东城东单北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富靠谱周期短Zui快7天下证

是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。比如我们日常生活中常见的体温计、血压计、心电图仪、雾化器等。

第3类:

是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。比如常见的销售xinguan实际检测盒、隐形眼镜、注射器、静脉留置针、心脏支架、呼吸机、ct、核磁共振等。

医疗器械经营许可证现为后置审批，有效期为5年。有效期届满需要延续的，依照有关行政许可的法律规定办理延续手续。

一、三类医疗器知械许可证注册所需材料

1、企业名称与经营范围，注册资本及股东出资比例，股东等身份证明;

2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;

3、质量管理文件等;

and management to ensure its safety and effectiveness. forexample, in our daily life, the common thermometer,sphygmomanometer, electrocardiogram instrument, atomizer and so on.category 3: it is a medical device with high risk and needs to takespecial measures to strictly control and manage it to ensure itssafety and effectiveness. for example, the common sales of covactual detection box, contact lenses, syringe, intravenousindwelling needle, heart stents, ventilators, ct, nuclear magneticresonance, etc. the medical device business license is nowpost-approval and valid for 5 years. if the term of validity needsto be extended upon expiration of the term, the extensionprocedures shall be handled in accordance with the relevant legalprovisions of the