The Inter-American Coalition for Regulatory Convergence in the Medical Devices Sector held its 5th Anniversary Session on 8 May 2025. The agenda included a first proposal of the approval times metrics of some countries in the region, as well as the presentation of a tool to consolidate them. Additionally, progress reports from the Working Groups were presented, along with a retrospective of the past five years of the Coalition, besides a review of the Action Plan 2020 – 2025 as a starting point for the preparation of the 2026 – 2030 Plan. The meeting was attended by 75 representatives from 8 countries, as shown below.

CountryAttendees
Argentina5
Brazil23
Colombia3
Ecuador1
Mexico29
Peru4
Spain1
United States9
Total75

Agenda

Recording

Presentations

IACRC Metrics for NRA Authorization Timelines – Sandra Ligia González, IACRC
Tools for Metrics – Iván Legazpi, AMID
Working Groups Updates:
GMPs. Strategies to increase NRAs affiliation to MDSAP – Duglas Rodrigues Calderón, Roche
Regulatory Reliance. Strategies to leverage resources available at GMTA & Coalition – Renata Brandão, Abbott
CFG & FSC – Apostille. Strategies to eliminate the requirement – Renata Brandão, Abbott
eIFU. Strategies to implement as general practice – Yenni Cruz, Abbott
Open public consultations. Industry active participation – Magdalena del Sel, J&J
IACRC – First five years in retrospective
IACRC Action Plan 2026 – 2030

REGULATORY COALITION PRINCIPAL MEMBERS