{"id":264,"date":"2023-07-06T11:59:04","date_gmt":"2023-07-06T03:59:04","guid":{"rendered":"https:\/\/consulting-hmk.com\/products\/simple-ways-to-protect-our-planet-copy-7\/"},"modified":"2024-02-20T14:52:27","modified_gmt":"2024-02-20T06:52:27","slug":"medical-device-ivd-consulting","status":"publish","type":"products","link":"https:\/\/www.consulting-hmk.com\/ja\/products\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8-ivd%e3%82%b3%e3%83%b3%e3%82%b5%e3%83%ab%e3%83%86%e3%82%a3%e3%83%b3%e3%82%b0\/","title":{"rendered":"NMPA\u533b\u7642\u6a5f\u5668\u3068IVD\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0"},"content":{"rendered":"

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\u00a0 \u00a0 \u00a0 \u65e5\u672c\u3001\u30a2\u30e1\u30ea\u30ab\u3068\u6b27\u5dde\u9023\u76df\u56fd\u7b49\u306e\u56fd\u306f\u305d\u308c\u305e\u308c\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u304c\u9055\u3063\u3066\u3044\u3066\u3001\u540c\u3058\u88fd\u54c1\u3067\u3082\u9055\u3046\u56fd\u3068\u5730\u57df\u306b\u304a\u3044\u3066\u3001\u307e\u3063\u305f\u304f\u9055\u3046\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u306a\u308b\u53ef\u80fd\u6027\u3082\u3042\u308a\u307e\u3059\u3002 <\/span>\u6b63\u5f0f\u306a\u767b\u9332\u7533\u8acb\u4f5c\u696d\u3092\u59cb\u3081\u308b\u524d\u306b\u3001\u88fd\u54c1\u767b\u9332\u6848\u3092\u78ba\u5b9a\u3059\u308b\u306e\u304c\u3068\u3066\u3082\u91cd\u8981\u306a\u4e00\u6b69\u3068\u306a\u308a\u307e\u3059\u3002\u3053\u306e\u904e\u7a0b\u306b\u304a\u3044\u3066\u3001\u88fd\u54c1\u306e\u5206\u985e\u3001\u88fd\u54c1\u304c\u9069\u7528\u3059\u308b\u6cd5\u5f8b\u898f\u5b9a\u57fa\u6e96\u3001\u81e8\u5e8a\u8a55\u4fa1\u306e\u30eb\u30fc\u30c8\u3092\u6c7a\u3081\u308b\u7b49\u91cd\u8981\u306a\u5185\u5bb9\u304c\u542b\u307e\u308c\u3001\u307e\u305f\u4e2d\u56fd\u56fd\u5185\u306e\u6cd5\u5b9a\u4ee3\u7406\u4eba\u3092\u9078\u5b9a\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u4f01\u696d\u304c\u30bf\u30fc\u30b2\u30c3\u30c8\u5e02\u5834\u306e\u76e3\u7763\u7ba1\u7406\u6a5f\u95a2\u3068\u826f\u597d\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u30eb\u30fc\u30c8\u3092\u6301\u3064\u3079\u304d\u3067\u3059\u3002\u767b\u9332\u306e\u9032\u6357\u3092\u968f\u6642\u628a\u63e1\u3057\u3001\u88dc\u8db3\u4fee\u6b63\u306e\u6307\u6458\u610f\u898b\u306b\u7a4d\u6975\u7684\u306b\u5fdc\u3058\u3001\u30bf\u30a4\u30e0\u30ea\u30fc\u306b\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3059\u308b\u3053\u3068\u3067\u3001\u8f38\u5165\u88fd\u54c1\u304c\u9806\u8abf\u306b\u767b\u9332\u3067\u304d\u308b\u3053\u3068\u3092\u4fdd\u969c\u3057\u307e\u3059\u3002<\/span><\/p>\n

\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u5206\u985e<\/span><\/strong><\/h2>\n

