6）新法律法規(guī)

7）員工檔案等

現(xiàn)場(chǎng)核查成功后一周內(nèi)就可以拿證了。

我公司主要經(jīng)營(yíng)代辦北京醫(yī)療器械公司注冊(cè)|代辦北京三類(lèi)醫(yī)療器械公司注冊(cè)|代辦北京二類(lèi)醫(yī)療器械備案憑證|代辦北京食品經(jīng)營(yíng)許可證|代辦北京醫(yī)療器械網(wǎng)絡(luò)備案|代辦北京輻射安全許可等資質(zhì)專(zhuān)項(xiàng)審批服務(wù)

三類(lèi)醫(yī)療器械指的是植入人體，用于支持、維持生命，對(duì)人體具有潛在危險(xiǎn)，對(duì)其安全性、有效性必須嚴(yán)格控制的醫(yī)療器械?，F(xiàn)行制度規(guī)范下，經(jīng)營(yíng)三類(lèi)醫(yī)療器械的經(jīng)營(yíng)主體需要按程序辦理三類(lèi)醫(yī)療器械經(jīng)營(yíng)許可證。

那么在北京如何辦理三類(lèi)醫(yī)療經(jīng)營(yíng)許可證，辦理許可證又有哪些條件及流程，小編今天帶著滿(mǎn)滿(mǎn)的干貨知識(shí)與您分享。

三類(lèi)醫(yī)療器械常見(jiàn)產(chǎn)品有哪些：

植入式心臟起搏器、體外震波碎石機(jī)、病人有創(chuàng)監(jiān)護(hù)系統(tǒng)、人工晶體、有創(chuàng)內(nèi)窺鏡、超聲手術(shù)刀、彩色超聲成像設(shè)備、激光手術(shù)設(shè)備、高頻電刀、微波緩解儀、醫(yī)用核磁共振成像設(shè)備、X線(xiàn)緩解設(shè)備、醫(yī)用高能設(shè)備、人工心肺機(jī)、內(nèi)固定器材、人工心臟瓣膜、人工腎、呼吸麻醉設(shè)備、一次性使用無(wú)菌注射器、一次性使用輸液器、輸血器、CT等。

三類(lèi)申請(qǐng)醫(yī)療器械經(jīng)營(yíng)許可證條件：

1.具有與經(jīng)營(yíng)規(guī)模和經(jīng)營(yíng)范圍相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者專(zhuān)職質(zhì)量管理人員。質(zhì)

rtificate within a week after the successful on-site verification. My company main business agent Beijing medical e company registration | agent Beijing three types of medical e company registration | agent Beijing class medical e for the record certificate | Beijing food business license | Beijing medical e network for the record | Beijing radiation safety license special examination and approval services Class III medical devices refer to the medical devices implanted in human body to support and maintain life, with potential danger to human body, and their safety and effectiveness must be strictly controlled. Under the current system and norms, the business entities of third class medical devices need to apply for the business license