{"id":7318,"date":"2026-11-06T10:54:33","date_gmt":"2026-11-06T03:54:33","guid":{"rendered":"https:\/\/anlitalog.com\/phan-loai-thiet-bi-y-te-a-b-c-d-cn\/"},"modified":"2026-11-06T14:17:09","modified_gmt":"2026-11-06T07:17:09","slug":"phan-loai-thiet-bi-y-te-a-b-c-d-cn","status":"publish","type":"post","link":"https:\/\/anlitalog.com\/zh-hans\/phan-loai-thiet-bi-y-te-a-b-c-d-cn\/","title":{"rendered":"\u533b\u7597\u5668\u68b0A\u3001B\u3001C\u3001D\u5206\u7c7b\uff1a\u6b63\u786e\u81ea\u6211\u5206\u7c7b\u4ee5\u9009\u5bf9\u7a0b\u5e8f"},"content":{"rendered":"<style>.anl-kb{line-height:1.75}.anl-kb h2{color:#2f5d7a;font-size:23px;margin:30px 0 12px;padding-left:12px;border-left:4px solid #538aad}.anl-kb h3{color:#2f5d7a;font-size:19px;margin:22px 0 8px}.anl-kb .lead{font-size:17px;color:#34495c}.anl-kb .box{background:#eef5f9;border-left:4px solid #538aad;border-radius:10px;padding:14px 18px;margin:18px 0}.anl-kb .box.warn{background:#fff6e5;border-left-color:#d99a1e}.anl-kb .box 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.toc{background:#f6fafc;border:1px solid #d7e4ee;border-radius:14px;padding:6px 18px;margin:18px 0}.anl-kb .toc summary{cursor:pointer;font-weight:700;color:#2f5d7a;padding:8px 0}.anl-kb .toc ol{margin:4px 0 10px 18px}.anl-kb .toc a{color:#1f2329;text-decoration:none}.anl-kb .toc a:hover{color:#3c7193}.anl-kb .tw{max-height:70vh;overflow:auto}.anl-kb .tw th{position:sticky;top:0;z-index:1}.anl-kb .upd{font-size:14px;color:#5b7083}<\/style>\n<div class=\"anl-kb\">\n<p class=\"upd\">\u6839\u636e\u73b0\u884c\u89c4\u5b9a\u66f4\u65b0\u81f32026\u5e7410\u670827\u65e5\u3002<\/p>\n<div class=\"lead\">\n<p>\u5728\u8fdb\u53e3\u4efb\u4f55\u533b\u7597\u5668\u68b0\uff08TBYT\uff09\u5230\u8d8a\u5357\u4e4b\u524d\uff0c\u7b2c\u4e00\u4e2a\u95ee\u9898\u6c38\u8fdc\u662f\uff1a<strong>\u8d27\u7269\u5c5e\u4e8eA\u3001B\u3001C\u8fd8\u662fD\u7c7b\uff1f<\/strong>\u5206\u7c7b\u7ed3\u679c\u51b3\u5b9a\u540e\u7eed\u5168\u90e8\u624b\u7eed\u2014\u2014\u5411\u7701\u536b\u751f\u5385\u8fd8\u662f\u536b\u751f\u90e8\u63d0\u4ea4\u3001\u9700\u8981\u51e0\u5929\u8fd8\u662f\u51e0\u4e2a\u6708\u3001\u662f\u5426\u9700\u8981\u8fdb\u53e3\u8bb8\u53ef\u8bc1\u3002\u5206\u7c7b\u9519\u8bef\uff0c\u6ce8\u518c\u53f7\u53ef\u80fd\u88ab\u64a4\u9500\uff0c\u8d27\u7269\u88ab\u6ede\u7559\u5728\u6e2f\u53e3\u3002<\/p>\n<\/div>\n<details class=\"toc\" open>\n<summary>\ud83d\udcd1 \u672c\u6587\u76ee\u5f55<\/summary>\n<ol>\n<li><a href=\"#can-cu-phap-ly-hien-hanh\">\u73b0\u884c\u6cd5\u5f8b\u4f9d\u636e<\/a><\/li>\n<li><a href=\"#4-loai-tbyt-va-thu-tuc-tuong-ung\">4\u7c7b\u533b\u7597\u5668\u68b0\u53ca\u5bf9\u5e94\u624b\u7eed<\/a><\/li>\n<li><a href=\"#hai-bien-so-quyet-dinh-muc-rui-ro\">\u51b3\u5b9a\u98ce\u9669\u7b49\u7ea7\u7684\u4e24\u4e2a\u53d8\u91cf<\/a><\/li>\n<li><a href=\"#nhan-dien-nhanh-theo-nhom-quy-tac\">\u6309\u89c4\u5219\u7ec4\u5feb\u901f\u8bc6\u522b<\/a><\/li>\n<li><a href=\"#ce-fda-co-thay-duoc-thu-tuc-viet-nam-khong\">CE\u3001FDA\u80fd\u5426\u66ff\u4ee3\u8d8a\u5357\u624b\u7eed\uff1f<\/a><\/li>\n<li><a href=\"#nhung-loi-phan-loai-hay-gap\">\u5e38\u89c1\u5206\u7c7b\u9519\u8bef<\/a><\/li>\n<li><a href=\"#anlita-ho-tro-gi\">ANLITA\u63d0\u4f9b\u4ec0\u4e48\u652f\u6301\uff1f<\/a><\/li>\n<\/ol>\n<\/details>\n<h2 id=\"can-cu-phap-ly-hien-hanh\">\u73b0\u884c\u6cd5\u5f8b\u4f9d\u636e<\/h2>\n<ul>\n<li><strong>\u7b2c98\/2021\/N\u0110-CP\u53f7\u8bae\u5b9a<\/strong>\u5173\u4e8e\u533b\u7597\u5668\u68b0\u7ba1\u7406\uff0c\u7ecf\u7b2c07\/2023\/N\u0110-CP\u53f7\u8bae\u5b9a\u548c\u7b2c04\/2025\/N\u0110-CP\u53f7\u8bae\u5b9a\u4fee\u8ba2\u3002<\/li>\n<li><strong>\u7b2c05\/2022\/TT-BYT\u53f7\u901a\u77e5<\/strong>\u2014\u2014\u9644\u5f55\u4e00\u89c4\u5b9a\u6309\u98ce\u9669\u7b49\u7ea7\u5206\u7c7b\u7684\u89c4\u5219\uff08\u7ecf\u7b2c24\/2026\/TT-BYT\u53f7\u901a\u77e5\u4fee\u8ba2\uff0c\u81ea2026\u5e747\u67081\u65e5\u751f\u6548\uff09\u3002<\/li>\n<li><strong>\u7b2c19\/2021\/TT-BYT\u53f7\u901a\u77e5<\/strong>\uff08\u7ecf\u7b2c10\/2023\/TT-BYT\u53f7\u901a\u77e5\u4fee\u8ba2\uff09\u2014\u2014\u516c\u544a\u3001\u6ce8\u518c\u3001\u6388\u6743\u4e66\u7b49\u8868\u683c\u6837\u5f0f\u3002<\/li>\n<li><strong>\u7b2c19\/2024\/TT-BYT\u53f7\u901a\u77e5<\/strong>\u2014\u2014\u533b\u7597\u5668\u68b0\u8fdb\u51fa\u53e3\u76ee\u5f55\u53caHS\u7f16\u7801\u3002<\/li>\n<\/ul>\n<p>\u81ea2022\u5e741\u67081\u65e5\u8d77\uff0c\u8d8a\u5357<strong>\u4e0d\u518d\u901a\u8fc7\u4e2d\u4ecb\u5355\u4f4d\u53d1\u653e&#8221;\u5206\u7c7b\u8bc1\u660e&#8221;<\/strong>\uff08\u5982\u7b2c36\/2016\/N\u0110-CP\u53f7\u8bae\u5b9a\u65f6\u671f\uff09\u3002\u4ee5\u516c\u544a\u6216\u6ce8\u518c\u4eba\u540d\u4e49\u7684\u4f01\u4e1a<strong>\u81ea\u884c\u5206\u7c7b\u5e76\u81ea\u8d1f\u5176\u8d23<\/strong>\u3002\u5206\u7c7b\u7ed3\u679c\u76f4\u63a5\u4f53\u73b0\u5728\u516c\u544a\/\u6ce8\u518c\u6863\u6848\u4e2d\uff0c\u5e76\u5728\u536b\u751f\u90e8\u533b\u7597\u5668\u68b0\u7ba1\u7406\u516c\u5171\u670d\u52a1\u95e8\u6237\u4e0a\u516c\u5f00\u3002<\/p>\n<h2 