1. Professional management personnel: there are quality management institutions or quality management personnel suitable for the business scope and scale, and the quality management personnel shall have relevant professional qualifications or titles recognized by the state.
2. Business premises: having business and storage premises suitable for the business scope and scale.
3. Storage conditions: If the storage conditions are suitable for the business scope and scale, and all of them are entrusted to other medical device business enterprises for storage, there is no need to set up a warehouse.
4. Management system: it has a quality management system suitable for the medical devices it operates.