{"id":171783,"date":"2021-07-23T08:48:12","date_gmt":"2021-07-23T15:48:12","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/blog\/latam-series-mexicos-medical-device-regulatory-pathway\/"},"modified":"2021-09-01T01:41:04","modified_gmt":"2021-09-01T08:41:04","slug":"%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e4%bc%81%e4%b8%9a%e5%a6%82%e4%bd%95%e8%8e%b7%e5%be%97%e5%a2%a8%e8%a5%bf%e5%93%a5%e7%9a%84%e5%b8%82%e5%9c%ba%e5%87%86%e5%85%a5","status":"publish","type":"post","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/blog\/%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e4%bc%81%e4%b8%9a%e5%a6%82%e4%bd%95%e8%8e%b7%e5%be%97%e5%a2%a8%e8%a5%bf%e5%93%a5%e7%9a%84%e5%b8%82%e5%9c%ba%e5%87%86%e5%85%a5\/","title":{"rendered":"\u62c9\u7f8e\u7cfb\u5217\u2014\u2014\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5982\u4f55\u83b7\u5f97\u58a8\u897f\u54e5\u7684\u5e02\u573a\u51c6\u5165"},"content":{"rendered":"

2019\u5e74\uff0c\u58a8\u897f\u54e5\u533b\u7597\u5668\u68b0\u8fdb\u53e3\u91d1\u989d\u7ea6\u4e3a57\u4ebf\u7f8e\u5143\u3002\u52302020\u5e74\uff0c\u8fdb\u53e3\u989d\u589e\u52a0\u523065\u4ebf\u7f8e\u5143\u3002\u968f\u7740\u58a8\u897f\u54e5\u7ecf\u6d4e\u7684\u53d1\u5c55\uff0c\u533b\u7597\u4f53\u7cfb\u4e0d\u65ad\u5b8c\u5584\uff0c\u533b\u7597\u8bbe\u5907\u7684\u9700\u6c42\u5c24\u5176\u662f\u5728\u65b0\u58a8\u897f\u54e5\u57ce\u548c\u74dc\u8fbe\u62c9\u54c8\u62c9\u7b49\u4e3b\u8981\u57ce\u5e02\u7684\u589e\u957f\u5c24\u4e3a\u660e\u663e\u3002\u5982\u8981\u5f00\u53d1\u62c9\u4e01\u7f8e\u6d32(LATAM)\u7684\u5e02\u573a\uff0c\u5c31\u9700\u8981\u5bf9\u58a8\u897f\u54e5\u7684\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u6709\u4e00\u4e2a\u5168\u9762\u7684\u4e86\u89e3\uff0c\u8fd8\u8981\u6ce8\u610f\u533a\u5206\u4e0e\u963f\u6839\u5ef7\uff08ANMAT\uff09\u548c\u5df4\u897f\uff08ANVISA\uff09\u7b49\u56fd\u5bb6\u7684\u76d1\u7ba1\u533a\u522b\u3002<\/p>\n

\u58a8\u897f\u54e5\u7684\u76d1\u7ba1\u673a\u6784<\/h3>\n

\u58a8\u897f\u54e5\u76d1\u7ba1\u533b\u7597\u8bbe\u5907\u7684\u76d1\u7ba1\u673a\u6784\u662f\u58a8\u897f\u54e5\u536b\u751f\u90e8\u9632\u5fa1\u536b\u751f\u98ce\u9669\u8054\u90a6\u59d4\u5458\u4f1a(COFEPRIS)\uff0c\u7531\u58a8\u897f\u54e5\u536b\u751f\u90e8\u7ba1\u8f96\u3002\u9664\u533b\u7597\u5668\u68b0\u5916\uff0cCOFEPRIS\u8fd8\u76d1\u7763\u836f\u54c1\u76d1\u7ba1\u3001\u98df\u54c1\u5b89\u5168\u548c\u73af\u5883\u4fdd\u62a4<\/p>\n

