September 24, 2023

Conformity Assessment of Medical Devices in Brazil and the in U.S.

As a workstream under the Medical Device Regulatory Convergence Project (MDRC) and, on September 24, 2023, the MDRC hosted in Brasília an Exchange of Information Workshop between ANVISA, INMETRO, USFDA and NIST. This workshop was part of the MDRC efforts to support good regulatory practices and medical device regulatory convergence. The objective was to review Medical Device Conformity Assessment in Brazil and the in U.S., to facilitate an exchange of related information, experiences and regulations between the authorities within the context of international practices, references, regulatory convergence and regulatory reliance.

Agenda

Presentations

ANVISA
INMETRO
USFDA
NIST
MDRC Positioning

REGULATORY COALITION PRINCIPAL MEMBERS