\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u591a\u5c11\u94b1\u662f\u8bb8\u591a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u4f01\u4e1a\u548c\u521d\u521b\u516c\u53f8\u6700\u5173\u5fc3\u7684\u95ee\u9898\u4e4b\u4e00\u3002<\/p>\n<\/p>\n
\u51c6\u786e\u5730\u8bf4\uff0c\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u7684\u8d39\u7528\u5e76\u975e\u4e00\u4e2a\u56fa\u5b9a\u6570\u5b57\uff0c\u5b83\u53d7\u5230\u4ea7\u54c1\u98ce\u9669\u7b49\u7ea7\u3001\u8ba4\u8bc1\u8def\u5f84\u3001\u6280\u672f\u590d\u6742\u7a0b\u5ea6\u3001\u6240\u9009\u54a8\u8be2\u670d\u52a1\u673a\u6784\u4ee5\u53ca\u7533\u8bf7\u5730\u533a\u5e02\u573a\u7b49\u591a\u79cd\u56e0\u7d20\u7684\u5171\u540c\u5f71\u54cd\u3002<\/p>\n<\/p>\n
\u4e00\u3001\u5f71\u54cd\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u8d39\u7528\u7684\u6838\u5fc3\u56e0\u7d20<\/strong><\/p>\n \u533b\u7597\u5668\u68b0\u7684\u8ba4\u8bc1\u6210\u672c\u6784\u6210\u590d\u6742\uff0c\u7406\u89e3\u5176\u7ec4\u6210\u90e8\u5206\u6709\u52a9\u4e8e\u4f01\u4e1a\u66f4\u7cbe\u51c6\u5730\u8fdb\u884c\u9884\u7b97\u89c4\u5212\u3002<\/p>\n<\/p>\n 1. \u4ea7\u54c1\u7684\u5206\u7c7b\u7b49\u7ea7<\/strong><\/p>\n \u8fd9\u662f\u51b3\u5b9a\u8ba4\u8bc1\u8d39\u7528\u7684\u6700\u6838\u5fc3\u56e0\u7d20\u3002\u5168\u7403\u4e3b\u8981\u5e02\u573a\u5982\u4e2d\u56fd\uff08NMPA\uff09\u3001\u7f8e\u56fd\uff08FDA\uff09\u548c\u6b27\u76df\uff08CE\uff09\u5747\u91c7\u7528\u57fa\u4e8e\u98ce\u9669\u7684\u5206\u7c7b\u89c4\u5219\u3002<\/p>\n \u901a\u5e38\uff0cClass I\/\u4e00\u7c7b\u533b\u7597\u5668\u68b0\u7ed3\u6784\u7b80\u5355\u3001\u98ce\u9669\u6700\u4f4e\uff0c\u8ba4\u8bc1\u6d41\u7a0b\u76f8\u5bf9\u7b80\u4fbf\uff0c\u8d39\u7528\u4e5f\u6700\u4f4e\u3002\u800cClass III\/\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u56e0\u5176\u9ad8\u98ce\u9669\u6027\uff0c\u9700\u8981\u63d0\u4f9b\u5927\u91cf\u7684\u4e34\u5e8a\u8bc4\u4ef7\u8d44\u6599\u548c\u975e\u4e34\u5e8a\u7814\u7a76\u6570\u636e\uff0c\u5176\u8ba4\u8bc1\u8fc7\u7a0b\u6f2b\u957f\u4e14\u590d\u6742\uff0c\u8d39\u7528\u81ea\u7136\u4e5f\u6700\u4e3a\u9ad8\u6602\uff0c\u53ef\u80fd\u8fbe\u5230\u4e00\u7c7b\u5668\u68b0\u7684\u6570\u5341\u500d\u751a\u81f3\u4e0a\u767e\u500d\u3002<\/p>\n<\/p>\n 2. \u76ee\u6807\u5e02\u573a\u4e0e\u8ba4\u8bc1\u8def\u5f84<\/strong><\/p>\n \u4e0d\u540c\u7684\u5e02\u573a\uff0c\u5176\u6cd5\u89c4\u4f53\u7cfb\u3001\u5ba1\u6838\u6d41\u7a0b\u548c\u7b2c\u4e09\u65b9\u673a\u6784\u6536\u8d39\u90fd\u4e0d\u540c\u3002<\/p>\n \u4f8b\u5982\uff0c\u5728\u7f8e\u56fdFDA\u8ba4\u8bc1\u4e2d\uff0c510(k)\u901a\u8def\u56e0\u5176\u9700\u8bc1\u660e\u4e0e\u5df2\u4e0a\u5e02 predicate device \u7684\u5b9e\u8d28\u6027\u7b49\u540c\uff0c\u8d39\u7528\u76f8\u5bf9\u53ef\u63a7\u3002\u800cPMA\uff08Premarket Approval\uff09\u901a\u8def\u56e0\u9700\u8fdb\u884c\u5168\u9762\u7684\u79d1\u5b66\u5ba1\u67e5\u5e76\u63d0\u4f9b\u5145\u5206\u7684\u4e34\u5e8a\u6570\u636e\uff0c\u5176\u7533\u8bf7\u8d39\u7528\u548c associated \u7684\u4e34\u5e8a\u7814\u7a76\u6210\u672c\u6781\u9ad8\u3002<\/p>\n \u5728\u6b27\u76df\uff0c\u6839\u636e\u65b0MDR\u6cd5\u89c4\uff0c\u6240\u6709\u5668\u68b0\u90fd\u5fc5\u987b\u7531\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u8fdb\u884c\u5ba1\u6838\uff0c\u5176\u5ba1\u6838\u4eba\u5929\u8d39\u7528\u548c\u5e74\u8d39\u662f\u8ba4\u8bc1\u6210\u672c\u7684\u4e3b\u8981\u90e8\u5206\u3002\u5728\u4e2d\u56fd\uff0cNMPA\u6ce8\u518c\u9700\u7ecf\u5386\u68c0\u6d4b\u3001\u4e34\u5e8a\u8bc4\u4ef7\uff08\u6216\u4e34\u5e8a\u8bd5\u9a8c\uff09\u3001\u4f53\u7cfb\u8003\u6838\uff08QMS\uff09\u548c\u7533\u62a5\u8d44\u6599\u51c6\u5907\u7b49\u591a\u4e2a\u73af\u8282\uff0c\u6bcf\u4e2a\u73af\u8282\u90fd\u6d89\u53ca\u76f8\u5e94\u8d39\u7528\u3002<\/p>\n<\/p>\n 3. \u6280\u672f\u6587\u4ef6\u4e0e\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09<\/strong><\/p>\n \u7f16\u5236\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u3001\u5185\u5bb9\u8be6\u5b9e\u7684\u6280\u672f\u6587\u4ef6\u662f\u8ba4\u8bc1\u7684\u57fa\u7840\uff0c\u8fd9\u9879\u5de5\u4f5c\u5f80\u5f80\u9700\u8981\u4f01\u4e1a\u5185\u90e8\u6295\u5165\u5927\u91cf\u4eba\u529b\u548c\u65f6\u95f4\u6210\u672c\uff0c\u6216\u59d4\u6258\u4e13\u4e1a\u54a8\u8be2\u673a\u6784\u5b8c\u6210\u3002<\/p>\n \u540c\u65f6\uff0c\u5efa\u7acb\u5e76\u8fd0\u884c\u4e00\u5957\u7b26\u5408ISO 13485\u6216\u76f8\u5e94\u56fd\u5bb6\/\u5730\u533aQMS\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u5e76\u63a5\u53d7\u5ba1\u6838\uff08\u5982\u4e2d\u56fd\u7684\u4f53\u7cfb\u8003\u6838\u3001\u6b27\u76df\u7684MDR\u5ba1\u6838\uff09\uff0c\u4e5f\u662f\u4e00\u7b14\u4e0d\u5c0f\u7684\u5f00\u652f\uff0c\u5305\u62ec\u4f53\u7cfb\u6784\u5efa\u54a8\u8be2\u8d39\u3001\u5ba1\u6838\u5458\u7684\u5dee\u65c5\u548c\u5ba1\u6838\u8d39\u7b49\u3002<\/p>\n<\/p>\n 