Medical Devices Act Article 10
The term "medical device manufacturers", as used in this Act, shall refer to businesses that fall into the following two types:1. Engaging in the manufacturing, packaging, labeling, sterilization, or final inspection and release of medical devices.2. Engaging in the design of medical devices and marketing the devices under their name.
中文原文 醫療器材管理法第10條
本法所稱醫療器材製造業者，指下列二類業者：
一、從事醫療器材製造、包裝、貼標、滅菌或最終驗放。
二、從事醫療器材設計，並以其名義於市場流通。
一、從事醫療器材製造、包裝、貼標、滅菌或最終驗放。
二、從事醫療器材設計，並以其名義於市場流通。