1, the person in charge of the enterprise should have a high school education;
2, should have the enterprise qualification of the "Business License";
3, the quality management personnel should have a relevant professional college education or intermediate (including) or above, the operation of the dispensing class of products of the enterprise, should have the medical profession College (including) or more or intermediate qualification of optometrists (hearing aid dispenser) professional and technical personnel; business implantable materials and artificial organs (excluding hearing aids) should have medical undergraduate degree or higher professional and technical personnel;
4, business products related to technical standards;
5, the business premises area requirements:
(1) Medical Device Retail Franchise stores: operating medical devices 10 (including 10) class code below, the floor area of the premises is not less than 30 square meters; operating medical devices more than 10 class code, the floor area of the premises is not less than 60 square meters;
(2) medical device retail store: with an independent product display area, and has a conspicuous logo. Operating medical devices 10 (including 10) class code below, the business field floor 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 field floor 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 and business scale appropriate to the business place, its total floor area shall not be less than 60 square meters. Business premises, the total floor area shall not be less than 60 square meters. Business premises set up reception room (area), examination room (area), optometry room (area) and fitting room, of which optometry room (area) visual distance of 5 meters, or set up with 2.5 meters of reflective lenses, and darkroom conditions;
(4) hearing aid companies should have a business premises compatible with the scale of operation, its total floor area shall not be less than 60 square meters. There should be a reception room (area), audiometric room (area) and meet the standards of hearing debugging room, have a good environment and sanitation;
6, storage: medical device business enterprises shall not be less than 30 square meters of storage area. Business premises and warehouses shall not be located in residential housing. Drug chain stores, optical stores operating corneal contact lenses retail enterprises may not set up an independent warehouse. Wholesale enterprises operating in vitro diagnostic reagents should also be set up not less than 20 cubic meters volume of cold storage.
In addition to these conditions also need to establish the relevant 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 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) Expiry date product management system;
(9) Failure to meet the product management system;
(10) Quality tracking and adverse event reporting system;
(11) Product after-sales service and complaint handling system;
(12) Problem products to assist in the recall system;
(13) Instruments, equipment, measuring instruments management system;
(14) Salesperson management system;
(15) Computerized information technology management system;
(16) Sales management system;
p>(17) documents, information, records, files, bills management system;
(18) employee training and health management system;
(19) system implementation self-examination system. Contact lenses, hearing aid retailers should also develop optometry operating procedures or hearing aid fitting operating procedures.
Legal basis
"Regulations for the Supervision and Administration of Medical Devices"
Article 40 Engaged in the operation of medical devices, there should be with the scale of operation and business scope of the business premises and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
Article 44 of the medical device business, shall be in accordance with the laws and regulations and the State Council drug regulatory authorities to develop quality management standards for the operation of medical devices, to establish and improve the operation of medical devices and ensure that the quality of management system and ensure its effective operation.