三类医疗器械经营许可证办理所需大致资料:

1、企业经营执照;2、企业负责人以及质检人员和技术人员的身份、学历、职称证明;3、经营场所证明以及地理位置图。

三类医疗器械经营许可证办理之后需要明确的几个注意事项

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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pon expiration, the medical device trading enterprise shall, 6 months prior to the expiration of the validity period, apply to the original issuing department for renewal of the license. 2. It shall have 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