FDA Registration - FDA Medical Devices 醫(yī)療器械注冊(cè)

The U.S. Food and Drug Administration [ FDA ] requires U.S. and non U.S. companies that engage in the manufacture and importing of a medical device to register its establishment with FDA 美國(guó)食品和藥物管理局要求所有美國(guó)和非美國(guó)境內(nèi)的生產(chǎn)商, 進(jìn)口商都要對(duì)其醫(yī)療器械產(chǎn)品在FDA進(jìn)行官方注冊(cè).

We offer below service: 我們?yōu)槟峁┤缦路?wù):

•File for and obtain your FDA Owner/Operator Number. 幫助客戶提供注冊(cè)申請(qǐng)料并獲得申請(qǐng)人權(quán)限號(hào)碼.

•File for and obtain your Establishment Registration Number. 幫助客戶提供注冊(cè)申請(qǐng)資料建立賬戶并獲得注冊(cè)號(hào)

•File for and obtain your device listing Number. 幫助客戶提供注冊(cè)申請(qǐng)資料并獲得醫(yī)療器械列名號(hào) •FDA U.S. agent and official correspondent 為客戶提供美國(guó)代理人和官方聯(lián)系人服務(wù)

•510(K) Administrative review and Submission service 2類醫(yī)療器械510(k)文件審核和提交 ( the administrative review is not a review of your science, data, technology or predicate device selection. 文件的審核不包括對(duì)產(chǎn)品本身的技術(shù)參數(shù)進(jìn)行核對(duì) )

•Labeling review 醫(yī)療器械標(biāo)簽,標(biāo)識(shí)審核

Service info 服務(wù)明細(xì)：

產(chǎn)品注冊(cè)項(xiàng)目:

生產(chǎn)質(zhì)量體系及現(xiàn)場(chǎng)考核項(xiàng)目: