{"id":15872,"date":"2025-01-07T22:16:10","date_gmt":"2025-01-07T14:16:10","guid":{"rendered":"https:\/\/greenoo.tw\/?p=15872"},"modified":"2025-01-07T22:19:14","modified_gmt":"2025-01-07T14:19:14","slug":"%e7%be%8e%e5%9b%bdfda%e6%b3%a8%e5%86%8c%e5%92%8c%e8%ae%a4%e8%af%81%e6%9c%89%e4%bb%80%e4%b9%88%e5%8c%ba%e5%88%ab%ef%bc%8c%e7%be%8e%e5%9b%bdfda%e8%ae%a4%e8%af%81%e6%9c%ba%e6%9e%84","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/%e7%be%8e%e5%9b%bdfda%e6%b3%a8%e5%86%8c%e5%92%8c%e8%ae%a4%e8%af%81%e6%9c%89%e4%bb%80%e4%b9%88%e5%8c%ba%e5%88%ab%ef%bc%8c%e7%be%8e%e5%9b%bdfda%e8%ae%a4%e8%af%81%e6%9c%ba%e6%9e%84\/","title":{"rendered":"\u7f8e\u56fdfda\u6ce8\u518c\u548c\u8ba4\u8bc1\u6709\u4ec0\u4e48\u533a\u522b\uff0c\u7f8e\u56fdfda\u8ba4\u8bc1\u673a\u6784"},"content":{"rendered":"

\u8de8\u5883\u96fb\u5546\u7d05\u5229\uff0c\u5343\u842c\u4e0d\u8981\u932f\u904e\uff01\u53f0\u7063\u5bb6\u5982\u4f55\u5feb\u901f\u9032\u5165\u969b\u5e02\u5834\uff1f\u5f9e\u5e02\u5834\u653f\u7b56\u5230\u71b1\u9ede\u8cc7\u8a0a\uff0c\u7da0\u5708\u5708\u96fb\u5546\u4e00\u7ad9\u5f0f\u70ba\u60a8\u641e\u5b9a\uff01\u6211\u5011\u79c9\u627f\u201c\u5408\u4f5c\u5171\u8d0f\uff0c\u5171\u540c\u6210\u9577\u201d\u7684\u5b97\u65e8\uff0c\u52a9\u60a8\u8de8\u8d8a\u5730\u57df\u9650\u5236\uff0c\u8f15\u958b\u555f\u5168\u7403\u696d\u52d9\u65b0\u7bc7\u7ae0\uff01\u5c31\u9ede\u64ca\u4e0b\u65b9\u9023\u7d50\uff0c\u95dc\u6ce8\u7da0\u5708\u5708LINE\u5b98\u65b9\u865f\uff08@greenoo\uff09\uff0c\u7372\u53d6\u6700\u65b0\u8cc7\u8a0a\uff0c\u63d0\u524d\u6436\u5360\u51fa\u6d77\u5148\u6a5f\uff01\ud83d\udc49 LINK\uff1ahttps:\/\/line.me\/ti\/p\/g2Vc38nLnR<\/p>\n

\u7f8e\u570bFDA\u8a3b\u518a\u8207\u8a8d\u8b49\u7684\u57fa\u672c\u5340\u5225<\/h3>\n

\u5c0d\u65bc\u5e0c\u671b\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u4f01\u696d\u4f86\u8aaa\uff0c\u4e86\u89e3\u4e26\u9075\u5b88\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u76f8\u95dc\u898f\u5b9a\u81f3\u95dc\u91cd\u8981\u3002FDA\u4f5c\u70ba\u7f8e\u570b\u4e3b\u8981\u7684\u76e3\u7ba1\u6a5f\u69cb\u4e4b\u4e00\uff0c\u8ca0\u8cac\u78ba\u4fdd\u98df\u54c1\u3001\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u53ca\u5176\u4ed6\u6d88\u8cbb\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u5728\u9019\u4e00\u904e\u7a0b\u4e2d\uff0c\u201cFDA\u8a3b\u518a\u201d\u548c\u201cFDA\u8a8d\u8b49\u201d\u5e38\u5e38\u88ab\u63d0\u53ca\uff0c\u4f46\u5f88\u591a\u4eba\u5c0d\u5169\u8005\u7684\u5177\u9ad4\u5340\u5225\u537b\u611f\u5230\u56f0\u60d1\u3002\u4e8b\u5be6\u4e0a\uff0c\u9019\u5169\u500b\u8853\u8a9e\u96d6\u7136\u6709\u4e9b\u76f8\u4f3c\uff0c\u4f46\u5b83\u5011\u4ee3\u8868\u4e86\u5b8c\u5168\u4e0d\u540c\u7684\u7a0b\u5e8f\u8207\u610f\u6db5\u3002<\/p>\n

