Regulation for Registration of Medical Devices Article 13
For application of registration and market approval, unless otherwise stated, reviews of its inspection specifications, submission for testing and technical document review progress concurrently.The operating procedures in the preceding paragraph shall be in accordance with the proclamations of the central health competent authority.
中文原文 醫療器材查驗登記審查準則第13條
查驗登記申請案,除別有規定外,其檢驗規格之審查、送驗作業與技術性書面作業同時進行。
前項作業流程,依中央衛生主管機關公告辦理。
前項作業流程,依中央衛生主管機關公告辦理。