Pharmaceutical Good Manufacturing Practice Regulations Article 62
For Class 2, Class 3, and Class 1 medical devices that are not listed as non-sterile or without a measuring function under Attachment 2 of the Regulations Governing Management of Medical Devices, their manufacturers shall comply with the requirements in Chapter 2 of this Part.For Class 1 medical devices that are listed as non-sterile or without a measuring function under Attachment 2 of the Regulations Governing Management of Medical Devices, their manufacturers shall comply with the requirements in Chapter 3 of this Part.Requirements in Chapter 3 of this Part shall be implemented one year after the date of promulgation.
中文原文 藥物優良製造準則第62條
第二等級、第三等級及第一等級非屬醫療器材管理辦法附件二所列未滅菌或不具量測功能品項之醫療器材，其製造業者，應符合本編第二章之規定。
第一等級列屬醫療器材管理辦法附件二未滅菌或不具量測功能品項之醫療器材，其製造業者，應符合本編第三章之規定。
本編第三章規定自發布日起一年後施行。
第一等級列屬醫療器材管理辦法附件二未滅菌或不具量測功能品項之醫療器材，其製造業者，應符合本編第三章之規定。
本編第三章規定自發布日起一年後施行。