{"id":19200,"date":"2026-01-02T15:52:37","date_gmt":"2026-01-02T07:52:37","guid":{"rendered":"https:\/\/greenoo.tw\/?p=19200"},"modified":"2026-01-02T15:52:37","modified_gmt":"2026-01-02T07:52:37","slug":"fda-medical-device-classification-class-i-ii-iii-differences-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/fda-medical-device-classification-class-i-ii-iii-differences-2026\/","title":{"rendered":"FDA \u91ab\u7642\u5668\u68b0\u5206\u985e\u8207\u6cd5\u898f\u5236\u5ea6\u5b8c\u6574\u89e3\u6790\uff1aClass I\/II\/III \u5dee\u5728\u54ea\uff1f\uff082026 \u6700\u65b0\uff09"},"content":{"rendered":"

\"FDA<\/h2>\n

<\/h2>\n

FDA \u91ab\u7642\u5668\u68b0\u5982\u4f55\u5206\u985e\uff1fClass I\/II\/III \u7684\u6838\u5fc3\u5dee\u7570<\/h2>\n

FDA \u5c07\u6240\u6709\u91ab\u7642\u5668\u68b0\u4f9d\u300c\u98a8\u96aa\u7b49\u7d1a\u300d\u5206\u70ba Class I\uff08\u4f4e\u98a8\u96aa\uff09\u3001Class II\uff08\u4e2d\u98a8\u96aa\uff09\u3001Class III\uff08\u9ad8\u98a8\u96aa\uff09\u4e09\u985e<\/strong>\uff0c\u9019\u5957\u5206\u985e\u5236\u5ea6\u76f4\u63a5\u6c7a\u5b9a\u7522\u54c1\u9700\u8981\u7684\u5be9\u67e5\u9014\u5f91\u3001\u4e0a\u5e02\u6642\u7a0b\u8207\u5408\u898f\u6210\u672c\u3002\u5c0d\u53f0\u7063\u91ab\u6750\u5ee0\u8207 ODM\/OEM \u4ee3\u5de5\u5ee0\u800c\u8a00\uff0c\u6b63\u78ba\u5224\u5b9a\u7522\u54c1\u5206\u985e\u662f\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u7b2c\u4e00\u6b65\uff0c\u5206\u985e\u932f\u8aa4\u53ef\u80fd\u5c0e\u81f4\u7533\u5831\u9014\u5f91\u932f\u8aa4\u3001\u5be9\u67e5\u5ef6\u9072\u751a\u81f3\u7522\u54c1\u88ab FDA \u6263\u7559\u3002<\/p>\n

\u5206\u985e\u4e3b\u8981\u57fa\u65bc\u5169\u500b\u6838\u5fc3\u5224\u5b9a\u6a19\u6e96\uff1a\u7522\u54c1\u9810\u671f\u7528\u9014\uff08Intended Use\uff09\u8207\u98a8\u96aa\u7b49\u7d1a\uff08Risk Level\uff09<\/strong>\u3002Intended Use \u5305\u542b\u7522\u54c1\u8a2d\u8a08\u76ee\u7684\u3001\u6a19\u793a\u5ba3\u7a31\u3001\u4f7f\u7528\u8aaa\u660e\u7b49\uff0c\u98a8\u96aa\u7b49\u7d1a\u5247\u8a55\u4f30\u7522\u54c1\u5c0d\u4eba\u9ad4\u7684\u6f5b\u5728\u5371\u5bb3\u7a0b\u5ea6\u3002\u8209\u4f8b\u4f86\u8aaa\uff0c\u540c\u6a23\u662f\u8840\u58d3\u8a08\uff0c\u5bb6\u7528\u578b\uff08\u975e\u4fb5\u5165\u6027\u3001\u4f4e\u98a8\u96aa\uff09\u901a\u5e38\u70ba Class II\uff0c\u4f46\u690d\u5165\u5f0f\u9023\u7e8c\u76e3\u6e2c\u88dd\u7f6e\uff08\u4fb5\u5165\u6027\u3001\u9ad8\u98a8\u96aa\uff09\u53ef\u80fd\u88ab\u6b78\u70ba Class III\u3002<\/p>\n

\u672c\u6587\u5c07\u5b8c\u6574\u89e3\u6790\u4e09\u7d1a\u5206\u985e\u7684\u5dee\u7570\u3001\u5be9\u67e5\u9014\u5f91\u9078\u64c7\u3001\u5e38\u898b\u8aa4\u5340\u8207\u53f0\u7063\u696d\u8005\u6700\u9700\u6ce8\u610f\u7684\u5408\u898f\u7d05\u7dda\u3002<\/p>\n

FDA \u91ab\u7642\u5668\u68b0\u5206\u985e\u7684\u6cd5\u5f8b\u57fa\u790e\u8207\u5224\u5b9a\u908f\u8f2f<\/h2>\n

