3.营业场所证明和地理位置图。
办理后的注意事项
1.医疗器械经营许可证的有效期只有5年。有效期需要延长的，医疗器械经营企业应当在有效期届满前6个月向原发证部门申请延期《医疗器械经营许可证》；
2.具有符合医疗器械经营质量管理要求的计算机信息管理系统，确保产品的可追溯性；
3.应建立销售记录制度和质量管理自查制度；
4.自行停业一年以上又重新营业的，应当提前向所在地设区的市级食品药品监督管理部门书面报告，经核实符合要求后方可恢复营业。
一、背景介绍
m and a quality management self-inspection system should beestablished; 4. If the company stops business for more than oneyear and does business again, it shall make a written report inadvance to the food and drug supervisory and administrativedepartment of the city divided into districts is located, andresume business only after verifying that it meets therequirements. 1. background information
