{"id":4289,"date":"2025-09-04T13:58:19","date_gmt":"2025-09-04T05:58:19","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4289"},"modified":"2025-09-04T13:58:19","modified_gmt":"2025-09-04T05:58:19","slug":"%e5%87%ba%e5%8f%a3%e7%be%8e%e5%9b%bd%e7%9a%84%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%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=4289","title":{"rendered":"\u51fa\u53e3\u7f8e\u56fd\u7684\u533b\u7597\u5668\u68b0\u9700\u8981\u4ec0\u4e48\u8ba4\u8bc1"},"content":{"rendered":"<p><strong>\u4e00\u3001\u51fa\u53e3\u7f8e\u56fd\u7684\u533b\u7597\u5668\u68b0\u9700\u8981\u4ec0\u4e48\u8ba4\u8bc1\uff1f\u5168\u9762\u89e3\u6790FDA\u8ba4\u8bc1\u6d41\u7a0b\u4e0e\u8981\u6c42<\/strong><\/p>\n<p>\u51fa\u53e3\u7f8e\u56fd\u7684\u533b\u7597\u5668\u68b0\u9700\u8981\u4ec0\u4e48\u8ba4\u8bc1\uff1f\u8fd9\u662f\u8bb8\u591a\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u548c\u51fa\u53e3\u5546\u9996\u5148\u4f1a\u63d0\u51fa\u7684\u95ee\u9898\u3002\u7b80\u5355\u6765\u8bf4\uff0c\u6700\u4e3b\u8981\u7684\u8ba4\u8bc1\u662f\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u4e0a\u5e02\u8bb8\u53ef\u3002\u7f8e\u56fd\u5e02\u573a\u5bf9\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u6781\u4e3a\u4e25\u683c\uff0c\u4efb\u4f55\u5e0c\u671b\u8fdb\u5165\u5176\u5e02\u573a\u7684\u4ea7\u54c1\u90fd\u5fc5\u987b\u9075\u5b88\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u6848\uff08FD&#038;C Act\uff09\u4ee5\u53ca21 CFR Part 800-1299\u7684\u76f8\u5173\u6cd5\u89c4\u3002\u672a\u80fd\u83b7\u5f97\u76f8\u5e94\u8ba4\u8bc1\u4e0d\u4ec5\u610f\u5473\u7740\u4ea7\u54c1\u65e0\u6cd5\u5408\u6cd5\u9500\u552e\uff0c\u8fd8\u53ef\u80fd\u5bfc\u81f4\u8d27\u7269\u88ab\u6263\u7559\u3001\u7f5a\u6b3e\u751a\u81f3\u4f01\u4e1a\u88ab\u5217\u5165\u9ed1\u540d\u5355\u3002\u56e0\u6b64\uff0c\u900f\u5f7b\u7406\u89e3FDA\u7684\u8ba4\u8bc1\u4f53\u7cfb\u662f\u6210\u529f\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u7684\u7b2c\u4e00\u6b65\u3002<\/p>\n<\/p>\n<p><strong>\u4e8c\u3001\u6838\u5fc3\u8ba4\u8bc1\u673a\u6784\uff1a\u7f8e\u56fdFDA<\/strong><\/p>\n<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u662f\u8d1f\u8d23\u76d1\u7ba1\u533b\u7597\u5668\u68b0\u7684\u6838\u5fc3\u8054\u90a6\u673a\u6784\u3002\u5176\u76d1\u7ba1\u6743\u529b\u6765\u6e90\u4e8e\u8054\u90a6\u6cd5\u5f8b\uff0c\u65e8\u5728\u786e\u4fdd\u5728\u7f8e\u56fd\u5e02\u573a\u4e0a\u9500\u552e\u7684\u533b\u7597\u5668\u68b0\u662f\u5b89\u5168\u6709\u6548\u7684\u3002FDA\u6839\u636e\u533b\u7597\u5668\u68b0\u7684\u98