Medical device supervision and management regulations fine amount

CIO Compliance Assurance Organization expert Poria cited an example of a business enterprise forging a medical device business license, has sold medical devices with a value of 10,000 yuan, the enterprise has no relevant mitigating, extenuating, or aggravating circumstances, and the relevant responsible persons actively cooperate with the investigation. Which clause is applicable to this case? The answer is to impose a fine of 13 times (including) to 17 times (including) the illegal income and confiscate all the medical devices. Because 10,000 yuan belongs to "less than 10,000 yuan of illegal income" of the "general situation", corresponding to 13 times (including) -17 times (including) the fine.

The revised "Regulations for the Supervision and Administration of Medical Devices" has been June 1, 2021 formally come into force. The "Regulations" 81 for the production and management of medical devices, there are the following three situations:

(a) production and operation of medical devices without obtaining a medical device registration certificate of the second class, the third class of medical devices;

(b) unauthorized to engage in the production of medical devices of the second class, the third class of medical device production activities;

(c) unauthorized to engage in the operation of medical devices of the third class of medical device business activities. "Illegal production and management of medical devices less than 10,000 yuan in value, and impose a fine of 50,000 yuan more than 150,000 yuan; value of more than 10,000 yuan, and impose a fine of 15 times the value of more than 30 times the amount of fine; the circumstances are serious, impose a fine of more than 30% of the income obtained more than three times the amount of fine".