{"id":13405,"date":"2026-08-06T14:00:25","date_gmt":"2026-08-06T14:00:25","guid":{"rendered":"https:\/\/www.sanner-group.com\/%e5%ae%9e%e5%8a%9b\/%e7%9b%91%e7%ae%a1%e6%9c%8d%e5%8a%a1\/"},"modified":"2026-09-29T07:37:06","modified_gmt":"2026-09-29T07:37:06","slug":"%e7%9b%91%e7%ae%a1%e6%9c%8d%e5%8a%a1","status":"publish","type":"page","link":"https:\/\/www.sanner-group.com\/zh-hans\/%E5%AE%9E%E5%8A%9B\/%E7%9B%91%E7%AE%A1%E6%9C%8D%E5%8A%A1\/","title":{"rendered":"\u6cd5\u89c4\u670d\u52a1"},"content":{"rendered":"
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\u6cd5\u89c4\u670d\u52a1<\/h1>

\u6cd5\u89c4\u652f\u6301\u8d2f\u7a7f\u4e8e Sanner \u4ea7\u54c1\u5f00\u53d1\u8fc7\u7a0b\u7684\u6bcf\u4e2a\u9636\u6bb5\u3002\u6211\u4eec\u7684\u5185\u90e8\u56e2\u961f\u8d1f\u8d23\u7ba1\u7406\u7533\u62a5\u7b56\u7565\u3001\u89e3\u8bfb\u4e0d\u65ad\u53d8\u5316\u7684\u6307\u5bfc\u539f\u5219\uff0c\u5e76\u9488\u5bf9 FDA \u548c\u5168\u7403\u6cd5\u89c4\u6846\u67b6\u7684\u53cd\u9988\u505a\u51fa\u54cd\u5e94\u3002<\/span><\/span><\/p>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n

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\u5f00\u53d1\u5404\u9636\u6bb5\u7684\u4e13\u5bb6\u6307\u5bfc <\/h2> <\/div>\n \n
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\u51ed\u501f\u5728<\/span>\u533b\u7597\u5668\u68b0\u548c\u7ec4\u5408\u4ea7\u54c1\u9886\u57df\u7684\u4e13\u4e1a\u77e5\u8bc6<\/span>\uff0c\u6211\u4eec\u7b80\u5316\u4e86\u6cd5\u89c4\u89c4\u5212\u3001\u7533\u62a5\u548c\u673a\u6784\u4e92\u52a8\uff0c\u4ee5\u7f29\u77ed\u5468\u671f\u3001\u786e\u4fdd\u5408\u89c4\uff0c\u5e76\u652f\u6301\u5411\u5546\u4e1a\u5316\u751f\u4ea7\u7684\u5e73\u7a33\u8fc7\u6e21\u3002<\/span><\/p>\n <\/div>\n \n <\/div>\n <\/div>\n <\/div>\n

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\u6cd5\u89c4\u7b56\u7565<\/h2><\/div>\n \n

\u6211\u4eec\u901a\u8fc7\u5c06\u5f00\u53d1\u4e0e\u5168\u7403\u5e02\u573a\u7684\u6b63\u786e\u6cd5\u89c4\u9014\u5f84\u76f8\u7ed3\u5408\uff08\u5305\u62ec\u7528\u4e8e\u6210\u529f\u7533\u62a5\u7684\u5bf9\u7167\u54c1\u9009\u62e9\u548c\u5206\u7c7b\u6307\u5bfc\uff09\uff0c\u5e2e\u52a9\u533b\u7597\u5668\u68b0\u66f4\u5feb\u83b7\u5f97\u6cd5\u89c4\u6279\u51c6\u3002<\/span><\/span><\/p>\n<\/div>\n \n <\/div>\n <\/div>\n

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\u6cd5\u89c4\u7533\u62a5\u4e0e\u4e92\u52a8<\/h2><\/div>\n \n

