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

The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector held the “External Stakeholders Virtual Meeting” on October 10th in San Salvador, El Salvador.

Topics covered during the event included Emergency Use Authorizations, Electronic CFG/FSC, Electronic Regulatory Tools, Reliance and Regulators’ Databases.

Agenda (English only)

Recordings

Presentations

Medical Device Regulatory Convergence, COVID 19 (MDRC). The Journey – Sandra Ligia González, MDRC

Conversation on Emergency Use Authorization (EUA). Where we were and where we are after COVID-19 Pandemic?:

Emergency Use Authorization (EUA) Where we were and where we are after COVID-19 Pandemic – Marcella Abreu, ANVISA. Coming soon!

Where we were and where we are now after COVID Pandemic. The Brazilian Perspective – Carlos Goūvea, CBDL.

Electronic CFG/FSC – A proactive approach to a new reality. Part I:

eCFG/eFSC benefits and risks for a regulator – Ethny Obas, US FDA CDRH.

Position paper on eCFG/eFSC – Marina Carvalho, IACRC.

Electronic Regulatory Tools – A proactive approach to a new reality. Part II. Reliance – Leveraging regulators’ data bases:

Electronic Regulatory Tools – a proactive approach to a new reality. Digital Systems of INPM. (Spanish) – Carolina Magnatti, ANMAT

(Electronic) Regulatory Tools Part II. Reliance – Leveraging regulator’s database – Hélio Bonfim de Macedo Filho, ANVISA. Coming soon!

Medical Devices Databases – Vesa Vuniqi, US FDA. Coming soon!

Turning Reliance into a Reality:

Turning Reliance into a Reality. The Brazilian proposal – Augusto Geyer, ANVISA. Coming soon!

Regulatory Reliance – A Reality. Singapore Experience – Rama Sethuraman, HSA. Coming soon!