1、医疗器械经营许可证的有效期只有5年。有效期届满需要延续的，医疗器械经营企业应当在有效期届满6个月前，向原发证部门提出《医疗器械经营许可证》延续申请。

2、应当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，保证经营产品的可追溯。

3、应当建立销售记录制度和建立质量管理自查制度。

4、自行停业一年以上，重新经营时，应当提前书面报告所在地设区的市级食品药品监督管理部门，经核查符合要求后方可恢复经营。

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一、三类医疗器械经营许可证如何办理

1、很多药品或者医疗器械的经销商，如果没有三类医疗器械经营许可证，很多产品就不能卖，比如说体外诊断试剂就属于三类医疗器械，只有有相关证书，才能销售这种产品。

5 years. If the term of validity needs to be extended upon expiration, the medical device trading enterprise shall, 6 months before the expiration of the validity period, apply to the original license issuing department for the renewal of the Medical Device Business License. 2. There shall be a computer information management system that meets the quality requirements of business management of medical devices to ensure the traceability of business products. 3. A sales record system and a quality management self-inspection system shall be established. 4. When suspending business for more than one year and re-operating, it shall submit a written report in advance to the food and drug supervisory and administrative department of the city where it i