La Coalición Interamericana para la Convergencia Regulatoria en el Sector de Tecnología Médica, como parte del Proyecto MDRC y en colaboración con la US FDA, organiza la sesión “La Implementación de Buenas Prácticas Regulatorias – Impacto Regulatorio y Efectividad” con el propósito de proporcionar un espacio para una discusión a profundidad y compartir recomendaciones para…
La Coalición Interamericana para la Convergencia Regulatoria, Sector de Tecnología Médica, llevó a cabo la «Sesión de Relacionamiento con Actores Externos» el 10 de Octubre en San Salvador, El Salvador. Entre los temas tratados en el evento se encuentran Autorizaciones para Uso en Emergencia, CGE/CLV electrónicos, Herramientas Regulatorias Electrónicas, Reliance y Bases de Datos de…
La Coalición Interamericana para la Convergencia Regulatoria en el Sector de Tecnología Médica, en el marco del Proyecto de Convergencia Regulatoria de Dispositivos Médicos (MDRC) de la Alianza por las Normas, en el que participan USAID, ANSI y AdvaMed, llevaron a cabo un entrenamiento sobre la aplicación de las Buenas Prácticas Regulatorias en México, conforme…
September 24, 2023
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…
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)…
May 17, 2023
La Coalición Interamericana para la Convergencia Regulatoria para el Sector de Tecnología Médica celebró la «Reunión Virtual con Partes Interesadas Externas» el 17 de mayo. Los temas tratados durante el evento incluyeron los materiales de capacitación de Buenas Prácticas de «Reliance» de la OMS presentados por la Dra. Marie Valentin – OMS; las experiencias de…
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…
June 6-8, 2022
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…
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…
