医疗器械监督管理条例 Regulations on Supervision and Management to Medical Instruments

cancelled and publicity shall be made.

　　Article 34 The advertisement of medical instruments shall be examined and approved by the medical supervision and management authority under the people's government at or above province level; without approval, no pub

lishing, broadcasting, handing-out or posting is allowed.

　　The contents of the advertisement of medical instruments shall be based on the instructions for use approved by the medical supervision and management authority of the State Council or the medical supervision and management authority of the people's governments in provinces, autonomous regions or municipalities directly under central authority.

　　Chapter V Penalty Provisions

　　Article 35 For an enterprise manufacturing without registration certificate of product manufacture of medical instruments in violation of provisions of this Regulations, the medical supervision and management authority of people's government at or above county level shall order the cessation of production, and confiscate the illegally manufactured products and illegal income, and if the illegal income exceeds RMB 10,000 Yuan, a fine of not less than 3 times and not more than 5 times the illegal income shall be imposed together; if there is no illegal income or the illegal income is less than RMB 10,000 Yuan, a fine of not less than RMB 10,000 Yuan and not more than RMB 30,000 Yuan shall be imposed together; if the circumstances are serious, the medical supervision and management authority of the people's government in a province, autonomous region or municipality directly under central authority shall cancel its (License for Enterprise Manufacturing Medical Instruments); if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

　　Article 36 For the enterprise manufacturing the second or the third category medical instruments without (License for Enterprise Manufacturing Medical Instruments) in violation of provisions of this Regulations, the medical supervision and management authority of people's government at or above county level shall order cessation of production, and confiscate the illegally manufactured products and illegal income, and if the illegal income exceeds RMB 10,000 Yuan, a fine of not less than 3 times and not more than 5 times the illegal income shall be imposed together; if there is no illegal income or the illegal income is less than RMB 10,000 Yuan, a fine of not less than RMB 10,000 Yuan and not more than RMB 30,000 Yuan shall be imposed together; if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

　　Article 37 For the enterprise manufacturing medical instruments not conforming to the state standards or industrial standards of medical instruments in violation of provisions of this Regulations, the medical supervision and management authority of people's government at or above county level shall impose warning, and order cessation of production, and confiscate the illegally manufactured products and illegal income, and if the illegal income exceeds RMB 5,000 Yuan, a fine of not less than 2 times and not more than 5 times the illegal income shall be imposed together; if there is no illegal income or the illegal income is less than RMB 5,000 Yuan, a fine of not less than RMB 5,000 Yuan and not more than RMB 20,000 Yuan shall be imposed together; if the circumstances are serious, the original issuing authority shall cancel its registration certificate of product manufacture; if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

　　Article 38 For the enterprise manufacturing the second or the third category medical instruments without (License for Enterprise Dealing with Medical Instruments) in violation of provisions of this Regulations, the medical supervision and management authority of people's government at or above county level shall order cessation of dealing, confiscate the illegally manufactured products and illegal income, and if the illegal income exceeds RMB 5,000 Yuan, a fine of not less than 2 times and not more than 5 times the illegal income shall be imposed together; if there is no

illegal income or the illegal income is less than RMB 5,000 Yuan, a fine of not less than RMB 5,000 Yuan and not more than RMB 20,000 Yuan shall be imposed together; if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

　　Article 39 For the enterprise dealing with medical instruments that are without product registration certificate, without certificate of quality product, expired, loss of effect or washed out, or purchasing medical instruments from enterprise without (License for Enterprise Manufacturing Medical Instruments) or (License for Enterprise Dealing with Medical Instruments) in violation of provisions of this Regulations, the medical supervision and management authority of people's government at county or above level shall order cessation of production, confiscate the illegally manufactured products and illegal income, and if the illegal income exceeds RMB 5,000 Yuan, a fine of not less than 2 times and not more than 5 times the illegal income shall be imposed together; if there is no illegal income or the illegal income is less than RMB 5,000 Yuan, a fine of not less than RMB 5,000 Yuan and not more than RMB 20,000 Yuan shall be imposed together; if the circumstances are serious, the original issuing authority shall cancel its (License for Enterprise Dealing with Medical Instruments); if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

　　Article 40 For the enterprise cheating its product registration certificate of medical instruments by furnishing false certificate, document, information or sample or by other deceitful means at the time of applying for registration of medical instruments, in violation of provisions of this Regulations, the original issuing authority shall cancel its product registration certificate, not accept its product registration applications within two years, and impose a fine of not less than RMB 10,000 Yuan and not more than RMB 30,000 Yuan; for products having been manufactured, shall confiscate the illegally manufactured products and illegal income, and if the illegal income exceeds RMB 10,000 Yuan, a fine of not less than 3 times and not more than 5 times the illegal income shall be imposed together; if there is no illegal income or the illegal income is less than RMB 10,000 Yuan, a fine of not less than RMB 10,000 Yuan and not more than RMB 30,000 Yuan shall be imposed together; if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

　　Article 41 For violation of provisions of Article 34 of these Regulations with respect to advertising of medical instruments, the administrative authority for industry and commerce shall deal with it in accordance with relevant state laws and regulations.

　　Article 42 For medical institution using medical instruments that are without product registration certificate, without certificate of quality product, expired, loss of effect or washed out, or purchasing medical instruments from enterprise without (License for Enterprise Manufacturing Medical Instruments) or (License for Enterprise Dealing with Medical Instruments) in violation of provisions of this Regulations, the medical supervision and management authority of people's government at county or above level shall order rectification, impose warning, confiscate the illegally used products and illegal income, and if the illegal income exceeds RMB 5,000 Yuan, a fine of not less than 2 times and not more than 5 times the illegal income shall be imposed together; if there is no illegal income or the illegal income is less than RMB 5,000 Yuan, a fine of not less than RMB 5,000 Yuan and not more than RMB 20,000 Yuan shall be imposed together; the chief responsible officer and other person with direct liability shall be imposed disciplinary punishment; if the matter constitutes a criminal offence, criminal liability shall be pursued accordi

ng to law.

　　Article 43 For medical institution repeatedly using one-off use medical instruments or failing to destroy the medical instruments that shall be destroyed, in violation of provisions of these Regulations, the medical supervision and management authority of people's government at or above county level shall order rectification and impose warning, and may impose a fine of not less than RMB 5,000 Yuan and not more than RMB 30,000 Yuan shall be imposed; the chief responsible officer and other person with direct liability shall be imposed disciplinary punishment; if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

　　Article 44 For medical institution in clinical tryout or clinical verification of medical instruments providing false report in violation of provisions of these Regulations, the medical supervision and management authority of the people's governments at or above provinces shall order rectification and impose warning, and may impose a fine of not less than RMB 10,000 Yuan and not more than RMB 30,000 Yuan shall be imposed; if the circumstances are serious, the qualification in clinical tryout or clinical verification of medical instruments shall be cancelled, and the chief responsible officer and other person with direct liability shall be imposed disciplinary punishment; if the matter constitutes a criminal offence, criminal liability shall be pursued according to law.

　　Article 45 For inspection institution of medical instruments and its staff engaged or participating in the development, manufacture

┨网页设计特效库┠ http://www。z┗co⊙l。com/网页特效/