6）新法律法規

7）員工檔案等

現場核查成功后一周內就可以拿證了。

我公司主要經營代辦北京醫療器械公司注冊|代辦北京三類醫療器械公司注冊|代辦北京二類醫療器械備案憑證|代辦北京食品經營許可證|代辦北京醫療器械網絡備案|代辦北京輻射安全許可等資質專項審批服務

三類醫療器械指的是植入人體，用于支持、維持生命，對人體具有潛在危險，對其安全性、有效性必須嚴格控制的醫療器械。現行制度規范下，經營三類醫療器械的經營主體需要按程序辦理三類醫療器械經營許可證。

那么在北京如何辦理三類醫療經營許可證，辦理許可證又有哪些條件及流程，小編今天帶著滿滿的干貨知識與您分享。

三類醫療器械常見產品有哪些：

植入式心臟起搏器、體外震波碎石機、病人有創監護系統、人工晶體、有創內窺鏡、超聲手術刀、彩色超聲成像設備、激光手術設備、高頻電刀、微波緩解儀、醫用核磁共振成像設備、X線緩解設備、醫用高能設備、人工心肺機、內固定器材、人工心臟瓣膜、人工腎、呼吸麻醉設備、一次性使用無菌注射器、一次性使用輸液器、輸血器、CT等。

三類申請醫療器械經營許可證條件：

1.具有與經營規模和經營范圍相適應的質量管理機構或者專職質量管理人員。質

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