No filing required for Class II medical devices 6826 for promotional purposes

No, the "Regulations on the Supervision and Administration of Medical Devices" stipulates: 1. Product instructions and labels must be reported and filed at the same time when the product is registered. After that, the instructions cannot be modified at will. Once modified, you need to go to the Food and Drug Administration. Filing; 2. Product advertising needs to be legal and pass the review of the advertising supervision department. Promotional color pages do not need to be registered.