Shanghai Class II Medical Devices Company Registration Process
The company registration process for Class II medical devices is the same as the general company registration process, except that there is an additional on-site inspection and filing process.
On the filing of Class II medical devices. Class II medical devices are medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness. According to the "supervision and management of medical devices business approach", engaged in the operation of Class II medical devices, the business enterprise should be the location of the municipal food and drug supervision and management department for the record, fill out the "Class II medical device business filing form", and submit the following materials:
1. A copy of the business license;
2. Legal representative, responsible person for the enterprise and the person responsible for quality of the Proof of identity, education or title copies;
3. Organizational structure and departmental setup description; description of the scope of business and mode of operation;
4. Business premises and warehouse address of the geographic location of the map, floor plan, proof of property rights or a copy of the lease agreement (with proof of property rights);
5. Operation of the facilities and equipment directory; management of the quality management system, work procedures and other Document catalog;
6. Other supporting materials.
Different medical devices have different requirements for warehouse space. If the business is blood transfusion, transfusion, injection of disposable medical device companies, the warehouse area should be not less than 100 square meters.