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Marketing Review Report Work Instruction

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Closing date
Working group
Good Regulatory Review Practices

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices (GRRP) Working Group is provided below for public comment.

Thank you for your contribution in reviewing and providing feedback for this document.

Consultation documents

Marketing Review Report Work Instruction

Please use the comments template to provide comments on the Proposed Documents and send comments to Ken Cavanaugh via email: kenneth.cavanaugh [at] fda.hhs.gov (kenneth[dot]cavanaugh[at]fda[dot]hhs[dot]gov) with the subject line 'Public Consultation on Proposed GRRP Working Draft'.

 

Comments - Marketing Review Report Work Instruction

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

World Health Organization (WHO)

Swissmedic

 

Affiliate members

SAHPRA - South African Health Products Regulatory Authority

TFDA - Taiwan Food and Drug Administration

CECMED (Cuba) - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos

EDA - Egyptian Drug Authority 

MTIIR (Israel) - The Medical Technology, Health Information, Innovation and Research Directorate

ISP - Public Health Institute of Chile

CinMED - Institute for Medicine and Medical Devices of Montenegro