Application for "medical device business license" should also have the following conditions:
1, with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles;
2, with the scale and scope of operation of relatively independent premises;
3, with the scale and scope of operation of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of medical equipment products;
4, 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;
5, should have the appropriate technical training and after-sales service with its business medical device products, or agreed by the third party to provide technical support.