Resources

A list of resources you may find useful are listed below. Please feel free to use and disseminate them however please If you have a suggestion for other resources that would be useful to PAHWP members please do not hesitate to contact Chris Sanders to recommend them.

New publication:

• Regulation of medical diagnostics and medical devices in the East African Community partner states.  Rugera et al BMC Health Services Research 2014, 14:524 http://www.biomedcentral.com/1472-6963/14/524 

Links to organisations and key documents relevant to harmonization of regulation for medical devices and IVD:

• AHWP PLAYBOOK for implementation of medical device regulatory frameworks
• Glossary of terms used at PAHWP meetings
• Clinical and Laboratory Standards Institute (CLSI)  Harmonized Terminology Database
• Global Harmonization Task Force GHTF
• GHTF Archived Documents
• International Medical Device Regulators Forum IMDRF
• AHWP Work Group 1a IVD Medical Devices
• The Latin American Alliance for the Development of In Vitro Diagnostics
• African Medicines Regulatory Harmonization Programme  AMRH
• Southern African Laboratory Diagnostics Association SALDA
• International Diagnostics Centre
• A Model Regulatory Program for Medical Devices published by WHO/PAHO 2009
• Definition of medical device and IVD medical device published by GHTF 2011
• Principles of In Vitro Diagnostic (IVD) Medical Devices Classification published by GHTF 2007
• Essential Principles of Safety and Performance of Medical Devices  published by GHFT 2007
• Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices published by GHFT 2011
• Guidance on Mapping of STED to CSDT published by AHWP Technical Committee Working Group 2012
• Proposal for a regulation of the European Parliament and of the council on IVD European Union 2012
• ISO13485 Medical Device Standard Translated Into Plain English  Praxiom Research Group Ltd