Because it is to the municipal Food and Drug Administration, the standards and materials may not be exactly the same in each place. The following is an example of Beijing:
1. "The second class of medical equipment business filing form";
2. A copy of the business license and organization code certificate (check the original); applicants holding business licenses issued by the administration for industry and commerce loaded with a unified social credit code, without the need to submit the organization code certificate;
3. Legal representative, the person in charge of the enterprise, Quality person in charge of identification, education or title certificate; (submit the original)
4. Organization and departmental setup description;
5. Business premises, storage location map, floor plan (indicating the area), storage of property rights and proof of use of a copy of the certificate; (commissioned by the storage should be submitted to the commissioned party to sign a copy of the written agreement, commissioned parties) Copy of the "Medical Device License" and "other medical device manufacturers and operators to provide storage and distribution services for the record" copy)
6. Business facilities, equipment directory;
7. Business quality management system, work procedures and other documents directory;
8. Computer information management system basic information and functional description (if any);
9. Where the application for the enterprise declaration materials, the specific processing personnel is not the legal representative or person in charge of himself, the enterprise should submit a "power of attorney";
10. Declaration of authenticity of the declaration material self-assurance statement, and the material to make a commitment to bear legal responsibility in the event of a false.
I. Class II medical device filing requirements
1. commercial nature of the office 80 square feet, 60 square feet of warehousing
2. 3 medical professionals as the person in charge of the enterprise
3. product business directory
Note: meet the above 3 points, basically can be for the record of Class II medical devices
Two. Requirements Submissions
1. Class II medical device filing application
2. Business license or pre-approval of the name notice
3. Legal representative, the person in charge of the enterprise, the person in charge of quality of the identity card, education or title certificates a copy of the copy of the
4. Business premises, warehouse address of the geographic location of the map, the floor plan, the documents of proof of ownership of housing or Lease agreement (with documents proving ownership of the house) copy
5. Product business catalog list
6. Product qualification certificates
7. Purchase and sales contracts from the previous owner, purchase channels
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