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。

2.經(jīng)營類代號為三類-6815注射穿刺器械、三類-6845體外循環(huán)及液處理設備、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)營場所使用面積不得少于60平方米，庫房使用面積不得少于80平方米。

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

 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 operating three types of medical devices, it shall have a business site and warehouse suitable for 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 dre