ce\u9669\u7b49\u7ea7\uff0c\u5c06\u5176\u5206\u4e3aI\u7c7b\u3001II\u7c7b\u548cIII\u7c7b\uff0c\u98ce\u9669\u9010\u7ea7\u5347\u9ad8\uff0c\u76f8\u5e94\u7684\u76d1\u7ba1\u548c\u63a7\u5236\u8981\u6c42\u4e5f\u8d8a\u6765\u8d8a\u4e25\u683c\u3002\u5bf9\u4e8e\u51fa\u53e3\u5546\u800c\u8a00\uff0c\u7b2c\u4e00\u6b65\u5c31\u662f\u51c6\u786e\u5224\u65ad\u81ea\u5df1\u4ea7\u54c1\u7684\u5206\u7c7b\uff0c\u8fd9\u5c06\u76f4\u63a5\u51b3\u5b9a\u540e\u7eed\u9700\u8981\u7533\u8bf7\u7684\u4e0a\u5e02\u8bb8\u53ef\u8def\u5f84\u548c\u6240\u9700\u5b8c\u6210\u7684\u51c6\u5907\u5de5\u4f5c\u3002<\/p>\n<\/p>\n<p><strong>\u4e09\u3001\u533b\u7597\u5668\u68b0\u7684\u5206\u7c7b\u4e0e\u5bf9\u5e94\u8def\u5f84<\/strong><\/p>\n<p>FDA\u5c06\u533b\u7597\u5668\u68b0\u5206\u4e3a\u4e09\u7c7b\uff0c\u8fd9\u662f\u786e\u5b9a\u8ba4\u8bc1\u8def\u5f84\u7684\u57fa\u7840\u3002I\u7c7b\u533b\u7597\u5668\u68b0\u98ce\u9669\u6700\u4f4e\uff0c\u4f8b\u5982\u538b\u820c\u677f\u3001\u5f39\u6027\u7ef7\u5e26\u7b49\uff0c\u5176\u4e2d\u5927\u90e8\u5206\u4ea7\u54c1\u53ea\u9700\u8fdb\u884c\u673a\u6784\u6ce8\u518c\u548c\u4ea7\u54c1\u5217\u540d\uff0c\u5e76\u9075\u5faa\u201c\u901a\u7528\u63a7\u5236\u201d\u8981\u6c42\uff08\u5982\u8d28\u91cf\u4f53\u7cfb\u3001\u6807\u7b7e\u3001\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u7b49\uff09\uff0c\u901a\u5e38\u8c41\u514d510(k)\u7533\u8bf7\u3002II\u7c7b\u533b\u7597\u5668\u68b0\u98ce\u9669\u4e2d\u7b49\uff0c\u4f8b\u5982\u7535\u52a8\u8f6e\u6905\u3001\u8f93\u6db2\u6cf5\u7b49\uff0c\u8fd9\u7c7b\u4ea7\u54c1\u901a\u5e38\u9700\u8981\u63d0\u4ea4510(k)\u9884\u5e02\u901a\u77e5\uff0c\u4ee5\u8bc1\u660e\u8be5\u5668\u68b0\u4e0e\u5df2\u5728\u7f8e\u56fd\u5408\u6cd5\u4e0a\u5e02\u7684 predicate device\uff08\u5bf9\u6bd4\u5668\u68b0\uff09\u5728\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u65b9\u9762\u662f\u5b9e\u8d28\u7b49\u540c\u7684\u3002III\u7c7b\u533b\u7597\u5668\u68b0\u98ce\u9669\u6700\u9ad8\uff0c\u901a\u5e38\u662f\u7528\u4e8e\u652f\u6301\u6216\u7ef4\u6301\u751f\u547d\u3001\u5bf9\u9632\u6b62\u4eba\u4f53\u5065\u5eb7\u53d7\u635f\u6709\u91cd\u8981\u4f5c\u7528\u7684\u5668\u68b0\uff0c\u6216\u5b58\u5728\u6f5c\u5728\u4e0d\u5408\u7406\u98ce\u9669\u75be\u75c5\u7684\u5668\u68b0\uff0c\u4f8b\u5982\u5fc3\u810f\u8d77\u640f\u5668\u3001\u4eba\u5de5\u5fc3\u810f\u74e3\u819c\u7b49\uff0c\u8fd9\u7c7b\u4ea7\u54c1\u5fc5\u987b\u63d0\u4ea4\u66f4\u4e3a\u4e25\u683c\u7684\u4e0a\u5e02\u524d\u6279\u51c6\uff08PMA\uff09\u7533\u8bf7\uff0c\u5176\u4e2d\u5305\u62ec\u5927\u91cf\u7684\u79d1\u5b66\u8bc1\u636e\u548