Information Disclosure Form of Administrative Punishment Decision (Guangzhou Huangyi Medical Technology Co., Ltd.)
Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 680)
Article 63: In any of the following situations，Illegal income shall be confiscated by the Food and Drug Administration of the People's Government at or above the county level、Illegal production and operation of medical devices and tools used in illegal production and operation、equipment、Raw materials and other items；The value of illegally produced and operated medical devices is less than 10,000 yuan，A fine of more than 50,000 yuan but less than 100,000 yuan will be imposed；The value of the goods is more than 10,000 yuan，A fine of more than 10 times and less than 20 times the value of the goods；Serious，5During the year, the medical device license applications submitted by relevant responsible persons and enterprises will not be accepted：
(1) Production、The second type of operation that has not obtained the medical device registration certificate、The third category of medical devices；
(2) Engaging in the second category without permission、The third category of medical device production activities；
(3) Engaging in the third-class medical device business activities without permission。
There is the first situation of the preceding paragraph、Serious，The original license-issuing department revokes the medical device production license or medical device business license。
Unauthorized configuration and use of large-scale medical equipment，The health and family planning department of the people's government at or above the county level ordered to stop using，Give warning，Confiscate illegal gains；The illegal income is less than 10,000 yuan，A fine of 10,000 yuan up to 50,000 yuan will be imposed；Illegal gains of more than 10,000 yuan，Also impose a fine of 5 times or more and 10 times the illegal income；Serious，5During the year, applications for large-scale medical equipment configuration licenses submitted by relevant responsible persons and units will not be accepted。
annex：Administrative Penalty Decision-Huangyi Medical
