| 英文摘要 |
Safe medical devices have been considered to improve human life and health. The legal standards for medical devices have gone through periods of Medicaments and Pharmaceutical Firms Act and Pharmaceutical Affairs Act, and as well as Medical Devices Act was formulated in 2020. In the Medical Devices Act, there are regulations for the management of manufacturing and sale, and listing and registration and market approval of medical devices before listing, and supervision prevention investigation and interdiction after listing, and management of medical device clinical trials and medical device advertisements. Articles 60 to 63 of the Medical Devices Act are provisions on criminal penalties to penalize these criminal acts that impede the safety of medical devices. These regulations are to ensure the safety of medical devices. However, there are deficiencies in the provisions on crimes that impede the safety of medical equipment, and the Medical Devices Act must be revised. First, the provisions on criminal penalties in the Medical Devices Act are inherently problematic. This paper comprehensively reviews related issues and puts forward specific suggestions for amending this Act. Next, artificial intelligence (AI) is making rapid progress, bringing medical devices into the era of AI, but new safety concerns have also arisen. Therefore, this paper aims to discuss relevant issues and hope that this Act can be all-inclusive. |
