{"id":1082,"date":"2024-07-22T17:28:46","date_gmt":"2024-07-22T09:28:46","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=1082"},"modified":"2024-07-22T17:30:20","modified_gmt":"2024-07-22T09:30:20","slug":"nmpa-requirements-for-post-market-surveillancepms-of-medical-devices","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/ja\/nmpa-requirements-for-post-market-surveillancepms-of-medical-devices\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u306b\u95a2\u3059\u308bNMPA\u306e\u8981\u6c42\u4e8b\u9805"},"content":{"rendered":"

\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u306b\u95a2\u3059\u308bNMPA\u306e\u8981\u6c42\u4e8b\u9805<\/span><\/strong><\/p>\n

\u533b\u7642\u6a5f\u5668\u306f\u3001\u76f4\u63a5\u30fb\u9593\u63a5\u3092\u554f\u308f\u305a\u4eba\u4f53\u306b\u4f7f\u7528\u3055\u308c\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u4eba\u306e\u5065\u5eb7\u3068\u5bc6\u63a5\u306a\u95a2\u4fc2\u304c\u3042\u308b\u3002\u4e2d\u56fd\u3067\u306f\u3001PMS\uff08Post-Market Surveillance\uff09\u304c\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u898f\u5236\u306e\u91cd\u8981\u306a\u4e00\u90e8\u3067\u3042\u308a\u3001NMPA\uff08(\u533b\u85ac\u54c1\u7ba1\u7406\u5c40<\/a>).\u4eba\u3005\u306e\u5065\u5eb7\u3092\u5b88\u308b\u305f\u3081\u306b\u3001\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3092\u3044\u304b\u306b\u52b9\u679c\u7684\u306b\u884c\u3046\u304b\u304c\u6ce8\u76ee\u3055\u308c\u3066\u3044\u308b\u3002\u4e2d\u56fd\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\u306e\u4e00\u90e8\u3092\u307e\u3068\u3081\u305f\u3002<\/span><\/p>\n

GB\/T 42061-2022\u306b\u3088\u308b \u533b\u7642\u6a5f\u5668\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0 \u898f\u5236\u8981\u4ef6\u7528<\/a>\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306f\u3001\u5e02\u8ca9\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u304b\u3089\u5f97\u3089\u308c\u305f\u7d4c\u9a13\u3092\u53ce\u96c6\u30fb\u5206\u6790\u3059\u308b\u4f53\u7cfb\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3002<\/span><\/p>\n

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 <\/p>\n

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    \n
  1. \n
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    6. \u5916\u90e8\u7d44\u7e54\u304b\u3089\u901a\u77e5\u3055\u308c\u305f\u6709\u5bb3\u4e8b\u8c61\u3001\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u307e\u305f\u306f\u30ea\u30b3\u30fc\u30eb\u3002<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

      \u2461 <\/b><\/strong>\u60c5\u5831\u306e\u52b9\u679c\u7684\u306a\u8a55\u4fa1<\/span><\/h2>\n

      \u533b\u7642\u6a5f\u5668\u767b\u9332\u7533\u8acb\u8005\u306f\u3001\u4e88\u9632\u53ca\u3073\u662f\u6b63\u51e6\u7f6e\u306e\u4e3b\u306a\u76ee\u7684\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u3001\u9069\u5207\u306a\u54c1\u8cea\u30c4\u30fc\u30eb\uff085Why\u3001\u30d5\u30a3\u30c3\u30b7\u30e5\u30dc\u30fc\u30f3\u30c0\u30a4\u30a2\u30b0\u30e9\u30e0\u3001\u30d5\u30a9\u30fc\u30eb\u30c8\u30c4\u30ea\u30fc\u7b49\uff09\u3092\u7528\u3044\u3066\u3001\u53ce\u96c6\u3055\u308c\u305f\u60c5\u5831\u306e\u30ec\u30d3\u30e5\u30fc\u53ca\u3073\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u7d44\u7e54\u3059\u308b\u8981\u54e1\u3092\u6307\u540d\u3057\u3001\u6839\u672c\u539f\u56e0\u3092\u767a\u898b\u3059\u308b\u305f\u3081\u306e\u8abf\u67fb\u53ca\u3073\u554f\u984c\u5206\u6790\u3092\u5b9f\u65bd\u3057\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u9023\u3059\u308b\u30cf\u30b6\u30fc\u30c9\u53ca\u3073\u5371\u967a\u306a\u72b6\u614b\u3092\u5b8c\u5168\u304b\u3064\u52b9\u679c\u7684\u306b\u7279\u5b9a\u3057\u3001\u4ee5\u4e0b\u306e\u72b6\u614b\u306e\u5b58\u5728\u3092\u8a55\u4fa1\u3059\u308b\uff1a<\/span><\/p>\n

