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Regulatory Convergence
Inter-American Coalition
About
Terms of Reference
Members
Technical Secretariat
Executive Committee
Join the Coalition
Contact Us
Coalition Action
Events
Positions by Country
Positions by Topic
Action Plan (2020-2025)
Multilateral Engagement
Policy
International Standardization
Standardization and Conformity Assessment
Standards Development Organizations, Committees and Standards for Medical Technology
ISO/IEC
ASTM International
AAMI
CLSI
MITA
National Standards Bodies from the Americas
Use of International Standards by Medical Device Regulators
FDA – Use of International Standards
Medical Device Sector Regulatory Convergence
World Health Organization Documents
WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Good Regulatory Practices
Good Reliance Practices
Post Market Surveillance
International Medical Device Regulators Forum
IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
IMDRF Documents
SaMD
Clinical Investigation
Medical Device Single Audit Program (MDSAP)
Good Regulatory Practices
OECD
APEC
WTO/TBT
WTO Agreements Implementation by Country
Regional & Bilateral Trade Agreements / GRP & TBT
USMCA
Pacific Alliance
ABD/IDB
Central Regulatory Coordination
Transparency & Trade
Relationship Between Regulatory and Transparency
Trade
Training
Policy Training
Regulator Sessions
International Symposia
Projects
Standards Alliance
Standards Alliance 1.0
Tier 1 – Good Regulatory Practices (GRP = Regulatory Coherence)
Colombia
Costa Rica
Mexico
Peru
United States
All Countries
Tier 1 – Global Benchmark Documents – Overarching Good Regulatory Practices and Technical Barriers to Trade Requirements
Tier 2 – Medical Device Sector-Specific Good Regulatory Practices, Technical Regulations, Standards, And Conformity Assessment
Tier 2 – Global Benchmark Documents – Medical Device Sector Regulatory Frameworks, GRPs, Regulations, Standards, Conformity Assessment mechanisms
Standards Alliance Phase 2 COVID-19 Medical Device Regulatory Convergence Project (MDRC)
Africa
Latin America
Southeast Asia
Quick Links
Medical Device Regulatory Authorities
WHO Medical Devices Web Page
WHO In vitro diagnostics
GMTA collaboration plan with WHO 2021-2023
PAHO Medical Devices Web Page
Central Regulatory Coordination Bodies
National Standards Bodies from the Americas
WTO/TBT National Enquiry Points
Harmonized System (HS) Codes for MedTech
WTO/TBT Notifications on Medical Technology
Open Public Consultations
COVID-19
Coalition Recommendations to the IDB
Coronavirus – Use of Antibody Tests
Brazil Response
Colombia Response
Mexico Response
United States of America Response
News
About
Terms of Reference
Members
Technical Secretariat
Executive Committee
Join the Coalition
Contact Us
Coalition Action
Events
Positions by Country
Positions by Topic
Action Plan (2020-2025)
Multilateral Engagement
Policy
International Standardization
Standardization and Conformity Assessment
Standards Development Organizations, Committees and Standards for Medical Technology
ISO/IEC
ASTM International
AAMI
CLSI
MITA
National Standards Bodies from the Americas
Use of International Standards by Medical Device Regulators
FDA – Use of International Standards
Medical Device Sector Regulatory Convergence
World Health Organization Documents
WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Good Regulatory Practices
Good Reliance Practices
Post Market Surveillance
International Medical Device Regulators Forum
IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
IMDRF Documents
SaMD
Clinical Investigation
Medical Device Single Audit Program (MDSAP)
Good Regulatory Practices
OECD
APEC
WTO/TBT
WTO Agreements Implementation by Country
Regional & Bilateral Trade Agreements / GRP & TBT
USMCA
Pacific Alliance
ABD/IDB
Central Regulatory Coordination
Transparency & Trade
Relationship Between Regulatory and Transparency
Trade
Training
Policy Training
Regulator Sessions
International Symposia
Projects
Standards Alliance
Standards Alliance 1.0
Tier 1 – Good Regulatory Practices (GRP = Regulatory Coherence)
Colombia
Costa Rica
Mexico
Peru
United States
All Countries
Tier 1 – Global Benchmark Documents – Overarching Good Regulatory Practices and Technical Barriers to Trade Requirements
Tier 2 – Medical Device Sector-Specific Good Regulatory Practices, Technical Regulations, Standards, And Conformity Assessment
Tier 2 – Global Benchmark Documents – Medical Device Sector Regulatory Frameworks, GRPs, Regulations, Standards, Conformity Assessment mechanisms
Standards Alliance Phase 2 COVID-19 Medical Device Regulatory Convergence Project (MDRC)
Africa
Latin America
Southeast Asia
Quick Links
Medical Device Regulatory Authorities
WHO Medical Devices Web Page
WHO In vitro diagnostics
GMTA collaboration plan with WHO 2021-2023
PAHO Medical Devices Web Page
Central Regulatory Coordination Bodies
National Standards Bodies from the Americas
WTO/TBT National Enquiry Points
Harmonized System (HS) Codes for MedTech
WTO/TBT Notifications on Medical Technology
Open Public Consultations
COVID-19
Coalition Recommendations to the IDB
Coronavirus – Use of Antibody Tests
Brazil Response
Colombia Response
Mexico Response
United States of America Response
News
Coalition Action
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Coalition Action
Past events
Engagement with External Stakeholders – WHO
May 18, 2021
GRP / TBT & Policy Training Webinars Series
May 26 - June 15, 2020
Executive Committee Conference Call
May 14, 2020
Executive Committee Members Appointment
April 7, 2020
Virtual Meeting
March 30, 2020
WTO/TBT Committee – GRP Thematic Session
February 25, 2020
Welcome Conference Call
January 29, 2020
Coalition Action Plan for 2020-2025
Multilateral Engagement
REGULATORY COALITION PRINCIPAL MEMBERS
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