\u963f\u6839\u5ef7\u7684\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u9014\u5f84<\/h3>\n

\u867d\u7136COFEPRIS\u3001ANMAT\u548cANVISA\u4e4b\u95f4\u6709\u76f8\u4f3c\u4e4b\u5904\uff0c\u4f46COFEPRIS\u4e3b\u8981\u662f\u6839\u636e\u529f\u80fd\u5c06\u533b\u7597\u5668\u68b0\u5206\u6210\u4e86\u516d\u7ec4\uff1a<\/p>\n

    \n
  1. \u533b\u7597\u8bbe\u5907\uff1a\u7528\u4e8e\u533b\u7597\u7684\u5668\u5177\u3001\u914d\u4ef6\u548c\u4eea\u5668<\/li>\n
  2. \u5047\u80a2\u3001\u77eb\u5f62\u5668\u548c\u529f\u80fd\u8f85\u52a9\u88c5\u7f6e<\/li>\n
  3. \u8bca\u65ad\u5242<\/li>\n
  4. \u7259\u79d1\u7528\u54c1<\/li>\n
  5. \u5916\u79d1\u6750\u6599<\/li>\n
  6. \u536b\u751f\u8bbe\u5907<\/li>\n<\/ol>\n

    \u4e0e\u5df4\u897f\u7684\u5206\u7c7b\u65b9\u6cd5\u7c7b\u4f3c\uff0c\u58a8\u897f\u54e5\u4f1a\u6839\u636e\u98ce\u9669\u6c34\u5e73\u5c06\u533b\u7597\u5668\u68b0\u5206\u6210\u4e0d\u540c\u7684\u7c7b\u522b\uff1a<\/p>\n\n\n\n\n\n\n\n
    \u7c7b\u522b<\/td>\n\u98ce\u9669\u7b49\u7ea7<\/td>\n\u5b9a\u4e49<\/td>\n\u5b9e\u4f8b<\/td>\n\u9884\u671f\u7684\u76d1\u7ba1\u5ba1\u67e5\u65f6\u95f4<\/td>\n<\/tr>\n
    \u4f4e\u98ce\u9669<\/td>\n\u4f4e<\/td>\n\u4e0d\u4f1a\u5bf9\u60a3\u8005\u6216\u4f7f\u7528\u8005\u9020\u6210\u4f24\u5bb3<\/td>\n\u53e3\u7f69\u3001\u7eb1\u5e03<\/td>\n1-3\u4e2a\u6708<\/td>\n<\/tr>\n
    I\u7c7b<\/td>\n\u4e2d\u4f4e<\/td>\n\u5b89\u5168\u6027\u53ef\u9760\u6709\u4fdd\u8bc1\uff0c\u975e\u690d\u5165\u6027\u5668\u68b0<\/td>\n\u7b80\u5355\u7684\u5916\u79d1\u624b\u672f\u5668\u68b0<\/td>\n\u7b49\u6548\u6027\u5ba1\u67e5\uff1a6-8\u4e2a\u6708<\/p>\n

     <\/p>\n

    \u6807\u51c6\u5ba1\u67e5\uff1a\u00a04-10\u4e2a\u6708<\/td>\n<\/tr>\n

    \u00a0II\u7c7b<\/td>\n\u4e2d\u9ad8<\/td>\n\u5e7f\u6cdb\u4f7f\u7528\u7684\u4ea7\u54c1\uff0c\u4fb5\u5165\u6027\u533b\u7597\u5668\u68b0\uff0c\u4f53\u5185\u6ede\u7559\u65f6\u95f4\u5c11\u4e8e30\u5929<\/td>\n\u6ce8\u5c04\u5668\u3001\u7535\u52a8\u8f6e\u6905<\/td>\n\u7b49\u6548\u6027\u5ba1\u67e5\uff1a6-8\u4e2a\u6708<\/p>\n

