{"id":700,"date":"2024-01-04T13:40:43","date_gmt":"2024-01-04T05:40:43","guid":{"rendered":"https:\/\/consulting-hmk.com\/?post_type=products&p=700"},"modified":"2024-02-20T14:55:41","modified_gmt":"2024-02-20T06:55:41","slug":"periodic-risk-assessment-report-of-medical-devices","status":"publish","type":"products","link":"https:\/\/www.consulting-hmk.com\/ja\/products\/periodic-risk-assessment-report-of-medical-devices\/","title":{"rendered":"NMPA\u533b\u7642\u6a5f\u5668\u306e\u5b9a\u671f\u30ea\u30b9\u30af\u8a55\u4fa1\u5831\u544a\u30b5\u30fc\u30d3\u30b9"},"content":{"rendered":"

\u00a0 \u00a0 \u00a0 2018\u5e748\u670831\u65e5\u3001\u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\u516c\u5f0f\u30b5\u30a4\u30c8\u304c\u300c\u533b\u7642\u6a5f\u5668\u4e0d\u826f\u4e8b\u4ef6\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3068\u518d\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u7ba1\u7406\u65b9\u6cd5\u300d\uff08\u56fd\u5bb6\u5e02\u5834\u76e3\u7763\u7ba1\u7406\u7dcf\u5c40\u4ee4\u7b2c1\u53f7\uff09\uff08\u4ee5\u4e0b\u300c\u65b9\u6cd5\u300d\u3068\u7565\u3059\u308b\uff09\u3092\u516c\u8868\u3057\u307e\u3057\u305f\u3002\u533b\u7642\u6a5f\u5668\u767b\u9332\u8005\u306b\u5bfe\u3057\u3001\u30ed\u30fc\u30f3\u30c1\u5f8c\u306e\u533b\u7642\u6a5f\u5668\u306e\u5b9a\u671f\u7684\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u4f5c\u6210\u7b49\u3001\u4e00\u9023\u306e\u65b0\u305f\u306a\u696d\u52d9\u8981\u6c42\u3092\u63d0\u793a\u3057\u307e\u3057\u305f\u3002\u300c\u65b9\u6cd5\u300d\u7b2c2\u7ae0\u7b2c14\u6761\u306e\u300c\u6240\u6709\u8005\u306e\u4e3b\u306a\u7fa9\u52d9\u300d\u306b\u3088\u308b\u3068\u3001\u6240\u6709\u8005\u306f\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u3001\u4eba\u54e1\u3068\u6a5f\u95a2\u306e\u914d\u7f6e\u3001\u4e0d\u826f\u4e8b\u4ef6\u306e\u5831\u544a\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u60c5\u5831\u516c\u958b\u3001\u5b9a\u671f\u7684\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u4f5c\u6210\u3001\u518d\u8a55\u4fa1\u3001\u8abf\u67fb\u3078\u306e\u5354\u529b\u3092\u3059\u3079\u304d\u3067\u3059\u3002\u4e0d\u826f\u4e8b\u4ef6\u304c\u8d77\u304d\u3066\u306a\u304f\u3066\u3082\u3001\u5b9a\u671f\u306b\u30ea\u30b9\u30af\u8a55\u4fa1\u5831\u544a\u66f8\u3092\u671f\u9650\u5185\u306b\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4e0d\u826f\u4e8b\u4ef6\u5831\u544a\u306f\u3001\u5b9a\u671f\u7684\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u4e00\u90e8\u3067\u3042\u308a\u3001\u5168\u3066\u306e\u5185\u5bb9\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u8cc7\u6599\u306f\u3001\u56fd\u5185\u5916\u30ea\u30b9\u30af\u60c5\u5831\u306e\u8981\u7d04\u3068\u5206\u6790\u3067\u3059\u3002\u5f0a\u793e\u306f\u3053\u306e\u5831\u544a\u66f8\u4f5c\u6210\u306e\u304a\u624b\u4f1d\u3044\u3092\u3044\u305f\u3057\u307e\u3059\u3002<\/span><\/p>\n

