{"id":155944,"date":"2021-02-03T19:34:53","date_gmt":"2021-02-04T02:34:53","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/blog\/%e7%94%a8%e9%ab%98%e8%b4%a8%e9%87%8f%e7%bf%bb%e8%af%91%e5%8a%a9%e5%8a%9b2021%e5%b9%b4%e6%ac%a7%e7%9b%9f%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e6%b3%95%e8%a7%84%e7%9b%91%e7%ae%a1%e8%ae%a4%e8%af%81\/"},"modified":"2021-02-03T19:35:00","modified_gmt":"2021-02-04T02:35:00","slug":"%e7%94%a8%e9%ab%98%e8%b4%a8%e9%87%8f%e7%bf%bb%e8%af%91%e5%8a%a9%e5%8a%9b2021%e5%b9%b4%e6%ac%a7%e7%9b%9f%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e6%b3%95%e8%a7%84%e7%9b%91%e7%ae%a1%e8%ae%a4%e8%af%81","status":"publish","type":"post","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/blog\/%e7%94%a8%e9%ab%98%e8%b4%a8%e9%87%8f%e7%bf%bb%e8%af%91%e5%8a%a9%e5%8a%9b2021%e5%b9%b4%e6%ac%a7%e7%9b%9f%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e6%b3%95%e8%a7%84%e7%9b%91%e7%ae%a1%e8%ae%a4%e8%af%81\/","title":{"rendered":"\u7528\u9ad8\u8d28\u91cf\u7ffb\u8bd1\u52a9\u529b2021\u5e74\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u76d1\u7ba1\u8ba4\u8bc1"},"content":{"rendered":"\n<p>2021\u5e745\u670826\u65e5\uff0c\u6b27\u76df\u300a\u533b\u7597\u5668\u68b0\u6307\u4ee4(MDD) 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href=\"https:\/\/www.medical-device-regulation.eu\/2019\/07\/10\/mdr-article-2-definitions\/\">\u300a\u533b\u7597\u8bbe\u5907\u6761\u4f8b\u300b\uff08MDR\uff09<\/a>\uff0c\u533b\u7597\u8bbe\u5907\u88ab\u5b9a\u4e49\u4e3a 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<a href=\"https:\/\/www.medical-device-regulation.eu\/2019\/07\/08\/mdr-article-10-general-obligations-of-manufacturers\/#:~:text=1.,the%20requirements%20of%20this%20Regulation.\">&#8220;\u4e00\u822c\u4e49\u52a1<\/a>&#8220;\uff0c\u9700\u8981\u5bf9\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5df2\u5efa\u7acb\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u8fdb\u884c\u4fee\u6539\u3002\u8fd9\u4e9b\u4fee\u6539\u65e8\u5728\u63d0\u9ad8\u6d88\u8d39\u8005\u3001\u76d1\u7ba1\u673a\u6784\u3001\u5236\u9020\u5546\u548c\u6240\u6709\u5176\u4ed6\u76f8\u5173\u65b9\u7684\u900f\u660e\u5ea6\uff0c\u5e76\u6539\u5584\u5176\u4ed6\u76d1\u7ba1\u673a\u6784\uff08\u5982\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\uff09\u4e4b\u95f4\u7684\u534f\u8c03\u6027\u3002\u6b64\u5916\uff0c\u65b0\u7684\u4e49\u52a1\u4e0d\u4ec5\u96c6\u4e2d\u5728\u6279\u51c6\u524d\u9636\u6bb5\u8fd8\u6982\u8ff0\u4e86\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5bf9\u5176\u4ea7\u54c1\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u7684\u7597\u6548\u6240\u5e94\u627f\u62c5\u7684\u8d23\u4efb\u3002\u8fd9\u4e00\u53d8\u5316\u6709\u52a9\u4e8e\u4e3a\u60a3\u8005\u63d0\u4f9b\u66f4\u597d\u7684\u4fdd\u62a4\u548c\u66f4\u9ad8\u7684\u751f\u6d3b\u8d28\u91cf\u3002<\/p>\n\n<p>\u6b27\u6d32\u5e02\u573a\u753127\u4e2a\u56fd\u5bb6\u7ec4\u6210\uff0c\u5176\u4e2d\u4e0d\u5305\u62ec\u82f1\u56fd\u4ee5\u53ca\u5c5e\u4e8e\u6b27\u6d32\u7ecf\u6d4e\u533a(EEA)\u7684\u5176\u4ed6\u533a\u57df\u3002<a 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