Port communication2020What requirements does the address need to meet when applying for a Class II medical device license in Shenzhen? What qualifications do personnel need?，And what complete materials are required to apply for a Class II medical device business license? Requirements for applying for a Class II medical device operating warehouse?
Shenzhen Medical Device Business License
one、Shenzhen applicationClass II medical device business recordRegistration address is required：
1、The office area is not less than 40 square meters；
2、The warehouse area is not less than 40 square meters;(Those containing in vitro diagnostic reagents require a refrigerated warehouse)
3、If disposable consumables are included, the office address and warehouse area together must not be less than 150 square meters.
Note：Business premises and warehouses are not allowed to be located in residential buildings
two、There are requirements for those applying for Shenzhen Class II medical device business registration：
1、A legal person who concurrently serves as the person in charge of an enterprise must have a college degree or above.，Professionalism is not required；
2、The quality manager needs to have more than 3 years of work experience，College degree or above，Graduated from related majors
three、Classified summary of requirements for applying for a Class II medical device operating warehouse：
one、Medical Devices and Equipment Category "Normal Temperature Warehouse Provided"
two、Medical device implantation and interventional category "Normal temperature library provided"
three、Medical device consumables and auxiliary materials "Provide room temperature warehouse"
Four、Medical device in vitro diagnostic reagent category "Provide warehouse cold storage"
Sales of medical device products must have a business license
Four、Materials required to apply for Class II medical device business license filing：
1.Class II medical device business registration form；
2.Copies of business license and organization code certificate；
3.Identity and academic qualification certificate of the legal representative or person in charge of the enterprise；
4.Description of corporate organization and department settings；
5.Business scope、Method description；
6.Business premises、Warehouse address rental voucher、House property ownership documents；
7.Business premises、Facilities at warehouse address、is cataloged；
8.Certificate of authorization of the person in charge；How long does it take to apply for a Class II medical device license?
9.Commitment materials for the authenticity of application materials，Signature and seal of legal person；
10.Other supporting materials。
five、Shenzhen Class II Medical Device License Renewal Guide
1.A copy of the loss statement (public media) (proofread original)；
2.A letter of authorization (with a copy of the handling person’s ID card)；
3.An application form for renewal of certificate；
4.One copy of the original "Business License" (proofread original)。
six、Documents required to cancel Class II medical device license
1、A letter of authorization (with a copy of the person’s ID card attached)；
2、Cancellation application form in triplicate；
3、"Medical Device Business Enterprise License"、copy。
Shenzhen Medical Device License
Special reminder：If you apply for a Class II medical device business license without an address、No competent inspector、No medical management software52Agency networkcan provide。
That's it，About the 2020 Shenzhen Class II Medical Device License Application Guide，Need to meet address requirements，and personnel qualifications，and complete materials required to apply for a Class II medical device business license.。