     <\/p>\n

    \u6807\u51c6\u5ba1\u67e5\uff1a4-10\u4e2a\u6708<\/td>\n<\/tr>\n

    III\u7c7b<\/p>\n

     <\/td>\n

    		\u9ad8<\/td>\n\u65b0\u533b\u7597\u5668\u68b0\u6216\u8005\u4f53\u5185\u6ede\u7559\u65f6\u95f4\u8d85\u8fc730\u5929<\/td>\n\u5fc3\u810f\u8d77\u640f\u5668\u3001\u547c\u5438\u673a<\/p>\n

     <\/td>\n

    		\u7b49\u6548\u6027\u5ba1\u67e5\uff1a6-8\u4e2a\u6708<\/p>\n

     <\/p>\n

    \u6807\u51c6\u5ba1\u67e5:4-10\u4e2a\u6708<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

     <\/p>\n

    \u5728\u5bf9\u533b\u7597\u5668\u68b0\u8fdb\u884c\u5206\u7ec4\u548c\u5206\u7c7b\u4e4b\u540e\uff0c\u5bfb\u6c42\u8fdb\u5165\u58a8\u897f\u54e5\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u516c\u53f8\u5fc5\u987b\u4e86\u89e3\u5e76\u9075\u5faa\u5176\u76d1\u7ba1\u6cd5\u89c4\uff0c\u624d\u80fd\u83b7\u5f97COFEPRIS\u7684\u5e02\u573a\u51c6\u5165\u6279\u51c6\u3002<\/p>\n

      \n
    • <\/b>\u58a8\u897f\u54e5\u6ce8\u518c\u6301\u6709\u4eba\uff08MRH\uff09\uff1a<\/b><\/strong>COFEPRIS\u4e0eANVISA\u548cANMAT\u7c7b\u4f3c\uff0c\u8981\u6c42\u4e00\u540d\u56fd\u5185\u76d1\u7ba1\u4ee3\u8868\u4f5c\u4e3a\u6ce8\u518c\u8fc7\u7a0b\u7684\u8054\u7edc\u70b9\u3002MRH\u8fd8\u53ef\u4ee5\u4e3a\u4efb\u4f55\u6d77\u5916\u533b\u7597\u5668\u68b0\u516c\u53f8\u63d0\u4f9b\u6307\u5bfc\uff0c\u4ee5\u786e\u5b9a\u4ed6\u4eec\u7684\u8bbe\u5907\u7684\u5206\u7c7b\u3002\u9664\u5c5e\u201c\u4f4e\u98ce\u9669\u201d\u7c7b\u522b\u7684\u533b\u7597\u5668\u68b0\u5916\uff0c\u6240\u6709\u533b\u7597\u5668\u68b0\u7684\u6ce8\u518c\u6863\u6848\u5747\u987b\u5305\u62ec:<\/li>\n<\/ul>\n

      –<\/b><\/strong>\u00a0ISO 13485\u6216CE\u8ba4\u8bc1\u6587\u4ef6<\/p>\n

      –<\/b><\/strong>\u00a0\u81ea\u7531\u9500\u552e\u8bc1\u4e66\uff08CFS\uff09\u6216\u81f4\u5916\u56fd\u653f\u5e9c\u51fd\uff08CFG\uff09\u3002<\/p>\n

