2, on-site submission of materials; window staff to receive, in line with the requirements of the confirmation of acceptance, does not meet the requirements of inadmissibility; material review, incomplete materials require the applicant to make up for the corrections; on-site acceptance: need to be accepted on-site acceptance to the site acceptance, without the need for on-site acceptance of the audit through the transfer of the approval; approval, meet the conditions of the license to be granted, do not meet the requirements of the Not licensed.
3, apply for Class II medical device business record vouchers:
4, Class II devices: refers to its safety, effectiveness should be controlled medical devices. Such as thermometers, sphygmomanometers, electrocardiographic diagnostic equipment, medical cotton wool, medical gauze, constant temperature incubators, glass cupping device.
5, need to prepare the materials are: Class II medical device business filing form; business license and a copy of the organization code certificate; legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity, education or title certificate copy; organizational structure and departmental setup description; business scope, mode of operation description; business premises, warehouse address of the geographic location of the map, floor plan, home ownership Proof of documents or a copy of the lease certificate issued by the housing lease.
6, business facilities, equipment directory; business quality management system, work procedures and other documents directory; the operator's authorization certificate.
7, apply for a Class III medical device license:
8, Class III medical devices: refers to the implanted in the human body or to support the life-sustaining, potentially dangerous to the human body, the safety and effectiveness of which must be strictly controlled medical devices. Such as implantable cardiac pacemaker ground, extracorporeal shock wave lithotripter, patient invasive monitoring system.
9, the enterprise should also provide the following information: business license, a copy of the organization code certificate; applying for the production of medical devices held by the enterprise registration certificate and a copy of the technical requirements of the product; legal representative, a copy of the identity of the person in charge of the enterprise; production, quality and technology responsible for the identity of the person in charge, a copy of the academic qualifications, professional titles; production management, quality inspection positions of the practitioner's academic qualifications, List of titles; production site documents, there are special production environment requirements should also be submitted to the facilities, environment, copies of documents; the main production equipment and inspection equipment directory; quality manuals and procedural documents, process flow diagrams, authorization certificates of the operator; other.