\u4e3b\u306a\u8981\u6c42<\/span><\/strong><\/h2>\n
    \n
  1. \n

    \u5b9a\u671f\u7684\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u4f5c\u6210\u671f\u9593\uff1a<\/span><\/h3>\n
      \n
    • \u521d\u56de\u767b\u9332\u307e\u305f\u306f\u5c4a\u3051\u51fa\u7533\u8acb\u5f8c\u306f\u3001\u5e74\u306b1\u56de\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1b<\/span><\/li>\n
    • \u767b\u9332\u5ef6\u671f\u5f8c\u306f\u3001\u7d045\u5e74\u3054\u3068\u306b1\u56de\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/li>\n<\/ul>\n<\/li>\n
    • \n

      \u5831\u544a\u66f8\u306e\u671f\u9593\u5185\u306b\u304a\u3051\u308b\u5b89\u5168\u60c5\u5831\u306e\u8981\u6c42 <\/span><\/h3>\n

      \u9023\u7d9a\u3067\u6f0f\u308c\u304c\u306a\u304f\u4e14\u3064\u91cd\u8907\u3057\u307e\u305b\u3093\u3002<\/span><\/li>\n

    • \n

      \u8a55\u4fa1\u5185\u5bb9\u306e\u8981\u6c42<\/span><\/h3>\n
        \n
      • \u30ea\u30b9\u30af\u60c5\u5831\u306e\u5206\u6790\uff1b<\/span><\/li>\n
      • \u4e0d\u826f\u6642\u9593\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u60c5\u5831\u306e\u5206\u6790\uff1b<\/span><\/li>\n
      • \u305d\u306e\u4ed6\u306e\u30ea\u30b9\u30af\u60c5\u5831\u306e\u307e\u3068\u3081\uff1b<\/span><\/li>\n
      • \u30ed\u30fc\u30f3\u30c1\u5f8c\u306e\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\uff1a\u30ea\u30b9\u30af\u306e\u5909\u5316\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3001\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u304b\u3069\u3046\u304b\u3002<\/span><\/li>\n<\/ul>\n<\/li>\n
      • \n

        \u5831\u544a\u66f8\u306b\u5bfe\u3059\u308b\u5168\u4f53\u8981\u6c42<\/span><\/h3>\n
          \n
        • \u5b8c\u5099\u5316\u3001\u6a19\u6e96\u5316\uff1b<\/span><\/li>\n
        • \u8ad6\u7406\u7684\u306a\u69cb\u9020\uff08\u5e8f\u8ad6\u3001\u30c7\u30fc\u30bf\u3001\u5206\u6790\u3001\u7d50\u8ad6\uff09\uff1b<\/span><\/li>\n
        • \u8b58\u5225\u53ef\u80fd\uff08\u65e5\u4ed8\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u3001\u767b\u9332\u8005\u3068\u9023\u7d61\u5148\u306a\u3069\uff09\u3002<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ol>\n

          \u4f5c\u696d\u671f\u9650<\/span><\/strong><\/h2>\n
            \n
          • \u30c7\u30fc\u30bf\u96c6\u8a08\u671f\u9593\u306f\u767b\u9332\u8a3c\u66f8\u306e\u6642\u671f\u3068\u4e00\u81f4\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u88fd\u54c1\u306e\u627f\u8a8d\u53d6\u5f97\u304c2018\u5e748\u670810\u65e5\u3067\u30012019\u5e74\u306b\u63d0\u51fa\u306e\u5fc5\u8981\u306a\u5b9a\u671f\u30ea\u30b9\u30af\u30a2\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u30c7\u30fc\u30bf\u96c6\u8a08\u671f\u9593\u306f2018\u5e748\u670810\u65e5\u304b\u30892019\u5e748\u67089\u65e5\u307e\u3067\u3068\u306a\u308a\u307e\u3059\u3002<\/span><\/li>\n
          • \u4e8b\u524d\u767b\u9332\u5ef6\u9577\u3092\u3057\u305f\u88fd\u54c1\u306e\u5f53\u671f\u5831\u544a\u66f8\u306e\u30c7\u30fc\u30bf\u96c6\u8a08\u671f\u9593\u306f\u3001\u5f93\u6765\u521d\u56de\u767b\u9332\u671f\u9593\u306b\u57fa\u3065\u304d\u8a08\u7b97\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u3042\u308b\u88fd\u54c1\u306e\u767b\u9332\u8a3c\u66f8\u306e\u6709\u52b9\u671f\u9650\u304c2020\u5e748\u670830\u65e5\u3067\u30012020\u5e745\u6708\u306b\u767b\u9332\u8a3c\u306e\u66f4\u65b0\u3092\u53d6\u5f97\u3057\u305f\u5834\u5408\u3001\u8a72\u5f53\u88fd\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u5f53\u671f\u30ec\u30dd\u30fc\u30c8\u3067\u3082\u96c6\u8a08\u671f\u9593\u306e\u7d42\u4e86\u65e5\u3068\u3057\u30662020\u5e748\u670830\u65e5\u304c\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002<\/span><\/li>\n<\/ul>\n

