Medical Devices Act Article 12

The term "medical institutions", as used in this Act, shall refer to institutions applied for operation by medical personnel specified in Paragraph 1 of Article 10 of the Medical Care Act in accordance with the relevant regulations of professions and occupation laws and have been approved for practice.
中文原文 醫療器材管理法第12條
本法所稱醫事機構,指醫療法第十條第一項所定醫事人員依其專門職業法規規定申請核准開業之機構。

English translation for reference only; the Chinese text prevails. Not legal advice.