\u6548\u6267\u884cMDR\uff0c\u662f\u8fc8\u5411\u9ad8\u8d28\u91cf\u3001\u7cbe\u7ec6\u5316\u7ba1\u7406\u7684\u5fc5\u7ecf\u4e4b\u8def\u3002<\/p>\n

\u6bcf\u4e00\u6b21\u53ca\u65f6\u3001\u51c6\u786e\u7684\u62a5\u544a\uff0c\u90fd\u53ef\u80fd\u963b\u6b62\u4e00\u573a\u6f5c\u5728\u7684\u5b89\u5168\u4e8b\u6545\uff0c\u633d\u6551\u4e00\u4e2a\u5b9d\u8d35\u7684\u751f\u547d\u3002<\/p>\n

\u56e0\u6b64\uff0cMDR\u8fdc\u4e0d\u6b62\u662f\u4e00\u4e2a\u7b80\u5355\u7684\u7f29\u5199\uff0c\u5b83\u4f53\u73b0\u4e86\u533b\u7597\u884c\u4e1a\u5bf9\u751f\u547d\u5b89\u5168\u548c\u8d28\u91cf\u6301\u7eed\u6539\u8fdb\u7684\u627f\u8bfa\u3002<\/p>\n<\/p>\n

\u514d\u8d23\u58f0\u660e\uff1a\u4ec5\u4f9b\u53c2\u8003\uff0c\u672c\u6587\u4f5c\u8005\u53ca\u53d1\u5e03\u5e73\u53f0\u4e0d\u627f\u62c5\u56e0\u53c2\u8003\u672c\u6587\u5185\u5bb9\u800c\u4ea7\u751f\u7684\u4efb\u4f55\u8d23\u4efb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

\u4e00\u3001\u533b\u9662MDR\u662f\u4ec0\u4e48\u610f\u601d\uff1f\u6df1\u5165\u89e3\u6790\u533b\u7597\u8bbe\u5907\u62a5\u544a\u7cfb\u7edf \u533b\u9662MDR\u662f\u4ec0\u4e48\u610f\u601d\uff1f\u8fd9\u662f\u8bb8\u591a\u533b\u7597\u4ece\u4e1a\u8005\u3001\u60a3\u8005\u6216\u76f8\u5173\u884c\u4e1a\u4eba […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[350],"class_list":["post-4026","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-mdr"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4026","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4026"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4026\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4026"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4026"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4026"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}