Is it illegal to change the label model of medical devices without authorization?
It is illegal to change the label model of medical devices without permission. According to the relevant public information, in order to standardize the instructions and labels of medical devices and ensure the safety of medical devices, these Provisions are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices. All medical devices sold and used in People's Republic of China (PRC) shall be accompanied by instructions and labels that meet the requirements of these Provisions. Instructions for medical devices refer to technical documents made by medical device registrants or filers and provided to users with products, which cover basic information of product safety and effectiveness and are used to guide correct installation, debugging, operation, use, maintenance and maintenance.