Legal analysis: medical device license is divided into three categories, including a class of medical device license can be directly for the second class of medical device license need to be filed for processing, the third class of medical device license need to be approved by the relevant departments before processing. The medical device license is used for the operation of medical devices used to handle the applicant needs to provide the product certificate of the device, as well as proof of business premises.
Legal basis: State Drug Administration "medical equipment business license management measures"
Article VII of the application for the "medical equipment business license" must be through the (food) drug supervision and management department of the inspection and acceptance.
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments should be based on this approach, combined with the actual situation in the jurisdiction, to develop medical device business enterprise inspection and acceptance standards, reported to the State Food and Drug Administration for the record.
Article VIII of the "medical device business license" set out the scope of business should be in accordance with the medical device classification directory of the management category, class code name to determine.
Article X Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal (food) drug supervision and management agencies to accept the entrusted area should be in its administrative website or application acceptance place to apply for the "Medical Device Business License" required conditions, procedures, deadlines, the need to submit all the materials directory and the application form model text.
Article XI of the application for "Medical Device Business License", the following information shall be submitted:
(A) "Medical Device Business License Application Form";
(B) the industrial and commercial administration department issued by the business name pre-approval of the supporting documents;
(C) the proposed quality management personnel's identity card, academic qualifications or professional title certificate Copies and biographical information;
(D) the proposed enterprise organization and functions;
(E) the proposed enterprise registered address, warehouse address geographic location map, floor plan (indicating the area), proof of property rights (or lease agreement) copy;
(F) the proposed enterprise product quality management system documents and storage facilities, equipment catalog;
(VII) the proposed enterprise business management system, business management and management of the enterprise; and
(VII) the proposed business scope of the enterprise.