        \n
      1. \n
          \n
        1. \u6709\u5bb3\u4e8b\u8c61\u306e\u6709\u7121\u3092\u8a55\u4fa1\u3059\u308b\u3002\u3059\u306a\u308f\u3061\u3001\u901a\u5e38\u306e\u4f7f\u7528\u4e0b\u3067\u767a\u751f\u3057\u3001\u4eba\u4f53\u3078\u306e\u50b7\u5bb3\u306b\u3064\u306a\u304c\u308b\u3001\u307e\u305f\u306f\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u3001\u3042\u3089\u3086\u308b\u7a2e\u985e\u306e\u6709\u5bb3\u4e8b\u8c61\u3092\u8a55\u4fa1\u3059\u308b\u3002<\/span><\/li>\n
        2. \u53ce\u96c6\u3055\u308c\u305f\u975e\u91cd\u7be4\u306a\u4e8b\u8c61\u307e\u305f\u306f\u4e88\u60f3\u3055\u308c\u308b\u526f\u4f5c\u7528\u4e8b\u8c61\u306e\u983b\u5ea6\u307e\u305f\u306f\u91cd\u7be4\u5ea6\u306b\u7d71\u8a08\u5b66\u7684\u306b\u6709\u610f\u306a\u5897\u52a0\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u5206\u6790\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u5206\u6790\u306b\u91cd\u5927\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u306e\u3042\u308b\u50be\u5411\u5831\u544a\u306e\u6709\u7121\u3092\u8a55\u4fa1\u3059\u308b\u3002<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

          \u65bd\u7b56\u306e\u78ba\u5b9f\u306a\u5b9f\u65bd<\/span><\/h2>\n

          \u7279\u5b9a\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u30ea\u30b9\u30af\u306e\u8abf\u67fb\u3001\u5206\u6790\u3001\u8a55\u4fa1\u3092\u901a\u3058\u3066\u3001\u4f01\u696d\u306f\u5408\u7406\u7684\u304b\u3064\u5fc5\u8981\u306a\u7ba1\u7406\u63aa\u7f6e\u3092\u8b1b\u3058\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u63aa\u7f6e\u3092\u8b1b\u3058\u308b\u969b\u306b\u306f\u3001\u4f01\u696d\u304c\u8003\u616e\u3059\u308b\u3053\u3068\u304c\u9069\u5207\u3067\u3042\u308b\uff1a<\/span><\/p>\n

            \n
          1. \n
              \n
            1. \u914d\u5e03\u3055\u308c\u305f\u3082\u306e\uff08\u3059\u306a\u308f\u3061\u3001\u4f01\u696d\u306e\u7ba1\u7406\u304c\u53ca\u3070\u306a\u3044\u3082\u306e\uff09\u306b\u3064\u3044\u3066\u306f\u3001\u4fee\u6b63\u307e\u305f\u306f\u524a\u9664\uff08\u30ea\u30b3\u30fc\u30eb\u3001\u52e7\u544a\u901a\u77e5\u306a\u3069\uff09\u304c\u5fc5\u8981\u304b\u3069\u3046\u304b\u3092\u691c\u8a0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\uff1b<\/span><\/li>\n
            2. \u88fd\u9020\u306f\u3055\u308c\u3066\u3044\u308b\u304c\u6d41\u901a\u306f\u3057\u3066\u3044\u306a\u3044\uff08\u3064\u307e\u308a\u307e\u3060\u4e8b\u696d\u8005\u306e\u7ba1\u7406\u4e0b\u306b\u3042\u308b\uff09\u3082\u306e\u306f\u3001\u751f\u7523\u3068\u51fa\u8377\u3092\u505c\u6b62\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u691c\u8a0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\uff1b<\/span><\/li>\n
            3. \u4eca\u5f8c\u88fd\u9020\u3055\u308c\u308b\u3082\u306e\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3068\u95a2\u9023\u3059\u308b\u88fd\u9020\u5de5\u7a0b\u3092\u6539\u5584\u3059\u308b\u5fc5\u8981\u6027\u3092\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

               <\/p>\n

              \u898f\u5236\u5f53\u5c40\u3068\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u5f37\u5316<\/b><\/strong><\/span><\/h1>\n