FDA \u91ab\u7642\u5668\u68b0\u5206\u985e\u5236\u5ea6\u6e90\u81ea 1976 \u5e74\u300a\u91ab\u7642\u5668\u68b0\u4fee\u6b63\u6cd5\u6848\u300b\uff08Medical Device Amendments\uff09\uff0c\u4e26\u5728 21 CFR Part 860-892 \u4e2d\u8a73\u7d30\u898f\u7bc4\u3002\u5206\u985e\u7684\u6838\u5fc3\u76ee\u7684\u662f\u78ba\u4fdd\u76e3\u7ba1\u5f37\u5ea6\u8207\u7522\u54c1\u98a8\u96aa\u6210\u6b63\u6bd4<\/strong>\uff0c\u907f\u514d\u904e\u5ea6\u76e3\u7ba1\u4f4e\u98a8\u96aa\u7522\u54c1\uff0c\u540c\u6642\u56b4\u683c\u63a7\u7ba1\u9ad8\u98a8\u96aa\u5668\u68b0\u3002<\/p>\n

\u5206\u985e\u5224\u5b9a\u7684\u4e09\u5927\u6838\u5fc3\u56e0\u7d20<\/h3>\n
    \n
  1. \u9810\u671f\u7528\u9014\uff08Intended Use\uff09<\/strong>: \u7522\u54c1\u8a2d\u8a08\u76ee\u7684\u3001\u6a19\u7c64\u5ba3\u7a31\u3001\u4f7f\u7528\u8aaa\u660e\u66f8\u5167\u5bb9\uff0c\u662f\u6700\u95dc\u9375\u7684\u5224\u5b9a\u4f9d\u64da<\/li>\n
  2. \u4f7f\u7528\u74b0\u5883\u8207\u5c0d\u8c61<\/strong>: \u5bb6\u7528 vs \u5c08\u696d\u91ab\u7642\u6a5f\u69cb\u3001\u4e00\u822c\u4eba\u7fa4 vs \u7279\u5b9a\u60a3\u8005\u65cf\u7fa4<\/li>\n
  3. \u6280\u8853\u7279\u6027\u8207\u98a8\u96aa<\/strong>: \u4fb5\u5165\u6027\u7a0b\u5ea6\u3001\u63a5\u89f8\u6642\u9593\u3001\u5c0d\u91cd\u8981\u5668\u5b98\u7684\u5f71\u97ff\u3001\u5931\u6548\u5f8c\u679c<\/li>\n<\/ol>\n

    \u26a0\ufe0f \u91cd\u8981\u63d0\u9192<\/strong>: Intended Use \u662f FDA \u5224\u5b9a\u5206\u985e\u7684\u9996\u8981\u6a19\u6e96\uff0c\u5373\u4f7f\u7522\u54c1\u6280\u8853\u4e0a\u53ef\u7528\u65bc\u591a\u7a2e\u7528\u9014\uff0c\u53ea\u8981\u6a19\u7c64\u6216\u884c\u92b7\u5ba3\u7a31\u6d89\u53ca\u91ab\u7642\u76ee\u7684\uff0c\u5c31\u6703\u88ab\u8996\u70ba\u91ab\u7642\u5668\u68b0\u4e26\u9032\u884c\u5206\u985e\u5be9\u67e5\u3002\u53f0\u7063\u696d\u8005\u5e38\u8aa4\u4ee5\u70ba\u300c\u4e0d\u4e3b\u52d5\u5ba3\u7a31\u5c31\u4e0d\u53d7\u7ba1\u300d\uff0c\u4f46\u82e5\u7522\u54c1\u8a2d\u8a08\u660e\u986f\u7528\u65bc\u91ab\u7642\u76ee\u7684\uff0c\u5373\u4f7f\u672a\u660e\u78ba\u6a19\u793a\uff0cFDA \u4ecd\u53ef\u80fd\u4f9d Intended Use \u5224\u5b9a\u3002<\/p>\n

    FDA \u5982\u4f55\u5224\u5b9a\u7522\u54c1\u98a8\u96aa\u7b49\u7d1a\uff1f<\/h3>\n

    FDA \u4f7f\u7528\u300c\u98a8\u96aa\u77e9\u9663\u300d\u8a55\u4f30\uff0c\u8003\u91cf\u56e0\u7d20\u5305\u542b\uff1a<\/p>\n

      \n
    • \u4fb5\u5165\u6027\u7a0b\u5ea6<\/strong>: \u975e\u4fb5\u5165 < \u4fb5\u5165\u9ad4\u8868 < \u4fb5\u5165\u9ad4\u5167 < \u690d\u5165\u9ad4\u5167<\/li>\n
    • \u63a5\u89f8\u6642\u9593<\/strong>: \u77ed\u66ab\u63a5\u89f8\uff08<24hr\uff09< \u77ed\u671f\u63a5\u89f8\uff08<30 \u5929\uff09< \u9577\u671f\u63a5\u89f8\uff08>30 \u5929\uff09<\/li>\n
    • \u5c0d\u91cd\u8981\u5668\u5b98\u5f71\u97ff<\/strong>: \u4e0d\u5f71\u97ff < \u9593\u63a5\u5f71\u97ff < \u76f4\u63a5\u63a5\u89f8\u91cd\u8981\u5668\u5b98\uff08\u5fc3\u3001\u8166\u3001\u8840\u7ba1\uff09<\/li>\n
    • \u5931\u6548\u5f8c\u679c<\/strong>: \u8f15\u5fae\u4e0d\u9069 < \u53ef\u9006\u50b7\u5bb3 < \u4e0d\u53ef\u9006\u50b7\u5bb3 < \u751f\u547d\u5371\u96aa<\/li>\n<\/ul>\n

