的备案并且持有证书;
3、产品要求：必须要有合乎业务范围的产品信息，并出具证书;
4、其他相关法律法规要求。
经营三类类医疗器械的，应具备与经营规模相适应的经营场所和库房
1.经营类代号为三类-6821医用电子仪器设备、三类-6846植入材料人工器官、三类-6863口腔科材料、三类-6877介入器材产品的，经营场所使用面积不得少于100平方米，库房使用面积不得少于40平方米。
2.经营类代号为三类-6815注射穿刺器械、三类-6845体外循环及液处理设备、三类-6864医用卫生材料及敷料、三类-6865医用缝合材料及粘合剂、三类-6866医用高分子材料及制品的,经营场所使用面积不得少于60平方米，库房使用面积不得少于80平方米。
materials, class III-6877 interventional equipment products, theuse area of the business site shall not be less than 100 squaremeters, and the warehouse area shall not be less than 40 squaremeters. 2. Business class code for three-6815 injection punctureinstruments, three-6845 extracorporeal circulation and liquidtreatment equipment, three-6864 medical health materials anddressings, three-6865 medical suture materials and adhesives,three-6866 medical polymer materials and products, premises usearea of not less than 60 square meters, warehouse use area shallnot be less than 80 square meters.
