5th Anniversary Meeting Internal Stakeholders Session – December 10, 2025

The Inter-American Coalition for Regulatory Convergence in the Medical Devices Sector successfully held its second bi-annual meeting of 2025.  Key highlights of the agenda included:

• Updates presented by the Technical Secretariat
• Progress reports from the Coalition’s Working  Groups.

The meeting was attended by 59 people from 8 countries, as shown below.

COUNTRY	ATTENDEES
Argentina	5
Brazil	20
Canada	1
Chile	3
Colombia	13
Mexico	10
Peru	2
United States	5
Total	59

Agenda

Recording

Presentations

1 – IACRC Metrics for NRA Authorization Timelines, Sandra Ligia González

2 – Regulatory Reliance. Strategies to leverage resources available at GMTA & Coalition, Renata Brandão

3 – Open public consultations. Industry active participation, Magdalena del Sel

4 – Participation in NSB Technical Committees, Márcio Godoy and Steven Bipes

5 – CFG & FSC – Apostille. Strategies to eliminate the requirement, Renata Brandão

6 – GMPs. Strategies to increase NRAs affiliation to MDSAP, Duglas Calderon

7 – eIFU. Strategies to implement as general practice, Yenni Cruz