Regulation for Registration of Medical Devices Article 1
This Regulation is established pursuant to Paragraph 3, Article 40 of the Pharmaceutical Affairs Act (hereafter referred to as the Act).
中文原文 醫療器材查驗登記審查準則第1條
本準則依藥事法（以下簡稱本法）第四十條第三項規定訂定之。