\u00a0 \u00a0 \u00a0 \u533b\u7642\u6a5f\u5668\u306f\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u3068\u4f7f\u7528\u76ee\u7684\u306e\u9055\u3044\u306b\u3088\u3063\u3066\u3001\u4e09\u3064\u306e\u985e\u578b\u306b\u5206\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u985e\u5225\u306f\u4e2d\u56fd\u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40(NMPA)\u304c\u5236\u5b9a\u3057\u305f\u300c\u533b\u7642\u6a5f\u5668\u5206\u985e\u76ee\u6b21\u300d\u306b\u57fa\u3065\u304d\u5206\u3051\u3066\u3044\u307e\u3059\u3002 <\/span><\/p>\n

    \n
  • \u4e00\u985e\u533b\u7642\u6a5f\u5668<\/span><\/li>\n<\/ul>\n

    \u4e00\u985e\u533b\u7642\u6a5f\u5668\u306f\u4f4e\u30ea\u30b9\u30af\u985e\u306e\u88fd\u54c1\u306b\u5c5e\u3055\u308c\u307e\u3059\u3002\u4e3b\u306b\u4f53\u5916\u3001\u6d3b\u6027\u80fd\u529b\u306e\u306a\u3044\u3001\u4eba\u4f53\u3068\u76f4\u63a5\u63a5\u89e6\u3059\u308b\u533b\u7642\u6a5f\u5668\u3068\u306a\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\uff1a\u30de\u30b9\u30af\u3001\u4e00\u822c\u6b6f\u79d1\u6750\u6599\u7b49\u3067\u3059\u3002 <\/span><\/p>\n

      \n
    • \u4e8c\u985e\u533b\u7642\u6a5f\u5668<\/span><\/li>\n<\/ul>\n

      \u4e8c\u985e\u533b\u7642\u6a5f\u5668\u306f\u4e2d\u30ea\u30b9\u30af\u985e\u306e\u88fd\u54c1\u306b\u5c5e\u3055\u308c\u307e\u3059\u3002\u4e3b\u306b\u691c\u67fb\u691c\u8a3c\u3092\u5fc5\u8981\u3068\u3059\u308b\u533b\u7642\u6a5f\u5668\u3068\u306a\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\uff1a\u5fc3\u96fb\u56f3\u6a5f\u5668\u3001X\u5c04\u7dda\u6a5f\u5668\u3001\u70b9\u6ef4\u30dd\u30f3\u30d7\u7b49\u3067\u3059\u3002 <\/span><\/p>\n

        \n
      • \u4e09\u985e\u533b\u7642\u6a5f\u5668<\/span><\/li>\n<\/ul>\n

        \u4e09\u985e\u533b\u7642\u6a5f\u5668\u306f\u9ad8\u30ea\u30b9\u30af\u88fd\u54c1\u306b\u5c5e\u3055\u308c\u307e\u3059\u3002\u4e3b\u306b\u4eba\u4f53\u306b\u4fb5\u5165\u7684\u306a\u64cd\u4f5c\u3092\u884c\u3046\u533b\u7642\u6a5f\u5668\u3068\u306a\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\uff1a\u5fc3\u81d3\u30da\u30fc\u30b9\u30e1\u30fc\u30ab\u30fc\u3001\u4eba\u5de5\u95a2\u7bc0\u3001\u8133\u30da\u30fc\u30b9\u30e1\u30fc\u30ab\u30fc\u7b49\u3067\u3059\u3002 <\/span><\/p>\n

