醫療器材安全及其刑法規制——兼論醫療器材智能化的影響

A Study on Criminal Regulation to Ensure the Safety of Medical Devices: Also a Discussion on the Impact of the Artificial Intelligence in Medical Devices

安全的醫療器材，有助於人類生活與健康的提升。醫療器材的法律規範，歷經藥物藥商管理法與藥事法的時期，方才於2020年制定醫療器材管理法。醫療器材管理法對於醫療器材商的業務，以及醫療器材的上市前審查、上市後監督與稽查、臨床試驗、廣告等事項，均有相應的管理規定，並於該法第六十條至第六十三條設計附屬刑法規定，抗制妨害醫療器材安全的犯罪行為，以期達成保障醫療器材安全的立法目的。然而，在醫療器材犯罪的抗制上，現行法恐有缺漏之處，應有法律修正的必要。首先，醫療器材管理法的附屬刑法規定，原本就存有檢討的空間，本文對此通盤檢討，並提出具體修法建議。其次，人工智慧發展快速，引領醫療器材進入智能化時代，但隨之發生新的安全疑慮，實有討論必要，以期法律規範周全。

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.