id=\"4-loai-tbyt-va-thu-tuc-tuong-ung\">4\u7c7b\u533b\u7597\u5668\u68b0\u53ca\u5bf9\u5e94\u624b\u7eed<\/h2>\n<div class=\"tw\">\n<table>\n<thead>\n<tr>\n<th class=\"anl-th\">\u7c7b\u522b<\/th>\n<th class=\"anl-th\">\u98ce\u9669\u7b49\u7ea7<\/th>\n<th class=\"anl-th\">\u6d41\u901a\u624b\u7eed<\/th>\n<th class=\"anl-th\">\u53d7\u7406\u673a\u5173<\/th>\n<th class=\"anl-th\">\u7ecf\u8425\u662f\u5426\u9700\u8981&#8221;\u7b26\u5408\u6761\u4ef6\u516c\u544a&#8221;\uff1f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A<\/td>\n<td>\u4f4e<\/td>\n<td>\u9002\u7528\u6807\u51c6\u516c\u544a<\/td>\n<td>\u603b\u90e8\u6240\u5728\u5730\u7701\u536b\u751f\u5385<\/td>\n<td>\u4e0d\u9700\u8981<\/td>\n<\/tr>\n<tr>\n<td>B<\/td>\n<td>\u4e2d\u4f4e<\/td>\n<td>\u9002\u7528\u6807\u51c6\u516c\u544a<\/td>\n<td>\u603b\u90e8\u6240\u5728\u5730\u7701\u536b\u751f\u5385<\/td>\n<td>\u9700\u8981\uff08\u90e8\u5206\u5546\u54c1\u83b7\u8c41\u514d\uff09<\/td>\n<\/tr>\n<tr>\n<td>C<\/td>\n<td>\u4e2d\u9ad8<\/td>\n<td>\u6ce8\u518c\u6d41\u901a\uff08\u9881\u53d1\u6d41\u901a\u6ce8\u518c\u8bc1\u4e66\uff09<\/td>\n<td>\u536b\u751f\u90e8<\/td>\n<td>\u9700\u8981<\/td>\n<\/tr>\n<tr>\n<td>D<\/td>\n<td>\u9ad8<\/td>\n<td>\u6ce8\u518c\u6d41\u901a<\/td>\n<td>\u536b\u751f\u90e8<\/td>\n<td>\u9700\u8981<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p>\u516c\u544a\u53f7\uff08A\u3001B\u7c7b\uff09\u548c\u6d41\u901a\u6ce8\u518c\u53f7\uff08C\u3001D\u7c7b\uff09\u7edf\u79f0\u4e3a<strong>\u6d41\u901a\u53f7<\/strong>\u3002\u5df2\u6709\u6d41\u901a\u53f7\u540e\uff0c\u8fdb\u53e3\u65f6\u4f01\u4e1a\u53ea\u9700\u5728\u62a5\u5173\u5355\u4e0a\u586b\u8be5\u53f7\uff0c<strong>\u65e0\u9700\u7533\u8bf7\u8fdb\u53e3\u8bb8\u53ef\u8bc1<\/strong>\uff08\u7279\u6b8a\u60c5\u51b5\u9664\u5916\uff09\u3002<\/p>\n<h2 id=\"hai-bien-so-quyet-dinh-muc-rui-ro\">\u51b3\u5b9a\u98ce\u9669\u7b49\u7ea7\u7684\u4e24\u4e2a\u53d8\u91cf<\/h2>\n<p>\u4e0e\u5176\u80cc\u4e0b\u666e\u901a\u533b\u7597\u5668\u68b016\u6761\u89c4\u5219\u548c\u4f53\u5916\u8bca\u65ad\u8bbe\u5907\uff08IVD\uff097\u6761\u89c4\u5219\uff0c\u4e0d\u5982\u5148\u95ee\u81ea\u5df1\u4e09\u4e2a\u95ee\u9898\uff1a<\/p>\n<ol>\n<li><strong>\u7528\u6765\u505a\u4ec0\u4e48\uff1f<\/strong>\u6cbb\u7597\u3001\u8bca\u65ad\u3001\u652f\u6301\uff0c\u8fd8\u662f\u4ec