1. FDA\u8a3b\u518a\uff08FDA Registration\uff09<\/p>\n

FDA\u8a3b\u518a\u662f\u4e00\u500b\u4f01\u696d\u6216\u751f\u7522\u5546\u5411FDA\u767b\u8a18\u5176\u7522\u54c1\u6216\u696d\u52d9\u7684\u904e\u7a0b\u3002\u9019\u901a\u5e38\u662f\u6240\u6709\u8a08\u5283\u5411\u7f8e\u570b\u5e02\u5834\u4f9b\u61c9\u7684\u7522\u54c1\u6240\u5fc5\u9808\u7d93\u6b77\u7684\u7b2c\u4e00\u6b65\u3002FDA\u8a3b\u518a\u4e26\u4e0d\u610f\u5473\u8457\u8a72\u7522\u54c1\u5df2\u7d93\u88abFDA\u6279\u51c6\u6216\u8a8d\u8b49\uff0c\u53ea\u662f\u8868\u660e\u8a72\u7522\u54c1\u7684\u751f\u7522\u5546\u6216\u9032\u53e3\u5546\u5df2\u7d93\u5411FDA\u767b\u8a18\u5176\u8cc7\u6599\u4e26\u627f\u8afe\u9075\u5b88\u76f8\u95dc\u7684\u6cd5\u5f8b\u8207\u898f\u7bc4\u3002<\/p>\n

FDA\u8a3b\u518a\u7684\u76ee\u7684\uff1a<\/h3>\n

\u8a3b\u518a\u7684\u4e3b\u8981\u76ee\u7684\u662f\u8b93FDA\u80fd\u5920\u8ffd\u8e64\u6240\u6709\u5728\u7f8e\u570b\u5e02\u5834\u4e0a\u7684\u7522\u54c1\uff0c\u5c24\u5176\u662f\u6d89\u53ca\u5065\u5eb7\u548c\u5b89\u5168\u7684\u7522\u54c1\u3002\u4f8b\u5982\uff0c\u91ab\u7642\u5668\u68b0\u548c\u85e5\u54c1\u7684\u751f\u7522\u5546\u5fc5\u9808\u5411FDA\u8a3b\u518a\uff0c\u78ba\u4fdd\u5b83\u5011\u80fd\u5920\u9075\u5faaFDA\u7684\u8981\u6c42\uff0c\u4e26\u8b93FDA\u80fd\u5920\u5728\u51fa\u73fe\u554f\u984c\u6642\u8ffd\u8e64\u5230\u76f8\u61c9\u7684\u751f\u7522\u5546\u3002<\/p>\n

\u8a3b\u518a\u8981\u6c42\uff1a<\/h3>\n

\u4e0d\u540c\u985e\u578b\u7684\u7522\u54c1\u6709\u4e0d\u540c\u7684\u8a3b\u518a\u8981\u6c42\u3002\u4f8b\u5982\uff0c\u85e5\u54c1\u751f\u7522\u5546\u9700\u5411FDA\u63d0\u4f9b\u6709\u95dc\u85e5\u54c1\u7684\u8a73\u7d30\u8cc7\u6599\uff0c\u5305\u62ec\u7522\u54c1\u6210\u5206\u3001\u4f7f\u7528\u65b9\u6cd5\u4ee5\u53ca\u81e8\u5e8a\u8a66\u9a57\u7684\u7d50\u679c\uff1b\u800c\u98df\u54c1\u6216\u4fdd\u5065\u54c1\u7684\u751f\u7522\u5546\u5247\u9700\u8981\u63d0\u4f9b\u539f\u6599\u4f86\u6e90\u3001\u7522\u54c1\u6a19\u7c64\u53ca\u751f\u7522\u6d41\u7a0b\u7684\u8a73\u7d30\u4fe1\u606f\u3002<\/p>\n

