{"id":4204,"date":"2025-09-04T13:58:14","date_gmt":"2025-09-04T05:58:14","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4204"},"modified":"2025-09-04T13:58:14","modified_gmt":"2025-09-04T05:58:14","slug":"%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0nmpa%e8%ae%a4%e8%af%81%e6%98%af%e4%bb%80%e4%b9%88","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4204","title":{"rendered":"\u533b\u7597\u5668\u68b0nmpa\u8ba4\u8bc1\u662f\u4ec0\u4e48"},"content":{"rendered":"

1. \u533b\u7597\u5668\u68b0NMPA\u8ba4\u8bc1\u662f\u4ec0\u4e48\uff1a\u5168\u9762\u89e3\u6790\u4e0e\u6307\u5357<\/strong><\/p>\n

\u533b\u7597\u5668\u68b0NMPA\u8ba4\u8bc1\u662f\u6307\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08National Medical Products Administration\uff0c\u7b80\u79f0NMPA\uff09\u5bf9\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u4e0a\u5e02\u524d\u5b9e\u65bd\u7684\u5f3a\u5236\u6027\u5ba1\u6279\u5236\u5ea6\uff0c\u65e8\u5728\u786e\u4fdd\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u548c\u8d28\u91cf\u53ef\u63a7\u6027\uff0c\u8be5\u8ba4\u8bc1\u662f\u533b\u7597\u5668\u68b0\u5728\u4e2d\u56fd\u5e02\u573a\u5408\u6cd5\u9500\u552e\u548c\u4f7f\u7528\u7684\u524d\u63d0\u6761\u4ef6\uff0c\u5176\u524d\u8eab\u4e3aCFDA\u8ba4\u8bc1\uff0c\u968f\u7740\u673a\u6784\u6539\u9769\u4e8e2018\u5e74\u66f4\u540d\u800c\u6765\uff0cNMPA\u8ba4\u8bc1\u8986\u76d6\u5404\u7c7b\u533b\u7597\u5668\u68b0\uff0c\u4ece\u4f4e\u98ce\u9669\u4ea7\u54c1\u5982\u533b\u7528\u7eb1\u5e03\u5230\u9ad8\u98ce\u9669\u4ea7\u54c1\u5982\u5fc3\u810f\u8d77\u640f\u5668\uff0c\u5747\u9700\u901a\u8fc7\u76f8\u5e94\u6d41\u7a0b\u83b7\u5f97\u6279\u51c6\uff0c\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u800c\u8a00\uff0c\u7406\u89e3NMPA\u8ba4\u8bc1\u7684\u6838\u5fc3\u8981\u6c42\u3001\u6d41\u7a0b\u548c\u5206\u7c7b\u81f3\u5173\u91cd\u8981\uff0c\u8fd9\u4e0d\u4ec5\u5173\u4e4e\u5e02\u573a\u51c6\u5165\uff0c\u8fd8\u5f71\u54cd\u4ea7\u54c1\u7814\u53d1\u548c\u5546\u4e1a\u7b56\u7565\u7684\u5236\u5b9a\uff0c\u672c\u6587\u5c06\u6df1\u5165\u63a2\u8ba8NMPA\u8ba4\u8bc1\u7684\u5b9a\u4e49\u3001\u91cd\u8981\u6027\u3001\u6d41\u7a0b\u3001\u5206\u7c7b\u53ca\u5e38\u89c1\u6311\u6218\uff0c\u4e3a\u76f8\u5173\u4ece\u4e1a\u8005\u63d0\u4f9b\u5b9e\u7528\u53c2\u8003\u3002<\/p>\n<\/p>\n

