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18px;">是的，對(duì)于在西班牙注冊(cè)的醫(yī)療器械，通常需要指定一家在歐洲聯(lián)盟（EU）境內(nèi)設(shè)有注冊(cè)辦事處的法定代表或授權(quán)代理。這要求是基于歐洲醫(yī)療器械法規(guī)（Medical Device Regulation，MDR）和歐洲診斷醫(yī)療器械法規(guī)（In Vitro Diagnostic Medical Devices Regulation，IVDR）。</span></p><p style="line-height: 2em;"><span style="font-size: 18px;">法定代表或授權(quán)代理在注冊(cè)過(guò)程中充當(dāng)制造商和監(jiān)管機(jī)構(gòu)之間的聯(lián)絡(luò)點(diǎn)，負(fù)責(zé)協(xié)助制造商履行其在歐洲市場(chǎng)上的法律義務(wù)。他們?cè)跉W洲聯(lián)盟境內(nèi)設(shè)有注冊(cè)辦事處，能夠有效履行這一職責(zé)。</span></p><p style="line-height: 2em;"><span style="font-size: 18px;">對(duì)于在西班牙注冊(cè)的醫(yī)療器械，法定代表或授權(quán)代理的指定通常是必需的。制造商需要在注冊(cè)申請(qǐng)中提供法定代表或授權(quán)代理的詳細(xì)信息。</span></p><p style="line-height: 2em;"><span style="font-size: 18px;">需要注意的是，法定代表或授權(quán)代理的要求可能隨時(shí)間和法規(guī)的變化而調(diào)整，因此建議在開(kāi)始注冊(cè)程序之前，直接聯(lián)系西班牙醫(yī)藥品和醫(yī)療器械局（Agencia Espa?ola de Medicamentos y Productos Sanitarios，AEMPS）或?qū)I(yè)的醫(yī)療器械法規(guī)咨詢服務(wù)機(jī)構(gòu)以獲取最新信息。</span></p><p><img 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