What are the differences between how to apply for Class 1, 2 and 3 medical device licenses in Shenzhen?

How to apply for Class 1, 2 and 3 medical device licenses in Shenzhen? What are the differences and core tips?：Applying for a medical device business license. Many medical device business companies operating Class 1, 2 and 3 medical devices don’t know what license to apply for.，I always think that everyone needs to apply for a medical device business license, but there is no medical device business license. Many medical device business companies operating Class 1, 2 and 3 medical devices do not know what license to apply for.，It is always wrong to think that you need to apply for a medical device business license.，actually，According to the latest "Regulations on the Supervision and Administration of Medical Devices"(State Council Order No. 650)and "Medical Device Operations Quality Management Standards"，First of all, we must understand that medical devices are divided into three categories:：A category、Category II、Category three，Currently, operating a category of products does not require a medical device business license.，Operating Category II products requires a Category II medical device business registration certificate，Only those who operate three types of products need to apply for a medical device business license.，So what materials do medical device operating companies need to submit when applying for Class II medical device business registration and Class III medical device business licenses??Please refer to the following service guide for details：For commercial medical device license application, just find one，Application materials required to apply for Class II medical device business registration certificate：

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。

The following materials are required to apply for a medical device business license:：

Things to note

：Before submitting written application materials，Administrative license pre-review applications should be submitted online through the Shenzhen Food and Drug Administration's comprehensive business application system，Passed pre-examination，Enterprises must submit this pre-acceptance number when submitting paper application materials.。Application materials must be stamped page by page or signed by the legal representative or person in charge of the enterprise.;Please use tie rod clamps to bind the materials neatly。

Application for commercial medical device license·Find out the materials that need to be submitted when applying for the "Medical Device Business License"：

1. "Medical Device Business License Application Form"(1 original copy);
2. "Business License"(a copy);
3. Organization code certificate(a copy);
4. legal representative、Business person in charge、Proof of identity of the quality manager、Educational qualifications or professional title certificate(1 copy);
5. Quality manager resume(1 original copy);
6. List of professional and technical personnel(1 original copy)and ID cards of professional and technical personnel、Education certificate、Professional title certificate(1 copy each);
7. Organizational Structure and Department Setup Instructions;
8. Business scope、Description of business methods;
9. Business premises、Geographical location map of warehouse address、floor plan、Housing property ownership certificate or a copy of the housing rental certificate issued by the housing rental agency。

It is a third-party logistics for medical devices entrusted by warehousing，Provide entrustment contract(1 copy，)。

1. Business facilities、Device catalog;
2. Operation quality management system、Directory of documents such as work procedures, 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);
3. Basic introduction and function description of the computer information management system installed by enterprises applying for medical device business licenses，Print the home page of the information management system(1 original copy)。
4. 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)。
5. 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)。For commercial medical device license application, just look for it

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