              \u533b\u7642\u6a5f\u5668\u4f1a\u793e\u306f\u3001\u8a72\u5f53\u3059\u308b\u898f\u5236\u8981\u4ef6\u306b\u5f93\u3044\u3001\u9069\u5408\u3057\u305f\u6709\u5bb3\u4e8b\u8c61\u307e\u305f\u306f\u50be\u5411\u5831\u544a\u3092\u95a2\u9023\u898f\u5236\u6a5f\u95a2\u306b\u9069\u6642\u306b\u6b63\u76f4\u306b\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u540c\u6642\u306b\u3001\u533b\u7642\u6a5f\u5668\u4f01\u696d\u306f\u3001\u898f\u5236\u5f53\u5c40\u304b\u3089\u516c\u8868\u3055\u308c\u305f\u5916\u90e8\u6709\u5bb3\u4e8b\u8c61\u60c5\u5831\u3092\u9069\u6642\u306b\u5165\u624b\u3057\u3001\u95a2\u9023\u8981\u54e1\u3092\u7d44\u7e54\u3057\u3066\u8abf\u67fb\u30fb\u5206\u6790\u3092\u884c\u3044\u3001\u8a55\u4fa1\u7d50\u679c\u3092\u898f\u5236\u5f53\u5c40\u306b\u9069\u6642\u306b\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3057\u3066\u3001\u60c5\u5831\u306e\u53cc\u65b9\u5411\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u308b\u3002<\/span><\/p>\n

              \u5e02\u8ca9\u5f8c\u8abf\u67fb\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u5b89\u5168\u304b\u3064\u52b9\u679c\u7684\u306b\u4f5c\u52d5\u3057\u7d9a\u3051\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3001\u307e\u305f\u3001\u533b\u7642\u6a5f\u5668\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u306b\u3088\u308b\u30ea\u30b9\u30af\u304c\u3001\u533b\u7642\u6a5f\u5668\u304c\u63d0\u4f9b\u3059\u308b\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3092\u4e0a\u56de\u3089\u306a\u3044\u3088\u3046\u306b\u3059\u308b\u305f\u3081\u306e\u3082\u306e\u3067\u3042\u308b\u3002\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306f\u3001\u81ea\u8b66\u30b7\u30b9\u30c6\u30e0\u3001\u7d4c\u6e08\u4e8b\u696d\u8005\u3001\u6a5f\u5668\u767b\u9332\u3068\u3068\u3082\u306b\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u8981\u4ef6\u306e\u91cd\u8981\u306a\u4e00\u90e8\u3067\u3042\u308b\u3002<\/span><\/p>\n

               <\/p>\n

              HMK\u306f\u3001\u56fd\u5185\u5916\u306e\u591a\u304f\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3084\u4f53\u5916\u8a3a\u65ad\u85ac\u30e1\u30fc\u30ab\u30fc\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u3092\u5b8c\u4e86\u3057\u3066\u304d\u307e\u3057\u305f\u3002<\/span><\/p>\n

              \u79c1\u305f\u3061\u306f\u4ee5\u4e0b\u306e\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\uff1a<\/span><\/p>\n

              \u5e02\u8ca9\u5f8c\u898f\u5236<\/span><\/p>\n

              \u5e02\u8ca9\u5f8c\u6027\u80fd\/\u81e8\u5e8a\u8a66\u9a13\u8ffd\u8de1\u30d7\u30ed\u30b0\u30e9\u30e0 PMPFPMCF\u8a08\u753b<\/span><\/p>\n

              \u5b9a\u671f\u30ea\u30b9\u30af\u8a55\u4fa1\u5831\u544a\u66f8<\/span><\/a><\/p>\n

              \u6709\u5bb3\u4e8b\u8c61\u5831\u544a<\/span><\/p>\n

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

              NMPA Requirements for Post-Market Surveillance(PMS) of Medical Devices Medical devices, whether directly or indirectly used in human body, are closely related to human health. In China, Post-Market Surveillance (PMS) is an important part of medical device safety and efficacy regulation, which is supervised by NMPA ((National Medical Products Administration). It has become a focus of attention how to effectively conduct post-market surveillance of medical devices to protect people’s health. We summarize some of the requirements for post-market surveillance of medical devices in China. According to GB\/T 42061-2022 Quality Management System for Medical Devices For Regulatory Requirements, post-market surveillance is a systematic process of collecting and analyzing the experience gained from […]<\/p>","protected":false},"author":4,"featured_media":1083,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[1,200],"tags":[204,607,608,609,610,611,612,613,614,615],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/1082"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/comments?post=1082"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/1082\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media\/1083"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media?parent=1082"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/categories?post=1082"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/tags?post=1082"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}