庫(kù)、出庫(kù)，實(shí)現(xiàn)產(chǎn)品在流通環(huán)節(jié)可追溯。

醫(yī)療器械經(jīng)營(yíng)許可證申請(qǐng)須知

醫(yī)療器械經(jīng)營(yíng)許可證是醫(yī)療器械經(jīng)營(yíng)企業(yè)必須具備的，開(kāi)辦第二類(lèi)醫(yī)療器械經(jīng)營(yíng)企業(yè)，應(yīng)當(dāng)向省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)備案；

開(kāi)辦第三類(lèi)醫(yī)療器械經(jīng)營(yíng)企業(yè)，應(yīng)當(dāng)經(jīng)省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)審查批準(zhǔn)，并發(fā)給《醫(yī)療器械經(jīng)營(yíng)許可證》。

依據(jù)《醫(yī)療器械經(jīng)營(yíng)監(jiān)督管理辦法》，開(kāi)設(shè)三類(lèi)醫(yī)療器械運(yùn)營(yíng)公司，食品類(lèi)藥品監(jiān)督管理局單位將會(huì)對(duì)經(jīng)營(yíng)地開(kāi)展當(dāng)場(chǎng)審查。對(duì)不符合要求標(biāo)準(zhǔn)的，明確提出整頓規(guī)定或未予批準(zhǔn)。根據(jù)《藥品醫(yī)療器械飛行檢查辦法》，食品類(lèi)藥品監(jiān)督管理局單位將會(huì)對(duì)醫(yī)療機(jī)械銷(xiāo)貨方式合理合法、工作人員在職人員在職、拿貨檢查、運(yùn)送儲(chǔ)存等層面開(kāi)展不事先告之的監(jiān)督管理。三類(lèi)醫(yī)療器械的界定

依據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》，第三類(lèi)醫(yī)療器械是具備較高危，必須采用非常對(duì)策嚴(yán)控管理方法以確保其安全性、合理的醫(yī)療機(jī)械。例如普遍的注射器、注射針、靜脈留置針、心臟支架、麻醉機(jī)、CT、磁共振等。

申請(qǐng)辦理三類(lèi)醫(yī)療器械許可證必須提前準(zhǔn)備的原材料

（1）企業(yè)營(yíng)業(yè)執(zhí)照；

（2）公司章；

（3）房屋產(chǎn)權(quán)證明、租賃協(xié)議；

（4）法定代表人、主要負(fù)責(zé)人、品質(zhì)管理員的身份、畢業(yè)證等證明材料；

（5）經(jīng)營(yíng)地平面設(shè)計(jì)圖，倉(cāng)庫(kù)平面設(shè)計(jì)圖。

申請(qǐng)辦理三類(lèi)醫(yī)療器械許可證的規(guī)定

（1）場(chǎng)所和倉(cāng)庫(kù)總面積規(guī)定：與經(jīng)營(yíng)地企業(yè)規(guī)模相一致。

erprise, and the establishment of the second class medical device trading enterprise shall be filed by the drug regulatory department of the people's government of the provincial, autonomous region or municipality directly under the Central Government; The establishment of a class III medical device trading enterprise shall be examined and approved by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, and a Medical Device Trading License shall be issued. According to the Measures for Supervision and Administration of Medical Device Operation, the third type of medical device operating company will be established, and the food and Drug Administration will carry out on-the-spot review of the place of operation. For those that do not meet the requir