      –<\/b><\/strong>\u00a0\u4f7f\u7528\u8bf4\u660e\uff08IFU\uff09<\/p>\n

      –<\/b><\/strong>\u00a0\u6807\u7b7e<\/p>\n

      –<\/b><\/strong>\u00a0\u6280\u672f\u548c\u5b89\u5168\u6587\u4ef6<\/p>\n

      –<\/b><\/strong>\u00a0\u6d4b\u8bd5\u62a5\u544a<\/p>\n

      \u6ce8\uff1a\u5bf9\u4e8e\u4f4e\u98ce\u9669\u8bbe\u5907\uff0c\u53ea\u9700\u63d0\u4ea4\u57fa\u672c\u7684\u533b\u7597\u8bbe\u5907\u4fe1\u606f\uff0c\u4ee5\u53caISO\u6216\u7b49\u6548\u56fd\u5bb6\u6587\u4ef6\uff0c\u4ee5\u53caCFS\u6216CFG\u3002\u5bf9\u4e8e\u76f8\u5173\u7684\u6d4b\u8bd5\u7ed3\u679c\uff0c\u7b2c\u4e09\u7c7b\u5668\u68b0\u9700\u8981\u751f\u7269\u76f8\u5bb9\u6027\u548c\u4e34\u5e8a\u6570\u636e\uff1b\u5728\u5168\u7403\u8303\u56f4\u5185\u8fdb\u884c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e5f\u88ab\u63a5\u53d7\u3002<\/p>\n

        \n
      • <\/b>\u897f\u73ed\u7259\u8bed\u7ffb\u8bd1\u7684\u8d44\u6599<\/b><\/strong>\uff1a\u6240\u6709\u63d0\u4ea4\u7ed9COFEPRIS\u7684\u6587\u4ef6\u5fc5\u987b\u4f7f\u7528\u897f\u73ed\u7259\u8bed\u3002<\/li>\n
      • <\/b>\u7b49\u6548\u6027\u5ba1\u67e5<\/b><\/strong>\uff1a\u5bf9\u4e8e\u5df2\u7ecf\u5728\u65e5\u672c\u3001\u7f8e\u56fd\u6216\u52a0\u62ff\u5927\u83b7\u5f97\u6279\u51c6\u7684\u533b\u7597\u6280\u672f\u516c\u53f8\uff0c\u53ea\u9700\u8981\u63d0\u4ea4\u4e00\u4efd\u6458\u8981\u6027\u7684\u8d44\u6599\u8fdb\u884c\u7b49\u6548\u6027\u5ba1\u67e5\u3002\u5bf9\u4e8e\u5df2\u7ecf\u83b7\u5f97\u52a0\u62ff\u5927\u536b\u751f\u7f72\u548c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6\u7684\u5668\u68b0\u6765\u8bf4\uff0c\u8fd9\u4e2a\u7533\u8bf7\u6d41\u7a0b\u5e76\u6ca1\u6709\u6bd4\u6807\u51c6\u7684\u5ba1\u67e5\u6d41\u7a0b\u66f4\u5feb\uff0c\u4f46\u662f\u6240\u8981\u6c42\u7684\u6587\u4ef6\u8d44\u6599\u6bd4\u8f83\u5c11\u3002\u5bf9\u4e8e\u90a3\u4e9b\u5728\u65e5\u672c\u83b7\u5f97\u6279\u51c6\u7684\u5236\u9020\u5546\u6765\u8bf4\uff0c\u53ea\u8981\u63d0\u4f9b\u4e00\u4efd\u7531\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\u51fa\u5177\u7684\u51fa\u53e3\u8bc1\u660e\u5c31\u53ef\u4ee5<\/li>\n
      • <\/b>\u7b2c\u4e09\u65b9\u5ba1\u67e5<\/b><\/strong>(TPR)<\/b><\/strong>\uff1aCOFEPRIS\u4e3a\u533b\u7597\u8bbe\u5907\u516c\u53f8\u63d0\u4f9b\u4e86\u5229\u7528\u7b2c\u4e09\u65b9\u5ba1\u67e5\uff08TPR\uff09\u7684\u9009\u62e9\u3002TPR\u5f80\u5f80\u662f\u7531COFEPRIS\u6388\u6743\u7684\u5546\u4e1a\u6027\u79c1\u4eba\u7ec4\u7ec7\u6765\u521d\u6b65\u5ba1\u67e5\u7533\u8bf7\u3002\u5982\u679c\u6240\u6709\u90e8\u5206\u90fd\u7b26\u5408\u4ed6\u4eec\u7684\u6807\u51c6\uff0c\u4ed6\u4eec\u5c06\u4e3aCOFEPRIS\u5199\u4e00\u4efd\u6b63\u5f0f\u7684\u6280\u672f\u62a5\u544a\uff0c\u5efa\u8bae\u6279\u51c6\u3002\u901a\u5e38\u60c5\u51b5\u4e0b\uff0c\u5728TPR\u63d0\u4ea4\u4ed6\u4eec\u7684\u62a5\u544a\u540e\uff0c\u4e0d\u9700\u8981\u518d\u5411COFEPRIS\u63d0\u4ea4\u5176\u4ed6\u8d44\u6599\uff0c\u56e0\u6b64\u80fd\u52a0\u5feb\u4e86\u5ba1\u6279\u65f6\u95f4\u3002\u4f46\u8fd9\u79cd\u670d\u52a1\u7684\u5f80\u5f80\u6709\u8f83\u9ad8\u7684\u8d39\u7528\u3002<\/li>\n<\/ul>\n