4. \u4e34\u5e8a\u8bc4\u4ef7\u4e0e\u4e34\u5e8a\u8bd5\u9a8c<\/strong><\/p>\n \u5bf9\u4e8e\u4e2d\u9ad8\u98ce\u9669\u5668\u68b0\uff0c\u4e34\u5e8a\u8bc4\u4ef7\u662f\u5fc5\u987b\u7684\u3002\u5982\u679c\u80fd\u901a\u8fc7\u73b0\u6709\u4e34\u5e8a\u6587\u732e\u5b8c\u6210\u8bc4\u4ef7\uff0c\u6210\u672c\u76f8\u5bf9\u8f83\u4f4e\u3002<\/p>\n \u82e5\u9700\u8981\u8fdb\u884c\u5168\u65b0\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5219\u8d39\u7528\u6781\u5176\u6602\u8d35\uff0c\u4ece\u51e0\u5341\u4e07\u5230\u6570\u767e\u4e07\u4eba\u6c11\u5e01\u4e0d\u7b49\uff0c\u8fd9\u5df2\u6210\u4e3aClass III\/\u9ad8\u98ce\u9669\u5668\u68b0\u8ba4\u8bc1\u4e2d\u6700\u70e7\u94b1\u7684\u73af\u8282\uff0c\u5176\u6210\u672c\u8fdc\u8d85\u8ba4\u8bc1\u7533\u8bf7\u672c\u8eab\u3002<\/p>\n<\/p>\n 5. \u7b2c\u4e09\u65b9\u670d\u52a1\u8d39\u7528<\/strong><\/p>\n \u7edd\u5927\u591a\u6570\u4f01\u4e1a\u4f1a\u9009\u62e9\u4e0e\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u54a8\u8be2\u516c\u53f8\u5408\u4f5c\u3002\u8fd9\u4e9b\u670d\u52a1\u673a\u6784\u63d0\u4f9b\u4ece\u7b56\u7565\u89c4\u5212\u3001\u6587\u4ef6\u7f16\u5199\u3001\u4f53\u7cfb\u5efa\u7acb\u5230\u7533\u62a5\u8ddf\u8fdb\u7684\u5168\u6d41\u7a0b\u670d\u52a1\uff0c\u5176\u670d\u52a1\u8d39\u6839\u636e\u9879\u76ee\u590d\u6742\u5ea6\u548c\u670d\u52a1\u8303\u56f4\uff0c\u4ece\u51e0\u4e07\u5230\u4e0a\u767e\u4e07\u4eba\u6c11\u5e01\u4e0d\u7b49\u3002<\/p>\n \u6b64\u5916\uff0c\u4ea7\u54c1\u5728\u5177\u6709\u8d44\u8d28\u7684\u68c0\u6d4b\u6240\u8fdb\u884c\u578b\u5f0f\u68c0\u9a8c\u7684\u8d39\u7528\u4e5f\u662f\u4e00\u7b14\u56fa\u5b9a\u652f\u51fa\u3002<\/p>\n<\/p>\n \u4e8c\u3001\u4e0d\u540c\u5e02\u573a\u8ba4\u8bc1\u8d39\u7528\u6982\u89c8\uff08\u4ec5\u4f9b\u53c2\u8003\uff09<\/strong><\/p>\n \u4ee5\u4e0b\u63d0\u4f9b\u4e00\u4e2a\u975e\u5e38\u7c97\u7565\u7684\u8d39\u7528\u8303\u56f4\u4f30\u7b97\uff0c\u8bf7\u6ce8\u610f\u8fd9\u4ec5\u662f\u8ba4\u8bc1\u76f4\u63a5\u76f8\u5173\u8d39\u7528\uff0c\u4e0d\u5305\u62ec\u4ea7\u54c1\u7814\u53d1\u3001\u751f\u4ea7\u6210\u672c\u548c\u540e\u7eed\u7ef4\u62a4\u8d39\u7528\u3002<\/p>\n<\/p>\n 