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2021年度FDA 医疗器械注册费

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发表于 2020-10-14 10:44:46 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="paragraph"><section data-tplid="89781" data-tools="gulangu"><section data-tools="gulangu" data-id="95298"><section><section><section><br  /></section><section><span>按照FDA规定,医疗器械相关厂家或者公司在进行工厂登记和产品list之前,都需要缴纳使用费(MDUFA User Fee),包括每年更新登记,需要缴纳下一年度的使用费。</span></section><section><span><br  /></span></section><section><span>2021年度工厂注册费用为$5,546,比2020年度的$5,236提高了$310。</span></section><section><span><br  /></span></section><section><span>具体2021年费用可以参考下表:</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/92d2ca0e9a71bbe2719777226984e05e_2.jpg" /></p></p><section><br  /></section><section><strong><span>续费黄金期:</span></strong></section><section><span><br  /></span></section><section><span>每年的10月1号至12月31号是FDA规定的医疗器械工厂登记更新的日期。保证自己的注册有效性,企业需要在每年的12月31号之前完成次年的费用缴纳。对于初次登记的企业在10月1号完成次年的年费缴纳,注册有效性可以一直保持到次年的12月31号,这样可以使得企业免费获得三个月的有效性。</span></section><article data-v-e1fd63b2=""><section><br  /></section></article></section></section></section></section></section><section><section data-color="#757576"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><section><br  /></section></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_3.gif" /></p></section><section data-brushtype="text"><span>戳一下,更有料!</span></section></section><section><br  /></section><section><a target="_blank" 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