As we all know, the medical industry is a very special industry. If you want to engage in the medical industry, you must have the relevant qualifications. For example, if you want to represent medical devices, you must have a medical device license. So, what conditions are needed to apply for a Class III medical device license in Shanghai?
Shanghai three types of medical device license need to have these conditions:
1. Business area of at least 45 square meters, the company's branch business area of at least 25 square meters; at least 25 square meters of the operation of hearing aids; business premises of at least 25 square meters; at least 10 square meters of business contact lenses and care solutions.
2. Warehouse area of at least 30 square meters; disposable sterile medical device management warehouse should be in the same building, an area of at least 135 square meters.
3. The quality manager and the person in charge of the quality organization should have a nationally recognized college degree or above in a product-related field. Or intermediate or higher technical roles in related professions. The operation of disposable sterile medical devices should be required to have at least hold a medical device quality management system internal auditor certificate of internal auditor.