Medical device application conditions and procedures

medical device

Application conditions

and

Process

医疗行业是一个需要有严谨态度的领域，Establishment of medical device companies，Although it is still for profit，But it seems that it also fills in a sense of mission to treat illnesses and save lives.。The medical device industry has become increasingly prosperous in recent years.，Many investors want to operate medical devices，bid，Financing，Enter the medical device industry。首先需要解决的问题就是设立医疗器械公司。

A type of medical device is like a band-aid，It is very routine to ensure its safety.，For example;基础外科用具听诊器拆线剪拔牙钳眼科耳鼻喉科口腔科基础用具创可贴消毒棉计生用品止痛贴二类医疗器械是需要对安全性有效性加以控制的，Mainly medical electronic equipment，Operating Class II medical devices requires registration；Class III medical devices are potentially dangerous，需要严格控制安全有效性的是维持生命的设备，Such as pacemakers implanted in the human body, etc.，Mainly sterile and implantable。

Class III medical devices require a medical device business license before they can carry out specific activities。申请医疗器械经营企业许可证办理需要的材料

1. Industrial and commercial business license。
2. Application report。
3. Business premises、Documentation proving the warehouse location，Include a copy of the property certificate or lease agreement and the lessor’s property certificate。
4. Business premises、Warehouse layout plan。
5. Person in charge of formulating the law、Business person in charge、Quality manager’s ID card、Copy of academic certificate or professional title certificate and resume。

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