{"id":5306,"date":"2026-07-02T00:57:05","date_gmt":"2026-07-02T00:57:05","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=5306"},"modified":"2026-07-22T16:33:08","modified_gmt":"2026-07-22T16:33:08","slug":"advanced-training-for-medical-device-regulators-around-critical-and-emerging-technologies-2026-atcet-2026","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/projects\/standards-alliance\/advanced-training-for-medical-device-regulators-around-critical-and-emerging-technologies-2026-atcet-2026\/","title":{"rendered":"Advanced Training for Medical Device Regulators Around Critical and Emerging Technologies 2026 (ATCET-2026)"},"content":{"rendered":"\n

ATCET-2026<\/strong> 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<\/strong> with the primary objective of advancing regulatory convergence and reliance for medical devices in Mexico and Paraguay.<\/p>\n\n\n\n

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

ATCET-2026<\/strong> 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.<\/p>\n\n\n\n

A major ATCET-2026<\/strong> 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 <\/strong>will be made public in Q4 2026.<\/p>\n\n\n\n

Agenda<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Day 1 (06\/15)<\/strong><\/h2>\n\n\n\n

Recording<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Presentations<\/h2>\n\n\n\n

ATCET-2026 Project and Goals for the Week \u2013 Sandra Ligia Gonz\u00e1lez, ATCET-2026 Project Director<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Panel. Regulators\u2019 Vision for the Future of Medical Device Oversight
Moderator: Sandra Ligia Gonz\u00e1lez, ATCET-2026 Project Director<\/strong><\/h5>\n\n\n\n
Alison Iglesias \u2013 Director. Directorate of Registration of Medical and Dental Devices, DINAVISA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Kenneth J. Cavanaugh Jr., USFDA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
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? \u2013 Tammy Steuerwald, Roche Diagnostics<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Implementation of a Quality Management System for the regulatory processes of a National Regulatory Authority. Challenges & Benefits \u2013 Nancy C. Braier, USFDA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Panel. Medical Device Regulatory Framework in Mexico. What to Expect from The Latest Regulation Updates?
Moderator: Juan Antonio Dorantes, Dorantes Advisors<\/strong><\/h5>\n\n\n\n
Rafael Hern\u00e1ndez, Pharmacopoeia of the United Mexican States (FEUM)<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Ana Riquelme, AMID<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
DINAVISA Regulatory Framework Overview
Moderator: Roberta Mele Mazza, Roche Diagnostics<\/strong><\/h5>\n\n\n\n
Alison Iglesias, DINAVISA<\/h5>\n\n\n\n
\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Carmen Portillo, Director, DINAVISA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Regulatory Convergence. Does a risk-based approach in developing regula ons have a role? \u2013 Diane Wurzburger, GE Healthcare<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Impact of variation in risk classification criteria on the implementation of Reliance. \u2013 Fatemeh Razjouyan, Medtronic<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Day 2 (06\/16)<\/strong><\/h2>\n\n\n\n

Recording<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Presentations<\/h2>\n\n\n\n

Panel. Good Reliance Practices at Work
Moderator: Diane Wurzburger, GE Healthcare<\/strong><\/h5>\n\n\n\n
High level principles, IMDRF Playbook and TGA Experience \u2013 Tracey Duffy, Australian Therapeutic Goods Administration (TGA)<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Implementation of Reliance. A success story for Singapore Health Sciences Authority (HSA) \u2013 Wong Woei Jiuang, Health Science Authority Singapore (HSA)<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Reliance Implementation Map \u2013 Tammy Steuerwald, Roche Diagnostics<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
A Reliance Journey by COFEPRIS
Moderator: Ana Riquelme, AMID<\/strong><\/h5>\n\n\n\n
Reliance Journey by COFEPRIS \u2013 Edgardo Arenas, COFEPRIS<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Impact of the Equivalence Agreements with USFDA, HC and PMD on access to medical devices \u2013 Adriana Flores Zambrano, AMID
Industry experiences to date \u2013 Case Studies Part I 
Nallely Contreras, Werfen, AMID
M\u00f3nica Garc\u00eda Rinc\u00f3n, Becton Dickinson, AMID<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Industry experiences to date \u2013 Case Studies Part II \u2013 Sandra Ligia Gonz\u00e1lez, IACRC<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Reliance for Software as Medical Device. Challenges and Opportunities \u2013 Renata Brand\u00e3o, Oracle<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Day 3 (06\/17)<\/strong><\/h2>\n\n\n\n