            \u6ce8\u610f\u4e8b\u9805<\/span><\/strong><\/h2>\n
              \n
            • \u521d\u3081\u3066\u767b\u9332\u3059\u308b\u7b2c\u4e8c\u985e\u3001\u7b2c\u4e09\u985e\u306e\u88fd\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u8cc7\u6599\u3092\u63d0\u51fa\u3057\u305f\u5f8c\u3001\u5be9\u67fb\u6a5f\u95a2\u306e\u9055\u3044\u306b\u3088\u308a\u3001\u56fd\u5bb6\u533b\u7642\u76e3\u7763\u7ba1\u7406\u5c40\u6216\u3044\u306f\u7701\u30ec\u30d9\u30eb\u533b\u7642\u76e3\u7763\u7ba1\u7406\u5c40\u304c\u5be9\u67fb\u3092\u884c\u3044\u3001\u5be9\u67fb\u7d50\u679c\u306f\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u691c\u7d22\u3067\u304d\u307e\u3059\uff1b <\/span><\/li>\n
            • \u5ef6\u671f\u3068\u5c4a\u3051\u51fa\u3092\u5ef6\u671f\u3059\u308b\u88fd\u54c1\u306b\u3064\u3044\u3066\u3001\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u5b9a\u671f\u30ea\u30b9\u30af\u8a55\u4fa1\u5831\u544a\u306e\u63d0\u51fa\u304c\u5fc5\u8981\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u4f5c\u6210\u5f8c\u4fdd\u7ba1\u3057\u3001\u691c\u67fb\u306b\u5099\u3048\u308c\u3070\u3044\u3044\u3067\u3059\u3002\u540c\u6642\u30e2\u30cb\u30bf\u30fc\u8cc7\u6599\u306e\u57fa\u6e96\u5316\u306b\u3082\u5165\u308c\u3066\u4fdd\u7ba1\u3057\u307e\u3059\u3002<\/span><\/li>\n<\/ul>\n

              \u00a0 \u00a0 \u00a0 \u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306e\u4e0d\u826f\u4e8b\u4ef6\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u901a\u3058\u3001\u5b9a\u671f\u7684\u306b\u88fd\u54c1\u306e\u30ea\u30b9\u30af\u3092\u5206\u6790\u3059\u308b\u306e\u304c\u88fd\u54c1\u5b89\u5168\u4fdd\u969c\u306e\u91cd\u8981\u306a\u30eb\u30fc\u30c8\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u63d0\u8d77\u30ea\u30b9\u30af\u8a55\u4fa1\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3059\u308b\u969b\u306b\u767b\u9332\u8005\u304c\u30ea\u30b9\u30af\u8b58\u5225\u3068\u539f\u56e0\u5206\u6790\u306e\u4e8c\u3064\u306e\u65b9\u9762\u304b\u3089\u30ea\u30b9\u30af\u3092\u5206\u6790\u3057\u3001\u5b89\u5168\u6027\u3078\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3057\u307e\u3059\u3002\u8b58\u5225\u30ea\u30b9\u30af\u304c\u4ee5\u4e0b\u306e\u5185\u5bb9\u3092\u542b\u307f\u307e\u3059\u3002<\/span><\/p>\n

                \n
              • \u4e0d\u826f\u4e8b\u4ef6\u306e\u7279\u5fb4\u3001\u983b\u5ea6\u3001\u50b7\u5bb3\u306e\u53b3\u91cd\u5ea6\u7b49\u306e\u5206\u6790\uff1b<\/span><\/li>\n
              • \u539f\u56e0\u5206\u6790\u3067\u306f\u3001\u8a2d\u8a08\u3001\u751f\u7523\u7ba1\u7406\u3001\u6d41\u901a\u3068\u4fdd\u7ba1\u3001\u4f7f\u7528\u8981\u7d20\u7b49\u306e\u65b9\u9762\u3092\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/span><\/li>\n<\/ul>\n
                  <\/ol>\n
                    <\/ol>\n

