Port communicationMedical device license is divided into one category of medical device license，Class II medical device business license，Class III medical device business license。The device license for Category I has been cancelled.，Currently, mainly Class II and III devices require a business license.。Below, 52 Agency Network will explain it to you.，What conditions and materials are needed to apply for a medical device license in Shenzhen?
medical device
one、Which types of medical devices require licenses in Shenzhen?
| Classification | What medical device products mainly include |
| Category 1 | Class I medical devices are low risk、All business activities will be liberalized，No license or registration required，You only need to obtain a business license issued by the industrial and commercial department。 |
| Class II medical devices | Class II medical devices are those with moderate risk，Licensing management is implemented by provincial food and drug regulatory authorities，Issue "Medical Device Registration Certificate" and "Medical Device Production License" respectively。
Business activitiesRegistration management shall be implemented by the food and drug regulatory authorities at the districted municipal level.; |
| Class III medical devices | Class III medical devices are those with higher risks，by the State Administration、Provincial food and drug regulatory authorities and districted city food and drug regulatory authorities implement licensing management。
Issue "Medical Device Registration Certificate" separately、"Medical Device Production License"、"Medical Device Business License" |
Medical device license agency
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 certificate of internal auditor of the medical device quality management system and other relevant application conditions.。
three、Shenzhen application for registration Category II、Information that should be prepared before using Class III medical devices：
1、Prepare the business license of the registered company、A copy of the organization code。
2、Copies of the registration certificate and product technical requirements of the medical devices produced by the applying enterprise
3、Office address requirements：(Original lease voucher-office、The actual usable area is more than 80㎡，Recommend about 120㎡)、floor plan，storehouse：The actual usable area is more than 40 square meters
4、legal representative、supervisor、Copy of shareholder’s ID card and USB shield
5、legal representative、Business person in charge、Quality manager (resume) with correct identity、Educational qualifications or professional title certificate、Original medical certificate
6、Professional and technical personnel (quality managers、Acceptance personnel、computer maintenance、Warehouse personnel、repair、After-sales) ID card、Educational certificate (medical device related major)
Shenzhen Medical Device License
Four、Shenzhen medical device business license service process：
| Shenzhen Class II and III medical device license application service process |
| Sign a service contract |
| Prepare application materials |
| Submit to government authorities for review |
| Passed preliminary review |
| Make an appointment for on-site inspection by a specialist |
| Review passed |
| Get the certificate after passing the reexamination |
Medical device class II、Application time for three categories respectively：Class II medical device registration can be completed within one day after receiving the information.。The application for Class III medical devices can be completed within 40 working days after receiving the information.。
Companies trying to sell medical device products，if worried：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! You can call for detailed consultationMedical device license application。
