代办备案广州和深圳医疗器械资质资料有哪些

作为在医疗器械行业十年工作经历的我来说，做的越久也越认识到学海无涯，如何灵活运用各种操作来满足法律条款

Require

，一直都是摆在行业人士的一道永远没有终点的答卷。在此奉劝各位行业朋友万不可掉以轻心、万万不可触碰法律的红线而违法经营！合法经营在紧急关头永远能确保企业平安。

If you choose an agency, you should choose one with strong technical capabilities.—-港信通国际为您服务！

广州和深圳医疗器械办理资料有哪些条件：

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,还应当有一名以上持有医疗器械质量管理体系内审员正书的内审员等其他相关

Application conditions

。

广州和深圳医疗器械办理资料有哪些：

1. business license、A copy of the organization code
2. Apply for the registration certificate and product technology of the medical devices produced by the enterprise

Require

a copy

1. legal representative、企业负责人身份正明复印件
2. Production、Identity of quality and technical manager、Educational qualifications、职称正明复印件
3. Production management、Educational qualifications of employees in quality inspection positions、List of professional titles
4. Official documentation of the production site，Have a special production environment

Require

facilities should also be submitted、环境的正明文件复印件

1. Catalog of main production equipment and inspection equipment
2. Quality Manual and Procedure Documentation、Process flow chart、经办人授权正明企业主如果担心：报批材料不合格！

经营地址不达标！没有库房！库房不合格！没有专业质量管理员而烦恼！请致电我们港信通国际商务有限公司：A professional team will assist you throughout the entire process，Let your business be put into operation as soon as possible，解除您的烦恼和后顾之忧！本文严禁任何网络和个人转载，Violators will be prosecuted。

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