{"id":401,"date":"2024-06-18T10:50:17","date_gmt":"2024-06-18T02:50:17","guid":{"rendered":"https:\/\/gvmmedical.com\/chinese\/?p=401"},"modified":"2024-06-18T10:50:17","modified_gmt":"2024-06-18T02:50:17","slug":"fda%e5%8f%91%e5%b8%83%e6%8c%87%e5%8d%97%e3%80%8a%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e5%86%8d%e5%88%b6%e9%80%a0%e3%80%8b","status":"publish","type":"post","link":"https:\/\/gvmmedical.com\/chinese\/fda%e5%8f%91%e5%b8%83%e6%8c%87%e5%8d%97%e3%80%8a%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e5%86%8d%e5%88%b6%e9%80%a0%e3%80%8b\/","title":{"rendered":"FDA\u53d1\u5e03\u6307\u5357\u300a\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u300b"},"content":{"rendered":"\n<p class=\"\"><a>2024<\/a>\u5e745\u670810\u65e5\uff0c\u7f8e\u56fdFDA\u53d1\u5e03\u4e86\u300a\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u300b\u6b63\u5f0f\u6307\u5357\u3002\u8be5\u6307\u5357\u4e3b\u8981\u76ee\u7684\u662f\u660e\u786e\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u548c\u4e0a\u5e02\u533b\u7597\u5668\u68b0\u6b63\u5e38\u7ef4\u4fee\u4fdd\u517b\u670d\u52a1\u4e4b\u95f4\u7684\u533a\u522b\uff0c\u5e76\u63d0\u51fa\u7b26\u5408\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u7684\u4f01\u4e1a\u5e94\u9075\u5faa\u7684\u6cd5\u89c4\u8981\u6c42\uff0c\u4ee5\u786e\u4fdd\u533b\u7597\u5668\u68b0\u5728\u5168\u751f\u547d\u5468\u671f\u7b26\u5408\u8d28\u91cf\u6807\u51c6\uff0c\u786e\u4fdd\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u6307\u5357\u4e3b\u8981\u5185\u5bb9<\/strong><\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li class=\"\">\u6307\u5357\u660e\u786e\u4e86\u5341\u4e2a\u5b9a\u4e49\u3002<\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>\u7528\u9014intended use<\/td><td>\u533b\u7597\u5668\u68b0\u518d\u5236\u9020remanufacture<\/td><\/tr><tr><td>\u7ffb\u65b0Recondition\/Refurbish\/Rebuild<\/td><td>\u7ef4\u4feerepair &nbsp;<\/td><\/tr><tr><td>\u518d\u52a0\u5de5reprocess<\/td><td>\u670d\u52a1service<\/td><\/tr><tr><td>\u6027\u80fd\u6807\u51c6performance specification<\/td><td>\u5b89\u5168\u6807\u51c6safety specification<\/td><\/tr><tr><td>\u751f\u4ea7\u5546Manufacturers (Manufacturers, OEMs, or Remanufacturers)<\/td><td>\u72ec\u7acb\u7684\u7b2c\u4e09\u65b9\u670d\u52a1\u5546ISOs<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"\">2. \u6307\u5357\u660e\u786e\u4e86\u516d\u4e2a\u51c6\u5219<ul><li>\u662f\u5426\u53d1\u751f\u4e86\u7528\u9014\u7684\u53d8\u5316\u6210\u54c1\u7684\u5b89\u5168\u6027\u6709\u6548\u6027\u662f\u5426\u53d1\u751f\u4e86\u53d8\u5316\u53d8\u5316\u662f\u5426\u89e6\u53d1\u4ea7\u54c1\u91cd\u65b0\u7533\u62a5\u7684\u9700\u6c42\u4ea7\u54c1\u7684\u8d28\u91cf\u6807\u51c6\u662f\u5426\u53d1\u751f\u4e86\u53d8\u5316\u63f4\u5f15ISO14971\u8fdb\u884c\u98ce\u9669\u7ba1\u7406\uff0c\u5224\u65ad\u662f\u5426\u5f15\u5165\u65b0\u98ce\u9669<\/li><\/ul><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"> \u51b3\u7b56\u8fc7\u7a0b\u9700\u8981\u5b58\u6863\u5907\u67e5<\/li>\n<\/ul>\n\n\n\n<p class=\"\">3. \u6307\u5357\u660e\u786e\u4e86\u5341\u4e09\u79cd\u4e0d\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u7684\u8f6f\u4ef6\u76f8\u5173\u53d8\u5316\uff0c\u5217\u4e3e\u516d\u9879\u5982\u4e0b<\/p>\n\n\n\n<p class=\"\">\uff081\uff09\u6536\u539f\u5382\u59d4\u6258\u7684\u53d8\u66f4\uff0c\u76ee\u6807\u662f\u6062\u590d\u5230\u7b26\u5408\u539f\u5382\u7684\u5404\u9879\u6807\u51c6\u3002<\/p>\n\n\n\n<p class=\"\">\uff082\uff09\u5b9e\u65bdOEM\u63d0\u4f9b\u7684\u66f4\u65b0\u548c\u5347\u7ea7(\u8be5\u66f4\u65b0\u548c\u5347\u7ea7\u4e0d\u5e94\u663e\u8457\u6539\u53d8\u9884\u671f\u4f7f\u7528\u7684\u5668\u68b0)<\/p>\n\n\n\n<p class=\"\">\uff083\uff09\u8fd0\u884c\u57fa\u4e8e\u8f6f\u4ef6\u7684\u786c\u4ef6\u8bca\u65ad<\/p>\n\n\n\n<p class=\"\">\uff084\uff09\u9488\u5bf9\u75c5\u6bd2\u3001\u6076\u610f\u8f6f\u4ef6\u53ca\u5176\u4ed6\u7f51\u7edc\u5b89\u5168\u76f8\u5173\u95ee\u9898\u7684\u5b89\u88c5\u66f4\u65b0\uff0c\u6216\u5b89\u88c5OEM\u6388\u6743\u7684\u7f51\u7edc\u5b89\u5168\u66f4\u65b0<\/p>\n\n\n\n<p