2. NMPA\u8ba4\u8bc1\u7684\u91cd\u8981\u6027\u4e0e\u6cd5\u5f8b\u4f9d\u636e<\/strong><\/p>\n

NMPA\u8ba4\u8bc1\u5728\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u4f53\u7cfb\u4e2d\u5177\u6709\u6838\u5fc3\u91cd\u8981\u6027\uff0c\u5b83\u4e0d\u4ec5\u662f\u6cd5\u5f8b\u5f3a\u5236\u8981\u6c42\uff0c\u8fd8\u662f\u4fdd\u969c\u516c\u4f17\u5065\u5eb7\u7684\u5173\u952e\u5c4f\u969c\uff0c\u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b\u7b49\u6cd5\u89c4\uff0c\u672a\u83b7\u5f97NMPA\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\u4e0d\u5f97\u5728\u4e2d\u56fd\u751f\u4ea7\u3001\u9500\u552e\u6216\u4f7f\u7528\uff0c\u5426\u5219\u5c06\u9762\u4e34\u7f5a\u6b3e\u3001\u4ea7\u54c1\u6263\u62bc\u751a\u81f3\u5211\u4e8b\u8d23\u4efb\uff0c\u8ba4\u8bc1\u8fc7\u7a0b\u901a\u8fc7\u4e25\u683c\u7684\u6280\u672f\u8bc4\u5ba1\u548c\u4e34\u5e8a\u8bd5\u9a8c\u8bc4\u4f30\uff0c\u786e\u4fdd\u4ea7\u54c1\u7b26\u5408\u56fd\u5bb6\u6807\u51c6\u548c\u884c\u4e1a\u89c4\u8303\uff0c\u4ece\u800c\u964d\u4f4e\u533b\u7597\u98ce\u9669\uff0c\u9632\u6b62\u4e0d\u5408\u683c\u4ea7\u54c1\u6d41\u5165\u5e02\u573a\uff0c\u6b64\u5916\uff0cNMPA\u8ba4\u8bc1\u63d0\u5347\u4e86\u4ea7\u54c1\u7684\u5e02\u573a\u7ade\u4e89\u529b\uff0c\u56e0\u4e3a\u5b83\u5411\u533b\u7597\u673a\u6784\u548c\u6d88\u8d39\u8005\u4f20\u9012\u4e86\u5b89\u5168\u53ef\u4fe1\u7684\u4fe1\u53f7\uff0c\u6709\u52a9\u4e8e\u5efa\u7acb\u54c1\u724c\u58f0\u8a89\uff0c\u5728\u5168\u7403\u5316\u7684\u80cc\u666f\u4e0b\uff0cNMPA\u8ba4\u8bc1\u4e5f\u4e0e\u56fd\u9645\u6807\u51c6\u5982ISO 13485\u63a5\u8f68\uff0c\u652f\u6301\u4f01\u4e1a\u62d3\u5c55\u6d77\u5916\u5e02\u573a\uff0c\u56e0\u6b64\uff0c\u4f01\u4e1a\u5fc5\u987b\u5c06\u8ba4\u8bc1\u89c6\u4e3a\u6218\u7565\u4f18\u5148\u4e8b\u9879\uff0c\u800c\u975e\u7b80\u5355\u7684\u5408\u89c4\u4efb\u52a1\u3002<\/p>\n<\/p>\n

3. NMPA\u8ba4\u8bc1\u7684\u5206\u7c7b\uff1a\u4e00\u7c7b\u3001\u4e8c\u7c7b\u548c\u4e09\u7c7b\u533b\u7597\u5668\u68b0<\/strong><\/p>\n

NMPA\u6839\u636e\u98ce\u9669\u7b49\u7ea7\u5c06\u533b\u7597\u5668\u68b0\u5206\u4e3a\u4e09\u7c7b\uff0c\u8ba4\u8bc1\u8981\u6c42\u9010\u7ea7\u4e25\u683c\uff0c\u4e00\u7c7b\u533b\u7597\u5668\u68b0\u4e3a\u4f4e\u98ce\u9669\u4ea7\u54c1\uff0c\u5982\u624b\u672f\u5200\u6216\u8f6e\u6905\uff0c\u901a\u5e38\u91c7\u7528\u5907\u6848\u5236\u7ba1\u7406\uff0c\u65e0\u9700\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4f46\u9700\u63d0\u4ea4\u4ea7\u54c1\u68c0\u9a8c\u62a5\u544a\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6587\u4ef6\uff0c\u4e8c\u7c7b\u533b\u7597\u5668\u68b0\u4e3a\u4e2d\u98ce\u9669\u4ea7\u54c1\uff0c\u5982\u8840\u538b\u8ba1\u6216\u8f93\u6db2\u6cf5\uff0c\u9700\u8981\u5b9e\u65bd\u6ce8\u518c\u5ba1\u6279\uff0c\u5305\u62ec\u6280\u672f\u8bc4\u5ba1\u548c\u53ef\u80fd\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u8bc1\u660e\u5176\u5b89\u5168\u6709\u6548\u6027\uff0c\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u4e3a\u9ad8\u98ce\u9669\u4ea7\u54c1\uff0c\u5982\u690d\u5165\u5f0f\u5668\u68b0\u6216\u5fc3\u810f\u652f\u67b6\uff0c\u5fc5\u987b\u901a\u8fc7\u6700\u4e25\u683c\u7684\u6ce8\u518c\u6d41\u7a0b\uff0c\u6d89\u53ca\u5168\u9762\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3001\u751f\u4ea7\u73b0\u573a\u5ba1\u6838\u548c\u957f\u671f\u968f\u8bbf\u6570\u636e\uff0c\u5206\u7c7b\u4f9d\u636e\u4ea7\u54c1\u7684\u4f7f\u7528\u65f6\u957f\u3001\u4fb5\u5165\u6027\u548c\u6f5c\u5728\u5371\u5bb3\uff0c\u4f01\u4e1a\u9700\u9996\u5148\u51c6\u786e\u5206\u7c7b\u4ea7\u54c1\uff0c\u4ee5\u907f\u514d\u7533\u8bf7\u9519\u8bef\u5bfc\u81f4\u7684\u5ef6\u8bef\uff0c\u9519\u8bef\u5206\u7c7b\u53ef\u80fd\u5f15\u53d1\u590d\u5ba1\u6216\u62d2\u7edd\uff0c\u589e\u52a0\u65f6\u95f4\u548c\u6210\u672c\u8d1f\u62c5\u3002<\/p>\n<\/p>\n

