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Shenzhen Class II and III medical device business license application process and registration conditions

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,Apply for a medical device business license,有需求的朋友请联系港信通-.投资者们应该都了解过医疗器械有三种类型,It can also be said that they are divided according to safety level standards.,A type of medical device is like a band-aid,It is very routine to ensure its safety.,二类医疗器械是需要对安全性有效性加以控制的,Like electric wheelchair etc.,Operating Class II medical devices requires registration;Class III medical devices are potentially dangerous,Need to strictly control safety and effectiveness,It's a life-sustaining device,Such as pacemakers implanted in the human body, etc.,Class III medical devices require a medical device business license before they can carry out specific activities。

在深圳地区对二类医疗器械进行备案对三类办理医疗器械经营许可证需要到深圳市食品药品监督管理局提交申请办理

Process

In simple terms,Application materials need to be submitted,Acceptance of confirmations that meet the conditions,Approval of materials,Need ready acceptance,机关人员会派专人到申请单位实地考察场地人员等是否符合办理

Require

Food and Drug Administration for approval,For those who meet the application conditions,Qualification certificates will be issued to enterprises with complete application materials.。申请备案的下发第二类医疗器械经营备案凭证,Issuing a medical device business license for the third category,The license is valid for 5 years,There is no time limit for filing。Want to know more about the registration conditions?,

Process

了解经营的产品是几类医疗器械的朋友请联系港信通-.


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