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Scope of business of Class II medical devices
Legal analysis

Scope of business: Category II: 6820 general diagnostic instruments, 682 1 medical electronic instruments and equipment, 6822 medical optical instruments, instruments and endoscope equipment, 6823 medical ultrasonic instruments and related equipment, 6824 medical laser instruments and equipment, 6825 medical high-frequency instruments and equipment, and 6826 physiotherapy rehabilitation equipment.

legal ground

Article 3 of the Measures for the Administration of Medical Device Business License shall hold a Medical Device Business License for operating Class II and Class III medical devices, but a few Class II medical devices that can ensure their safety and effectiveness through routine management in the circulation process may not apply for a Medical Device Business License. The catalogue of Class II medical device products that do not need to apply for the Medical Device Business License shall be formulated by the State Food and Drug Administration of the United States.

Article 225 of the Criminal Law of People's Republic of China (PRC) violates state regulations and commits one of the following illegal business operations.

(a) without permission, the franchise, monopoly of goods or other restricted goods as stipulated by laws and administrative regulations;

(2) buying and selling import and export licenses, import and export certificates of origin and other business licenses or approval documents stipulated by laws and administrative regulations;

(three) without the approval of the relevant competent departments of the state, illegally engaged in securities, futures, insurance business or illegally engaged in fund settlement business;

(four) engaged in other illegal business activities, disrupting the market order, and the circumstances are serious.