Apply for Songjiang Class III medical device business license.

Conditions and materials for handling three types of medical device licenses in Songjiang District, Shanghai There are three types of business licenses for medical enterprises, among which the first type of medical device licenses can be handled directly, the second type of products need to be handled with the filing certificate, and the third type of products need to be handled with the third type of medical device licenses. Conditions for handling three types of business licenses for medical devices: 1. The business scope of the business license includes the business (sales) of medical devices; 2. It has quality management institutions or quality management personnel that are suitable for the business scope and scale, and the quality management personnel should have professional qualifications or titles recognized by the state; 3. Having a business and storage place suitable for the business scope and scale; 4, with storage conditions suitable for the business scope and scale, all entrusted to a third-party medical device business enterprise storage can not set up a warehouse; 5, with the management of medical devices to adapt to the quality management system; 6. Having the ability of professional guidance, technical training and after-sales service suitable for the medical devices operated, or agreeing to provide technical support by a third-party organization. What information do you need to apply for the three types of business licenses for medical devices? 1 medical device business license application form; 2. Business license; 3 copies of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality; 4. Description of organization and department setting; 5. Description of business scope and mode of operation; 6. The geographical location map, floor plan, certificate of house property right or a copy of lease agreement (with certificate of house property right) of the address of the business place and warehouse, and the need for the warehouse to entrust a third party to entrust the warehouse agreement; 7. Catalogue of operating facilities and equipment; 8 management quality management system, working procedures and other documents; 9. Certificate of authorization and letter of commitment of the agent. Processing period of Class III business license for medical devices: the materials meet the requirements, and the time limit for completion is about 2 working days.