c\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u6765\u8bc1\u660e\u5176\u5b89\u5168\u6709\u6548\u6027\u3002<\/p>\n<\/p>\n<p><strong>\u56db\u3001\u5173\u952e\u8ba4\u8bc1\u6d41\u7a0b\u4e0e\u8981\u6c42<\/strong><\/p>\n<p>\u51fa\u53e3\u7f8e\u56fd\u7684\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u5e76\u975e\u5355\u4e00\u6b65\u9aa4\uff0c\u800c\u662f\u4e00\u4e2a\u7cfb\u7edf\u6027\u7684\u8fc7\u7a0b\u3002\u9996\u5148\uff0c\u4f01\u4e1a\u5fc5\u987b\u8fdb\u884c\u4f01\u4e1a\u6ce8\u518c\uff08Establishment Registration\uff09\u548c\u4ea7\u54c1\u5217\u540d\uff08Device Listing\uff09\u3002\u4efb\u4f55\u751f\u4ea7\u3001\u51c6\u5907\u3001\u7e41\u6b96\u3001\u590d\u5408\u6216\u52a0\u5de5\u5728\u7f8e\u56fd\u5546\u4e1a\u5206\u9500\u7684\u533b\u7597\u5668\u68b0\u7684\u56fd\u5185\u5916\u4f01\u4e1a\u90fd\u5fc5\u987b\u5411FDA\u6ce8\u518c\u5176\u4f01\u4e1a\u4fe1\u606f\uff0c\u5e76\u5c06\u5176\u4ea7\u54c1\u8fdb\u884c\u5217\u540d\u3002\u5176\u6b21\uff0c\u786e\u5b9a\u4ea7\u54c1\u5206\u7c7b\u540e\uff0c\u9009\u62e9\u6b63\u786e\u7684\u4e0a\u5e02\u524d\u63d0\u4ea4\u8def\u5f84\u3002\u5bf9\u4e8eII\u7c7b\u4ea7\u54c1\uff0c510(k)\u63d0\u4ea4\u662f\u6838\u5fc3\u73af\u8282\uff0c\u9700\u8981\u63d0\u4f9b\u8be6\u7ec6\u7684\u6280\u672f\u6587\u4ef6\uff0c\u5305\u62ec\u4ea7\u54c1\u63cf\u8ff0\u3001\u4e0e\u5bf9\u6bd4\u5668\u68b0\u7684\u5bf9\u6bd4\u5206\u6790\u3001\u6027\u80fd\u6d4b\u8bd5\u6570\u636e\uff08\u751f\u7269\u76f8\u5bb9\u6027\u3001\u7535\u6c14\u5b89\u5168\u3001\u8f6f\u4ef6\u9a8c\u8bc1\u7b49\uff09\u3001\u6807\u7b7e\u4ee5\u53ca\u5b9e\u8d28\u7b49\u540c\u6027\u7ed3\u8bba\u3002\u5bf9\u4e8eIII\u7c7b\u4ea7\u54c1\uff0cPMA\u7533\u8bf7\u5219\u662f\u4e00\u4e2a\u66f4\u4e3a\u6f2b\u957f\u4e14\u6602\u8d35\u7684\u8fc7\u7a0b\uff0c\u9700\u8981\u63d0\u4f9b\u5168\u9762\u7684\u79d1\u5b66\u6587\u732e\u3001\u975e\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u7814\u7a76\u4ee5\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u3002<\/p>\n<\/p>\n<p><strong>\u4e94\u3001\u8d28\u91cf\u4f53\u7cfb\u6cd5\u89c4\uff08QSR\uff09\u8981\u6c42<\/strong><\/p>\n<p>\u65e0\u8bba\u60a8\u7684\u533b\u7597\u5668\u68b0\u5c5e\u4e8e\u54ea\u4e00\u7c7b\u522b\uff0c\u90fd\u5fc5\u987b\u9075\u5b88FDA\u7684\u8d28\u91cf\u4f53\u7cfb\u6cd5\u89c4\uff08Quality System Regulation, QSR\uff09\uff0c\u537321 CFR Part 