Regulations for Governing the Management of Medical Device Article 8
The regulations shall be implemented on the date of announcement, except the manufacturing of Optical Impression Systems for CAD/CAM (Classification Number: F.3661) under the amendment of Article 3 Item 2 Annex 1 on January 7th, 2014, shall comply with this regulation from July 1st, 2014.The manufacturing of Quality Control Material (assayed and unassayed) (Classification Number: A.1660), Ear, Nose, and Throat Drug Administration Device (Classification Number: G.5220), and Corrective Spectacle Lens (Classification Number: M.5844) under the amendment of Article 3 Item 2 Annex 1 on June 3rd, 2015, shall comply with this regulation from September 1st, 2016.The manufacturing of Influenza virus antigen detection test system (Classification Number: C.3328), Surgical Gloves (Classification Number: I.4460), Patient Examination Gloves (Classification Number: J. 6250)" and Mechanical Wheelchair (Classification Number: O. 3850) under the amendment of Article 3 Item 2 Annex 1 on July 29th, 2019, shall comply with this regulation from July 29th, 2020.
中文原文 醫療器材管理辦法第8條
本辦法除中華民國一百零三年一月七日修正發布之第三條第二項附件一「F.3661CAD/CAM光學取模系統」鑑別規定，自一百零三年七月一日施行外，自發布日施行。
中華民國一百零四年六月三日修正發布之第三條第二項附件一「A.1660品管材料（分析與非分析）」、「G.5220耳鼻喉佈施藥裝置」及「M.5844矯正鏡片」鑑別規定，自一百零五年九月一日施行。
中華民國一百零八年七月二十九日修正發布之第三條第二項附件一「C.3328流感病毒抗原快篩檢測系統」、「I.4460手術用手套」、「J.6250病患檢查用手套」及「O.3850機械式輪椅」鑑別規定，自一百零九年七月二十九日施行。
中華民國一百零四年六月三日修正發布之第三條第二項附件一「A.1660品管材料（分析與非分析）」、「G.5220耳鼻喉佈施藥裝置」及「M.5844矯正鏡片」鑑別規定，自一百零五年九月一日施行。
中華民國一百零八年七月二十九日修正發布之第三條第二項附件一「C.3328流感病毒抗原快篩檢測系統」、「I.4460手術用手套」、「J.6250病患檢查用手套」及「O.3850機械式輪椅」鑑別規定，自一百零九年七月二十九日施行。