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提供國際醫藥法規、國際醫藥聞、國內醫藥法規重要政策等新知與相關出版品。

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
  71   美國之軟體類醫療器材指引  

Software as a Medical Device (SAMD): Clinical Evaluation, 2017

  2020-12-24  
  72   美國之醫療器材屬性判定指引  

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Guidance for Industry and Food and Drug Administration Staff, 2019.

  2020-12-24  
  73   美國之醫療器材屬性判定指引  

Clinical Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff, 2019

  2020-12-24  
  74   美國之醫療器材屬性判定指引  

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.

  2020-12-24  
  75   美國之醫療器材屬性判定指引  

General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.

  2020-12-24  
  76   美國之醫療器材屬性判定指引  

Policy for Device Software Functions and Mobile Medical Applications, 2019.

  2020-12-24  
  77   美國之產品變更管理指引  

Deciding When To Submit A 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff, 2017

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

Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.

  2020-12-24  
  79   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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff, 2018

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

Postmarket Management of Cybersecurity in Medical Devices, 2016

  2020-12-24  
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