One, the business premises requirements are different
1, Class II medical devices: there should be with the production of products and the scale of production, warehousing space and environment.
2, Class III medical devices: business premises should be used in an area of not less than 40 square meters, the use of legal entity branches of the business premises should be used in an area of not less than 25 square meters (except across the municipal setup); business hearing aids, the use of business premises should be used in an area of not less than 25 square meters; business contact lenses and care solutions, the use of business premises should be used in an area of not less than 10 Square meters.
Second, the business license is different
1, Class II medical devices: Class II medical device sales only for the record.
2, Class III medical devices: Class III medical devices require a business license.
Three, the personnel requirements are different
1, Class II medical devices: the person in charge of the enterprise should have a secondary school education or junior title or above. The person in charge of the quality inspection organization should have college education or above or intermediate title. Engineering and technical personnel with junior title or above should occupy the corresponding proportion of the total number of employees.
2, three types of medical devices: quality management, quality institutions should have a nationally recognized, and business products related to the profession, college degree or above, or intermediate or higher technical title in related disciplines. The operation of single-use sterile medical devices, there should also be more than one medical device quality management system internal auditor certificate of internal auditor and other relevant application conditions.
Baidu Encyclopedia - Class III Medical Devices
Baidu Encyclopedia - Class II Medical Devices