Passarini Blog
New ANVISA System: 3 Essential Compliance Rules and the 5-Year Risk
New ANVISA Scheduling System: 3 Compliance Rules You Need to Master (And the 5-Year Record Keeping Risk) The end of the Parlatório and ANVISA's new digital era: Understand how Ordinance 54/2021 and automation demand Compliance 4.0 to avoid rejections and ensure the legal security of [...]
ANVISA Revolution: AFE and AE Are Now Automatic!
The End of Waiting: ANVISA Automates AFE and AE, Transforming Brazil’s Regulatory Routine The Authorization to Operate (AFE) and Special Authorization (AE) are foundational documents for any company seeking to operate in a market regulated by the Brazilian Health Regulatory Agency (ANVISA), covering sectors such [...]
Devices to America: How U.S. Tariffs Are Changing Medical Device Exports
The “Tarifaço” and the Changing Export Routes of Brazilian Medical Devices The term “tarifaço” refers to the steep tariffs imposed by the United States on certain imported products — in this case, Brazilian medical devices — which increase the cost of direct access to the [...]
DDR and DUIMP: How ANVISA’s Import Rules Stand
ANVISA Confirms Continuity of Direct Imports via DDR ANVISA has recently published the new Import Manual, confirming that the Declaration of the Registration Holder (DDR) will remain valid. This document allows the holder of a product registered in Brazil to authorize third parties to carry [...]
Agility and Efficiency: How COFEPRIS’ Fast-Track Path Speeds Up Medical Device Registration in Mexico
Accelerating Market Access in Mexico: Understanding COFEPRIS's New Abridged Regulatory Pathway The regulatory landscape for the entry of medical devices into Mexico has just undergone a significant transformation. On July 18, 2025, the "Acuerdo por el que se emiten los Lineamientos generales para la aplicación [...]
ANVISA Sets New Rule for Good Practice Certificate Validity
ANVISA Changes How Certificate Validity is Counted, Providing Clarity for Renewals The Brazilian Health Regulatory Agency (ANVISA) has published a crucial update that directly impacts the industry and regulated sector, bringing more clarity and legal certainty to certification processes. From now on, the way the [...]
