Hearing aids belong to the medical device, ordinary merchants can operate?

Hearing aids are classified as Class II medical devices, and this class of products is the most common. Business products need to obtain a medical device product registration certificate, medical device business license; need to have the relevant academic or qualification of the audiometric technicians; need to be equipped with hearing test room, reception room, fitting room area, effect assessment room, speech rehabilitation guidance room; should also be equipped with pure tone audiometer, hearing aid programmer and supporting computer, otoscope, otoscope pen, ear impression syringe, disinfection utensils and other hearing aid Monitoring and maintenance equipment; all the testing instruments need to be qualified by the metrological verification and used within the validity period.