Hearing aids are medical devices, and ordinary merchants are not allowed to sell them.
Hearing aids are classified as Class II medical devices, which are medical devices with moderate risk that require strict control and management to ensure their safety and effectiveness. The state implements a strict licensing and management system for such products.
According to the "supervision and management of medical devices regulations"
Article 29 engaged in the operation of medical equipment, there should be with the scale and scope of operation of the business premises and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
Article 30 engaged in the second class of medical devices, by the business enterprise to the municipal people's government where the municipal food and drug supervision and management department for the record and submit it to comply with the conditions set out in Article 29 of these Regulations.
Expanded Information:
According to the "Supervision and Administration of Medical Devices Regulations"
Article 63 of one of the following circumstances, the food and drug administration department of the people's government at or above the county level Food and drug supervision and management department of the people's government at or above the county level shall confiscate the illegal income, illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation;
Illegal production and operation of medical devices less than 10,000 yuan of the value of the goods and impose a fine of 50,000 yuan to 100,000 yuan of the following; more than 10,000 yuan of the value of the goods and impose a fine of more than 10 times the amount of 10 times the amount of the goods and impose a fine of 20 times the following Fines; the circumstances are serious, within five years will not accept the relevant responsible persons and enterprises to apply for a medical device license
(a) the production and operation of medical devices without obtaining the certificate of registration of medical devices of the second class, the third class of medical devices;
(b) unauthorized to engage in the production of medical devices of the second and third class of medical device activities;
(c) unauthorized to engage in the third class of medical devices Business activities.
The first paragraph of the preceding situation, the circumstances are serious, the original licensing department to revoke the medical device manufacturing license or medical device license.
Jian Food and Drug Administration - Class III, Class II medical device classification catalog