Regulations for the Assessment and Approval Process of Hazardous Medical Device Article 1
The Guideline is stipulated pursuant to Paragraph 3, Article 93 of the Medical Care Act (hereinafter referred to as the Act).
中文原文 危險性醫療儀器審查評估辦法第1條
本辦法依醫療法（以下簡稱本法）第九十三條第三項規定訂定之。