Port communication2020Site requirements and material list for Shenzhen’s application for Class III medical device business license in 2019。
Class III medical device license application is a medical device classification，The most difficult one。Class III medical devices refer to：refers to implantation into the human body，for support、sustain life，Potentially dangerous to human body，to its security、Medical devices whose effectiveness must be strictly controlled。Such as various syringes、infusion set、pacemaker、artificial heart valve、artificial joint、Vascular stents, etc.。
one、Shenzhen applies for Category IIIMedical device business licenseVenue requirements：
1、(52 Agency Network recommends renting a venue of no less than 80 square meters.，Easy to approve)。
2、Office space rental certificate (the area of the apartment is not less than 80㎡)、lease contract、floor plan；Building fire protection design review opinion letter、Letter of opinion on building fire protection acceptance (the copy must be stamped with the official seal of the management office)。
3、Sign a third-party logistics warehousing agreement，Area≥40㎡，A third party provides documents proving property ownership or use rights、Geographical location map、floor plan indicating area、Indoor layout plan。
Medical equipment
two、List of materials for applying for a Class III medical device business license in Shenzhen：
1． "Medical Device Business License Application Form" (1 original copy)。
2． "Business License" (copy)。
3、Organization code certificate (copy)
4、ID card of the legal representative of the enterprise (1 copy，(check the original)。
5、Business person in charge、ID card of quality management personnel、Education certificate or professional title certificate (1 copy，(check the original)；Quality management personnel’s resume (1 original copy)。
6、List of professional and technical personnel (1 original) and ID cards of professional and technical personnel、Education certificate、Professional title certificate (1 copy each)，(check the original)。
7、Business premises、Floor plan of the warehouse site and documents proving the property or use rights of the warehouse (1 copy)。It is a third-party logistics for medical devices entrusted by warehousing，Provide entrustment contract (1 copy，(check the original)。
Fire protection plan of business premises floor
8、Organizational Structure and Department Setup Instructions
9、Business scope、Description of business methods
10、Business facilities、Device catalog
11、Operation quality management system、Work program and other file directories、including procurement、acceptance、Warehouse、out of warehouse、Quality tracking、User feedback、Adverse event monitoring and quality incident reporting system and other documents (1 original copy)。
12、Basic introduction and function description of the computer information management system installed by the enterprise，Print the home page of the information management system (1 original copy)。
13、When applying for enterprise declaration materials，The person handling the matter is not the legal representative or the person in charge of the enterprise himself，The enterprise should submit a "Power of Attorney" (1 original copy)。
14、 Self-guarantee statement on the authenticity of application materials，Including the catalog of application materials and the company's commitment to bear legal responsibility if the materials are false (1 original copy)
Medical device business license
Replenish：When applying for a license，Proof of rental of office space is required，The requirement for each district in Shenzhen is that the area of the apartment should not be less than 80 square meters.，Ability to provide building fire protection design review opinions。The warehouse can be self-owned，It can also be a third-party medical device company with relevant qualifications。Then you need to sign a logistics and warehousing agreement, etc.。
52Agency network，It is an excellent enterprise service organization in China，Have excellent handling personnel and related medical device service resources，Can help customers quickly complete the application for medical device related qualifications，Even including the registration and filing of medical devices。It is recommended to learn more aboutSite requirements and material list for applying for a Class III medical device business licenseof customers，You can call directly for consultation。
