三、公司增加三類醫(yī)療器械經(jīng)營(yíng)范圍

三類醫(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;

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;

4、其他相關(guān)法律法規(guī)要求。

經(jīng)營(yíng)三類類醫(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)類代號(hào)為三類-6821醫(yī)用電子儀器設(shè)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(yíng)場(chǎng)所使用面積不得少于100平方米，庫(kù)房使用面積不得少于40平方米。

2.經(jīng)營(yíng)類代號(hào)為三類-6815注射穿刺器械、三類-6845體外循環(huán)及液處理設(shè)備、三類-6864醫(yī)用衛(wèi)生材料及敷料、三類-6865醫(yī)用縫合材料及粘合劑、三類-6866醫(yī)用高分子材料及制品的,經(jīng)營(yíng)場(chǎng)所使用面積不得少于60平方米，庫(kù)房使用面積不得少于80平方米。

3.從事類代號(hào)為三類-6822醫(yī)用光學(xué)器具、儀器及內(nèi)窺鏡設(shè)備(jinxian軟性角膜接

son, inspection personnel) need to record and hold the certificate; 3, product re: must have the product information in accordance with the business scope, and issue a certificate; 4. Other relevant laws and regulations and re. For three types of medical devices, it shall have a business site and warehouse suitable with the scale of operation 1. If the business code is class III-6821 medical electronic e, Class III-6846 implant materials artificial organs, Class III-6863 stomatology materials, class III-6877 interventional e products, the use area of the business site shall not be less than 100 square meters, and the warehouse area shall not be less than 40 square meters. 2. Business class code for three-6815 injection puncture instruments, three-6845 extracorporeal circulation and liquid treatment e, three-6864 medical health materials and dressings, three-6865 medical suture materials and adhesives, three-6866 medical polymer materials and products, premises use area of not less than 60 square meters, warehouse use area shall not be less than 80 square meters. 3. Engaged in class III-6822 me