      Class I\/II\/III \u5b8c\u6574\u6bd4\u8f03\uff1a\u98a8\u96aa\u7b49\u7d1a\u3001\u5be9\u67e5\u9014\u5f91\u3001\u5408\u898f\u8981\u6c42<\/h2>\n
      \n\n\n\n\n\n\n\n
      \u5206\u985e\u7b49\u7d1a<\/th>\n\u98a8\u96aa\u7b49\u7d1a<\/th>\n\u7522\u54c1\u7bc4\u4f8b<\/th>\n\u5be9\u67e5\u9014\u5f91<\/th>\n\u4e0a\u5e02\u524d\u5be9\u67e5<\/th>\nQSR \u8981\u6c42<\/th>\n\u5178\u578b\u4e0a\u5e02\u6642\u7a0b<\/th>\n<\/tr>\n<\/thead>\n
      Class I<\/strong><\/td>\n\u4f4e\u98a8\u96aa<\/td>\n\u7e43\u5e36\u3001\u624b\u8853\u624b\u5957\u3001\u58d3\u820c\u677f\u3001\u624b\u52d5\u8f2a\u6905<\/td>\n\u591a\u6578\u8c41\u514d 510(k)<\/td>\n\u50c5\u9700\u8a3b\u518a\u8207\u5217\u8868<\/td>\n\u90e8\u5206\u8c41\u514d QSR<\/td>\n1-2 \u500b\u6708<\/td>\n<\/tr>\n
      Class II<\/strong><\/td>\n\u4e2d\u98a8\u96aa<\/td>\n\u8840\u58d3\u8a08\u3001\u96fb\u52d5\u8f2a\u6905\u3001\u96b1\u5f62\u773c\u93e1\u3001X \u5149\u6a5f<\/td>\n510(k) \u6216\u7279\u5b9a\u8c41\u514d<\/td>\n\u9700 510(k) Clearance<\/td>\n\u5b8c\u6574 QSR<\/td>\n3-12 \u500b\u6708<\/td>\n<\/tr>\n
      Class III<\/strong><\/td>\n\u9ad8\u98a8\u96aa<\/td>\n\u5fc3\u5f8b\u8abf\u7bc0\u5668\u3001\u4eba\u5de5\u5fc3\u81df\u74e3\u819c\u3001\u51a0\u72c0\u52d5\u8108\u652f\u67b6<\/td>\nPMA \u6216 De Novo<\/td>\n\u9700 PMA Approval<\/td>\n\u5b8c\u6574 QSR + \u81e8\u5e8a\u8a66\u9a57<\/td>\n1-3 \u5e74\u4ee5\u4e0a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
      \n

      \u5716 2: FDA \u91ab\u7642\u5668\u68b0\u5206\u985e\u5224\u5b9a\u6c7a\u7b56\u6a39<\/h3>\n

      \u5716\u7247\u7528\u9014\u8aaa\u660e<\/strong>:
      \n\u6b64\u6c7a\u7b56\u6a39\u5c07 Class I\/II\/III \u5206\u985e\u5224\u5b9a\u908f\u8f2f\u8996\u89ba\u5316\uff0c\u5e6b\u52a9\u53f0\u7063\u91ab\u6750\u5ee0\u5feb\u901f\u81ea\u6211\u6aa2\u6e2c\u7522\u54c1\u61c9\u5c6c\u54ea\u4e00\u985e\u5225\u3002<\/p>\n

      \n
      \n
      \n
      \"FDA<\/div>\n
      <\/div>\n<\/div>\n<\/div>\n<\/div>\n
      \n

      Class I\uff08\u4f4e\u98a8\u96aa\uff09\uff1a\u8c41\u514d\u5236\u5ea6\u8207\u5408\u898f\u8981\u9ede<\/h2>\n

      Class I \u91ab\u7642\u5668\u68b0\u5c6c\u65bc\u4f4e\u98a8\u96aa\u7522\u54c1<\/strong>\uff0c\u7d04\u4f54\u6240\u6709\u91ab\u7642\u5668\u68b0\u7684 47%\u3002\u9019\u985e\u7522\u54c1\u5c0d\u4eba\u9ad4\u5371\u5bb3\u6975\u4f4e\uff0c\u5373\u4f7f\u5931\u6548\u4e5f\u4e0d\u6703\u9020\u6210\u56b4\u91cd\u5f8c\u679c\u3002<\/p>\n

      Class I \u7522\u54c1\u7279\u6027\u8207\u7bc4\u4f8b<\/h3>\n