Connect and stay on top of the MedTech regulatory landscape globally.

This week in global medical device news: Brazil's ANVISA goes 100% digital, more Approved Bodies in the UK, revised guidance on HIV self-test kits in Malaysia, and more.

Regulatory Update

February 12, 2025

The fifth revision to the EU's guidance on Notified Body requirements under the MDR and IVDR has been released. Canada published new guidance on machine learning-enabled devices, findings from China's Medical Device Standards Management Annual Report, and more in this week's round-up of medical device regulatory news.

Regulatory Update

February 5, 2025

To close out January 2025, we are reporting on medical device regulatory developments in the European Union and Switzerland, including IVDR compliance challenges cited in the MedTech Europe 2024 Regulatory Survey, as well as guidance, FAQ, and form updates from Swissmedic.

Regulatory Update

January 29, 2025

Wrapping up January 2025, medical device regulatory developments include new forms for NBs in Europe, new PMS guidance in the UK, an expedited approval partnership between China and Malaysia, and warnings of supply chain disruptions for pediatric patients in the US.

Blog

Recent Blog Posts

Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.

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Blog Article

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.

Blog Article

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.

Blog Article

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.

Pure Global Team attends IMDEC 2024 in Malaysia

Blog Article

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.

Events

Come meet our team at Pure Global and discover how we can help with your regulatory questions and help you gain market access for your device.

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Trade Fair

Baltimore, Maryland, USA

Mar 11, 2025

RAPS Global Regulatory Strategy Conference

The RAPS 2025 Global Regulatory Strategy Conference will provide you with the latest insights, practical tools, and networking opportunities that can be used to inspire and enhance your global regulatory strategies.

Trade Fair

Coventry, United Kingdom

Mar 12, 2025

Medical Technology UK 2025

Pure Global is available to meet with you at Medical Technology UK 2025, a conference for medical device engineers.

Trade Fair

Zhejiang Province, China

Mar 22, 2025

CACLP & CISCE

At CACLP's 21st edition, the focus is on amplifying collaboration for global IVD industry development, showcasing cutting-edge tech and innovations to drive shared growth and reshape a smarter future.

Trade Fair

Cologne, Germany

Mar 25, 2025

International Dental Show 2025

The Pure Global team is attenting the International Dental Show, the world's largest trade fair for the dental industry. We look forward to seeing you there.