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

作为一家的工商服务行业销售，北京星期三企业咨询有限公司致力于为客户提供全方位的工商税务代办、公司注册、代理记账等服务。在这篇文章中，我们将着重介绍，以帮助您更加了解并顺利获得该许可证。

riod of the medical device business license is only 5 years. If the period of validity needs to be extended, the medical device trading enterprise shall apply to the original license-issuing department for the extension of the Medical Device Business License 6 months before the expiration of the validity period; 2. Have a computer information management system that meets the business quality management requirements of medical devices to ensure the traceability of products; 3. A sales record system and a quality management self-inspection system should be established; 4. If the company stops business for more than one year and does bu