"Supervision and Administration of Medical Devices Regulations" Article 63: In any of the following cases, the food and drug administration department of the people's government at or above the county level shall confiscate the illegal income, the illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation of such devices; the value of less than 10,000 yuan of medical devices produced and operated in violation of the law and impose a fine of more than 50,000 yuan and 100,000 yuan. Fines; the value of more than 10,000 yuan, and impose a value of more than 10 times the amount of 20 times the amount of fines; the circumstances are serious, within five years will not be accepted by the relevant responsible person and the enterprise to apply for a medical device license:
Types of penalties
1. Confiscation of the illegal income, the illegal production and operation of medical devices and tools used for illegal production and operation, equipment, raw materials and other items;
2. illegal production and management of medical devices less than 10,000 yuan in value, and impose a fine of 50,000 yuan or more than 100,000 yuan;
3. value of more than 10,000 yuan, and impose a fine of more than 10 times the amount of 20 times the amount of the goods;
4. the circumstances of the seriousness of the situation, the relevant responsible person and the enterprise will not be accepted within five years of the application for a permit for medical devices.
Enforcement procedures
The facts of the violation are clear, the evidence is conclusive, the penalty has a legal basis, to give to the citizens of the following 50 yuan, a legal person or other organization to impose a fine of less than 1,000 yuan or a warning of administrative punishment, according to the simplified procedures on the spot administrative punishment. To order the suspension of production and business, revocation of licenses, revocation of drug approval documents or larger fines (i.e., a fine of 1,000 yuan or more for non-business activities; a fine of 30,000 yuan or more for business activities with illegal income, or 10,000 yuan or more for no illegal income) and other administrative penalties, notify the party concerned of the right to request a hearing; the party concerned requests a hearing; the party concerned has the right to request a hearing. The right to hold a hearing; the party requesting a hearing, in accordance with the requirements of the procedures for hearing administrative penalties. Other cases in accordance with the general procedures for administrative penalties.
1, simple procedures: show law enforcement documents; on-site investigation and evidence collection; explain the reasons for punishment; hear statements, defense; the system issued "on-the-spot administrative penalty decision"; for the record.
2, general procedures: filing; investigation and evidence collection; case deliberation; administrative penalty prior notice; hearing statements, defense; review and approval of the decision; issued "administrative penalty decision.
3, hearing procedures: the issuance of the "Notice of Hearing"; hearing applications; serving the "Notice of Hearing"; organization of the hearing; the production of the "Hearing Transcript" and "Hearing Opinion"; transfer to the general procedure.