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Regulatory Convergence
Inter-American Coalition
About
Medical Device Definition
Terms of Reference
Members
Technical Secretariat
Executive Committee
Multilateral Engagement
Join the Coalition
Contact Us
Coalition Action
Action Plan (2020-2025)
IACRC Positions
IACRC Meetings
Regulatory Policies
International Obligations on GRP
OECD
WTO
Regional & Bilateral Trade Agreements focusing on Regulatory Convergence and GRP
Implementation of GRP by Country
ABD/IDB
Central Regulatory Coordination
Medical Device Sector Regulatory Convergence
World Health Organization Documents
International Medical Device Regulators Forum (IMDRF)
IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
IMDRF Documents
SaMD
Clinical Investigation
IMDRF Meetings
Medical Device Single Audit Program (MDSAP)
How International Standards are applied by Medical Device Regulators
International Standards on Medical Device applied by Countries
ISO/IEC
AAMI
ASTM International
CLSI
MITA
National Standards Bodies from the Americas
Capacity Building
Training Sessions
External Participation of the IACRC
Projects
Standards Alliance
Standards Alliance 1.0
Tier 1
Tier 2
Standards Alliance 2.0
Quick Links
Medical Device Regulatory Authorities
WHO Medical Devices Web Page
PAHO Medical Devices Web Page
National Standards Bodies from the Americas
Central Regulatory Coordination Bodies
ePing
HS and HTS codes for Medical Devices (The MD export codes for use on the ePing site)
News
About
Medical Device Definition
Terms of Reference
Members
Technical Secretariat
Executive Committee
Multilateral Engagement
Join the Coalition
Contact Us
Coalition Action
Action Plan (2020-2025)
IACRC Positions
IACRC Meetings
Regulatory Policies
International Obligations on GRP
OECD
WTO
Regional & Bilateral Trade Agreements focusing on Regulatory Convergence and GRP
Implementation of GRP by Country
ABD/IDB
Central Regulatory Coordination
Medical Device Sector Regulatory Convergence
World Health Organization Documents
International Medical Device Regulators Forum (IMDRF)
IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
IMDRF Documents
SaMD
Clinical Investigation
IMDRF Meetings
Medical Device Single Audit Program (MDSAP)
How International Standards are applied by Medical Device Regulators
International Standards on Medical Device applied by Countries
ISO/IEC
AAMI
ASTM International
CLSI
MITA
National Standards Bodies from the Americas
Capacity Building
Training Sessions
External Participation of the IACRC
Projects
Standards Alliance
Standards Alliance 1.0
Tier 1
Tier 2
Standards Alliance 2.0
Quick Links
Medical Device Regulatory Authorities
WHO Medical Devices Web Page
PAHO Medical Devices Web Page
National Standards Bodies from the Americas
Central Regulatory Coordination Bodies
ePing
HS and HTS codes for Medical Devices (The MD export codes for use on the ePing site)
News
Canada
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Regulatory Policies
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International Obligations on GRP
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Implementation of GRP by Country
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Canada
USMCA – Chapter on GRP
CPTPP – Chapter on Regulatory Convergence
Cabinet Directive on Regulation
Policy on Regulatory Development
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