         <\/p>\n

        \u533b\u7597\u5668\u68b0\u4f01\u4e1a\u9700\u8981\u8003\u8651\u54ea\u4e9b\u91cd\u8981\u56e0\u7d20\uff1f<\/h3>\n

        \u5bf9\u4e8e\u5e0c\u671b\u5f00\u62d3\u58a8\u897f\u54e5\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u516c\u53f8\u6765\u8bf4\uff0c\u8fd8\u9700\u8981\u8003\u8651\u5176\u5b83\u51e0\u4e2a\u91cd\u8981\u56e0\u7d20\uff1a<\/p>\n

          \n
        • <\/b>\u8bb8\u53ef\u6709\u6548\u6027<\/b><\/strong>\uff1a\u6240\u6709\u83b7\u5f97\u6279\u51c6\u7684\u533b\u7597\u5668\u68b0\u5728\u58a8\u897f\u54e5\u5e02\u573a\u4e0a\u7684\u6709\u6548\u671f\u4e3a5\u5e74\u3002<\/li>\n
        • <\/b>\u4e0a\u5e02\u540e\u76d1\u7763<\/b><\/strong>\uff1a\u533b\u7597\u5668\u68b0\u516c\u53f8\u5fc5\u987b\u76d1\u6d4b\u5e76\u901a\u8fc7MRH\u5411COFEPRIS\u62a5\u544a\u6240\u6709\u4e0d\u826f\u4e8b\u4ef6\u548c\u53ec\u56de\u4e8b\u4ef6\u3002<\/li>\n<\/ul>\n

          \u9010\u5e74\u589e\u957f\u7684\u58a8\u897f\u54e5\u533b\u7597\u5668\u68b0\u9700\u6c42\u7ed9\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5e26\u6765\u4e86\u8bb8\u591a\u673a\u4f1a\uff0c\u8981\u60f3\u987a\u5229\u5f00\u62d3\u58a8\u897f\u54e5\u5e02\u573a\uff0c\u6311\u9009\u62e5\u6709\u58a8\u897f\u54e5\u533b\u7597\u8bbe\u5907\u76d1\u7ba1\u6846\u67b6\u7684\u7ecf\u9a8c\u548c\u4e13\u4e1a\u77e5\u8bc6\u7684\u8bed\u8a00\u670d\u52a1\u4f9b\u5e94\u5546\uff08LSP\uff09\uff0c\u4e0e\u4e13\u4e1a\u7684\u4e3b\u9898\u4e13\u5bb6\u548c\u6bcd\u8bed\u8bd1\u5458\u5408\u4f5c\uff0c\u4e0d\u4ec5\u53ef\u4ee5\u83b7\u5f97\u4e13\u4e1a\u7684\u8bed\u8a00\u672c\u5730\u5316\u89e3\u51b3\u65b9\u6848\uff0c\u8fd8\u80fd\u52a0\u5feb\u5ba1\u6279\u901f\u5ea6\uff0c\u8282\u7701\u66f4\u591a\u65f6\u95f4\u6210\u672c\uff0c\u53ca\u65f6\u628a\u63e1\u5e02\u573a\u673a\u9047\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

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