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。
vices to ensure the traceability of products; 3. A sales recordsystem 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.