\u8a3b\u518a\u6d41\u7a0b\uff1a<\/h3>\n

\u8a3b\u518a\u904e\u7a0b\u901a\u5e38\u9700\u8981\u4f01\u696d\u5411FDA\u63d0\u4f9b\u4e00\u7cfb\u5217\u7684\u8cc7\u6599\u548c\u6587\u6a94\uff0c\u4e26\u4e14\u6839\u64da\u7522\u54c1\u985e\u578b\u7684\u4e0d\u540c\uff0cFDA\u6703\u9032\u884c\u521d\u6b65\u7684\u5be9\u67e5\u8207\u767b\u9304\u3002\u6210\u529f\u8a3b\u518a\u5f8c\uff0c\u4f01\u696d\u4fbf\u53ef\u4ee5\u5728\u7f8e\u570b\u5e02\u5834\u4e0a\u92b7\u552e\u76f8\u61c9\u7684\u7522\u54c1\uff0c\u4f46\u9019\u4e26\u4e0d\u610f\u5473\u8457\u8a72\u7522\u54c1\u5df2\u7d93\u7372\u5f97FDA\u7684\u6279\u51c6\uff0c\u53ea\u6709\u5728\u5f8c\u7e8c\u7684\u5be9\u67e5\u4e2d\u901a\u904e\u8a8d\u8b49\uff0c\u7522\u54c1\u624d\u53ef\u80fd\u9032\u5165\u5e02\u5834\u3002<\/p>\n

2. FDA\u8a8d\u8b49\uff08FDA Certification\uff09<\/p>\n

\u8207FDA\u8a3b\u518a\u4e0d\u540c\uff0cFDA\u8a8d\u8b49\u662f\u4e00\u500b\u66f4\u70ba\u56b4\u683c\u7684\u904e\u7a0b\uff0c\u5b83\u6307\u7684\u662fFDA\u5c0d\u67d0\u4e00\u7522\u54c1\u6216\u670d\u52d9\u9032\u884c\u5be9\u67e5\uff0c\u4e26\u78ba\u8a8d\u8a72\u7522\u54c1\u7b26\u5408\u4e00\u5b9a\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u4ee5\u53ca\u6a19\u6e96\u7684\u904e\u7a0b\u3002\u7c21\u55ae\u4f86\u8aaa\uff0c\u8a8d\u8b49\u662f\u5c0d\u7522\u54c1\u9032\u884c\u7684\u8cea\u91cf\u8207\u5408\u898f\u6027\u6aa2\u67e5\uff0c\u9019\u4e00\u904e\u7a0b\u6703\u6d89\u53ca\u5be6\u969b\u7684\u6e2c\u8a66\u3001\u5be9\u67e5\u4ee5\u53ca\u8a8d\u53ef\u3002<\/p>\n

FDA\u8a8d\u8b49\u7684\u76ee\u7684\uff1a<\/h3>\n

FDA\u8a8d\u8b49\u7684\u4e3b\u8981\u76ee\u7684\u662f\u78ba\u8a8d\u7522\u54c1\u6216\u670d\u52d9\u5df2\u7d93\u901a\u904e\u4e86FDA\u7684\u56b4\u683c\u5be9\u67e5\uff0c\u7b26\u5408\u6240\u6709\u7684\u5b89\u5168\u548c\u6548\u80fd\u6a19\u6e96\uff0c\u5f9e\u800c\u4fdd\u969c\u6d88\u8cbb\u8005\u7684\u5065\u5eb7\u3002\u9019\u901a\u5e38\u9069\u7528\u65bc\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u3001\u8a3a\u65b7\u5de5\u5177\u7b49\u9ad8\u98a8\u96aa\u985e\u7522\u54c1\u3002<\/p>\n

