Port communicationin recent years，The medical device industry is one of the important fields in emerging industries.，Shenzhen also pays special attention to。At present, Shenzhen has developed into an important industrial cluster area for my country's medical device industry.。It is well known that there are barriers to entry into the medical device industry.。Today, 52 Agency Network will explain it to you.，How to apply for a medical device license in Shenzhen，What are the procedures and conditions?。
Medical device license is a post-approval，Apply for industrial and commercial business license first,Medical device sales are indicated on the business scope。Apply for a medical device business license again。
one、Shenzhen medical device license application process：
1、Submit materials on-site to the Shenzhen Municipal Food and Drug Administration。
2、Window staff pick up，Acceptance of confirmation that meets the requirements，Those that do not meet the requirements will not be accepted。
3、Material review，If the materials are incomplete, the applicant will be required to complete them.。
4、On-site acceptance：If on-site acceptance is required, transfer to on-site acceptance，After passing the review without on-site acceptance, it will be transferred to approval.。
5、Approval，Permission will be granted if conditions are met，Those who do not meet the conditions will not be granted permission。
Medical equipment and supplies
two、Shenzhen handles Category II、Class III medical devices need to meet the following conditions::
1、Business scope with permitted matters in business license。
2、The company has legal venue certification documents：Real estate certificate、Proof of venue use or lease registration certificate and lease agreement。
3、Relevant quality manager，Operating different products requires different professional backgrounds for quality managers，At the same time, three years of management experience related to quality manager。
5、Establishment of warehouse，We still need some necessary supplies in the warehouse，If you don’t build your own cold storage for in vitro diagnostic reagents，You can find a third-party qualified cold chain warehousing and delivery company，Large equipment can also be shipped from the manufacturer，But relevant agreements must be signed。
5、Medical device operation quality management system documents。
6、Operation and management software system that meets the requirements of the Food and Drug Administration。
7、The business license for Class III medical devices is subject to on-site review by the Food and Drug Administration before issuance.。
Shenzhen Medical Device License
three、Shenzhen processing 2、Documents required for Class III medical device business license：
1、Class II medical device business registration form
2、Copies of business license and organization code certificate
3、legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate
4、Organizational Structure and Department Setup Instructions
5、Business scope、Description of business methods
6、Business premises、Geographical location map of warehouse address、floor plan、Property ownership certificate or a copy of the lease certificate issued by the house leasing agency
7、Business facilities、Device catalog
8、Operation quality management system、Work program and other file directories
9、Certificate of authorization of the person in charge。
at presentApply for medical device license in ShenzhenIt needs to comply with the "Regulations on the Supervision and Administration of Medical Devices" revised on June 1, 2014. The above is what 52 Agency Network interprets.Apply for medical device licensehour，A very large amount of information needs to be prepared。And when applying, you still need to go through multiple approval processes.，Therefore, companies in Shenzhen can consult the 52 Agency Network when applying for medical device qualifications.，Provide you with professionalShenzhen medical device license agency service。
more aboutMedical device license informationPlease check the columns of 52 Agency Network。
