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 24. 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…

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…

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).…

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…

September 24, 2023

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…

May 17, 2023

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…

June 6-8, 2022

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…

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…

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…