The Medical Device Regulatory Convergence Project, co-led by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector, in collaboration with the U.S. Food and Drug Administration (FDA), hosted a webinar on June 1 to present “Fundamentals of establishing sterile barrier systems for medical devices: package stability (shelf life)…
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 on 29 August 2022, a webinar to provide an overview and practical implementation of IMDRF’s principles of conformity assessment…
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.…
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…
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…
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…
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…
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)
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…
