注：二類醫(yī)療器械備案有效期為長期,，到期前6個月到所在地設區(qū)的市級食品藥品監(jiān)督管理部門換發(fā)二類醫(yī)療器械備案新憑證

三,、公司增加三類醫(yī)療器械經(jīng)營范圍

三類醫(yī)療器械經(jīng)營許可證要求：

1、場地要求：必須是辦公性質(zhì),，使用面積要最少達到60平方米;

2,、人員要求：需要有3名相關人員(公司負責人,、質(zhì)量負責人、質(zhì)量檢查人員)的備案并且持有證書;

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

4、其他相關法律法規(guī)要求,。

經(jīng)營三類類醫(yī)療器械的,，應具備與經(jīng)營規(guī)模相適應的經(jīng)營場所和庫房

1.經(jīng)營類代號為三類-6821醫(yī)用電子儀器設備、三類-6846植入材料人工器官,、三類-6863口腔科材料,、三類-6877介入器材產(chǎn)品的，經(jīng)營場所使用面積不得少于100平方米,，庫房使用面積不得少于40平方米,。

lidity period of class II medical 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, the site re: must be the office nature, the use of the area to reach 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: must have the product information in accordance with the business