Mechanical product sales of industrial and commercial administration issued by the business name pre-approval documents; the proposed enterprise quality management personnel identity card, academic or professional title certificate copies and personal resume; the proposed enterprise organization and functions and other materials.
According to the "Medical Device Business License Management Measures" Article 11 Application for "Medical Device Business License", the following information should be submitted:
(a) "Medical Device Business License Application Form";
(b) Business name pre-approval of the administrative department of industry and commerce issued by the document;
(c) the proposed enterprise Quality management personnel's identity cards, certificates of academic qualifications or titles and copies of personal resume;
(D) the proposed enterprise organization and functions;
(E) the proposed enterprise registered address, warehouse address of the geographic location of the map, the floor plan (indicating the area), the proof of ownership of the house (or lease agreement) copies;
(F) the proposed enterprise product quality management system Documents and storage facilities, equipment catalog;
(vii) the proposed business scope of the enterprise.
Expanded Information: Extended information:
"Medical Device Business License Measures," Article 13 Provinces, autonomous regions and municipalities ( Food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies in accordance with the medical device business inspection and acceptance criteria for the proposed enterprise on-site verification, and review of application information in accordance with these measures.
Article XIV provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department shall within 30 working days from the date of acceptance to make a decision whether or not to issue a "medical device business license". Considered to meet the requirements, shall make a decision to grant the issuance of "medical device business license", and within 10 days of the date of the decision to the applicant to issue "medical device business license". That does not meet the requirements, shall notify the applicant in writing, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration according to law or to bring an administrative lawsuit.
Baidu Encyclopedia - Medical Device Business License Management Measures