Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector – External Stakeholders Session

The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector hosted the “External Stakeholders Hybrid Meeting” in Washington D.C. on March 23. Topics covered during the event included The Role of Manufacturers in Ensuring Quality, Safety & Performance, Initiatives to Increase the Use of International Standards for Medical Devices, Key Initiatives in the Medical Device Sector, GRP & TBT; MDR / IVDR; GMDN and Measures to Align El Salvador’s Medical Device Regulatory Framework with International References.

Agenda

Presentations

The Role of Manufacturers in Ensuring Quality, Safety & Performance – Regulatory Authority Views – Scott Colburn – USFDA

The Role of Manufacturers in Ensuring Quality, Safety & Performance – Regulatory Authority Views – Thiago Cunha – ANVISA

The Role of Manufacturers in Ensuring Quality, Safety & Performance – Manufacturer’s Views – Fatemeh Razjouyan, Medtronic and Tammy Steuerwald, Roche Diagnostics

Medical Device International Standardization – Initiatives to increase use of international standards for medical devices and engagement in Standards Development Organizations for medtech across the Americas – Terry Woods – USFDA

Dirección Nacional de Medicamentos, El Salvador – Karina Flores – DNM Mario Vega – DNM

GMDN Overview – Deniz Bruce – GMDN