\u8a8d\u8b49\u8981\u6c42\uff1a<\/h3>\n

\u4e0d\u540c\u985e\u578b\u7684\u7522\u54c1\u6703\u6839\u64da\u98a8\u96aa\u7d1a\u5225\uff0c\u63a5\u53d7\u4e0d\u540c\u985e\u578b\u7684\u8a8d\u8b49\u8981\u6c42\u3002\u8209\u4f8b\u4f86\u8aaa\uff0c\u91ab\u7642\u5668\u68b0\u7684\u8a8d\u8b49\u904e\u7a0b\u6703\u975e\u5e38\u8a73\u7d30\uff0c\u5305\u62ec\u5c0d\u8a2d\u5099\u7684\u8a2d\u8a08\u3001\u81e8\u5e8a\u6e2c\u8a66\u6578\u64da\u3001\u88fd\u9020\u904e\u7a0b\u7b49\u65b9\u9762\u7684\u5be9\u67e5\u3002FDA\u6703\u6839\u64da\u7522\u54c1\u7684\u985e\u5225\u3001\u7528\u9014\u4ee5\u53ca\u6f5b\u5728\u98a8\u96aa\u4f86\u6c7a\u5b9a\u662f\u5426\u9700\u8981\u9032\u884c\u5168\u9762\u7684\u81e8\u5e8a\u8a66\u9a57\u6216\u5176\u4ed6\u5c08\u696d\u6e2c\u8a66\u3002<\/p>\n

\u8a8d\u8b49\u6d41\u7a0b\uff1a<\/h3>\n

\u4e00\u65e6\u7522\u54c1\u63d0\u4ea4\u81f3FDA\u9032\u884c\u8a8d\u8b49\uff0cFDA\u6703\u5b89\u6392\u5c08\u696d\u7684\u5be9\u67e5\u5c0f\u7d44\u4f86\u5be9\u6838\u6240\u6709\u7684\u8cc7\u6599\u3002\u5982\u679c\u9700\u8981\uff0c\u9084\u6703\u9032\u884c\u5be6\u5730\u6aa2\u67e5\u548c\u6e2c\u8a66\u3002\u6839\u64da\u5be9\u67e5\u7d50\u679c\uff0cFDA\u5c07\u6c7a\u5b9a\u662f\u5426\u5411\u8a72\u7522\u54c1\u9812\u767c\u8a8d\u8b49\u3002\u5982\u679c\u7522\u54c1\u7372\u5f97\u8a8d\u8b49\uff0c\u5b83\u5c07\u88ab\u8996\u70ba\u7b26\u5408\u6240\u6709\u7684FDA\u6a19\u6e96\uff0c\u53ef\u4ee5\u5408\u6cd5\u5730\u5728\u7f8e\u570b\u5e02\u5834\u4e0a\u92b7\u552e\u3002<\/p>\n

\u8a3b\u518a\u8207\u8a8d\u8b49\u7684\u95dc\u9375\u5340\u5225<\/h3>\n

\u7e3d\u7d50\u4f86\u8aaa\uff0cFDA\u8a3b\u518a\u548cFDA\u8a8d\u8b49\u6709\u5169\u500b\u95dc\u9375\u5340\u5225\uff1a<\/h3>\n

\u8a3b\u518a\u662f\u767b\u8a18\uff0c\u8a8d\u8b49\u662f\u5be9\u67e5\u8207\u6279\u51c6\uff1a<\/h3>\n

\u8a3b\u518a\u662f\u4e00\u500b\u521d\u6b65\u7684\u767b\u8a18\u7a0b\u5e8f\uff0c\u4f01\u696d\u5411FDA\u63d0\u4f9b\u7522\u54c1\u53ca\u751f\u7522\u5546\u7684\u57fa\u672c\u8cc7\u6599\uff0c\u800c\u8a8d\u8b49\u5247\u662f\u5c0d\u7522\u54c1\u7684\u8cea\u91cf\u8207\u5b89\u5168\u9032\u884c\u6df1\u5165\u5be9\u67e5\u548c\u6279\u51c6\u7684\u904e\u7a0b\u3002<\/p>\n

