Pharmaceutical Good Manufacturing Practice Regulations Article 60
In this Part, standards related to the design, development, production, installation, and servicing of medical devices are prescribed in accordance with the contents of medical device quality management system of the International Standard Organization (ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes).
中文原文 藥物優良製造準則第60條
本編有關醫療器材之設計、開發、生產、安裝與服務之規範，係依據國際標準組織醫療器材品質管理系統（ISO13485：Medicaldevices—Qual-itymanagementsystems—Requirementsforregulatorypurposes）之內容訂定。