\u6211\u4eec\u5728 510(k) \u548c De Novo \u7533\u62a5\u65b9\u9762\u62e5\u6709\u4e30\u5bcc\u7684\u7ecf\u9a8c\uff0c\u80fd\u591f\u5f15\u5bfc\u4ea7\u54c1\u9ad8\u6548\u901a\u8fc7 FDA \u8bb8\u53ef\u6d41\u7a0b\uff0c\u5e76\u652f\u6301 CE \u6280\u672f\u6587\u4ef6\u3001FDA Q-submissions \u4ee5\u53ca 510(k)\u3001De Novo \u548c PMA \u9014\u5f84\u7684\u9884\u7533\u62a5\u4f1a\u8bae\u51c6\u5907\uff0c\u4ee5\u53ca\u4e0e IND \u548c NDA \u9014\u5f84\u76f8\u5173\u7684\u4f1a\u8bae\u3002<\/span><\/span><\/p>\n<\/div>\n \n <\/div>\n <\/div>\n

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\u7ec4\u5408\u4ea7\u54c1\u652f\u6301<\/h2><\/div>\n \n

\u6211\u4eec\u4e3a\u7ec4\u5408\u4ea7\u54c1\u63d0\u4f9b\u5168\u9762\u7684\u6cd5\u89c4\u548c\u5f00\u53d1\u652f\u6301\uff0c\u5f25\u5408\u5668\u68b0\u4e0e\u836f\u7269\u8981\u6c42\u4e4b\u95f4\u7684\u5dee\u8ddd\u3002\u6211\u4eec\u7684\u56e2\u961f\u5728 <\/span>eCTD \u7533\u62a5\u652f\u6301<\/span>\u3001\u5668\u68b0<\/span>\u7ec4\u6210\u90e8\u5206<\/span>\u548c\u521d\u7ea7\u5305\u88c5\u5bb9\u5668\u6587\u6863\u4ee5\u53ca CDER \u9884\u7533\u62a5\u65b9\u9762\u62e5\u6709\u4e13\u4e1a\u77e5\u8bc6\u3002<\/span><\/span> <\/span><\/p>\n<\/div>\n \n <\/div>\n <\/div>\n

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\u957f\u671f\u5408\u89c4<\/h2><\/div>\n \n

\u9664\u4e86\u83b7\u5f97\u6279\u51c6\u5916\uff0c\u6211\u4eec\u8fd8\u534f\u52a9<\/span>\u7ef4\u6301<\/span>\u957f\u671f\u5408\u89c4\uff0c<\/span>\u51c6\u5907<\/span>\u6587\u6863\uff0c<\/span>\u7ba1\u7406<\/span>\u6cd5\u89c4\u6c9f\u901a\uff0c\u5e76<\/span>\u652f\u6301<\/span>\u6211\u4eec\u7684\u5ba2\u6237\u5e94\u5bf9\u5ba1\u8ba1\u548c\u5404\u5e02\u573a\u4e0d\u65ad\u53d8\u5316\u7684\u8981\u6c42\u3002<\/span><\/span><\/p>\n<\/div>\n \n <\/div>\n <\/div>\n <\/div>\n\n

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\n <\/span>\n \n \u6cd5\u89c4\u7b56\u7565 <\/button>\n \n \u6cd5\u89c4\u7533\u62a5\u4e0e\u4e92\u52a8 <\/button>\n \n \u7ec4\u5408\u4ea7\u54c1\u652f\u6301 <\/button>\n \n \u957f\u671f\u5408\u89c4 <\/button>\n <\/div>\n <\/div>\n <\/section>
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\u6bcf\u4e2a\u9636\u6bb5\u7684\u8d28\u91cf\u4fdd\u8bc1<\/h2><\/div>\n \n \n

Sanner \u5728 ISO 13485 \u8ba4\u8bc1\u7684\u8d28\u91cf\u4f53\u7cfb\u4e0b\u8fd0\u884c\uff0c\u5176\u5de5\u5382\u5df2\u5728 FDA \u6ce8\u518c\u5e76\u7b26\u5408 cGMP \u6807\u51c6<\/span>\u3002<\/span> <\/span>\u6211\u4eec\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb (QMS) \u652f\u6301 FDA 21 CFR Part 4 \u4e0b\u7684\u7ec4\u5408\u4ea7\u54c1\uff0c\u6574\u5408\u4e86 21 CFR Parts 820<\/span> (QMSR)<\/span> \u548c 211\uff0c\u540c\u65f6\u7b26\u5408\u6b27\u76df MDR (2017\/745)<\/span> \u548c NMPA (<\/span>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40<\/span>)<\/span> \u7684\u8981\u6c42\u3002<\/span> <\/span><\/span> <\/span><\/p>\n<\/div>\n \n \u4e86\u89e3\u66f4\u591a\u5173\u4e8e Sanner \u8d28\u91cf\u7684\u4fe1\u606f<\/a>\n \n <\/div>\n <\/div>\n\n \n <\/div>\n <\/div>\n<\/section>\n