820\u3002\u8be5\u6cd5\u89c4\u901a\u5e38\u88ab\u79f0\u4e3a\u201c\u73b0\u884c\u826f\u597d\u751f\u4ea7\u89c4\u8303\u201d\uff08cGMP\uff09\u3002\u5b83\u6db5\u76d6\u4e86\u533b\u7597\u5668\u68b0\u8bbe\u8ba1\u3001\u5236\u9020\u3001\u5305\u88c5\u3001\u6807\u7b7e\u3001\u50a8\u5b58\u3001\u5b89\u88c5\u548c\u670d\u52a1\u7b49\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8981\u6c42\u3002FDA\u4f1a\u901a\u8fc7\u73b0\u573a\u5ba1\u6838\uff08\u5373FDA\u9a8c\u5382\uff09\u6765\u786e\u8ba4\u4f01\u4e1a\u662f\u5426\u6301\u7eed\u7b26\u5408QSR\u8981\u6c42\u3002\u5bf9\u4e8e\u6d77\u5916\u5236\u9020\u5546\uff0cFDA\u540c\u6837\u6709\u6743\u8fdb\u884c\u68c0\u67e5\uff0c\u4f01\u4e1a\u5fc5\u987b\u505a\u597d\u51c6\u5907\u3002\u5efa\u7acb\u5e76\u6709\u6548\u8fd0\u884c\u4e00\u4e2a\u7b26\u5408QSR\u7684\u8d28\u91cf\u4f53\u7cfb\uff0c\u662f\u83b7\u5f97\u5e76\u7ef4\u6301FDA\u8ba4\u8bc1\u7684\u57fa\u77f3\u3002<\/p>\n<\/p>\n<p><strong>\u516d\u3001\u5176\u4ed6\u91cd\u8981\u8003\u91cf\u56e0\u7d20<\/strong><\/p>\n<p>\u9664\u4e86\u4e0a\u8ff0\u6838\u5fc3\u8ba4\u8bc1\u5916\uff0c\u51fa\u53e3\u5546\u8fd8\u9700\u5173\u6ce8\u5176\u4ed6\u8981\u6c42\u3002\u4e00\u662f\u7f8e\u56fd\u4ee3\u7406\u4eba\uff08U.S. Agent\uff09\u7684\u8981\u6c42\u3002\u6240\u6709\u5916\u56fd\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5728\u5411FDA\u6ce8\u518c\u65f6\uff0c\u5fc5\u987b\u6307\u5b9a\u4e00\u540d\u5728\u7f8e\u56fd\u5c45\u4f4f\u6216\u8bbe\u6709\u8425\u4e1a\u5730\u70b9\u7684\u4ee3\u7406\u4eba\uff0c\u8be5\u4ee3\u7406\u4eba\u5c06\u4f5c\u4e3aFDA\u4e0e\u5236\u9020\u5546\u4e4b\u95f4\u7684\u5b98\u65b9\u6c9f\u901a\u6e20\u9053\u3002\u4e8c\u662f\u6807\u7b7e\u548c\u72ec\u7279\u8bbe\u5907\u8bc6\u522b\uff08UDI\uff09\u8981\u6c42\u3002\u533b\u7597\u5668\u68b0\u7684\u6807\u7b7e\u5fc5\u987b\u7b26\u5408FDA\u7684\u6807\u7b7e\u89c4\u5b9a\uff0c\u5e76\u4e14\u5927\u90e8\u5206\u8bbe\u5907\u9700\u8981\u5728\u5176\u6807\u7b7e\u548c\u5305\u88c5\u4e0a\u6807\u6ce8UDI\u7801\uff0c\u4ee5\u4fbf\u4e8e\u8ffd\u6eaf\u3002\u4e09\u662f\u552e\u540e\u670d\u52a1\u4e0e\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u3002\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u7a0b\u5e8f\uff0c\u76d1\u63a7\u4e0a\u5e02\u540e\u4ea7\u54c1\u7684\u6027\u80fd\uff0c\u5e76\u6309\u89c4\u5b9a\u5411FDA\u62a5\u544a\u4efb\u4f55\u53ef\u80fd\u5bfc\u81f4\u4e25\u91cd\u4f24\u5bb3\u6216\u6b7b\u4ea1\u7684\u4e0d\u826f\u4e8b\u4ef6\u4ee5\u53ca\u4ea7\u54c1\u53ec\u56de\u884c\u52a8\u3002<\/p>\n<\/p>\n<p><strong>\u4e03\u3001\u603b\u7ed3\u4e0e\u5efa\u8bae<\/strong><\/p>\n<p>\u603b\u800c\u8a00\u4e4b\uff0c\u51fa\u53e3\u7f8e\u56fd\u7684\u533b\u7597\u5668\u68b0\u9700\u8981\u83b7\u5f97\u7684\u8ba4\u8bc1\u662f\u4e00\u4e2a\u4ee5FDA\u4e0a\u5e02\u8bb8\u53ef\u4e3a\u