1. \u4e2d\u56fdNMPA\u6ce8\u518c\uff08\u4eba\u6c11\u5e01\uff09<\/strong><\/p>\n \u4e00\u7c7b\u533b\u7597\u5668\u68b0\uff08\u5907\u6848\uff09\uff1a\u8d39\u7528\u6700\u4f4e\uff0c\u4e3b\u8981\u96c6\u4e2d\u5728\u68c0\u6d4b\u8d39\u548c\u54a8\u8be2\u670d\u52a1\u8d39\uff0c\u5927\u81f4\u57282-5\u4e07\u5143\u533a\u95f4\u3002<\/p>\n \u4e8c\u7c7b\u533b\u7597\u5668\u68b0\uff1a\u8d39\u7528\u9002\u4e2d\uff0c\u6d89\u53ca\u68c0\u6d4b\u3001\u4e34\u5e8a\u8bc4\u4ef7\uff08\u5982\u9700\uff09\u3001\u4f53\u7cfb\u8003\u6838\u548c\u54a8\u8be2\u670d\u52a1\uff0c\u603b\u8d39\u7528\u901a\u5e38\u572810-30\u4e07\u5143\u4e4b\u95f4\uff0c\u590d\u6742\u4ea7\u54c1\u4f1a\u66f4\u9ad8\u3002<\/p>\n \u4e09\u7c7b\u533b\u7597\u5668\u68b0\uff1a\u8d39\u7528\u6700\u9ad8\u3002\u7531\u4e8e\u5927\u591a\u9700\u8981\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5176\u603b\u6210\u672c\u53ef\u80fd\u4ece50\u4e07\u5143\u8d77\u6b65\uff0c\u590d\u6742\u6216\u521b\u65b0\u5668\u68b0\u7684\u4e34\u5e8a\u8bd5\u9a8c\u8d39\u7528\u53ef\u80fd\u8fbe\u5230\u6570\u767e\u4e07\u5143\uff0c\u6574\u4f53\u8d39\u7528\u53ef\u80fd\u5728100\u4e07\u81f3500\u4e07\u5143\u751a\u81f3\u66f4\u9ad8\u3002<\/p>\n<\/p>\n 2. \u7f8e\u56fdFDA\u6ce8\u518c\uff08\u7f8e\u5143\uff09<\/strong><\/p>\n Class I\u5668\u68b0\uff1a\u591a\u6570\u53ef\u8c41\u514d510(k)\uff0c\u53ea\u9700\u8fdb\u884c\u5de5\u5382\u6ce8\u518c\u548c\u4ea7\u54c1\u5217\u540d\uff0cFDA\u5b98\u65b9\u5e74\u8d39\u76f8\u5bf9\u8f83\u4f4e\uff0c\u4f01\u4e1a\u81ea\u884c\u64cd\u4f5c\u6210\u672c\u4e0d\u9ad8\u3002\u82e5\u9700\u54a8\u8be2\u534f\u52a9\uff0c\u603b\u8d39\u7528\u7ea6\u57285,000 – 15,000\u7f8e\u5143\u3002<\/p>\n 510(k)\u63d0\u4ea4\uff08Class II\u4e3a\u4e3b\uff09\uff1aFDA\u5b98\u65b9\u5ba1\u6838\u8d39\u52a0\u4e0a\u54a8\u8be2\u670d\u52a1\u8d39\uff0c\u603b\u6210\u672c\u901a\u5e38\u57283\u4e07 – 8\u4e07\u7f8e\u5143\u4e4b\u95f4\uff0c\u82e5\u9700\u8fdb\u884c\u6027\u80fd\u68c0\u6d4b\u6216\u90e8\u5206\u4e34\u5e8a\u6570\u636e\uff0c\u8d39\u7528\u4f1a\u589e\u52a0\u3002<\/p>\n PMA\u7533\u8bf7\uff08Class III\uff09\uff1a\u5b98\u65b9\u7533\u8bf7\u8d39\u7528\u9ad8\u6602\uff0c\u52a0\u4e4b\u5fc5\u987b\u7684\u4e34\u5e8a\u7814\u7a76\uff0c\u603b\u6210\u672c\u53ef\u8fbe\u6570\u767e\u4e07\u81f3\u6570\u5343\u4e07\u7f8e\u5143\u3002<\/p>\n<\/p>\n 