Roughly divided into the following two parts, for reference only (the bottom is a sample):
Application conditions:
Application for "Medical Device Business License" should have the following conditions:
(a) with the scale of operation and the scope of operation of the quality management body or college degree or more quality management personnel two. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;
(e) should have its business with the medical device products appropriate technical training and after-sales service capabilities, or agreed to provide technical support by a third party.
Second, the procedure:
1, the start of the second and third class of medical equipment business enterprises, should be operating in the local food and drug supervision sub-bureau to apply for and submit the following information:
(1) "Shanghai Medical Device Business License Application Form";
(2) "Medical Device Business License Application Materials Registration Form";
p>(3) industrial and commercial administration department issued by the enterprise name pre-approval documents or "business license" copy (check the original);
(4) the proposed enterprise quality management person in charge of the identity card, education or title certificate copy and personal resume;
(5) proposed enterprise quality management personnel's identity card, education or title copy of the certificate;
(6) proposed business organization and functions or full-time quality management personnel;
(7) proposed business registration, warehouse location map, floor plan (indicating the area), proof of ownership of the house or a copy of the lease agreement (accompanied by proof of ownership of the leased premises, the same below);
(8) proposed business product quality management system documents and storage facilities, equipment directory. Endeavor to accept the branch shall be in accordance with the "Medical Device Business License Management Measures" Article 12, paragraph 2 of the provisions of the processing decision.
District (county) Food and Drug Administration Branch accepts the application information, shall be accepted within 30 working days from the date of data review and on-site review, and make a decision on 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 enterprise license", and within 10 working days from the date of decision to the applicant issued "medical device business enterprise license". Considered does not meet the requirements, shall notify the applicant in writing, and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration according to law or to bring an administrative lawsuit.
2, apply for the business scope of "all types of medical devices" enterprises, by the Municipal Food and Drug Administration in conjunction with the county where the enterprise business food and drug regulatory branch for approval, day-to-day supervision by the branch is responsible for.
3, enterprise separation, merger or migration across the original jurisdiction, should be in accordance with the provisions of the re-application of "medical device business license.