5\u4e3a\u76db\u88c5\u5668\u5177\u3002<\/li>\n<li><strong>\u63a5\u89e6\u90e8\u4f4d\u548c\u65f6\u957f\uff1f<\/strong>\u4f53\u5916\u76ae\u80a4\u3001\u81ea\u7136\u8154\u9053\u3001\u7ecf\u624b\u672f\uff1b\u4e34\u65f6\uff0860\u5206\u949f\u4ee5\u5185\uff09\u3001\u77ed\u671f\uff0860\u5206\u949f\u201330\u5929\uff09\u8fd8\u662f\u957f\u671f\uff0830\u5929\u4ee5\u4e0a\uff09\u3002<\/li>\n<li><strong>\u5982\u679c\u635f\u574f\u6216\u7ed3\u679c\u51fa\u9519\u540e\u679c\u5982\u4f55\uff1f<\/strong>\u76f4\u63a5\u5371\u53ca\u751f\u547d\u5219\u98ce\u9669\u9ad8\u3002<\/li>\n<\/ol>\n<div class=\"tw\">\n<table>\n<thead>\n<tr>\n<th class=\"anl-th\">\u8fde\u7eed\u4f7f\u7528\u65f6\u95f4<\/th>\n<th class=\"anl-th\">\u672f\u8bed<\/th>\n<th class=\"anl-th\">\u542b\u4e49<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>60\u5206\u949f\u4ee5\u5185<\/td>\n<td>\u4e34\u65f6<\/td>\n<td>\u77ed\u65f6\u95f4\u4f7f\u7528\u4e00\u6b21\uff0c\u968f\u5373\u66f4\u6362\u4e3a\u540c\u7c7b\u8bbe\u5907<\/td>\n<\/tr>\n<tr>\n<td>60\u5206\u949f\u201330\u5929<\/td>\n<td>\u77ed\u671f<\/td>\n<td>\u63a5\u89e6\u5ef6\u957f\u4f46\u4e0d\u8d85\u8fc71\u4e2a\u6708<\/td>\n<\/tr>\n<tr>\n<td>30\u5929\u4ee5\u4e0a<\/td>\n<td>\u957f\u671f<\/td>\n<td>\u690d\u5165\u5668\u68b0\u3001\u957f\u671f\u751f\u547d\u652f\u6301\u8bbe\u5907<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p>\u76f4\u63a5\u63a5\u89e6<strong>\u5fc3\u810f\u3001\u4e2d\u592e\u5faa\u73af\u7cfb\u7edf\u6216\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf<\/strong>\uff08\u8111\u3001\u8111\u819c\u3001\u810a\u9ad3\uff09\u7684\u8bbe\u5907\u51e0\u4e4e\u603b\u662f\u5f52\u4e3a<strong>D\u7c7b<\/strong>\u3002<\/p>\n<h2 id=\"nhan-dien-nhanh-theo-nhom-quy-tac\">\u6309\u89c4\u5219\u7ec4\u5feb\u901f\u8bc6\u522b<\/h2>\n<div class=\"tw\">\n<table>\n<thead>\n<tr>\n<th class=\"anl-th\">\u89c4\u5219\u7ec4<\/th>\n<th class=\"anl-th\">\u539f\u7406<\/th>\n<th class=\"anl-th\">\u8fdb\u53e3\u5e38\u89c1\u793a\u4f8b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u975e\u4fb5\u5165\u5f0f\uff08\u89c4\u52191\u20134\uff09<\/td>\n<td>\u9ed8\u8ba4\u4e3aA\u7c7b\uff1b\u82e5\u5904\u7406\u6df1\u5ea6\u4f24\u53e3\u3001\u50a8\u5b58\u8840\u6db2\u3001\u6539\u53d8\u8840\u6db2\u6210\u5206\u5219\u5347\u4e3aB\/C<\/td>\n<td>\u666e\u901a\u7eb1\u5e03\uff08A\uff09\u3001\u8840\u888b\uff08C\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u7ecf\u81ea\u7136\u8154\u9053\u4fb5\u5165\uff08\u89c4\u52195\uff09<\/td>\n<td>\u65f6\u95f4\u8d8a\u957f\u3001\u90e8\u4f4d\u8d8a\u654f\u611f\u5219\u7b49\u7ea7\u8d8a\u9ad8<\/td>\n<td>\u538b\u820c\u677f\uff08A\uff09\u3001\u957f\u671f\u7559\u7f6e\u5bfc\u7ba1\uff08B\/C\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u7ecf\u624b\u672f\u4fb5\u5165\uff08\u89c4\u52196\u20138\uff09<\/td>\n<td>\u53ef\u91cd\u590d\u4f7f\u7528\u624b\u672f\u5668\u68b0\u4e3aA\u7c7b\uff1b\u957f\u671f\u690d\u5165\u4e3aC\u7c7b\uff1b\u63a5\u89e6\u5fc3\u810f\/\u5927\u8111\u4e3aD\u7c7b<\/td>\n<td>\u6ce8\u5c04\u9488\uff08B\uff09\u3001\u51a0\u72b6\u52a8\u8109\u652f\u67b6\uff08D\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u6709\u6e90\u8bbe\u5907\uff08\u89c4\u52199\u201312\uff09<\/td>\n<td>\u8003\u91cf\u53d1\u51fa\u80fd\u91cf\u53ca\u4fe1\u606f\u9519\u8bef\u7684\u540e\u679c<\/td>\n<td>\u8840\u538b\u8ba1\uff08B\uff09\u3001X\u5149\u673a\uff08C\uff09\u3001\u91cd\u75c7\u76d1\u62a4\u60a3\u8005\u76d1\u62a4\u4eea\uff08C\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u7279\u522b\u89c4\u5219\uff0813\u201316\uff09<\/td>\n<td>\u542b\u836f\u7269\u6210\u5206\u3001\u52a8\u7269\u6e90\u3001\u690d\u5165\u5f0f\u907f\u5b55\u9ed8\u8ba4\u4e3aD\u7c7b\uff1b\u533b\u7597\u5668\u68b0\u706d\u83cc\u8bbe\u5907\u4e3aC\u7c7b<\/td>\n<td>\u9690\u5f62\u773c\u955c\u62a4\u7406\u6db2\uff08C\uff09\u3001\u706d\u83cc\u5668\uff08C\uff09<\/td>\n<\/tr>\n<tr>\n<td>IVD\uff08\u89c4\u52191\u20137\uff09<\/td>\n<td>\u57fa\u4e8e\u68c0\u6d4b\u7ed3\u679c\u5bf9\u516c\u5171\u536b\u751f\u7684\u91cd\u8981\u7a0b\u5ea6<\/td>\n<td>\u6837\u54c1\u7ba1\uff08A\uff09\u3001\u5bb6\u7528\u81ea\u6d4b\uff08C\uff09\u3001\u8f93\u8840HIV\u7b5b\u67e5\uff08D\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h2 id=\"ce-fda-co-thay-duoc-thu-tuc-viet-nam-khong\">CE\u3001FDA\u80fd\u5426\u66ff\u4ee3\u8d8a\u5357\u624b\u7eed\uff1f<\/h2>\n<p><strong>\u4e0d\u80fd\u3002<\/strong>CE\u8ba4\u8bc1\uff08\u6b27\u6d32\uff09\u6216FDA 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href=\"https:\/\/anlitalog.com\/zh-hans\/contact\/\">\u8054\u7cfbANLITA\u83b7\u53d6\u54a8\u8be2<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u6839\u636e\u73b0\u884c\u89c4\u5b9a\u66f4\u65b0\u81f32<\/p>\n<div class=\"read-more-wrapper\"><a class=\"more-link read-more-link\" href=\"https:\/\/anlitalog.com\/zh-hans\/phan-loai-thiet-bi-y-te-a-b-c-d-cn\/\">Read 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