        \u00a0 \u00a0 \u00a0 \u300c\u533b\u7642\u6a5f\u5668\u76e3\u7763\u7ba1\u7406\u6761\u4f8b\u300d\u306b\u57fa\u3065\u304d\u3001\u7b2c\u4e00\u985e\u533b\u7642\u6a5f\u5668\u306f\u88fd\u54c1\u5c4a\u3051\u51fa\u7ba1\u7406\u3001\u7b2c\u4e8c\u985e\u3001\u7b2c\u4e09\u985e\u533b\u7642\u6a5f\u5668\u306f\u88fd\u54c1\u767b\u9332\u7ba1\u7406\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u88fd\u54c1\u7814\u7a76\u958b\u767a\u3001\u767b\u9332\u7533\u8acb\u3001\u81e8\u5e8a\u5b9f\u9a13\u3001\u7d4c\u55b6\u8ca9\u58f2\u3001\u751f\u7523\u3001\u8f38\u5165\u8f38\u51fa\u7b49\u3082\u95a2\u9023\u6cd5\u5f8b\u6cd5\u898f\u306b\u5b9a\u3081\u3089\u308c\u305f\u8a73\u7d30\u898f\u5b9a\u3092\u9075\u5b88\u3059\u3079\u304d\u3067\u3059\u3002\u66f4\u306b\u8a73\u3057\u3044\u60c5\u5831\u3092\u77e5\u308a\u305f\u3044\u5834\u5408\u3001\u968f\u6642\u3054\u9023\u7d61\u304f\u3060\u3055\u3044\u3002 <\/span><\/p>\n

        \u56fd\u5916\u7533\u8acb\u4eba\u306f\u4e0b\u8a182\u7a2e\u985e\u306e\u4f01\u696d\u3092\u4e2d\u56fd\u56fd\u5185\u306e\u6cd5\u5b9a\u4ee3\u7406\u4eba\u3068\u3057\u3066\u9078\u5b9a\u3067\u304d\u307e\u3059\u3002<\/span><\/span><\/strong><\/h2>\n
          \n
        • \u56fd\u5916\u7533\u8acb\u4eba\u306f\u4e2d\u56fd\u56fd\u5185\u306b\u304a\u3044\u3066\u4ee3\u8868\u6a5f\u95a2\u3092\u8a2d\u3051\u3066\u3044\u307e\u3059\u3002<\/span><\/li>\n
        • \u4e2d\u56fd\u56fd\u5185\u306b\u304a\u3051\u308b\u4f01\u696d\u6cd5\u4eba\u3067\u3059\u3002 <\/span><\/li>\n<\/ul>\n

          \u00a0 \u00a0 \u00a0 \u66f4\u306b\u8a73\u3057\u3044\u60c5\u5831\u3092\u77e5\u308a\u305f\u3044\u5834\u5408\u3001\u968f\u6642\u3054\u9023\u7d61\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n

          \u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u30b5\u30fc\u30d3\u30b9<\/span><\/strong><\/span><\/h2>\n

          \u00a0 \u00a0 \u00a0 HMK\u306e\u5c02\u9580\u5bb6\u30c1\u30fc\u30e0\u306f\u6bce\u65e5NMPA\u3068\u63a5\u89e6\u3057\u3001\u696d\u52d9\u63d0\u643a\u3084\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306e\u66f8\u985e\u7533\u8acb\u306e\u5354\u529b\u4f5c\u696d\u3092\u884c\u3044\u3001NMPA\u306e\u8cc7\u6599\u88dc\u8db3\u7b49\u306e\u6307\u6458\u306b\u5bfe\u5fdc\u3057\u307e\u3059\u3002\u6211\u3005\u306e\u7d4c\u9a13\u3068\u5c02\u9580\u77e5\u8b58\u3092\u901a\u3058\u3066\u3001\u8cb4\u793e\u306e\u533b\u7642\u6a5f\u5668\u6216\u3044\u306fIVD\u304c\u65e9\u304f\u4e2d\u56fd\u76e3\u7763\u7ba1\u7406\u5f53\u5c40\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306b\u3001\u3054\u5354\u529b\u3001\u3054\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u308b\u3068\u5b58\u3058\u307e\u3059\u3002\u4e2d\u56fd\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u3068\u88fd\u54c1\u767b\u9332\u306e\u65b9\u6cd5\u3092\u66f4\u306b\u8a73\u3057\u304f\u77e5\u308a\u305f\u3044\u5834\u5408\u3001\u968f\u6642\u3054\u9023\u7d61\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
          \u767b\u9332\u5be9\u67fb\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0<\/span><\/strong><\/span><\/p>\n

