論違法輸入醫療器材罪之刑罰管制【醫法新論】 試閱
The Research of the Penalties of Illegal import Medical Devices
醫療器材管理法於2020年1月15日經由總統公布，本法之制定及施行將保障消費者權益。然而立法者認定自外國輸入之醫療器材若未經主管機關許可而販賣，將視為會對人體產生抽象危險，而需用刑罰處罰。惟依照國際通用之醫療器材分級原則，並非認定所有的醫療器材均會對消費者產生潛在危害，因此相關刑罰規定明顯有違刑法謙抑性。本文將介紹醫療器材分級原則之標準，並建議依照分級原則標準，就無危害人體之虞之醫材，縮小刑罰管制範圍。
Medical Devices Act, which will protect the rights of consumer, was promulgated by the President on January 15, 2020. The legislators have determined in respect of it that it will be considered to endanger human bodies abstractly and need to be punished by penalties if someone sell the medical devices which were imported from foreign countries without the permission of the competent authorities. However, according to the principle of classification of medical devices which is international generally accepted, it is not every medical devices to endanger potentially to the consumers. The relative penal norms violate the modesty of Criminal Law obviously. It would be introduced the standard of classification of medical devices in this paper, and would be advised to reduce the scope of the criminal control for the medical devices which are not dangerous to human bodies according to the principle of the classification.
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