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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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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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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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RIVM report: The impact of the new European IVD-classification rules on notified body involvement A study on IVDs registered in the Netherlands
Blog Article

Engaging a Notified Body under the IVDR: What legacy manufacturers need to know about the pre-application process

The IVDR transition includes structured processes IVD manufacturers must follow to engage with Notified Bodies. Many IVD manufacturers are interacting with Notified Bodies for the first time and must understand what is required to ensure a successful partnership. In this article, Dr. Oliver Eikenberg clarifies what manufacturers must prepare and when to engage a Notified Body for IVDR CE Marking.

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Blog Article

Regulatory requirements and challenges for new and old Class D devices under IVDR

Class D IVD manufacturers face fast-approaching IVDR transition deadlines, though some are more familiar with the regulatory process. In this article, Dr. Oliver Eikenberg discusses the difference between "new" and "old" Class Ds, and regulatory logistics they need to consider during the transition process.

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Blog Article

Intended purpose for IVDs and impact on the classification under IVDR

Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.

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Blog Article

Why and How EU IVDR Compliance Matters before the May 2025 Deadline

Many IVD and legacy IVD device manufacturers are obligated to comply with certain aspects of the IVDR even before their transition deadline. In this article, Oliver Eikenberg discusses how IVD companies can maintain EU compliance during the transition period.

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Blog Article

Adapting your QMS to IVDR requirements until May 2025: what manufacturers need to know

The official IVDR transition period is here. IVDR expert Dr. Oliver Eikenberg discusses how IVD manufacturers should take action, starting with how to implement IVDR QMS requirements for the May 2025 deadline.

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Kuala Lumpur Malaysia Skyline
Blog Article

MDA Updates at IMDEC 2024: Paving the Way for Regulatory Excellence and Innovation in Medical Technology

Pure Global participated in IMDEC 2024 in Kuala Lumpur to discuss the latest advancements in medical technology, regulatory efficiency, and the role of AI in transforming the industry. Highlights included updates from the Malaysian Medical Device Authority (MDA) that showcased their commitment to driving regional leadership in medical device regulation and innovation.

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