A, verification, reissue of the required conditions:
1, the person in charge of the enterprise should have a high school education; 2, quality management personnel should have a relevant professional college education or intermediate (including) above the title, the operation of the business of dispensing products of the enterprise, should have a medical specialty college (including) above the education or intermediate above the qualification of optometrists. Optometrist qualification (hearing aid dispenser) professional and technical personnel; business implantable materials and artificial organs (excluding hearing aids) should have a medical undergraduate degree or higher professional and technical personnel; 3, business products related to technical standards; 4, the business premises area requirements: (1) medical device retail stores: 10 (including 10) class code of the following business medical devices, the building area of the business premises is not less than 30 square meters. Business premises floor area of not less than 30 square meters; operating medical equipment more than 10 class code, the business premises floor area of not less than 60 square meters; (2) medical device retail stores: with independent product display area, and have a conspicuous logo. Operating medical devices 10 (including 10) class code below, the business field construction area of not less than 20 square meters and retail counters of not less than one section; operating medical devices more than 10 class code, the business premises construction area of not less than 30 square meters and retail counters of not less than three sections; (3) corneal contact lenses should have a bright and tidy office business premises with the scale of operations to adapt to Its total floor area shall not be less than 60 square meters. Business place to set up the reception room (area), examination room (area), optometry room (area) and wearing room, of which optometry room (area) visual distance of 5 meters, or set up meters reflective mirrors, and with darkroom conditions; (4) hearing aid companies should have a business with the scale of the business premises, with a total floor area of not less than 60 square meters. There should be a reception room (area), audiometric room (area) and meet the standards of hearing debugging room, a good environment and health conditions; 5, the establishment of the management system: (1) enterprise departments, organizations and personnel responsibilities and authority system; (2) quality and safety management accountability system; (3) the first enterprise qualification audit management system; (4) the first species Qualification audit management system; (5) product purchase and quality acceptance management system; (6) product care and storage management system; (7) product display management system; (8) expiration date product management system; (9) unqualified product management system; (10) quality tracking and adverse event reporting system; (11) products After-sales service and complaint handling system; (12) Problematic products to assist the recall system; (13) Instruments, equipment, measuring instruments management system; (14) Salesperson management system; (15) Computerized information management system; (16) Sales management system; (17) Documents, information, records, files, bills management system ) (18) Employee training and health management system; (19) Self-examination system for the implementation of the system. Contact lenses, hearing aid retailers should also develop optometry operating procedures or hearing aid fitting operating procedures.