Medical Devices Act Article 51
The competent authority may send officials to inspect the facilities and relevant business operations of medical device firms or medical institutions, and may randomly test their medical devices. Those being inspected shall not evade, impede, or refuse. The quantity of test samples to be taken shall be limited to the extent sufficient for use in testing, and receipts shall be given to business operators.
中文原文 醫療器材管理法第51條
主管機關得派員檢查醫療器材商或醫事機構之處所設施及有關業務，並得抽驗其醫療器材，受檢者不得規避、妨礙或拒絕；其抽驗數量，以足供檢驗之用者為限，並應交付憑據予業者。