门头沟周边北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证,
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,
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。
2、要办理三类医疗器械经营许可证,必须有相关的营业执照,一般营业执照上的经营范围这一栏,需要明确写道可以销售三类医疗器械。如果没有,需要去工商局办理增项。
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 in advance to the food and drug supervisory and administrative department of the city where it is located,