{"id":71175,"date":"2023-08-23T15:05:15","date_gmt":"2023-08-23T07:05:15","guid":{"rendered":"https:\/\/naipnews.naipo.com\/?p=71175"},"modified":"2026-09-07T15:24:30","modified_gmt":"2026-09-07T07:24:30","slug":"%e7%b2%be%e5%87%86%e5%8c%bb%e7%96%97%e8%b6%8b%e5%8a%bf%ef%bc%9a%e4%bb%8e%e5%9b%bd%e9%99%85%e7%b2%be%e5%87%86%e6%a3%80%e6%b5%8b%e6%b3%95%e8%a7%84%e7%9c%8bldts%e5%8f%91%e5%b1%95","status":"publish","type":"post","link":"https:\/\/naipnews.naipo.com\/zh-hans\/71175\/","title":{"rendered":"\u7cbe\u51c6\u533b\u7597\u8d8b\u52bf\uff1a\u4ece\u56fd\u9645\u7cbe\u51c6\u68c0\u6d4b\u6cd5\u89c4\u770bLDTs\u53d1\u5c55"},"content":{"rendered":"
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\u7f8e\u56fd\u4fee\u6cd5\u5c1a\u672a\u901a\u8fc7<\/span><\/p>\n

LDTs\u5728\u7f8e\u56fd\u662f\u7531\u8054\u90a6\u533b\u7597\u4fdd\u9669\u548c\u8865\u52a9\u670d\u52a1\u4e2d\u5fc3\uff08The Centers for Medicare and Medicaid Services\uff0cCMS\uff09\u8fdb\u884c\u5b9e\u9a8c\u5ba4\u8ba4\u8bc1\uff0c\u968f\u7740LDTs\u7684\u6570\u91cf\u53ca\u7c7b\u578b\u5927\u5e45\u589e\u52a0\u3001\u53d1\u5c55\u8d8a\u8d8b\u5546\u4e1a\u5316\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08Food and Drug Administration\uff0cFDA\uff09\u57282014\u5e74\u53d1\u5e03LDTs\u76d1\u7ba1\u67b6\u6784\u6307\u5f15\u8349\u6848\uff0c\u4ee5\u98ce\u9669\u57fa\u7840\u65b9\u6cd5\u5bf9LDTs\u52a0\u4ee5\u76d1\u7ba1\u548c\u8fdb\u884c\u5206\u7ea7\u3002\u9664\u4e86\u5e94\u5411FDA\u901a\u77e5\u6216\u6ce8\u518cLDTs\uff0c\u82e5\u8fdb\u884c\u91cd\u5927\u6539\u53d8\u4e5f\u5fc5\u987b\u989d\u5916\u901a\u77e5FDA\uff0c\u7ed3\u679c\u5f15\u53d1\u5404\u754c\u62a8\u51fb\u3002FDA\u53e6\u4e8e2017\u5e74\u53d1\u5e03LDTs\u8ba8\u8bba\u6587\u4ef6\uff0c\u5c1a\u672a\u6267\u884c\u6b64\u76d1\u7ba1\u67b6\u6784\u3002<\/p>\n

2018\u5e74\uff0c\u7f8e\u56fd\u56fd\u4f1a\u8bae\u5458\u63d0\u51fa\u7531FDA\u76d1\u7ba1\u7684\u300a\u8bc4\u4f30\u7cbe\u51c6\u4e14\u5148\u8fdb\u7684\u4f53\u5916\u4e34\u5e8a\u68c0\u9a8c\u6280\u672f\u53d1\u5c55\u6cd5\u300b\uff08Verifying Accurate\uff0cLeading-edge \/VCT Development Act\uff0c VALID Act\uff09\u8349\u6848\u3001\u53c2\u8bae\u9662\u8bae\u5458\u53e6\u63d0\u51fa\u7531CMS\u76d1\u7ba1\u4e4b\u300a\u8bc4\u4f30\u7f8e\u56fd\u9a8c\u5ba4\u4e4b\u521b\u65b0\u68c0\u6d4b\u6cd5\u300b\uff08Verified Innovative Testing in American Laboratories Act\uff0cVITAL Act\uff09\u8349\u6848\uff0c\u867d\u7136\u5728116\u5c4a\u548c117\u5c4a\u7f8e\u56fd\u56fd\u4f1a\u90fd\u66fe\u63d0\u51fa\u8fc7\u6cd5\u6848\uff0c\u81f3\u4eca\u7686\u4ecd\u672a\u901a\u8fc7\u3002<\/p>\n

