Medtech Guidance Tracker - January 2016
This article was originally published in SRA
Executive Summary
Click on the links to access the documents.
Country
Organization
Document
Status
International
AHWP
Regulation of Combination Products – a Review of International Practice
Final
International
AHWP
Final
International
AHWP
Definition of the Terms "Medical Device" and "In Vitro Diagnostic (IVD) Medical Device"
Final
International
AHWP
Guidance Document on Qualification of Medical device Software
Final
International
AHWP
Final
International
AHWP
Final
International
AHWP
Clinical Evidence for Medical Device – Key Definitions and Concepts
Final
International
AHWP
Clinical Evidence for IVD Medical Device – Key Definitions and Concept
Final
International
AHWP
Final
International
AHWP
Final
International
AHWP
Final
International
AHWP
Final
International
AHWP
Final
EU
EUnetHTA
Final
Germany
BfArM
Final
Malaysia
MDA
Final
US
FDA
Draft
US
FDA
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
Draft
US
FDA
Draft
US
FDA
Draft
US
FDA
Final
US
FDA
Applying Human Factors and Usability Engineering to Medical Devices
Final
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