2, business license and organization code certificate copy (positive, copy)
3, legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity, education or title certificate copy
4, organization and departmental setup description (organizational framework, departmental functions, practitioners roster)
5, the scope of business, mode of operation (three kinds of medical devices business scope, mode of operation, with the same content as the application form) p>5, the scope of business, business mode description (three types of medical equipment business scope, business mode, and the application form to fill in the same content)
6, business premises, warehouse address geographic location map (labeled with the name of the street and the surrounding landmark buildings), floor plan (indicating the size, area and regional division), documents proving ownership of the house or lease agreement (with the ownership of the house) copy Proof of documents) copies
7, business facilities, equipment directory (office and warehousing facilities and equipment, refrigerated product storage and transportation equipment, refer to Chapter IV of the specification)
8, business quality management system, work procedures and other documents directory (must contain the specification of Article VIII, Article IX requirements of the system)
9, the basic introduction of computerized information management systems and Functional description (software name, fact sheet, functional description of reference norms, Article 30)
10, proof of authorization of the operator (name, identity card number, authorization period, authorization, and attach a copy of the ID card)
11, medical device business (business) license original and copy (original and copy)
12, other supporting materials
Enterprise quality person in charge of the number of years of experience in the field of proof, enterprise quality acceptance of personnel identity cards, copies of academic certificates.
Diagnostic reagents require a copy of the medical device personnel identification, education or title certificate.
Implantation and interventional medical devices business personnel identification, education or title certificate copy and the manufacturer or supplier training certificate.
Corneal contact lenses, hearing aids and other medical devices with special requirements of the operator's identity card, certificate of education or professional qualifications.
Documentation of cold chain verification of diagnostic reagents. (including cold storage and transportation equipment).
Declaration of information authenticity commitment.