4. NMPA\u8ba4\u8bc1\u7684\u6d41\u7a0b\u4e0e\u6b65\u9aa4\u8be6\u89e3<\/strong><\/p>\n

NMPA\u8ba4\u8bc1\u6d41\u7a0b\u590d\u6742\u4e14\u8017\u65f6\uff0c\u901a\u5e38\u5305\u62ec\u51c6\u5907\u3001\u7533\u8bf7\u3001\u8bc4\u5ba1\u548c\u6279\u51c6\u56db\u4e2a\u9636\u6bb5\uff0c\u9996\u5148\uff0c\u4f01\u4e1a\u9700\u8fdb\u884c\u4ea7\u54c1\u5206\u7c7b\u548c\u6807\u51c6\u786e\u8ba4\uff0c\u51c6\u5907\u6280\u672f\u6587\u4ef6\uff0c\u5982\u4ea7\u54c1\u8bf4\u660e\u4e66\u3001\u8bbe\u8ba1\u56fe\u7eb8\u3001\u98ce\u9669\u5206\u6790\u62a5\u544a\u548c\u68c0\u9a8c\u7ed3\u679c\uff0c\u8fd9\u4e9b\u6587\u4ef6\u5fc5\u987b\u7b26\u5408NMPA\u7684\u683c\u5f0f\u8981\u6c42\uff0c\u5e76\u57fa\u4e8eGB\u6807\u51c6\u6216ISO\u6807\u51c6\uff0c\u5176\u6b21\uff0c\u63d0\u4ea4\u6ce8\u518c\u7533\u8bf7\u81f3NMPA\u6216\u7701\u7ea7\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\uff0c depending on the classification\uff0c\u5bf9\u4e8e\u4e8c\u7c7b\u548c\u4e09\u7c7b\u5668\u68b0\uff0cNMPA\u5c06\u8fdb\u884c\u6280\u672f\u8bc4\u5ba1\uff0c\u53ef\u80fd\u8981\u6c42\u8865\u5145\u8d44\u6599\u6216\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u9700\u5728\u8ba4\u8bc1\u673a\u6784\u6279\u51c6\u540e\u8fdb\u884c\uff0c\u5e76\u9075\u5faa\u4f26\u7406\u51c6\u5219\uff0c\u968f\u540e\uff0c\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8003\u6838\uff08\u5982GMP\u68c0\u67e5\uff09\u53ef\u80fd\u88ab\u5b89\u6392\uff0c\u4ee5\u786e\u4fdd\u5236\u9020\u8fc7\u7a0b\u5408\u89c4\uff0c\u6700\u7ec8\uff0c\u8bc4\u5ba1\u901a\u8fc7\u540e\uff0cNMPA\u9881\u53d1\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\uff0c\u6709\u6548\u671f\u4e3a5\u5e74\uff0c\u5230\u671f\u9700\u7eed\u8bc1\uff0c\u6574\u4e2a\u6d41\u7a0b\u53ef\u80fd\u8017\u65f66\u4e2a\u6708\u81f33\u5e74\uff0c\u4f01\u4e1a\u9700\u63d0\u524d\u89c4\u5212\u8d44\u6e90\u5e76\u5e94\u5bf9\u53ef\u80fd\u7684\u590d\u5ba1\u3002<\/p>\n<\/p>\n

