1, the person in charge of the enterprise should have a high school education.
2, quality management personnel should have the relevant *** college education or intermediate (including) or more titles, business fitting products, enterprises should have medical *** college (including) or intermediate qualification of optometrists (hearing aid dispenser)*** technical personnel.
3, business products related to technical standards.
4, the business premises area requirements: (1) medical equipment retail franchise: operating medical equipment 10 (including 10) class code below, the business premises floor space of not less than 30 square meters; operating medical equipment more than 10 class code, the business premises floor space of not less than 60 square meters; (2) medical equipment retail part-time stores: with independent product display area, and have a Eye-catching signs. 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 enterprises should have a bright and tidy office business premises compatible with the scale of operation, and its total construction area shall not be less than 60 square meters. The total construction area shall not be less than 60 square meters. The business premises shall be set up with reception room (area), examination room (area), optometry room (area) and fitting room, in which the optometry room (area) has a visual distance of 5 meters, or is set up with a 2.5-meter reflective mirror, and has darkroom conditions; (4) Hearing aid enterprises shall have a business premise appropriate to the scale of operation, 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 management systems: (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 varieties of 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) product after-sales service and complaint handling system; (12) problematic products to assist in the recall system; (13) instruments, equipment, measuring instruments management system; (14) salesperson management system; (15) computer 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 system implementation. ***, hearing aid retailers should also develop optometry operating procedures or hearing aid fitting operating procedures.