Breakthroughs, acceleration, and smarter strategies—this edition delivers timely insights for Medtech and Biopharma leaders working across borders. Navigate Brazil’s complex import logistics with confidence Cut first-in-human trial timelines by up to 40% in LATAM Understand how QMSR aligns U.
first-in-human · MedTech · biopharma · import
Can your study survive Brazil’s import maze?
Breakthroughs, acceleration, and smarter strategies—this edition delivers timely insights for Medtech and Biopharma leaders working across borders.
Explore the momentum shaping early-phase trials 👇
Running a clinical trial in Brazil? Success hinges on more than protocol design — it begins with mastering the country’s intricate import system. From RADAR licensing and SISCOMEX registration to ANVISA oversight and Ministry of Health approvals, the logistics chain is dense, layered, and time-sensitive. Even with ethics and regulatory green lights, devices can be stranded at customs for weeks if paperwork or timing falters. Recent reforms have improved review timelines, but operational bottlenecks persist where strategy is lacking. Why It Matters: For Medtech and Biopharma companies pursuing first-in-human and early feasibility trials, import planning isn’t just a task — its a risk lever. The smoother the path at the border, the faster you get to first patient in.
https://www.clinicalsupplyleader.com
Speed and efficiency are redefining early-phase clinical trial strategies — and Latin America is stepping into the spotlight. Sponsors are now accelerating first-in-human and early feasibility studies by up to 40% faster compared to traditional markets. With ethics approvals in as little as 8 weeks and startup costs trimmed by 30%, the region offers a compelling alternative for Medtech and Biopharma companies under pressure to deliver faster proof-of-concept data. Regulatory clarity, high enrollment potential, and aligned infrastructure make LATAM a strategic launchpad for innovation.
https://globaltrialaccelerators.com
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MolecuLightDX has been formally recognized by the FDA as a qualified Medical Device Development Tool (MDDT) — unlocking new possibilities for sponsors running wound care studies. Enables use as a validated clinical endpoint in FDA-regulated trialsFunctions as a standardized response biomarker — supporting more efficient, approvable trial designsOffers non-contact, real-time wound measurement, streamlining data collectionImproves trial precision and regulatory confidence from first-in-human through pivotal phasesWhy It Matters: When tools like this gain FDA recognition, they dont just measure healing — they accelerate it. A faster path to high-quality data means a faster route to approval.
https://prnewswire.com
A major shift is coming to the way medical device manufacturers manage quality. The FDAs new Quality Management System Regulation (QMSR) — taking effect in February 2026 — will fully align U.S. requirements with ISO 13485:2016, the international gold standard for device manufacturing and clinical quality systems. The QMSR replaces the legacy 21 CFR Part 820 regulation, streamlining compliance for companies operating globally and reducing the burden of maintaining parallel systems. It introduces a risk-based framework that modernizes design controls, supplier oversight, and corrective actions, while signaling the end of QSIT inspections in favor of a more harmonized global model.
https://fda.gov
Corify Care has introduced the worlds first cardiac mapping system capable of capturing electrical activity across all four heart chambers — in just one heartbeat. The technology, already CE-marked in Europe and under FDA review, offers a real-time, non-contact, panoramic view of arrhythmic activity. By eliminating the need for sequential chamber mapping, it enables faster, more precise diagnostics and potentially shorter procedure times. Its also designed to integrate with existing navigation systems, making adoption easier for EP labs seeking next-gen capabilities. Why It Matters: Innovations like this reshape whats possible in early cardiac studies — and give sponsors new tools to accelerate rhythm-based device development.
https://www.dicardiology.com
Idorsia has partnered with EMS, Brazils largest private pharmaceutical company, to bring QUVIVIQ™ (daridorexant) to patients across Latin America. The collaboration includes regulatory filing, distribution, and commercialization rights — with a dossier already submitted to ANVISA in Brazil. The move reflects a growing trend: innovative Biopharma companies are using regional licensing deals to accelerate market entry in LATAM while reducing internal resource strain. With milestone payments and royalty structures built in, the partnership creates both access and upside.
https://lifesciencesbc.ca
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