          (\u56fd\u7523\uff0f\u8f38\u5165\uff09<\/span><\/strong><\/span><\/td>\n

          		\u6280\u8853\u30c7\u30b6\u30a4\u30f3\u6bb5\u968e<\/span><\/strong><\/span><\/td>\n\u88fd\u54c1\u30c7\u30b6\u30a4\u30f3\u958b\u767a\u306f\u6cd5\u898f\u5236\u3078\u306e\u9069\u5408\u6027\u306e\u30b3\u30f3\u30b5\u30bf\u30f3\u30c8<\/span><\/td>\n<\/tr>\n
          \u88fd\u54c1\u5b9f\u7528\u6027\u306e\u5206\u6790<\/span><\/td>\n<\/tr>\n
          \u88fd\u54c1\u767b\u9332\u7533\u8acb\/\u5be9\u67fb\u6bb5\u968e<\/span><\/strong><\/span><\/td>\n\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\u5b9a\u7fa9<\/span><\/td>\n<\/tr>\n
          \u88fd\u54c1\u6280\u8853\u8981\u6c42\u7de8\u6210\u306e\u6307\u5c0e<\/span><\/td>\n<\/tr>\n
          \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3084\u30a4\u30f3\u30bf\u30cd\u30c3\u30c8\u5b89\u5168\u30d5\u30a1\u30a4\u30eb\u306e\u7de8\u6210\u306e\u6307\u5c0e<\/span><\/td>\n<\/tr>\n
          \u88fd\u54c1\u8cea\u91cf\u7ba1\u7406\u4f53\u7cfb\u7de8\u6210\u306e\u6307\u5c0e<\/span><\/td>\n<\/tr>\n
          \u88fd\u54c1\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/span><\/td>\n<\/tr>\n
          \u88fd\u54c1\u767b\u9332\/\u5be9\u67fb\u7533\u8acb\u904e\u7a0b\u306b\u304a\u3051\u308b\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u30b5\u30fc\u30d3\u30b9\uff08\u521d\u56de\/\u5ef6\u9577\/\u5909\u66f4\u306a\u3069\uff09<\/span><\/td>\n<\/tr>\n
          \u88fd\u54c1\u767b\u9332\u95a2\u9023\u306e\u8a66\u9a13\u5b9f\u65bd\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/span><\/td>\n<\/tr>\n
          \u9769\u65b0\u6280\u8853\u533b\u7642\u6a5f\u5668\u306e\u7533\u8acb\u554f\u3044\u5408\u308f\u305b<\/span><\/td>\n<\/tr>\n
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          \u30ed\u30fc\u30f3\u30c1\u5f8c\u76e3\u7763\u7ba1\u7406\u6bb5\u968e<\/span><\/strong><\/span><\/td>\n\u533b\u7642\u6a5f\u5668\u306e\u751f\u7523\u8a31\u53ef\u306e\u7533\u8acb\u554f\u3044\u5408\u308f\u305b<\/span><\/td>\n<\/tr>\n
          \u533b\u7642\u6a5f\u5668\u7d4c\u55b6\u8a31\u53ef\u306e\u7533\u8acb\u554f\u3044\u5408\u308f\u305b<\/span><\/td>\n<\/tr>\n
          \u56fd\u5916\u4f01\u696d\u4ee3\u7406\u6cd5\u4eba\u53ca\u3073\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u30b5\u30fc\u30d3\u30b9<\/span><\/td>\n<\/tr>\n
          \u4e0a\u5834\u8a31\u53ef\u6240\u6709\u8005\u554f\u3044\u5408\u308f\u305b<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

          NMPA\u533b\u7642\u6a5f\u5668\u767b\u9332\u7533\u8acb\u30d7\u30ed\u30bb\u30b9<\/span><\/strong><\/span><\/h2>\n

          \"\u533b\u7642\u6a5f\u5668\u3068IVD\"<\/span><\/p>\n

           <\/p>","protected":false},"excerpt":{"rendered":"

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