Do hearing AIDS belong to medical devices? Can ordinary businesses operate?

Hearing AIDS are medical devices, and ordinary businesses cannot operate them.

Hearing AIDS belong to Class II medical devices, and Class II medical devices with moderate risks need to be strictly controlled and managed to ensure their safety and effectiveness. The state implements a strict licensing and management system for such products.

According to the Regulations on the Supervision and Administration of Medical Devices

Twenty-ninth engaged in medical device business activities, should have the business premises and storage conditions suitable for the scale and scope of business, as well as the quality management system and quality management institutions or personnel suitable for the medical devices operated.

Thirtieth engaged in the second kind of medical devices business, business enterprises should be located in the districts of the municipal people's government food and drug supervision and management departments for the record, submit proof materials that meet the conditions stipulated in Article 29 of these regulations.

Extended data:

According to the Regulations on the Supervision and Administration of Medical Devices

Article 63 Under any of the following circumstances, the food and drug supervision and administration department of the people's government at or above the county level shall confiscate the illegal income, medical devices produced and operated illegally, tools, equipment, raw materials and other articles used for illegal production and operation;

If the value of medical devices illegally produced and operated is less than 654.38+10,000 yuan, a fine of 50,000 yuan to 654.38+10,000 yuan shall be imposed; If the value of the goods is more than 10000 yuan, a fine of more than 10 and less than 20 times shall be imposed; If the circumstances are serious, the application for medical device license put forward by the relevant person in charge and enterprises will not be accepted within 5 years.

(a) the production and operation of Class II and Class III medical devices that have not obtained the medical device registration certificate;

(2) engaging in the production of Class II and Class III medical devices without permission;

(3) engaging in the business activities of Class III medical devices without permission.

If the circumstances listed in the first paragraph of the preceding paragraph are serious, the original issuing department shall revoke the medical device production license or medical device business license.

Ji 'an US Food and Drug Administration-Category III and Category II Medical Devices Classification Catalogue