                    \u00a0 \u00a0 \u00a0 \u672c\u6587\u306e\u7d50\u8ad6\u90e8\u5206\u3067\u306f\u3001\u767b\u9332\u8005\u306f\u6b21\u306e\u3088\u3046\u306b\u793a\u3059\u3079\u304d\u3067\u3059\uff1a<\/span><\/p>\n

                      \n
                    1. \u5f53\u671f\u5831\u544a\u66f8\u3068\u904e\u53bb\u306e\u5831\u544a\u66f8\u306e\u30ea\u30b9\u30af\u5206\u6790\u7d50\u679c\u306e\u76f8\u9055\u3092\u793a\u3057\u307e\u3059\uff1b<\/span><\/li>\n
                    2. \u4e0a\u8a18\u306e\u30ea\u30b9\u30af\u5dee\u7570\u306e\u8a31\u5bb9\u7bc4\u56f2\u3092\u793a\u3057\u307e\u3059\uff1b<\/span><\/li>\n
                    3. \u5b9f\u65bd\u3057\u305f\u30ea\u30b9\u30af\u7ba1\u7406\u63aa\u7f6e\u3092\u307e\u3068\u3081\u307e\u3059\u3002<\/span><\/li>\n<\/ol>\n

                      \u3088\u304f\u3042\u308b\u8cea\u554f<\/span><\/strong><\/h2>\n

                      Q1\uff1a\u521d\u56de\u767b\u9332\u671f\u9593\u4e2d\u306e\u88fd\u54c1\u3067\u3001\u8ca9\u58f2\u6d3b\u52d5\u3092\u884c\u3063\u305f\u5f8c\u306b\u751f\u7523\u30fb\u8ca9\u58f2\u3092\u4e2d\u6b62\u3057\u305f\u5834\u5408\u3001\u30ea\u30b9\u30af\u5831\u544a\u66f8\u306e\u5b9a\u671f\u63d0\u51fa\u3092\u7d99\u7d9a\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u3059\u304b\uff1f<\/span><\/strong><\/p>\n

                      A1\uff1a\u306f\u3044\u3001\u5fc5\u8981\u3067\u3059\u3002\u751f\u7523\u30fb\u8ca9\u58f2\u304c\u4e2d\u6b62\u3055\u308c\u3066\u3044\u3066\u3082\u3001\u5e02\u5834\u306b\u6d41\u901a\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u88fd\u54c1\u306e\u30ea\u30b9\u30af\u3092\u78ba\u5b9f\u306b\u7ba1\u7406\u3059\u308b\u305f\u3081\u306b\u3001\u5b9a\u671f\u7684\u306b\u30ea\u30b9\u30af\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n

                      Q2\uff1a\u767b\u9332\u8a3c\u66f8\u53d6\u5f97\u5f8c\u3001\u4e00\u5ea6\u3082\u30ed\u30fc\u30f3\u30c1\u3055\u308c\u3066\u3044\u306a\u3044\u88fd\u54c1\u306b\u3064\u3044\u3066\u3001\u5b9a\u671f\u7684\u306b\u30ea\u30b9\u30af\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u3059\u304b\uff1f<\/span><\/strong><\/p>\n

                      A2\uff1a\u306f\u3044\u3001\u5fc5\u8981\u3067\u3059\u3002\u5b9a\u671f\u30ea\u30b9\u30af\u5831\u544a\u66f8\u3092\u30b7\u30b9\u30c6\u30e0\u5185\u3067\u63d0\u51fa\u3059\u308b\u5834\u5408\u3001\u5831\u544a\u66f8\u672c\u6587\u306b\u7c21\u5358\u306a\u8aac\u660e\u3092\u8a18\u8f09\u3059\u308b\u304b\u3001\u5831\u544a\u66f8\u672c\u6587\u306e\u4ee3\u308f\u308a\u306b\u300c\u3053\u306e\u88fd\u54c1\u306f\u56fd\u5185\u5916\u306b\u304a\u3044\u3066\u767a\u58f2\u3055\u308c\u3066\u3044\u306a\u3044\u300d\u65e8\u3092\u8a18\u8f09\u3059\u308b\u8aac\u660e\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n

                      Q3\uff1a\u7dca\u6025\u767b\u9332\u88fd\u54c1\u306f\u3001\u5b9a\u671f\u7684\u306b\u30ea\u30b9\u30af\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/span><\/strong><\/p>\n

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