Class II medical qualification

As we all know, since June 2014, the scope of business involves the operation of Class II medical devices business enterprises should fill out the Class II medical device business filing form to the location of the municipal food and drug supervision and management department for the record, and submit to meet the requirements of the Class II medical device business filing materials for the record. So, the second class of medical qualification how to handle, what materials are needed? After reading the Ape Creator this introduction you will understand to

1, the second class of medical qualification how to handle

(1) apply for

Pharmacovigilance department to check whether the application information is consistent with the basic requirements, to decide whether to accept or not to accept the application. Not accept the decision to apply; (application for the need to fill out as many as nearly a hundred pieces of information, acceptance of the application staff, such as any one of the information found to fill out the problem will need to be returned to modify, such as the discovery of major non-conformity is directly detained application)

(2) on-site review of the drug administration department to assign one to three auditors to the enterprise business on-site audits, audits, the way the on-site questioning assessment and on-site examination and assessment of the inspection, and truthful records Audit information and give audit conclusions, such as failure to meet the requirements of the enterprise can be required to rectify until the rectification meet the requirements, such as rectification _ do not meet the requirements of the notice given by the non-license.

(3) evaluation, publicity, licensing

that is, the leadership of the drug supervision department to approve the relevant information to decide whether to give the business license, such as through the evaluation of the relevant information on the relevant website on the business information for publicity, publicity without objection to notify the enterprise to receive the license to operate medical devices.

2, for the second class of medical qualification materials needed

(1) business license and organization code certificate copy;

(2) legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity card, education or title certificate copy;

(3) organization and departmental setting description;

(4) ) (4) business scope of business mode description;

(5) business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copy;

(6) business facilities, equipment catalog;

(7) business quality management system, work procedures and other documents catalog;

(8) computer information management system Basic information and functional description;

(9) Proof of authorization of the operator;