我國與歐盟醫療器材的監理機制

The Supervision Mechanism of Medical Devices in Taiwan and EU

醫療器材管理法立法的主要目的在於使用上的安全、效能及品質，確保健康。除民眾使用醫療器材之安全與健康有重大關聯外，醫療器材管理制度具有濃厚的風險等級分類管理的管制，並牽涉到行政主管機關針對醫療器材的負擔與效能，以及醫療器材製造、進出口與販賣業之法規環境，並間接影響民眾使用新進醫療器材之機會。目前歐盟監管機制具有參考意義，使業者能在醫療器材許可制度，以及連結我國醫療器材監管制度得減少上市阻力與縮短時程。依據醫療器材管理法第82條規定，若醫療器材使用注意義務，因使用上致生損害於病人或使用者，以故意或違反醫療必要說明書如裝置介紹、警告標語、訊息或注意事項等，注意義務說明且逾越合理臨床專業裁量所致者為限，負損害賠償責任。

The main legislative purpose of the Medical Devices Act is to ensure the safety, efficiency and quality of use, and to ensure health. In addition to the important relationship between the safety and health of the public using medical equipment, the medical equipment management system has a strong risk level and classification management control, and involves the burden and efficiency of the administrative authority on medical equipment, as well as the manufacturing, import and export of medical equipment. The regulatory environment of the vending industry also indirectly affects the opportunities for the public to use new medical equipment. The current EU regulatory mechanism is of reference significance, enabling the industry to reduce market resistance and shorten the timetable in the medical device licensing system and in conjunction with my country’s medical device regulatory system. According to Article 82 of the Medical Devices Act, the use of medical equipment causes damage to the patient or user due to the use of the obligation of care. The obligation of care and beyond the reasonable clinical professional discretion shall be liable for damage to intentionally or violate the necessary medical instructions such as equipment introduction, warning slogans, messages or precautions, etc.