Shanghai medical device license application conditions and materials required
A, should have the conditions:
( a) with the scale and scope of business with the quality of the quality management institutions or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
( two) with the scale and scope of operation of relatively independent premises;
( three) with the scale and scope of operation of the storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device product;
( four) should be Establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
( v ) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.
Two, the required materials: (registered capital must be more than 1 million)
1, the start of the second and third class of medical equipment business enterprises, should be the operation of the local food and drug regulatory 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";
( 3 ) business administration department issued a pre-approval of the enterprise name documents or a copy of the "business license";
( 4 ) the proposed enterprise quality management person in charge of the identity card, academic or professional title certificate copy and resume;
( 5 ) the proposed enterprise quality management personnel's identity card, education or professional title certificate Copies;
( 6 ) the proposed enterprise organization and functions or full-time quality management personnel functions;
( 7 ) the proposed enterprise registered address, warehouse address of the geographic location map, floor plan (indicating the area), proof of ownership of the house or a copy of the lease agreement (with proof of ownership of the leased premises);
( 8 ) the proposed enterprise product quality management system and documents Storage facilities, equipment catalog;
( 9 ) the proposed business scope of the enterprise, in accordance with the provisions of the medical device classification catalog management category, class code name to determine;
( 10 ) electronic filing materials .