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智慧醫療法規知識區
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編號 類別 標題名稱 刊登日期
  81   美國之軟體確效與網路安全指引  

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, 2014

  2020-12-24  
  82   美國之軟體確效與網路安全指引  

General Principles of Software Validation: Guidance for Industry and FDA Staff, 2002.

  2020-12-24  
  83   歐盟之法規文件  

“MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD”, 2020.

  2020-12-24  
  84   歐盟之法規文件  

“MDCG 2019-11:Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745-MDR and Regulation (EU) 2017/746-IVDR”, 2019.

  2020-12-24  
  85   歐盟之法規文件  

“REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, 2017.

  2020-12-24  
  86   歐盟之法規文件  

“REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL”, 2016.

  2020-12-24  
  87   歐盟之法規文件  

“EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines Annex 11”

  2020-12-24  
  88   其他國家/組織之法規文件  

MHRA Guidance: Medical Device stand-alone software including apps (including IVDMDs)

  2020-12-24  
  89   其他國家/組織之法規文件  

IMDRF/SaMD WG/N41FINAL, “Software as a Medical Device (SaMD): Clinical Evaluation”

  2020-12-24  
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