Pharmaceutical Good Manufacturing Practice Regulations Article 118
Manufacturers shall record the identity of personnel performing any inspection or testing of active implantable medical devices and implantable medical devices.
中文原文 藥物優良製造準則第118條
製造業者應記錄執行植入式主動醫療器材與植入式非主動醫療器材檢查測試人員之身分。