1, the business premises should be used in an area of not less than 40 square meters, branches of legal entities should be used in an area of not less than 25 square meters of business premises (except across the municipal setup); hearing aids, the use of business premises should be used in an area of not less than 25 square meters; contact lenses and care solutions, business premises should be used in an area of not less than 10 square meters. Area should be not less than 10 square meters.
2, the warehouse area should be not less than 30 square meters; the operation of single-use sterile medical devices, the warehouse should be in the same building, the use of the area should be not less than 200 square meters.
3, 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. Operation of single-use sterile medical devices, there should also be more than one medical device quality management system with an internal auditor certificate of internal auditor and other relevant application conditions.