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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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Mexico city landmark with Mexico flag flying in the wind.
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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Brazil flag waves in the wind
Blog Article

Brazil’s UDI System Nears Enforcement: What Medical Device Manufacturers Must Know for 2025 and Beyond

Brazil’s Unique Device Identification (UDI) system is moving toward full enforcement, with mandatory labeling for Class IV devices starting July 10, 2025. This post breaks down the key requirements under RDC 591/2021 and RDC 884/2024, including SIUD database functions, labeling rules, and preparation steps for manufacturers.

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Research Report

[Research Report] ASEAN MedTech Import Market

Exploring the profound opportunities and increasing complexity in the Association of South-East Asian Nations medical technology import market from 2021-2024. The ASEAN MedTech import market presents significant opportunities amid increasing complexity. Analysis of export data from 2021-2024 reveals robust growth drivers despite top-line volatility. While demographic and economic trends signal sustained demand, aggregate import value fluctuated from $19.16 billion in 2021 to $18.34 billion in 2022, $17.79 billion in 2023, before rebounding to $19.26 billion in 2024.

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Hands typing on a laptop keyboard
Blog Article

5 Reasons EU device manufacturers should register in EUDAMED today

The European Commission has confirmed that key EUDAMED modules will become mandatory by Q3 2026 and manufacturers selling into the EU need to be ready. This article outlines five key reasons to prioritize EUDAMED registration now to avoid disruption, ensure compliance, and maintain market access.

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Singapore device registration expedites access to other markets.
Blog Article

Singapore HSA as a Gateway to Faster Device Registration in Key Markets

Singapore’s Health Sciences Authority (HSA) is now a globally recognized reference agency, offering manufacturers a fast track into key Asia-Pacific markets. This article explains how HSA approval can streamline registration in Thailand, Australia, and Hong Kong, and how its WHO Stringent Regulatory Authority status boosts access for high-risk IVDs. Leveraging HSA can cut costs, reduce timelines, and accelerate international expansion.

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A patient adjusts a medical device smart watch.
Blog Article

Wireless Compliance for Medical Device Manufacturers: Overview of Radio Frequency Module Integration

Manufacturers marketing a wireless medical device must consider communications authority regulations as well as medical device regulations. In this article, Michael Cassidy explains global market access requirements that manufacturers need to consider when integrating wireless module to their device.

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A globe sits on top of a desk next to a business man working on this laptop.
Blog Article

How the EU IVDR opens doors beyond the EU

Under the IVDR, European CE Marking requires more time and resources from IVD manufacturers than ever before. However, as more countries adopt the EU's approach to medical device and IVD regulation, IVD companies will find themselves well positioned to access other markets beyond the EU once their IVDR CE Mark is in place. In this article, Dr. Oliver Eikenberg discusses the potential to leverage IVDR CE Marking to streamline global market access.

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Supply chain controls for Economic Operators under the EU IVDR
Blog Article

Supply chain requirements for Economic Operators under the EU IVDR

Inadequate supply chain controls are a leading cause of non-conformities in Notified Body Technical Documentation Assessments under the IVDR. In this article, Dr. Oliver Eikenberg discusses how manufacturers should assess and update their supply chain agreements to ensure Economic Operator roles and obligations are clearly defined in line with IVDR requirements.

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Blog Article

Clinical Evidence under IVDR: what is an “adequate level” for IVD manufacturers?

Conformity under the IVDR requires a rigorous approach to clinical evidence quality. In this article, Dr. Oliver Eikenberg explains the importance of performance evaluation processes and documentation to ensure adequate clinical evidence for EU IVDR compliance.

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