class=\"\">\uff085\uff09\u6267\u884c\u6570\u636e\u5907\u4efd\u548c\u6062\u590d\u64cd\u4f5c\u3001\u6536\u96c6\u7cfb\u7edf\u65e5\u5fd7\u3001\u8bc4\u4f30\u8f6f\u4ef6\u5e93\u5b58\u6216\u7ba1\u7406\u7528\u6237\u8d26\u6237<\/p>\n\n\n\n<p class=\"\">\uff086\uff09\u91cd\u65b0\u5b89\u88c5OEM\u8f6f\u4ef6\u4ee5\u6062\u590d\u539f\u59cb\u6027\u80fd\u548c\u5b89\u5168\u89c4\u8303\uff0c\u6216\u5c06\u8f6f\u4ef6\u6062\u590d\u5230\u4ee5\u524d\u7684\u914d\u7f6e<\/p>\n\n\n\n<p class=\"\">4. \u6307\u5357\u753b\u51fa\u4e86\u5224\u65ad\u662f\u5426\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u7684\u51b3\u7b56\u6d41\u7a0b\u56fe<\/p>\n\n\n\n<p class=\"\">5. \u6307\u5357\u660e\u786e\u63d0\u51fa\uff0c\u5982\u679c\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u7684\u8303\u7574\uff0c\u8be5\u518d\u5236\u9020\u4f01\u4e1a\u548c\u518d\u5236\u9020\u7684\u4ea7\u54c1\u5747\u9700\u63a5\u53d7FDA\u7684\u76d1\u7ba1\u3002\u63a5\u53d7FDA\u76d1\u7ba1\u5305\u62ec\uff1a\u4f01\u4e1a\u9700\u5728FDA\u5907\u6848\uff08Establishment) \uff0c\u4ea7\u54c1\u9700\u7533\u62a5\uff0c\u6807\u7b7e\u9700\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u3002FDA\u8fd8\u4f1a\u4e0d\u5b9a\u671f\u73b0\u573a\u68c0\u67e5<\/p>\n\n\n\n<p class=\"\">6. \u6307\u5357\u5217\u4e3e\u4e86\u5f88\u591a\u4f8b\u5b50\u5e2e\u52a9\u4f01\u4e1a\u5224\u65ad<\/p>\n\n\n\n<p class=\"\">\u6307\u5357\u539f\u6587\uff1a<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-57074575-61c9-4f77-8d04-3e563d82a430\" href=\"https:\/\/gvmmedical.com\/chinese\/wp-content\/uploads\/2024\/06\/Remanufacturing-of-Medical-Devices-Guidance.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Remanufacturing-of-Medical-Devices-Guidance<\/a><a href=\"https:\/\/gvmmedical.com\/chinese\/wp-content\/uploads\/2024\/06\/Remanufacturing-of-Medical-Devices-Guidance.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-57074575-61c9-4f77-8d04-3e563d82a430\">\u4e0b\u8f7d<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>2024\u5e745\u670810\u65e5\uff0c\u7f8e\u56fdFDA\u53d1\u5e03\u4e86\u300a\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u300b\u6b63\u5f0f\u6307\u5357\u3002\u8be5\u6307\u5357\u4e3b\u8981\u76ee\u7684\u662f\u660e\u786e\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u548c\u4e0a\u5e02\u533b\u7597 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","om_disable_all_campaigns":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14],"tags":[10,29],"class_list":["post-401","post","type-post","status-publish","format-standard","hentry","category-14","tag-fda","tag-29"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"rttpg_featured_image_url":null,"rttpg_author":{"display_name":"admin","author_link":"https:\/\/gvmmedical.com\/chinese\/author\/admin\/"},"rttpg_comment":0,"rttpg_category":"<a href=\"https:\/\/gvmmedical.com\/chinese\/category\/%e5%9b%bd%e5%a4%96%e8%b5%84%e8%ae%af\/\" rel=\"category tag\">\u56fd\u5916\u8d44\u8baf<\/a>","rttpg_excerpt":"2024\u5e745\u670810\u65e5\uff0c\u7f8e\u56fdFDA\u53d1\u5e03\u4e86\u300a\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u300b\u6b63\u5f0f\u6307\u5357\u3002\u8be5\u6307\u5357\u4e3b\u8981\u76ee\u7684\u662f\u660e\u786e\u533b\u7597\u5668\u68b0\u518d\u5236\u9020\u548c\u4e0a\u5e02\u533b\u7597&hellip;","_links":{"self":[{"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/posts\/401","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/comments?post=401"}],"version-history":[{"count":1,"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/posts\/401\/revisions"}],"predecessor-version":[{"id":403,"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/posts\/401\/revisions\/403"}],"wp:attachment":[{"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/media?parent=401"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/categories?post=401"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gvmmedical.com\/chinese\/wp-json\/wp\/v2\/tags?post=401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}