Regulations of Medicament Manufacturer Inspection Article 2
Medicament manufacturers that shall be inspected in accordance with this set of regulations are as follows:(1) Firms in the manufacturing, processing of pharmaceutical products;(2) Firms in the manufacturing, assembling of medical devices;(3) Other firms related to the manufacturing, processing or assembling of medicaments, including firms that are approved by the central competent health authority to manufacture medicaments for development, firms that produce drug labeling, and firms related to the packaging of medicaments.
中文原文 藥物製造業者檢查辦法第2條
應依本辦法實施檢查之藥物製造業者如下：
一、經營藥品製造、加工之業者。
二、經營醫療器材製造、裝配之業者。
三、其他與藥物製造、加工或裝配有關之業者，包括經中央衛生主管機關核准為研發而製造藥物者、兼作藥物標示及與分裝或包裝藥物有關之業者等。
一、經營藥品製造、加工之業者。
二、經營醫療器材製造、裝配之業者。
三、其他與藥物製造、加工或裝配有關之業者，包括經中央衛生主管機關核准為研發而製造藥物者、兼作藥物標示及與分裝或包裝藥物有關之業者等。