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How to register medical devices and IVDs 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.
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.
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.
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.
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.
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.
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."
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.
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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