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Regulatory Convergence
Inter-American Coalition
Regulatory Convergence
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  • About
    • Terms of Reference
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  • Policy
    • International Standardization
      • Standardization and Conformity Assessment
      • Standards Development Organizations, Committees and Standards for Medical Technology
        • ISO/IEC
        • AAMI
        • AdvaMed Imaging
        • ASTM International
        • CTA
        • GMDN Agency
        • 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
        • Final Report
  • 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
  • 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
        • AAMI
        • AdvaMed Imaging
        • ASTM International
        • CTA
        • GMDN Agency
        • 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
        • Final Report
  • 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
  • News

News

Home » News

Colombia, Cuba and Mexico agree to begin talks to create the AMLAC, with the aim of achieving health self-sufficiency and access to medicines and medical devices in the region.

April 28, 2023

During the Second National Week Against Sanitary Risks, the “Declaration of Acapulco” was signed, which includes the…

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Strong and Inclusive Democratic Governance

June 3, 2022

The ABD through its working groups has developed Policy Recommendations to the IX Summit of…

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High-Level Economic Dialogue (HLED) Mid-Year Review

April 25, 2022

The U.S. and Mexican HLED co-chairs met on April 18 to review key accomplishments. Under…

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Inter-American Coalition for Regulatory Convergence – Medical Technology Sector formally approved as Liaison Member of the Global Harmonization Working Party (GHWP)

December 6, 2021

On 27 October 2021, Mr. Ali M. AL-DALAAN, Chair of Asia/Global Harmonization Working Party (AHWP/GHWP)…

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Webinar ABIIS – Medical Devices: regulation, advances and perspectives

November 17, 2021

The Brazilian Alliance of Innovative Health Industry (ABIIS), will promote from 9:00 am to 12:00…

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MDRC Project – LoI Signature

September 2, 2021

Alejandro Svarch Pérez, Federal Commissioner – COFEPRIS; Bruce Adams, Mission Director – USAID; Joseph Tretler,…

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Congratulations to ANMAT for becoming an Official Observer of the International medical Devices Regulators Forum (IMDRF)

August 27, 2021

It is the first health authority in the region to acquire this membership in the…

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USAID, ANSI, and AdvaMed Announce Multi-Year Partnership to Strengthen Global COVID-19 Response

October 8, 2020

As the medical technology industry combats COVID-19, Coalition Executive Committee member, the Advanced Medical Technology…

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Policy Recommendations on addressing the Coronavirus disease (COVID-19) pandemic and mitigating its impacts

May 27, 2020

On April 27, 2020, the American Business Dialogue after consultation with its members, issued a…

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AdvaMed Applauds Summit of the Americas’ Focus On Importance of Business Ethics and Good Regulatory Practices

April 20, 2018

The Advanced Medical Technology Association (AdvaMed) issued this press release following the recent conclusion of the VIII…

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