VALID Act\u5c06LDTs\u5217\u4e3a\u300c\u4f53\u5916\u4e34\u5e8a\u68c0\u6d4b\u300d\uff08In vitro clinical tests\uff0cIVCTs\uff09\uff0c\u8ba4\u4e3a\u5e94\u6709\u72ec\u7acb\u7684\u76d1\u7ba1\u67b6\u6784\uff0c\u5fc5\u987b\u4f9d\u7167\u5bf9\u75c5\u4eba\u548c\u516c\u4f17\u5371\u5bb3\u4e25\u91cd\u7a0b\u5ea6\uff0c\u5206\u4e3a\u9ad8\u3001\u4e2d\u3001\u4f4e\u98ce\u9669\u3002\u9664\u4e86\u8981\u6c42\u4e34\u5e8a\u786e\u6548\u62a5\u544a\u4f7f\u7528\u771f\u5b9e\u4e16\u754c\u6570\u636e\uff0c\u8fd8\u8981\u5236\u5b9aFDA\u54a8\u8be2\u673a\u5236\u5e76\u4e3e\u884c\u516c\u542c\u4f1a\u3002\u5415\u653f\u8c1a\u6307\u51fa\uff0cVALID Act\u6bd4\u300a\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u6539\u8fdb\u4fee\u6b63\u6848\u300b\uff08CLIA\uff09\u66f4\u4e3a\u4e25\u683c\uff0c\u76f8\u5173\u89c4\u5b9a\u6db5\u76d6\u7ba1\u7406\u804c\u8d23\u3001\u8d28\u91cf\u7a3d\u6838\u8981\u6c42\u3001\u4eba\u5458\u3001\u8bbe\u8ba1\u7ba1\u7406\u3001\u6587\u4ef6\u7ba1\u7406\u7b49\u5404\u65b9\u9762\u8981\u6c42\uff0c\u53cd\u5bf9\u8005\u8ba4\u4e3aVALID Act\u662f\u5728\u963b\u788d\u521b\u65b0\uff0c\u52a0\u4e0aFDA\u7f3a\u8db3\u591f\u7684\u8d44\u6e90\u5c65\u884c\u8fd9\u4e9b\u4e49\u52a1\uff0c\u4e0d\u53ef\u9884\u6d4b\u7684\u76d1\u7ba1\u6d41\u7a0b\u5c06\u4f1a\u9020\u6210\u6210\u672c\u589e\u52a0\u30022020\u5e74\u7f8e\u56fd\u536b\u751f\u53ca\u516c\u5171\u670d\u52a1\u90e8\uff08United States Department of Health and Human Services\uff0cHHS\uff09\u4e5f\u7981\u6b62FDA\u9488\u5bf9LDTs\u8fdb\u884c\u4e0a\u5e02\u524d\u5ba1\u67e5\u3002\u4e0d\u8fc7\uff0c\u65e0\u8bbaVALID Act\u662f\u5426\u901a\u8fc7\uff0cFDA\u4ecd\u53ef\u80fd\u4ee5\u5176\u4ed6\u65b9\u5f0f\u76d1\u7ba1LDTs\u3002<\/p>\n

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\u6b27\u76df\u5168\u9762\u5b9e\u65bdIVDR<\/span><\/p>\n

\u6b27\u76df\u5c06LDTs\u5b9a\u4e49\u4e3a\u300c\u533b\u7597\u673a\u6784\uff08Health institutions\uff09\u5728\u5185\u90e8\u81ea\u884c\u5236\u9020\u3001\u53d8\u66f4\u548c\u4f7f\u7528\u81ea\u884c\u7814\u53d1\u68c0\u6d4b\uff0c\u5e76\u672a\u4ee5\u5de5\u4e1a\u89c4\u6a21\u751f\u4ea7\uff0c\u6765\u89e3\u51b3\u76ee\u6807\u75c5\u4eba\u7fa4\u4f53\u7684\u9700\u6c42\uff0c\u800c\u75c5\u4eba\u65e0\u6cd5\u5728\u5e02\u573a\u4e0a\u81ea\u884c\u8d2d\u4e70\u76f8\u540c\u6548\u80fd\u7684\u68c0\u6d4b\u300d\u3002\u6b27\u76df\u5df2\u4e8e2022\u5e745\u670826\u65e5\u5168\u9762\u5b9e\u65bd\u300c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u6750\u6cd5\u89c4\u300d\uff08IVDR\uff09\uff0c\u53d6\u4ee3\u539f\u6709\u7684\u300a\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u6750\u6307\u4ee4\u300b\uff08IVDD\uff09\uff0c\u7531\u6b27\u76df\u6267\u884c\u59d4\u5458\u4f1a\uff08EC\uff09\u3001\u533b\u7597\u5668\u6750\u534f\u8c03\u5c0f\u7ec4\u6267\u884c\uff0c\u8d85\u8fc7\u516b\u6210\u7684\u4ea7\u54c1\u9700\u8981\u900f\u8fc7\u7b2c\u4e09\u65b9\u673a\u6784\u9a8c\u8bc1\u3002<\/p>\n

