Legal analysis: First, 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;
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 products;
Four, 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 reporting system of adverse events;
V. 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.
Legal basis: "Measures for the Administration of Medical Device Business License" Article 6 The application for "Medical Device Business License" shall have the following conditions:
(a) 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 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 the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.