Workshop on ISO 13485 Certification

The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector collaborated with Health Canada to organize a workshop on Certification on ISO 13485 with the objective to learn on the experience from a regulator and an auditing organization on this process.…

Webinar Series on Unique Device Identification

Session 1 - 20 January 2022 / Session 2 - 27 January 2022

The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector collaborated with the United States Food and Drug Administration (FDA) to organize a webinar series on Unique Device Identification. Objective: Provide an overview of the requirements related to Unique Device Identification (UDI) and FDA’s perspective and…

Webinar Series on Utilization of Voluntary Consensus Standards

The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector collaborated with the United States Food and Drug Administration (FDA) to organize a webinar series on the Utilization of Voluntary Consensus Standards. Session I. 7 December 2021 Objective: Provide USFDA’s experience…

Overview on FDA´s Regulation of Medical Devices – Colombia

July 30, 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…

USFDA – IACRC Webinar Series on Medical Device: ISO 13485 and MDSAP

June 2, 10 and 17, 2021

In June, the Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector collaborated with the United States Food and Drug Administration (FDA) to organize a webinar series. Sessions from the series focused on ISO 13485 and Medical Device Single Audit Program (MDSAP) outcomes utilization for…

National Health Institute of Chile

Webinar November 19, 2020

Regulation of Medical Devices in Chile: The challenge ahead. Experts from the FDA (United States), ANVISA (Brazil) and ANDID (Chile), convened by ADIMECH and the Coalition, analyzed their experiences and practices in regulatory matters. Session Recording (Available in Spanish)

U.S. Food and Drug Administration – LatAm Office

Webinar June 15, 2020

U.S. FDA Latin America Office, IMDRF: WGs and Priorities, MD Division (CDRH) & LatAm Activities, FDA Standards & Conformity Program/Policy and MDSAP & ISO13485. Agenda, Slides Deck, FDA Presentation – Talking Points, Webinar Recording U.S. Food and Drug Administration The Center for Devices and Radiological Health (CDRH) – FDA provides a web page for multimedia industry education. The…

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