Regulation for Registration of Medical Devices Article 32

In the event of application for change in Class I medical device registration, in addition to complying articles in this chapter, Articles 14 and 16 shall be applied mutatis mutandis.
中文原文 醫療器材查驗登記審查準則第32條
申請變更之醫療器材如係第一等級者,除適用本章規定外,並得準用第十四條及第十六條規定辦理。

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