6838\u5fc3\uff0c\u6db5\u76d6\u4f01\u4e1a\u6ce8\u518c\u3001\u4ea7\u54c1\u5217\u540d\u3001510(k)\u6216PMA\u7533\u8bf7\u4ee5\u53ca\u6301\u7eed\u7b26\u5408QSR\u7684\u7efc\u5408\u6027\u5408\u89c4\u8fc7\u7a0b\u3002\u6574\u4e2a\u8fc7\u7a0b\u4e13\u4e1a\u6027\u5f3a\u3001\u8017\u65f6\u8f83\u957f\u4e14\u6210\u672c\u4e0d\u83f2\u3002\u5bf9\u4e8e\u4e2d\u56fd\u4f01\u4e1a\u800c\u8a00\uff0c\u5efa\u8bae\u5c3d\u65e9\u542f\u52a8\u5408\u89c4\u5de5\u4f5c\uff0c\u53ef\u4ee5\u5bfb\u6c42\u4e13\u4e1a\u7684\u6cd5\u89c4\u54a8\u8be2\u516c\u53f8\u6216\u987e\u95ee\u7684\u5e2e\u52a9\uff0c\u51c6\u786e\u8fdb\u884c\u4ea7\u54c1\u5206\u7c7b\uff0c\u51c6\u5907\u7b26\u5408\u8981\u6c42\u7684\u6280\u672f\u6587\u4ef6\uff0c\u5e76\u5efa\u7acb\u5b8c\u5584\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3002\u5145\u5206\u7684\u524d\u671f\u51c6\u5907\u548c\u4e13\u4e1a\u7684\u6307\u5bfc\u662f\u6210\u529f\u83b7\u5f97FDA\u8ba4\u8bc1\u3001\u987a\u5229\u8fdb\u5165\u5e9e\u5927\u7684\u7f8e\u56fd\u533b\u7597\u5668\u68b0\u5e02\u573a\u7684\u5173\u952e\u3002<\/p>\n<\/p>\n<p><strong>\u514d\u8d23\u58f0\u660e\uff1a<\/strong><\/p>\n<p>\u672c\u6587\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\uff0c\u4e0d\u6784\u6210\u4efb\u4f55\u6cd5\u5f8b\u6216\u4e13\u4e1a\u5efa\u8bae\u3002\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u548c\u8981\u6c42\u53ef\u80fd\u968f\u65f6\u53d1\u751f\u53d8\u5316\uff0c\u8bfb\u8005\u5728\u505a\u51fa\u4efb\u4f55\u51b3\u7b56\u524d\uff0c\u5e94\u54a8\u8be2\u76f8\u5173\u7684\u4e13\u4e1a\u6cd5\u89c4\u987e\u95ee\u6216\u5b98\u65b9\u673a\u6784\u3002\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":"<p>\u4e00\u3001\u51fa\u53e3\u7f8e\u56fd\u7684\u533b\u7597\u5668\u68b0\u9700\u8981\u4ec0\u4e48\u8ba4\u8bc1\uff1f\u5168\u9762\u89e3\u6790FDA\u8ba4\u8bc1\u6d41\u7a0b\u4e0e\u8981\u6c42 \u51fa\u53e3\u7f8e\u56fd\u7684\u533b\u7597\u5668\u68b0\u9700\u8981\u4ec0\u4e48\u8ba4\u8bc1\uff1f\u8fd9\u662f\u8bb8\u591a\u4e2d\u56fd [&hellip;]<\/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":[613],"class_list":["post-4289","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-613"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4289","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=4289"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4289\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4289"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4289"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4289"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}