3. \u6b27\u76dfCE\u8ba4\u8bc1\uff08\u6b27\u5143\uff09<\/strong><\/p>\n \u6839\u636e\u65b0MDR\u6cd5\u89c4\uff0c\u8d39\u7528\u666e\u904d\u4e0a\u6da8\u3002Class I\uff08\u65e0\u83cc\/\u6d4b\u91cf\u529f\u80fd\uff09\u5668\u68b0\uff1a\u6d89\u53ca\u516c\u544a\u673a\u6784\u5ba1\u6838\uff0c\u8d39\u7528\u9884\u8ba1\u57281.5\u4e07 – 4\u4e07\u6b27\u5143\u3002<\/p>\n Class IIa \/ IIb\u5668\u68b0\uff1a\u516c\u544a\u673a\u6784\u5ba1\u6838\u66f4\u4e3a\u4e25\u683c\uff0c\u603b\u8d39\u7528\u8303\u56f4\u8f83\u5e7f\uff0c\u901a\u5e38\u57283\u4e07 – 8\u4e07\u6b27\u5143\u4ee5\u4e0a\u3002<\/p>\n Class III\u5668\u68b0\uff1a\u5ba1\u6838\u6d41\u7a0b\u6700\u590d\u6742\u3001\u8017\u65f6\u6700\u957f\uff0c\u8d39\u7528\u4e5f\u6700\u9ad8\uff0c\u8d77\u4ef7\u53ef\u80fd\u5c31\u572810\u4e07\u6b27\u5143\u4ee5\u4e0a\uff0c\u6839\u636e\u6280\u672f\u6587\u4ef6\u548c\u4e34\u5e8a\u8bc4\u4ef7\u7684\u590d\u6742\u7a0b\u5ea6\uff0c\u53ef\u8fbe\u6570\u5341\u4e07\u6b27\u5143\u3002<\/p>\n<\/p>\n \u4e09\u3001\u5982\u4f55\u5408\u7406\u89c4\u5212\u4e0e\u63a7\u5236\u8ba4\u8bc1\u6210\u672c\uff1f<\/strong><\/p>\n \u9762\u5bf9\u9ad8\u6602\u7684\u8ba4\u8bc1\u8d39\u7528\uff0c\u4f01\u4e1a\u53ef\u4ee5\u901a\u8fc7\u79d1\u5b66\u7684\u89c4\u5212\u6765\u5b9e\u73b0\u6210\u672c\u4f18\u5316\u3002<\/p>\n \u9996\u5148\uff0c\u8fdb\u884c\u65e9\u671f\u7684\u6cd5\u89c4\u7b56\u7565\u8bc4\u4f30\u81f3\u5173\u91cd\u8981\uff0c\u660e\u786e\u4ea7\u54c1\u7684\u5206\u7c7b\u548c\u76ee\u6807\u5e02\u573a\uff0c\u907f\u514d\u8d70\u9519\u8def\u3001\u82b1\u51a4\u6789\u94b1\u3002<\/p>\n \u5176\u6b21\uff0c\u51b3\u5b9a\u662f\u7ec4\u5efa\u5185\u90e8\u56e2\u961f\u8fd8\u662f\u5916\u5305\u7ed9\u54a8\u8be2\u516c\u53f8\uff0c\u5bf9\u4e8e\u4ea7\u54c1\u7ebf\u4e0d\u591a\u7684\u521d\u521b\u516c\u53f8\uff0c\u5916\u5305\u53ef\u80fd\u66f4\u5177\u6210\u672c\u6548\u76ca\u3002<\/p>\n \u518d\u8005\uff0c\u7cbe\u5fc3\u51c6\u5907\u6280\u672f\u6587\u4ef6\u548c\u8d28\u91cf\u4f53\u7cfb\uff0c\u4e00\u6b21\u901a\u8fc7\u5ba1\u6838\u662f\u6700\u5927\u7684\u6210\u672c\u8282\u7ea6\uff0c\u53cd\u590d\u4fee\u6539\u548c\u8865\u5145\u6750\u6599\u5c06\u6781\u5927\u589e\u52a0\u65f6\u95f4\u548c\u91d1\u94b1\u6210\u672c\u3002<\/p>\n 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