According to the Regulations on the Supervision and Administration of Medical Devices and other relevant laws and regulations, medical devices are divided into three categories, of which the second category refers to medical devices that directly or indirectly act on the human surface, puncture in the body and drain through body cavities. Units operating medical devices, including purchasing, selling and leasing, must hold a medical device business license. At the same time, those engaged in the production of medical devices need to obtain the license of the medical device manufacturing enterprise. In addition, medical devices also need to be registered and obtain a medical device product registration certificate.
It should be noted that the operating procedures and license requirements for purchasing Class II equipment may be different. It is recommended that you consult relevant government departments or laws and regulations for accurate understanding before specific operation to ensure legal and compliant operation.