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Legal responsibility

The seventh chapter legal liability

63rd article has following case one of of, by County above government food drug supervision management sector confiscated illegal proceeds, and illegal production business of medical devices and for illegal production business of tool, and equipment, and raw materials, items; illegal production business of medical devices goods value amount insufficient 10,000 yuan of, and at 50,000 yuan above 100,000 yuan following fine; goods value amount 10,000 yuan above of, and at goods value amount 10 times times above 20 times times following fine; plot serious of, Within 5 years will not be accepted relevant responsible persons and firms ' medical device license application:

(A) production, management has not obtained the registration certificate of medical devices of type II and class III medical devices;

(B) without the permission of class II and class III medical device production;

(C) unauthorized operation of class III medical devices.

Preceding paragraph of the first case, the circumstances are serious, medical device manufacturing license issuing Department revoked licence or a medical device license.

64th provide false information or other deceptive means to obtain medical registration certificate, medical device production license, business license, advertising approval documents permit, has been made by the original certificate revoked by the Department of permits and fines of between 50,000 yuan and 100,000 yuan, within 5 years will not be accepted persons responsible for licensing of medical devices and enterprise applications.