Policy Training

Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector – External Stakeholders Session – November 13, 2024

The Inter-American Coalition for Regulatory Convergence in the Medical Device Sector hosted the “External Stakeholders Virtual Session” on November 13, 2024. Topics covered during the event included the role of the OECD in promoting GRPs, discussions between NRAs from Brazil, El Salvador and the United States on regulatory convergence and Reliance, and the Coalition’s engagement…

Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector – External Stakeholders Session – March 14, 2024

The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector hosted the “External Stakeholders Hybrid Meeting” in Washington D.C. on March 14. Topics covered during the event included The Role of Manufacturers in Ensuring Quality, Safety & Performance, Initiatives to Increase the Use of International Standards for Medical Devices, Key Initiatives in the Medical…

Conformity Assessment of Medical Devices in Brazil and the in U.S.

As a workstream under the Medical Device Regulatory Convergence Project (MDRC) and, on September 24, 2023, the MDRC hosted in Brasília an Exchange of Information Workshop between ANVISA, INMETRO, USFDA and NIST. This workshop was part of the MDRC efforts to support good regulatory practices and medical device regulatory convergence. The objective was to review…

How to apply Good Regulatory Practices in Mexico

The Inter-American Coalition for Regulatory Convergence, Medical Technology Sector, under the Medical Device Regulatory Convergence Project (MDRC) within the Standards Alliance initiative, where USAID, ANSI and AdvaMed participate, held a training session on the implementation of Good Regulatory Practices in Mexico, according to the country legal domestic and international obligations before the Technical Barriers to…

MDRC – Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector External Stakeholders Meeting

The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector held the “External Stakeholders Virtual Meeting” on October 10th in San Salvador, El Salvador. Topics covered during the event included Emergency Use Authorizations, Electronic CFG/FSC, Electronic Regulatory Tools, Reliance and Regulators’ Databases. Agenda (English only) Recordings Presentations Medical Device Regulatory Convergence, COVID 19 (MDRC).…

The Implementation of Good Regulatory Practices – Regulatory Impact and Effectiveness 

The Inter-American Coalition for Regulatory Convergence, Medical Technology Sector, under the MDRC Project and in collaboration with the US FDA, organized a session on “The Implementation of Good Regulatory Practices – Regulatory Impact and Effectiveness” with the purpose to provide in-depth discussion and recommendations for conducting Regulatory Impact Analysis and effectiveness of rules through a…

Engagement with External Stakeholders Virtual Meeting, May 17th  – WHO, Anvisa (Brazil), MoH Colombia, GMTA and CMI.

The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector held the “External Stakeholders Virtual Meeting” on May 17th. Topics covered during the event included WHO’s Good Reliance Practice training materials presented by Dr. Marie Valentin – WHO; Anvisa’s and MoH’s experiences in implementing Good Regulatory Practice presented by Dr. Thiago Carvalho – Anvisa…

Inter-American Coalitions, COVID-19 Medical Device Regulatory Convergence Project (MDRC) Sessions and the Summit of the Americas

We have compiled a comprehensive readout of the Coalitions Sessions as well as key Summit outcomes, including links to the presentations and recordings of each session, including a printable version of the report which can be accessed here. Photos Coalition and MDRC meeting photos from 6-8 June may be accessed here (password: crowell). Agendas Agendas…

GRPs Workshop Peru

The United States Agency for International Development (USAID) and the Inter-American Coalition for Regulatory Convergence, Medical Technology Sector (IACRC), organized a Workshop on Good Regulatory Practices, as part of the activities under the MDRC Project. The Presidency of the Ministries Council, the Ministry of Foreign Commerce and Tourism, as well as DIGEMID and the private…

Workshop on the “Experience on the Regulatory Impact Analysis – Problem Tree – for Good Manufacturing Practices of Medical Devices” – Colombia. September 6, 2021

The United States Agency for International Development (USAID), the National Planning Department (DNP), the Ministry of Health and Social Protection (MinSalud), the Ministry of Commerce, Industry and Tourism (MinCIT), the National Institute of Vigilance od Medicines and Food (INVIMA) through the Directorate of Medical Devices and Other Technologies, the Medical Devices and Health Supplies Chamber…

Webinar Series on Good Regulatory Practices and Its Implementation in the Medical Devices Sector in Mexico

The Inter-American Coalition for Regulatory Convergence, Medical Technology Sector, under the Medical Device Regulatory Convergence Project (MDRC) within the Standards Alliance initiative, where USAID, ANSI and AdvaMed participate, and in collaboration with the Federal Commission for Protection Against Sanitary Risks (COFEPRIS), held a Series on Good Regulatory Practices and Its Implementation in the Medical Device…

Workshop on Good Regulatory Practices and International Trade Chile, 26 – 27 October, 2021

The Inter-American Coalition for Regulatory Convergence, Medical Technology Sector along with ADIMECH organized a Workshop on Good Regulatory Practices in Chile, that aimed to contribute to the development of capacities among all MD’s relevant stakeholders, both from public and private sectors and which will help us identify opportunities to leverage their utilization while Chile is…

