Medical device business license application process disclosure

不同的工作都有自身的工作内容,如果可以对医疗器械经营许可证

Application process

披露的工作内容都有更好的了解,这样才可以更好的完成相关方面的工作.如果不是提前对相关方面的工作都有认识,很多事情就不会是如此的顺利.现在我们就来对总体上涉及到的工作内容都有更好的认识,这些对我们都是极为关键的.类医疗器械是风险程度低、Implementing routine management can ensure the safety and effectiveness of medical devices，Like a scalpel、surgical scissors、Manual hospital bed、medical ice pack、Cooling patches, etc.，Its products and production activities are subject to registration management by the local districted municipal food and drug regulatory authorities.。

All business activities will be liberalized，No permission or registration required，You only need to obtain a business license issued by the industrial and commercial department。Medical device business license

Application process

披露第二类医疗器械是具有中度风险，Medical devices that require strict control and management to ensure their safety and effectiveness，For example, the common band-aids in our daily life、condom、thermometer、sphygmomanometer、oxygen concentrator、Atomizer, etc.。

Its products and production activities are licensed and managed by provincial food and drug regulatory authorities.，Medical device business license

Application process

披露经营活动由设区的市级食品药品监管部门实行备案管理;Class III medical devices are those with higher risks，Medical devices that require special measures to be strictly controlled and managed to ensure their safety and effectiveness，For example, a common infusion set、syringe、intravenous indwelling needle、heart stent、Ventilator、CT、NMR, etc.，代办医疗器械许可证公司认为其产品和生产经营活动分别由国家总局、省级食品药品监管部门和设区的市食品药品监管部门实行许可管理医疗器械经营许可证

Application process

Show off。

Medical device business license

Application process

披露场地

Require

：

1. The usable area of ​​the business premises should be no less than 40 square meters，The usable area of ​​the business premises of a branch of a legal entity shall be no less than 25 square meters.(Except for those set up across districts and cities);Dealer of hearing aids，The usable area of ​​the business premises should not be less than 25 square meters;Those who deal in contact lenses and care solutions，The usable area of ​​the business premises should not be less than 10 square meters。
2. The usable area of ​​the warehouse should be no less than 30 square meters;Dealing in disposable sterile medical equipment，The warehouse should be in the same building，The usable area should be no less than 200 square meters。
3. quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management，College degree or above or intermediate technical title or above in related majors。

Dealing in disposable sterile medical equipment,There should also be more than one internal auditor holding a medical device quality management system internal auditor certificate and other relevant

Application conditions

。If you are：The materials submitted for approval are not up to standard! The business address is not up to standard! There is no warehouse! The warehouse is unqualified! Worry without a professional quality manager!

please call us，A professional team will assist you throughout the entire process，Let your business be put into operation as soon as possible，Medical device business license

Application process

披露解除您的烦恼和后顾之忧！本文内容严禁任何网站和个人转载，Violators will be prosecuted。Related products：Medical device transfer , Medical device registration , Apply for medical devices

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