Latin America's medical device regulators moved on three fronts this past week — Brazil accelerated backlog reduction and completed the shutdown of a legacy certification system, Colombia and Brazil deepened bilateral cooperation, and Argentina issued a fresh counterfeit-IVD alert. This edition covers the market-access developments most likely to affect device sponsors' short-term filings and post-market controls in the region.
Brazil · Colombia · Argentina · ANVISA · INVIMA · ANMAT
Latin America's medical device regulators moved on three fronts this past week — Brazil accelerated backlog reduction and completed the shutdown of a legacy certification system, Colombia and Brazil deepened bilateral cooperation, and Argentina issued a fresh counterfeit-IVD alert. This edition covers the market-access developments most likely to affect device sponsors' short-term filings and post-market controls in the region.
ANVISA published two operational milestones affecting the device registration pipeline this week. On July 1, the agency launched Phase 2 of its passivo (backlog) reduction plan for materiais de uso em saúde, reorganizing 310 petitions filed in the second half of 2025 into 81 technological groupings for parallel review by the Gerência de Materiais de Uso em Saúde (Gemat). Nine groups are already under active analysis; orthopedic implants remain on a separate track. Two days later, ANVISA permanently decommissioned the legacy Sicert device-certificate system, migrating all future certificate issuance to the Solicita platform integrated with the Portal de Consultas (ANVISA — Redução de passivo; Sincofarma SP — Sicert descontinuado)
Why It Matters: Sponsors with device petitions filed between July and December 2025 should confirm their technological grouping and monitor for exigências under the accelerated cadence. Companies still using Sicert to generate certificates must transition immediately to Solicita — the six-month legacy window is closed and certificate workflows executed outside the new system will not be valid.
On July 1, ANVISA published Nota Técnica nº 41/2026, updating its regulatory position on ozone-emitting devices. The note replaces Nota Técnica nº 43/2022 and formally recognizes local ozone-oxygen exposure (via the "bag" technique) as an adjuvant therapy for ulcerated diabetic-foot wounds and acute infected wounds in patients aged 18 and older (ANVISA — Nota Técnica 41/2026 announcement)
Bottom Line: Ozone-emitting device manufacturers now have a defined indication set to reference for Brazilian labeling and technical documentation. Existing registrations should be reviewed against the updated indication language, and companies developing new ozone-based wound-care platforms should incorporate the July 2026 evidence framework into their submission dossiers
On July 1, INVIMA and ANVISA announced an expanded cooperation framework aimed at accelerating access to health technologies across both markets, including medical devices. The bilateral engagement covers information exchange, joint capacity-building, and alignment on regulatory science pathways (INVIMA — Sala de Prensa).
What to Focus On: Sponsors already registered with one agency should monitor whether the cooperation ultimately produces a formal reliance mechanism between INVIMA and ANVISA, similar to Mexico's evolving reliance framework. Even absent a formal pathway, greater alignment between the two largest LATAM device markets reduces documentation friction for cross-country submissions
On July 3, ANMAT issued a public safety alert warning that illegitimate Accu-Chek Guide glucose test strips are circulating in Argentina. The agency advised against their use, citing risks to measurement accuracy and patient safety, and reinforced the need for supply-chain authentication across in-vitro diagnostic consumables (ANMAT — Alertas Sanitarias).
Why It Matters: IVD distributors in Argentina should immediately verify product authenticity across current inventory, tighten distributor authorization documentation, and reinforce traceability to reduce recall, penalty, and reputational risk. Companies whose glucose-monitoring products share visual characteristics with Accu-Chek Guide should also review anti-counterfeit controls, since alerts of this nature often trigger broader ANMAT inspections of category peers
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