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\u63a2\u7d22 Sanner \u7684\u6cd5\u89c4\u4e13\u4e1a\u77e5\u8bc6
\u5982\u4f55\u52a9\u529b\u4ea7\u54c1\u4e0a\u5e02 <\/h3> <\/div>\n \n
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\n \u773c\u79d1\u690d\u5165\u7269\u6ce8\u5c04\u5668<\/a>\n <\/h3>\n

\u52a0\u901f\u65b0\u578b\u773c\u79d1\u690d\u5165\u836f\u7269\u7684\u4e0a\u5e02\u8fdb\u7a0b\u3002<\/p>\n

\n \u4e86\u89e3\u66f4\u591a<\/a>\n <\/div>\n <\/div>\n <\/div>\n
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\n \u5bc6\u95ed\u5f0f\u836f\u7269\u8f6c\u8fd0\u88c5\u7f6e<\/a>\n <\/h3>\n

\u5f00\u53d1\u4e00\u79cd\u65e2\u80fd\u4fdd\u62a4\u4e34\u5e8a\u533b\u751f\u514d\u53d7\u5371\u9669\u836f\u7269\u4fb5\u5bb3\uff0c\u53c8\u4e0d\u4f1a\u964d\u4f4e\u5176\u5de5\u4f5c\u6548\u7387\u7684\u5bc6\u95ed\u5f0f\u836f\u7269\u8f6c\u8fd0\u88c5\u7f6e\u3002<\/p>\n

\n \u4e86\u89e3\u66f4\u591a<\/a>\n <\/div>\n <\/div>\n <\/div>\n
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\n \u65e0\u9488\u7a7a\u8f93\u6db2\u888b<\/a>\n <\/h3>\n

\u521b\u65b0\u578b\u8f93\u6db2\u888b\u7684\u7aef\u5230\u7aef\u5f00\u53d1\u4e0e\u5236\u9020\u3002<\/p>\n

\n \u4e86\u89e3\u66f4\u591a<\/a>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<\/section>\n
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\u6cd5\u89c4\u6d1e\u5bdf<\/h3>
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\u76f4\u63a5\u4ece Sanner \u7684\u6cd5\u89c4\u548c\u8d28\u91cf\u56e2\u961f\u83b7\u53d6\u6cd5\u89c4\u8d8b\u52bf\u3001\u6307\u5bfc\u66f4\u65b0\u548c\u884c\u4e1a\u7ecf\u9a8c\u7684\u6700\u65b0\u52a8\u6001\u3002<\/span><\/span> <\/span><\/p>\n <\/div>\n <\/div>\n \n

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\n Understanding the Regulatory Difference Between SiMD and SaMD<\/a>\n <\/h3>\n
\n \u9605\u8bfb\u6587\u7ae0<\/a>\n <\/div>\n <\/div>\n <\/div>\n
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\n 510(k) Exempt Medical Device Guide<\/a>\n <\/h3>\n
\n \u9605\u8bfb\u6587\u7ae0<\/a>\n <\/div>\n <\/div>\n <\/div>\n
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\n FDA Medical Device Classifications<\/a>\n <\/h3>\n
\n \u9605\u8bfb\u6587\u7ae0<\/a>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<\/section>
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<\/div>\n \u8054\u7cfb\u65b9\u5f0f<\/span>\n <\/div>\n \n \n
\n \u6b63\u5728\u8fdb\u884c\u7533\u62a5\u6216\u89c4\u5212\u60a8\u7684\u6cd5\u89c4\u9014\u5f84\uff1fSanner \u7684\u6cd5\u89c4\u56e2\u961f\u4e3a\u60a8\u63d0\u4f9b\u4ece\u65e9\u671f\u7b56\u7565\u5230\u6279\u51c6\u53ca\u957f\u671f\u5408\u89c4\u7684\u5168\u65b9\u4f4d\u652f\u6301\u3002 <\/div>\n \n
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