注：二類(lèi)醫(yī)療器械備案有效期為長(zhǎng)期，到期前6個(gè)月到所在地設(shè)區(qū)的市級(jí)食品藥品監(jiān)督管理部門(mén)換發(fā)二類(lèi)醫(yī)療器械備案新憑證

三、公司增加三類(lèi)醫(yī)療器械經(jīng)營(yíng)范圍

三類(lèi)醫(yī)療器械經(jīng)營(yíng)許可證要求：

1、場(chǎng)地要求：必須是辦公性質(zhì)，使用面積要最少達(dá)到60平方米;

2、人員要求：需要有3名相關(guān)人員(公司負(fù)責(zé)人、質(zhì)量負(fù)責(zé)人、質(zhì)量檢查人員)的備案并且持有證書(shū);

3、產(chǎn)品要求：必須要有合乎業(yè)務(wù)范圍的產(chǎn)品信息，并出具證書(shū);

4、其他相關(guān)法律法規(guī)要求。

經(jīng)營(yíng)三類(lèi)類(lèi)醫(yī)療器械的，應(yīng)具備與經(jīng)營(yíng)規(guī)模相適應(yīng)的經(jīng)營(yíng)場(chǎng)所和庫(kù)房

1.經(jīng)營(yíng)類(lèi)代號(hào)為三類(lèi)-6821醫(yī)用電子儀器設(shè)備、三類(lèi)-6846植入材料人工器官、

edical devices is long-term, and the new record certificate of Class II medical devices shall be issued to the municipal food and drug regulatory department 6 months before the expiration 3. The company has increased the business scope of the three types of medical devices Re for the Business License of Class III Medical Device: 1, site re: must be office nature, the use area of at least 60 square meters; 2. Personnel re: 3 relevant personnel (company responsible person, responsible person, inspection personnel) need to record and hold the certificate; 3, product re