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Blog Article

How to use your FDA and EU medical device approvals to access 25+ markets

Your medical device and IVD approvals in the US and EU can streamline pathways in 25+ markets worldwide, from Australia and Switzerland to Brazil and Singapore, cutting the time and cost of international expansion. And with AI-powered tools now helping regulatory specialists build submissions up to 50% faster, scaling your device portfolio across borders has never been more achievable.

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Blog Article

Ultimate Guide to Medical Device and IVD registration in Australia

Australia is a highly attractive market for medical device manufacturers, but gaining access requires navigating the TGA's rigorous registration process. This step-by-step guide covers the full pathway to ARTG inclusion, from device classification and Sponsor obligations through to Manufacturer Evidence, application submission, and audit preparation, with practical guidance on costs and timelines.

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Blog Article

ANVISA’s International Cooperation and Regulatory Convergence Are Reshaping Brazil's Medical Device Market

Brazil's health regulator is moving fast, strengthening international alliances and overhauling key rules for medical devices, software, and post-market surveillance. Learn how ANVISA's 2026–2027 priorities will affect your registration strategy.

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Christ the Redeemer statue in Rio de Janeiro, Brazil at sunset.
Blog Article

40+ Statistics About Brazil’s Medical Device Import Market Manufacturers Need to Know

Brazil is the largest medical device import market in Latin America, and it's growing faster than it was three years ago. But the countries winning share, the clinical specialties leading growth, and the risks manufacturers need to plan for have all shifted meaningfully since 2021. This article compiles 40+ statistics from Pure Global's four-year import analysis to show what the data actually says.

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Research Report

Indonesia's Medical Device and IVD Import Market

Indonesia's $3.28 Billion MedTech Import Market Reset: The IVD Bubble Is Over; The Surgical Boom Has Begun. The report emphasizes that the 2024 boom was not a simple recovery but a fundamental shift in market demand. The growth was overwhelmingly powered by specialties related to elective and high-acuity procedures, reflecting a move to clear surgical backlogs and a long-term government strategy to improve domestic hospital capabilities.

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Blog Article

Leveraging Medical Device CE Marking for Faster Entry into Brazil

Medical device manufacturers sometimes shy away from Brazil as a potential market due to its cumbersome and meticulous regulatory requirements. But if you already have CE Marking, ANVISA approval is more accessible than you think. Learn how ANVISA requirements overlap with the EU MDR.

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Blog Article

Medical Device Registration Costs and Timelines for Brazil, Mexico, and Colombia

Expanding into Brazil, Mexico, and Colombia can be a major growth driver if you understand the true costs and timelines involved. This guide shows much it costs and how long approvals really take.

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Research Report

Thailand's Medical Device and IVD Import Market

Thailand's $3.29 Billion MedTech Import Market Undergoes Radical Shift as Post-Pandemic Demand for Aesthetics and Elder Care Surges, New Research Reveals. An analysis of historical data from 2021 to 2024 reveals an import-driven ecosystem with a total market value fluctuating between approximately $3.15 billion and $3.29 billion annually. This market is fundamentally sustained by two long-term drivers: a rapidly aging population and a thriving medical tourism sector, both of which are amplified by the government's strategic goal to establish the nation as a global "Medical Hub."

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Research Report

Brazil's Medical Device and IVD Import Market

Brazil's market for imported medical technology has demonstrated exceptional growth and a significant competitive realignment, establishing itself as a critical destination for global MedTech manufacturers. The total import market surged to USD $9.33 billion in 2024, an impressive 18.0% year-over-year increase, signaling a robust and accelerating demand for advanced healthcare solutions.

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Blog Article

Mexico’s Abbreviated Regulatory Pathway is a Game-Changer for Medical Device Market Access

Mexico’s COFEPRIS will launch its new Abbreviated Regulatory Pathway on September 1, 2025, enabling medical device and drug manufacturers to fast-track approvals by leveraging prior authorizations from trusted international regulators. The streamlined process promises 30-day evaluations, aligning Mexico more closely with global regulatory standards and offering manufacturers a faster route to market.

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Research Report

[Research Report] Mexico's Medical Device and IVD Import Market

Mexico's medical device and in-vitro diagnostic (IVD) import market is a dynamic and rapidly expanding landscape, presenting both significant opportunities and complex challenges for global manufacturers. An analysis of historical import data from 2021 to 2024 reveals a market characterized by robust overall growth, shifting competitive dynamics among global trade partners, and transformative regulatory reforms. The total value of medical device and in-vitro diagnostic (IVD) imports to Mexico surged from $6.86 billion in 2021 to $11.40 billion in 2024, marking a 12.6% increase in the final year alone.

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Research Report

[Research Report] Malaysia's Medical Device and IVD Market

The Malaysian medical device and in-vitro diagnostic (IVD) market presents a compelling, high-growth opportunity, projected to reach US$4.5 billion by 2028 with a robust compound annual growth rate (CAGR) of approximately 9%. This expansion is underpinned by strong economic fundamentals, a consistent increase in government healthcare spending—highlighted by a 10% budget increase for 2025—and a clear national strategy to modernize the healthcare sector.

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A patient is taking a COVID test with part of the test displayed on a tabletop.
Blog Article

MDCG 2025-5 Clarifies EU Rules for IVD Performance Studies Under IVDR

Dr. Oliver Eikenberg breaks down the European Commission’s new MDCG 2025-5 guidance on IVD performance studies under the IVDR. He highlights how the document clarifies when studies require ethics and authority submissions, what qualifies as a substantial modification, and how to ensure data quality and compliance. For manufacturers and sponsors preparing for CE marking, these insights are essential to avoid costly delays and rejections.

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