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…
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…
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…
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…
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…
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…
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…
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…
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…
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)