第五章 結論
第二節 研究限制與建議
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器材製造實行審查和批准管理。
(d)產品販賣：第一類醫療器材不需要許可和備案，第二類醫療器材經營 實行備案管理，第三類醫療器材經營實行許可管理。
(2)審查制度精簡：將中央政府一部分行政管理權力下放至地方政府，使監督 管理的權力、義務和責任更加清楚。可以加快醫療器材產品註冊備案與產 品製造備案之監督管理的一致性。
(3)產品流向追蹤：增進醫療器材製造商、販賣和經銷商在產品品質管理責任。
建立販賣和使用過程中的進貨登記與銷貨記錄，提倡使用單位的醫療器材 安全管理責任制度。
(4)管理功能強化：強化監管部門的日常監督，持續增進醫療器材註冊、隨機 抽查等監督管理方法，完備全程監督管理制度，包含：增設醫療器材不良 事件監測制度、已註冊醫療器材再評價制度、醫療器材召回制度等方法。
(5)明確法律責任：詳細訂定法條、調整處罰幅度、增加處罰種類、對嚴重違 法行為的嚴懲不怠。
第二節 研究限制與建議
本研究的分析結果，主要是藉此檢視中國大陸醫療器材法律規章之起源與形 成由來；並瞭解中國大陸醫療器材監督管理制度的發展情況；以及探索探討中國 大陸醫療器材監督管理相對人違法責任與違法處罰行為。對於其他的研究構面，
仍有無法深入不足之處。然而對於意欲了解中國大陸醫療器材法規與監督管理制 度的學術研究與實務人員，提供了良好的參考資訊。
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