The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector collaborated with the United States Food and Drug Administration (FDA) to organize a webinar series on the Utilization of Voluntary Consensus Standards.
Session I. 7 December 2021
Objective: Provide USFDA’s experience in developing and applying consensus standards while making regulatory decisions that promote safety and effectiveness of medical devices.
Agenda
Recording
Presentation
Session II. 3 March 2022
Objective: Provide the perspectives of PAHO/WHO, WTO and Standards Developing Organization (SDOs) on how international voluntary consensus standards for medical technologies are developed, maintained, and used by regulators and industry to operationalize regulatory reliance, regulatory convergence and to facilitate the manufacturing and approval of quality, safe, secure, interoperable, effective, and accessible medical devices for health systems and patients in the Americas.
Agenda
Recording
Presentations
Part 1. Use of International Standards for Medical Technologies as Key Operationalization of Regulatory Reliance, Regulatory Convergence and Legal Compliance
Health References for Medical Device National Regulatory Authorities – Alexandre Lemgruber, PAHO
Legal Obligations applicable to medical device National Regulatory Authorities – Technical Barriers to Trade Agreement – Devin McDaniels, WTO
Legal Obligations applicable to medical device National Regulatory Authorities – Renata Amaral, IACRC
International Standards – Development, Adoption and Use by Stakeholders including Regulatory Authorities – Kory Eguino, COPANT
Part 2. Panel Discussion: Overview of MedTech Standard Development Organizations Work
ISO / TC210 – Peter Linders, Philips
Spanish Translations Task Force ISO / TC210 – Veronica Viscovich, IRAM. Coming soon!
IEC / TC 62 – Brodie Pedersen
IMDRF and standards – Kenneth Cavanaugh, USFDA
AAMI – Hae Choe
CLSI & ISO TC212 – Patrick McGinn
MITA – Carolyn Hull
ASTM International – Craig Updyke
Session III. 10 March 2022
Objective: Provide the perspectives of National Standards Bodies (NSBs) on how international voluntary consensus standards for medical technologies are developed, maintained and used by regulators and industry to operationalize regulatory reliance, regulatory convergence and to facilitate the manufacturing and approval of quality, safe, secure, interoperable, effective and accessible medical devices for health systems and patients in the Americas.
Agenda
Recording
Presentations
Brazil
ABNT, Jorge Cajazeira, Assesor de Área Internacional
CB-036, Humberto Tiburcio, SBAC
Colombia
ICONTEC – Andrés Hernández
Mexico
DGN – Emeterio Mosso
ANCE – Luis Iván Hernández Becerril
Peru
INACAL – Soraya Lastra
Session IV. 17 March 2022
Objective: Provide the perspectives of government authorities, industry and the conformity assessment sector and industry on how conformity assessment is a global tool used by regulators and industry to demonstrate compliance with requirements – facilitating the manufacture and approval of quality, safe, secure, interoperable, effective and accessible medical devices for health systems and patients in the Americas.