IVDR\u5c06\u4ea7\u54c1\u4f9d\u98ce\u9669\u5206\u6210A~D\u7ea7\uff0c\u9700\u7b2c\u4e09\u673a\u6784\u9a8c\u8bc1\u7684\u4ea7\u54c1\u4ece20%\u5927\u5e45\u63d0\u9ad8\u81f380%\u3002\u539f\u5148\u53d6\u5f97IVDD\u9a8c\u8bc1\u7684\u4ea7\u54c1\uff0c\u4ecd\u987b\u900f\u8fc7\u7b2c\u4e09\u65b9\u673a\u6784\u8fdb\u884cIVDR\u9a8c\u8bc1\uff0c\u4e0d\u4ec5\u6280\u672f\u6587\u4ef6\u53ca\u4e34\u5e8a\u6570\u636e\u8981\u6c42\u589e\u52a0\uff0c\u5e76\u5f3a\u5316\u4ea7\u54c1\u53ef\u8ffd\u6eaf\u6027\uff0c\u8981\u6c42\u900f\u8fc7\u6b27\u76df\u533b\u7597\u5668\u6750\u6570\u636e\u5e93\uff08EU medical devices database\uff0cEUDAMED\uff09\u5411\u5927\u4f17\u516c\u5f00\u5b89\u5168\u4e0e\u6027\u80fd\u6458\u8981\u3002\u6b64\u5916\uff0c\u9664\u4e86\u4e0a\u5e02\u540e\u76d1\u7763\uff0c\u6bcf\u4e94\u5e74\u8fd8\u4f1a\u5bf9\u4ea7\u54c1\u8fdb\u884c\u4e00\u6b21\u65e0\u9884\u8b66\u7a3d\u6838\u3002\u8003\u8651\u5230\u76ee\u524d\u7b2c\u4e09\u65b9\u673a\u6784\u9a8c\u8bc1\u80fd\u91cf\u4e0d\u8db3\uff0c\u6b27\u76df\u5df2\u4f9d\u533b\u6750\u98ce\u9669\u7b49\u7ea7\u4e0d\u540c\u63d0\u4f9b\u5ef6\u957f\u8fc7\u6e21\u671f\u3002<\/p>\n

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\u97e9\u56fd\u98df\u54c1\u836f\u7269\u5b89\u5168\u90e8\uff08Ministry of Food and Drug Safety\uff0cMFDS\uff09\u57282019\u5e74\u4fee\u8ba2\u300a\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u6750\u6cd5\u300b\uff0c\u5c06LDTs\u7eb3\u5165\u76d1\u7ba1\u5e76\u4e8e2020\u5e745\u67081\u65e5\u5f00\u59cb\u5b9e\u65bd\uff0c\u5c06\u4ea7\u54c1\u4f9d\u98ce\u9669\u52061~4\u7ea7\uff0c\u7c7b\u4f3c\u4e8e\u6b27\u76dfIVDR\u98ce\u9669\u5206\u7ea7\u65b9\u5f0f\uff0c\u5e76\u6b63\u9762\u8868\u5217\u57fa\u56e0\u68c0\u6d4b\u673a\u6784\u53ef\u8fdb\u884c\u68c0\u6d4b\u7684\u9879\u76ee\u3002<\/p>\n

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\u6570\u636e\u6e90\uff1a<\/p>\n

    \n
  1. 2023\/8\/16\uff0c\u53f0\u6e7e\u5730\u533a\u8d44\u7b56\u4f1a\u79d1\u6280\u6cd5\u5f8b\u7814\u7a76\u6240\u300a\u7cbe\u51c6\u5065\u5eb7\u6cd5\u5236\u7814\u8ba8\u4f1a\u300b\uff0c\u5415\u653f\u8c1a\u7b80\u62a5\u3002<\/li>\n<\/ol>\n

    <\/a>\u5907\u6ce8\uff1a<\/p>\n

    \n
      \n
    1. \u53c2\u8003\u6570\u636e\uff1a2018\/2\/9\uff0c\u53f0\u6e7e\u5730\u533a\u8d22\u56e2\u6cd5\u4eba\u533b\u836f\u67e5\u9a8c\u4e2d\u5fc3\uff1a\u5b9e\u9a8c\u5ba4\u81ea\u884c\u7814\u53d1\u68c0\u9a8c\u6280\u672f(LDTs)\u7684\u53d1\u5c55\u4e0e\u6cd5\u89c4\u7ba1\u7406\u73b0\u51b5<\/a>\u3002<\/li>\n<\/ol>\n<\/div>\n\n\n\n
      \n\n\n\n
      \n

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      		\"\"<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/p>\n\n\n\n
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