ATCET-2026 was a project conducted in May-June 2026 to build capacities and provide training for medical device regulatory authorities around Critical and Emerging (CET) technologies with the primary objective of advancing regulatory convergence and reliance for medical devices in Mexico and Paraguay.

ATCET-2026 was a public private partnership project between the American National Standards Institute (ANSI) and the U.S. Department of State under the Standards Alliance Phase 2 for which AdvaMed and the Inter-American Coalition for Regulatory Convergence – Medical Technology Sector (IACRC) were implementing partners and remain active as ongoing ATECT-2026 legacy supporters.

ATCET-2026 focused on strengthening reliance on international and U.S. benchmarks, standards, conformity assessment, and reference medical device market authorizations in a context of foundational Good Regulatory Practices (GRP), minimizing technical barriers to trade, and improving market and patient access to life-saving and life-improving critical and emerging medical technologies.

A major ATCET-2026 project component was training organized by AdvaMed and the IACRC for Mexican and Paraguayan authorities and realized in Mexico City, Mexico 15-19 June 2026 conducted by subject matter experts from the U.S. Food and Drug Administration (FDA) and other reference medtech regulatory authorities, the Office of the U.S. Trade Representative (USTR), and the U.S. medtech industry. The proceedings from these sessions are available below. The final report for ATCET-2026 will be made public in Q4 2026.

Agenda

Day 1 (06/15)

Recording

Presentations

ATCET-2026 Project and Goals for the Week – Sandra Ligia González, ATCET-2026 Project Director

Panel. Regulators’ Vision for the Future of Medical Device Oversight
Moderator: Sandra Ligia González, ATCET-2026 Project Director

Alison Iglesias – Director. Directorate of Registration of Medical and Dental Devices, DINAVISA

Kenneth J. Cavanaugh Jr., USFDA

WHO Global Model Regulatory Framework for medical devices including in vitro diagnostic medical devices. How is it relevant to the rapidly evolving medical device technologies? – Tammy Steuerwald, Roche Diagnostics

Implementation of a Quality Management System for the regulatory processes of a National Regulatory Authority. Challenges & Benefits – Nancy C. Braier, USFDA

Panel. Medical Device Regulatory Framework in Mexico. What to Expect from The Latest Regulation Updates?
Moderator: Juan Antonio Dorantes, Dorantes Advisors

Rafael Hernández, Pharmacopoeia of the United Mexican States (FEUM)

Ana Riquelme, AMID

DINAVISA Regulatory Framework Overview
Moderator: Roberta Mele Mazza, Roche Diagnostics

Alison Iglesias, DINAVISA

Carmen Portillo, Director, DINAVISA

Regulatory Convergence. Does a risk-based approach in developing regula ons have a role? – Diane Wurzburger, GE Healthcare

Impact of variation in risk classification criteria on the implementation of Reliance. – Fatemeh Razjouyan, Medtronic

Day 2 (06/16)

Recording

Presentations

Panel. Good Reliance Practices at Work
Moderator: Diane Wurzburger, GE Healthcare

High level principles, IMDRF Playbook and TGA Experience – Tracey Duffy, Australian Therapeutic Goods Administration (TGA)

Implementation of Reliance. A success story for Singapore Health Sciences Authority (HSA) – Wong Woei Jiuang, Health Science Authority Singapore (HSA)

Reliance Implementation Map – Tammy Steuerwald, Roche Diagnostics

A Reliance Journey by COFEPRIS
Moderator: Ana Riquelme, AMID

Reliance Journey by COFEPRIS – Edgardo Arenas, COFEPRIS

Impact of the Equivalence Agreements with USFDA, HC and PMD on access to medical devices – Adriana Flores Zambrano, AMID
Industry experiences to date – Case Studies Part I 
Nallely Contreras, Werfen, AMID
Mónica García Rincón, Becton Dickinson, AMID

Industry experiences to date – Case Studies Part II – Sandra Ligia González, IACRC

Reliance for Software as Medical Device. Challenges and Opportunities – Renata Brandão, Oracle

Day 3 (06/17)

Recording

Presentations

DINAVISA. Experiencing Reliance for MDs and IVDs
Moderator: María Fernanda Carvajal, GE Healthcare

Alison Iglesias, DINAVISA

Carmen Portillo, Director, DINAVISA

Industry experiences to date, Roberta Mele Mazza, Roche Diagnostics

Enabling Reliance Through Data – Hands-on Experience – Part I

Health Canada Database – Seema Vyas, Medtronic

Enabling Reliance Through Data – Hands-on Experience – Part II
Moderator: María Fernanda Carvajal, GE Healthcare

FDA Database – Scott Colburn, USFDA

ANVISA Database – Leticia Fonseca, IACRC

Enabling Reliance Through Data – Hands-on Experience – Part III
Moderator: Tammy Steuerwald, Roche Diagnostics

Australia: Therapeutic Goods Administra on (TGA) Database – Jane Shum, TGA

Singapore: Health Sciences Authority (HSA) Database – Wong Woei Jiuang, HSA

Reliance through medical device lifecycle. Post-market surveillance – Tammy Steuerwald, Roche Diagnostics

Day 4 (06/18)

Recording

Presentations

International Obligations and its relationship with Domestic Regulations & Good Regulatory Practices – Kristan Callahan, USTR

Technical Barriers to Trade (TBT) & GRP – Checklist Update Launch – Marina Carvalho, IACRC

Regulatory Impact Assessment. A practical approach – Marina Carvalho, IACRC

Good Regulatory Practices in Mexico. How current frameworks impact medical devices – Juan Antonio Dorantes, Dorantes Advisors

International Standards – What for? – Scott Colburn, USFDA

International Standards – Role of the Mexican General Directorate of Standards (Dgn) and the Paraguayan National Institute of Technology, Standardization and Metrology (Intn) to Facilitate Access to Medical Devices
Moderator: Juan Antonio Dorantes, Dorantes Advisors

Luis Iván Hernández, Mexican Association for Standardization and Certification (ANCE)

Carolina Barrios, National Standards Department, INTN

The Role of Voluntary Consensus Standards in Regulatory Frameworks – Terry O. Woods, USFDA

Standards and Conformity Assessment – building regulators’ confidence in device safety and performance – Eric Franca, USFDA

Conformity Assessment Checklist – Compliance with International Obligation, Marina Carvalho – IACRC

Day 5 (06/19)

Recording

Presentations

Trade and Regulations – Opportunities and Challenges in Paraguay for the Medical Technology Sector – Andrea Fernández, Ministry of Industry and Commerce (MIC) Paraguay

Medical Technology Sector Map – Brazil and the Americas – Leticia Fonseca, IACRC

The Role of Manufacturers in Ensuring Quality, Safety & Performance – Fatemeh Razjouyan, Medtronic

MDSAP. A Success Story: Auditing Organizations and Industry Perspective

Melissa Torres, AdvaMed

John Castro, Auditor, SGS North America Inc.

Rosa Castañeda, Medtronic