What documents are required to operate Class II medical devices

The second class to the municipal bureau for the record, submit the following information:

Business license, organization code certificate

Corporate person, the person in charge of the enterprise, the person in charge of quality of the identity of the person, academic qualifications, title certificate

Organizational structure and departmental setup description

Operational scope, mode of operation description

Business premises, depot address of the location, floor plan, Proof of house ownership, lease agreement

Business facilities, equipment directory

Business quality management system, work procedures, etc.

Computer information management system basic information and functional description

Certificate of authorization of the operator

Other supporting materials

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