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Do I need three certificates and one photo to buy second-class equipment?
The purchase of Class II devices can only be legally carried out with the License of Medical Device Business Enterprise, the License of Medical Device Manufacturing Enterprise and the Registration Certificate of Medical Device Products. In addition, a series of documents and licenses, such as medical device manufacturing enterprise filing and medical device management filing, are also needed. Therefore, it is in line with the actual requirements to purchase the second-class equipment with three certificates and one photo.

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.