The punishment basis for unlicensed operation of Class II and Class III medical devices.

Legal analysis: if a medical device is sold without a license, the pharmaceutical supervisory and administrative department at or above the county level shall order it to stop operating, confiscate the illegally operated products and illegal income, and impose a fine of more than 2 times and less than 5 times the illegal income if the illegal income is more than 5,000 yuan; If there is no illegal income or the illegal income is less than 5,000 yuan, a fine of 5,000 yuan to 20,000 yuan shall be imposed; If a crime is constituted, criminal responsibility shall be investigated according to law.

Legal basis: Article 38 of the Regulations on the Supervision and Administration of Medical Devices. Those who have not obtained the Medical Device Business License to operate Class II and Class III medical devices shall be ordered by the pharmaceutical supervisory and administrative department at or above the county level to stop operating, and the illegally operated products and illegal income shall be confiscated. If the illegal income is more than 5,000 yuan, a fine of more than 2 times and less than 5 times the illegal income shall be imposed. If there is no illegal income or the illegal income is less than 5,000 yuan, a fine of 5,000 yuan to 20,000 yuan shall be imposed; If a crime is constituted, criminal responsibility shall be investigated according to law.