北京星期三企业管理咨询有限公司业务部
工商注册 , 资质审批 , 代理记账 , 建委资质 , 舞美资质 , 拍卖资质
顺义石园北京医疗器械三类经营许可证,医疗器械二类备案提供进销存软件库房速度快专业方便,

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。

关于在京办理三类医疗器械经营许可证的更多问题,欢迎私信小编,

 after handling the business license of class III medical devices 1. The validity period of the medical device business license is only 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. It shall have a computer information management system that meets the requirements of business quality 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 i


展开全文
相关产品
拨打电话 发送询价