\u8a3b\u518a\u4e0d\u7b49\u65bc\u8a8d\u8b49\uff1a<\/h3>\n

\u4f01\u696d\u5b8c\u6210\u8a3b\u518a\u5f8c\uff0c\u4e26\u4e0d\u610f\u5473\u8457\u7522\u54c1\u53ef\u4ee5\u7acb\u5373\u9032\u5165\u5e02\u5834\u92b7\u552e\u3002\u53ea\u6709\u901a\u904eFDA\u7684\u8a8d\u8b49\u7a0b\u5e8f\uff0c\u7522\u54c1\u624d\u6703\u88ab\u6b63\u5f0f\u6279\u51c6\u4e26\u5141\u8a31\u92b7\u552e\u3002<\/p>\n

\u9019\u6a23\u7684\u5340\u5225\u5c0d\u65bc\u4f01\u696d\u4f86\u8aaa\uff0c\u610f\u5473\u8457\u5fc5\u9808\u5145\u5206\u7406\u89e3\u4e26\u9075\u5faaFDA\u7684\u898f\u5b9a\uff0c\u4e26\u5728\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u6bcf\u4e00\u968e\u6bb5\u4e2d\uff0c\u90fd\u4fdd\u6301\u9ad8\u5ea6\u7684\u5408\u898f\u6027\u8207\u900f\u660e\u5ea6\u3002\u7406\u89e3\u9019\u4e9b\u57fa\u672c\u7684\u5340\u5225\uff0c\u4e0d\u50c5\u80fd\u5920\u5e6b\u52a9\u4f01\u696d\u5feb\u901f\u901a\u904e\u5be9\u67e5\uff0c\u9084\u80fd\u5920\u6e1b\u5c11\u4e0d\u5fc5\u8981\u7684\u6cd5\u5f8b\u98a8\u96aa\u3002<\/p>\n

\u5982\u4f55\u6e96\u5099FDA\u8a3b\u518a\u548c\u8a8d\u8b49\u7684\u6d41\u7a0b\uff1f<\/h3>\n

\u4e86\u89e3\u4e86FDA\u8a3b\u518a\u8207\u8a8d\u8b49\u7684\u5340\u5225\uff0c\u63a5\u4e0b\u4f86\uff0c\u4f01\u696d\u61c9\u8a72\u5982\u4f55\u6e96\u5099\u9019\u4e9b\u7a0b\u5e8f\u5462\uff1f\u9019\u662f\u6bcf\u500b\u5e0c\u671b\u5728\u7f8e\u570b\u5e02\u5834\u7acb\u8db3\u7684\u4f01\u696d\u6240\u9700\u8981\u9762\u5c0d\u7684\u91cd\u8981\u554f\u984c\u3002\u4e0b\u9762\uff0c\u6211\u5011\u5c07\u5206\u5225\u63a2\u8a0e\u5982\u4f55\u6e96\u5099FDA\u8a3b\u518a\u548c\u8a8d\u8b49\u7684\u76f8\u95dc\u6b65\u9a5f\u3002<\/p>\n

1. \u5982\u4f55\u6e96\u5099FDA\u8a3b\u518a\uff1f<\/h3>\n

FDA\u8a3b\u518a\u7684\u6d41\u7a0b\u96d6\u7136\u76f8\u5c0d\u7c21\u55ae\uff0c\u4f46\u4e5f\u9700\u8981\u7d30\u5fc3\u6e96\u5099\u548c\u4e86\u89e3\u5177\u9ad4\u8981\u6c42\u3002\u4ee5\u4e0b\u662f\u4e00\u4e9b\u95dc\u9375\u6b65\u9a5f\uff1a<\/p>\n

\u4e86\u89e3\u7522\u54c1\u985e\u5225\uff1a<\/h3>\n

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