Engagement with External Stakeholders Session – November 30, 2021 – World Bank, Brazil’s ANVISA, Colombia’s: National Planning Department, Ministry of Commerce, Industry and Tourism, Ministry of Health, INVIMA

Good Regulatory Practices and its impact on health care discussed by Alfredo González, World Bank, how GRPs are embraced by a National Regulatory Agency shared by Cristiane Rose Jourdan Gomes, ANVISA and a panel involving representatives from the Colombian government: María Jimena Padilla, National Planning Department, Hernán Alonso Zúñiga, Ministry of Commerce, Industry and Tourism, Óscar Arturo Marin, Ministry of…

Engagement with External Stakeholders Session – May 18, 2021 – WHO

WHO Relevant Recent Publications on Good Regulatory Practices, Good Reliance Practices and Post-market Surveillance were introduced by the leaders responsible for their development at the WHO, with the purpose to get the Coalition’s members becoming familiar with them and promote a wider utilization. Presentation on Good regulatory practices for regulatory oversight of medical products and…

Workshop on GRP and International Trade: Brazil – March 16 and 17, 2021

On March 16th and 17th the InterAmerican Coalition for Regulatory Convergence – Medical Technology Sector (IACRC) hosted the Workshop on Good Regulatory Practices (GRP) and International Trade for the Brazilian stakeholders. The workshop was co-hosted and supported by ABIMED, ABIIS, ABRAIDI and CBDL, and joined by several authorities, representatives from academia and the private sector.…

Office of the United States Trade Representative

Western Hemisphere Leadership in Good Regulatory Practices

This virtual series spotlight how countries in the Western Hemisphere are applying Good Regulatory Practices (GRPs) and provide an opportunity for trade and regulatory officials from the region to exchange information about ongoing GRP-related initiatives and ideas for the future. Presentations can be accessed through the following links in the original languages:

World Trade Organization

Regulatory Cooperation during the COVID-19 Pandemic – June 2, 2021

Objective: The webinar focused on regulatory cooperation and its role in facilitating access to medical technologies, especially in the context of COVID-19.  While technical regulations, standards and conformity assessment procedures for health-related products are vital for ensuring safety, efficacy and quality, differences between countries could prevent businesses from engaging in trade and supplying their products to patients…

Workshop on Ex-Post Analysis – Colombia. July 27, 2021

The United States Agency for International Development (USAID), the National Planning Department (DNP), the Ministry of Health and Social Protection (MinSalud), the Ministry of Commerce, Industry and Tourism (MinCIT), the National Institute of Vigilance od Medicines and Food (INVIMA) through the Directorate of Medical Devices and Other Technologies, the Medical Devices and Health Supplies Chamber…

Workshop on Good Regulatory Practices – Colombia. July 23, 2021

The United States Agency for International Development (USAID), the National Planning Department (DNP), the Ministry of Health and Social Protection (MinSalud), the Ministry of Commerce, Industry and Tourism (MinCIT), the National Institute of Vigilance od Medicines and Food (INVIMA) through the Directorate of Medical Devices and Other Technologies, the Medical Devices and Health Supplies Chamber…

Workshop on “Problem Tree” – Colombia. August 25, 2021

The United States Agency for International Development (USAID), the National Planning Department (DNP), the Ministry of Health and Social Protection (MinSalud), the Ministry of Commerce, Industry and Tourism (MinCIT), the National Institute of Vigilance od Medicines and Food (INVIMA) through the Directorate of Medical Devices and Other Technologies, the Medical Devices and Health Supplies Chamber…

Webinar GRPs in Mexico – November 12, 2020

Good Regulatory Practices in Mexico from the perspective of the Executive (CONAMER, DGN, COFEPRIS), Legislative (Chamber of Deputies) and Judicial (Superior Court of Administrative Justice) Powers, including obligations stated at multilateral agreements (TBT, OECD and USMCA). Materials available in Spanish only. Agenda Slides Deck Recording The Coalition held a series of educational webinars to provide…

Webinar – May 26 – June 9, 2020

Session 1 – May 26, 2020 Regulatory Convergence and International Benchmarks: WHO, IMDRF, MDSAP. Session 2 – June 2, 2020 Global Perspectives: GMTA, MDUFA, 21st Century Cures, APEC MD Initiative, GRPs and International Benchmarks: OECD, IDB, ABD, APEC & Advancing Opportunities from the COVID-19 Pandemic. Session 3 – June 9, 2020 World Trade Organization and…

Engagement with External Stakeholders Session – December 1, 2020

COVID-19, Impact, response, recovery; Lessons learned from COVID-19 & The Role of the WTO TBT Agreement & GRPs in support of Medical Device Regulatory Convergence were address by experts at the London School of Hygiene and Tropical Medicine, FDA — LATAM Office, WHO, PAHO, CBDL/ALADDIV, Ministry of Economy of Brazil and The Office of the U.S.…