5. \u5e38\u89c1\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n

\u4f01\u4e1a\u5728\u7533\u8bf7NMPA\u8ba4\u8bc1\u65f6\u5e38\u9762\u4e34\u591a\u9879\u6311\u6218\uff0c\u5305\u62ec\u6cd5\u89c4\u53d8\u5316\u3001\u6280\u672f\u6587\u4ef6\u51c6\u5907\u4e0d\u8db3\u3001\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u590d\u6742\u6216\u8bc4\u5ba1\u5ef6\u8fdf\uff0c\u6cd5\u89c4\u66f4\u65b0\u9891\u7e41\uff0c\u59822021\u5e74\u65b0\u4fee\u8ba2\u7684\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b\uff0c\u8981\u6c42\u4f01\u4e1a\u6301\u7eed\u5173\u6ce8\u52a8\u6001\u5e76\u8c03\u6574\u7b56\u7565\uff0c\u6280\u672f\u6587\u4ef6\u9700\u8be6\u7ec6\u4e14\u51c6\u786e\uff0c\u4efb\u4f55 discrepancies \u53ef\u80fd\u5bfc\u81f4\u7533\u8bf7\u9000\u56de\uff0c\u5efa\u8bae\u4f01\u4e1a\u501f\u52a9\u4e13\u4e1a\u987e\u95ee\u6216\u4f7f\u7528\u6570\u5b57\u5316\u5de5\u5177\u7ba1\u7406\u6587\u6863\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u9762\uff0c\u53d7\u8bd5\u8005\u62db\u52df\u548c\u6570\u636e\u8d28\u91cf\u662f\u5173\u952e\u95ee\u9898\uff0c\u5c24\u5176\u5bf9\u4e8e\u521b\u65b0\u5668\u68b0\uff0c\u9700\u4e0e\u8ba4\u8bc1\u673a\u6784\u63d0\u524d\u6c9f\u901a\u65b9\u6848\uff0c\u6b64\u5916\uff0c\u8bed\u8a00\u548c\u6587\u5316\u5dee\u5f02\u53ef\u80fd\u5f71\u54cd\u56fd\u9645\u4f01\u4e1a\u7684\u7533\u8bf7\uff0c\u56e0\u6b64\uff0c\u672c\u5730\u5316\u56e2\u961f\u6216\u5408\u4f5c\u4f19\u4f34\u81f3\u5173\u91cd\u8981\uff0c\u4e3a\u5e94\u5bf9\u8fd9\u4e9b\u6311\u6218\uff0c\u4f01\u4e1a\u5e94\u5c3d\u65e9\u542f\u52a8\u8ba4\u8bc1\u6d41\u7a0b\uff0c\u8fdb\u884c\u9884\u8bc4\u4f30\u548c\u57f9\u8bad\uff0c\u5e76\u5efa\u7acb\u5185\u90e8\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4ee5\u786e\u4fdd\u5408\u89c4\u6027\u3002<\/p>\n<\/p>\n

6. \u7ed3\u8bba\u4e0e\u672a\u6765\u5c55\u671b<\/strong><\/p>\n

NMPA\u8ba4\u8bc1\u662f\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u5e02\u573a\u7684\u6838\u5fc3\u51c6\u5165\u673a\u5236\uff0c\u5bf9\u4f01\u4e1a\u6210\u529f\u81f3\u5173\u91cd\u8981\uff0c\u968f\u7740\u4e2d\u56fd\u533b\u7597\u884c\u4e1a\u7684\u5feb\u901f\u53d1\u5c55\uff0cNMPA\u6b63\u4e0d\u65ad\u4f18\u5316\u6d41\u7a0b\uff0c\u5f15\u5165\u6570\u5b57\u5316\u5ba1\u6279\u548c\u56fd\u9645\u4e92\u8ba4\u63aa\u65bd\uff0c\u4ee5\u63d0\u9ad8\u6548\u7387\uff0c\u672a\u6765\uff0c\u4eba\u5de5\u667a\u80fd\u548c\u8fdc\u7a0b\u533b\u7597\u7b49\u521b\u65b0\u6280\u672f\u5c06\u5e26\u6765\u65b0\u7684\u76d1\u7ba1\u6311\u6218\uff0c\u4f01\u4e1a\u9700\u4fdd\u6301\u654f\u6377\uff0c\u79ef\u6781\u9002\u5e94\u53d8\u5316\uff0c\u901a\u8fc7\u83b7\u5f97NMPA\u8ba4\u8bc1\uff0c\u4e0d\u4ec5\u80fd\u5408\u89c4\u7ecf\u8425\uff0c\u8fd8\u80fd\u63d0\u5347\u4ea7\u54c1\u4ef7\u503c\u548c\u793e\u4f1a\u4fe1\u4efb\uff0c\u6700\u7ec8\u63a8\u52a8\u884c\u4e1a\u5065\u5eb7\u53d1\u5c55\u3002<\/p>\n<\/p>\n

\u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\uff0c\u4e0d\u6784\u6210\u4efb\u4f55\u4e13\u4e1a\u5efa\u8bae\u6216\u6cd5\u5f8b\u610f\u89c1\uff0c\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u6cd5\u89c4\u53ef\u80fd\u968f\u65f6\u53d8\u5316\uff0c\u8bfb\u8005\u5e94\u54a8\u8be2\u5b98\u65b9\u6e20\u9053\u6216\u4e13\u4e1a\u673a\u6784\u83b7\u53d6\u6700\u65b0\u4fe1\u606f\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":"

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