Medical equipment business license is a medical device business enterprises must have the documents, the opening of the second class of medical equipment business enterprises, should be to the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for the record; the opening of the third class of medical equipment business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for examination and approval, and issued the "medical device business enterprise License". Medical equipment business license is now a post approval, the business administration department issued a business license to apply for approval.
Three types of medical equipment business license requires the following conditions:
1, with the scope of business to match the business premises and warehouses, and its specific area of specific requirements;
2, with nationally recognized, and business products related to the professional on duty;
3, with business products related to the possession of secondary school education or above, technical personnel
4, with the operation of medical devices and the appropriate quality management system.
"Medical Device Business License Management Measures" Article 11 Application for "Medical Device Business License" shall be submitted as follows:
(a) "Medical Device Business License Application Form";
(b) industrial and commercial administration issued by the business name pre-approval of documents;
(c) the proposed enterprise quality (C) the proposed enterprise quality management personnel identity card, a copy of proof of academic qualifications or titles and personal resume;
(D) the proposed enterprise organization and functions;
(E) the proposed enterprise registered address, warehouse address of the geographic location of the map, floor plan (indicating the area), proof of ownership of housing (or lease agreement) copy;
(F) the proposed enterprise product quality management system documents And storage facilities, equipment catalog;
(vii) the proposed business scope of the enterprise.
Article XII of the applicant shall be to the proposed business location of the province, autonomous region, municipality directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies to submit the "medical device business license" of the application for licensing.
For the applicant's "medical device business license" licensing application, the province, autonomous region, municipality directly under the central government (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies should be dealt with in accordance with the following:
(a) the application does not fall within the purview of the department, it should be made immediately inadmissible Decision, issued a "Notice of Inadmissibility", and inform the applicant to the relevant departments;
(ii) application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
(iii) application materials are incomplete or do not comply with the statutory form, it should be on the spot or within five working days to the applicant to issue a "Notice of Supplementary Materials", a one-time notice of All the contents that need to be corrected. Late notification, from the date of receipt of the application materials shall be accepted;
(d) the application matters within the purview of the department, the application materials are complete, meet the statutory form, or the applicant in accordance with the requirements to submit all the corrections to the application materials, issued a "Notice of Acceptance". Notice of acceptance" should be stamped with the acceptance of the special seal and indicate the date of acceptance.