Recording<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Presentations<\/h2>\n\n\n\n

DINAVISA. Experiencing Reliance for MDs and IVDs
Moderator: Mar\u00eda Fernanda Carvajal, GE Healthcare<\/strong><\/h5>\n\n\n\n
Alison Iglesias, DINAVISA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Carmen Portillo, Director, DINAVISA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Industry experiences to date, Roberta Mele Mazza, Roche Diagnostics<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Enabling Reliance Through Data \u2013 Hands-on Experience – Part I<\/strong><\/h5>\n\n\n\n
Health Canada Database \u2013 Seema Vyas, Medtronic<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Enabling Reliance Through Data \u2013 Hands-on Experience – Part II
Moderator: Mar\u00eda Fernanda Carvajal, GE Healthcare<\/strong><\/h5>\n\n\n\n
FDA Database \u2013 Scott Colburn, USFDA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
ANVISA Database \u2013 Leticia Fonseca, IACRC<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Enabling Reliance Through Data \u2013 Hands-on Experience – Part III
Moderator: Tammy Steuerwald, Roche Diagnostics<\/strong><\/h5>\n\n\n\n
Australia: Therapeutic Goods Administra on (TGA) Database \u2013 Jane Shum, TGA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Singapore: Health Sciences Authority (HSA) Database \u2013 Wong Woei Jiuang, HSA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Reliance through medical device lifecycle. Post-market surveillance \u2013 Tammy Steuerwald, Roche Diagnostics<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Day 4 (06\/18)<\/strong><\/h2>\n\n\n\n

Recording<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Presentations<\/h2>\n\n\n\n

International Obligations and its relationship with Domestic Regulations & Good Regulatory Practices \u2013 Kristan Callahan, USTR<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Technical Barriers to Trade (TBT) & GRP – Checklist Update Launch \u2013 Marina Carvalho, IACRC<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Regulatory Impact Assessment. A practical approach \u2013 Marina Carvalho, IACRC<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Good Regulatory Practices in Mexico. How current frameworks impact medical devices \u2013 Juan Antonio Dorantes, Dorantes Advisors<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
International Standards \u2013 What for? \u2013 Scott Colburn, USFDA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
International Standards \u2013 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<\/strong><\/h5>\n\n\n\n
Luis Iv\u00e1n Hern\u00e1ndez, Mexican Association for Standardization and Certification (ANCE)<\/h5>\n\n\n\n
\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Carolina Barrios, National Standards Department, INTN<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
The Role of Voluntary Consensus Standards in Regulatory Frameworks \u2013 Terry O. Woods, USFDA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Standards and Conformity Assessment – building regulators\u2019 confidence in device safety and performance \u2013 Eric Franca, USFDA<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Conformity Assessment Checklist \u2013 Compliance with International Obligation, Marina Carvalho \u2013 IACRC<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Day 5 (06\/19)<\/strong><\/h2>\n\n\n\n

Recording<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Presentations<\/h2>\n\n\n\n

Trade and Regulations – Opportunities and Challenges in Paraguay for the Medical Technology Sector \u2013 Andrea Fern\u00e1ndez, Ministry of Industry and Commerce (MIC) Paraguay<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Medical Technology Sector Map \u2013 Brazil and the Americas \u2013 Leticia Fonseca, IACRC<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
The Role of Manufacturers in Ensuring Quality, Safety & Performance \u2013 Fatemeh Razjouyan, Medtronic<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
MDSAP. A Success Story: Auditing Organizations and Industry Perspective<\/strong><\/h5>\n\n\n\n
Melissa Torres, AdvaMed<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
John Castro, Auditor, SGS North America Inc.<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Rosa Casta\u00f1eda, Medtronic<\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":91,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-5306","page","type-page","status-publish","hentry","description-off"],"acf":[],"featured_image_src":null,"yoast_head":"\nAdvanced Training for Medical Device Regulators Around Critical and Emerging Technologies 2026 (ATCET-2026) - Regulatory Convergence<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/projects\/standards-alliance\/advanced-training-for-medical-device-regulators-around-critical-and-emerging-technologies-2026-atcet-2026\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Advanced Training for Medical Device Regulators Around Critical and Emerging Technologies 2026 (ATCET-2026) - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"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. 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