Medical devices are divided into Class 1, Class 2, and Class 3, with strict qualification requirements for the operation and use of Class 2 and Class 3 medical devices. The medical devices in some cases are only suitable for professional personnel in medical institutions to operate and are not suitable for personal home use. If an individual needs to purchase home medical equipment, they should choose a business channel that complies with regulations, carefully read the product manual, and consult a doctor if necessary.

Medical institutions using medical devices must have corresponding diagnosis and treatment subject licenses, and establish a sound quality management system for the use of medical devices, including procurement inspection, storage and maintenance, usage records, and maintenance. For some high-risk medical devices, relevant operators may also be required to possess professional professional qualification certificates.