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FDA 510(k) 注冊(cè)流程
CREATE TIME:2018-06-29 11:34BROWSE TIMES:2396
FDA是食品藥品監(jiān)督管理局(Food and Drug Administration)的簡(jiǎn)稱。FDA有時(shí)也代表美國(guó)FDA,是國(guó)際醫(yī)療審核權(quán)威機(jī)構(gòu),由美國(guó)國(guó)會(huì)即聯(lián)邦政府授權(quán),專門(mén)從事食品與藥品管理的最高執(zhí)法機(jī)關(guān)。
對(duì)于生產(chǎn)II類醫(yī)療器械的生產(chǎn)商來(lái)說(shuō),需要在美國(guó)食品藥品管理局(FDA) 申請(qǐng)市場(chǎng)準(zhǔn)入,即FDA 510K申請(qǐng)。只有通過(guò)美國(guó)FDA注冊(cè)認(rèn)證,才能獲得在美國(guó)合法的銷(xiāo)售許可。
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