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…
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).…
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
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
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…
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…
