Medical device business license handling some enterprise bosses are operating class I, II and III medical devices. They don't know what license to handle,It's not correct to always think that it's necessary to apply for the business license of medical devices,Now let's explain the latest medical device regulations and policies, and the difference between handling the business license of class 123 medical devices and filing:According to the latest Regulations on the supervision and administration of medical devices (Order of the State Council No650number)and Code for quality management of medical device operation ,First of all, we should understand that medical devices are divided into three categories Class I Class II three classes of initials,At present, the operation of class I products does not need to apply for the operation license of medical devices,For the operation of class II products, it is necessary to handle the business Filing Certificate of class II medical devices,Operating three types of products is to apply for the business license of medical devices.

What are the materials that medical device business enterprises need to submit when applying for class II medical device business filing and class III medical device business license?See the following guidelines for details

Application materials required for applying for class II medical device business Filing Certificate

1.Class II medical device business record form

2.Copy of business license and organization code certificate

3.Legal representative Person in charge of the enterprise Identification of the person in charge of quality Copy of education or professional title certificate

4.Organization and department setting description

5.Nature of Business Description of business mode;

6.place of business Geographical location map of warehouse address plan A copy of the house property right certificate or the lease certificate issued by the house lease;

7.Operating facilities Equipment catalog;

8.Operation quality management system Directory of working procedures and other documents;

9.Certificate of authorization of handler.

The materials required for applying for medical device business license are as follows

matters needing attention Before submitting the written declaration materials,The pre-trial application for administrative license shall be submitted online through the comprehensive business application system of Shenzhen food and drug administration,Prequalified,When submitting paper application materials, the enterprise shall submit the pre acceptance number at the same time.

       Please seal the application materials page by page or sign by the legal representative or the person in charge of the enterprise;Materials shall be bound neatly with tie rod clips.

apply Business license of medical devices Materials to be submitted when

1. Application form for medical device business license (original script1share);

2. Business license (copy);

3.Organization code certificate(copy);

4.Legal representative Person in charge of the enterprise Identification of the person in charge of quality Certificate of educational background or professional title(copy1share);

5.Resume of quality management personnel(original script1share);

6.List of professional technicians(original script1share)ID cards of and professional technicians Academic certificate Title Certificate(Copies each1share);

7.Organization and department setting description;

8.Nature of Business Description of business mode;

9.place of business Geographical location map of warehouse address plan A copy of the house property right certificate or the house lease certificate issued by the house lease.It belongs to the third-party logistics of medical devices entrusted by the warehouse,Provide entrustment contract(copy1share,).

10.Operating facilities Equipment catalog;

11.Operation quality management system Directory of working procedures and other documents. Including procurement check before acceptance Warehousing Ex warehouse Quality tracking User feedback Adverse event monitoring and quality accident reporting system and other documents(original script1share);

12.Basic information and function description of the computer information management system installed by the enterprise handling the business license of medical devices ,Print the home page of information management system(original script1share).

13.When applying for enterprise application materials,The handling personnel are not the legal representative or the person in charge of the enterprise,The enterprise shall submit Power of attorney (original script1share).

14.Self assurance statement on the authenticity of application materials,Including the catalogue of application materials and the enterprise's commitment to bear legal liability for false materials(original script1share).