The registration process of Shanghai Class II medical device companies is the same as that of general companies, except that there is an on-site inspection and filing process. On the filing of the second kind of medical devices. The second category of medical devices refers to medical devices with moderate risk and need strict control and management to ensure their safety and effectiveness. According to the Measures for the Supervision and Administration of Medical Device Operation, if an operating enterprise engages in the operation of Class II medical devices, it shall file a record with the municipal food and drug supervision and administration department at the district level, fill in the record form for the operation of Class II medical devices, and submit the following materials: Shanghai Class II medical device company registration process 1. Copy of business license; 2 copies of the identity certificates, academic qualifications or professional titles of the legal representative, the person in charge of the enterprise and the person in charge of quality; 3. Description of organizational structure and department setting; Description of business scope and mode of operation; 4. A copy of the geographical location map, floor plan, title certificate or lease agreement (with title certificate attached) of the business premises and warehouse address; 5. Catalogue of operating facilities and equipment; Managing the catalogue of documents such as quality management system and working procedures; 6. Other supporting materials. Different medical devices have different requirements for warehouse area. If it is a disposable medical device enterprise for blood transfusion, infusion and injection, the warehouse area should be not less than 100 square meter.