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Regulatory Updates

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Stay ahead of the curve with timely updates on the latest regulatory changes impacting the MedTech industry.

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Take a look at our participation at key conferences, summits, and networking opportunities with our list of upcoming MedTech events.

Blog Articles

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Gain valuable insights and perspectives from seasoned MedTech professionals through our thought-provoking blog articles.

NEWS

Regulatory News

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

Regulatory Update
November 20, 2024

This week in medical device regulatory news, Thailand has introduced new refer and transfer guidelines, Europe released an updated Q&A on IVDR and MDR vigilance terms, and Romania has new rules for Economic Operators.

Regulatory Update
November 13, 2024

This week, we bring you medical device regulatory update coverage from around the world, including new registration Q&A resources in Taiwan and Japan, UK relaunches ILAP pathway, Mexico will apply a new acquisition model, and more.

Regulatory Update
November 6, 2024

This week in medical device regulatory news, EU parliament moves toward a revision of the EU MDR, the UK enhances post-market surveillance requirements, US FDA prioritizes guidance revisions for 2025, and more.

Regulatory Update
October 30, 2024

Peru joins IMDRF, updated clinical trial guidance in Denmark, Romania implements new compliance requirements for professionals users, and more in this week's medical device regulatory update.

Blog

Recent Blog Posts

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

Blog Article
EU Parliament Revises MDR and IVDR

On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.

Blog Article
Language Challenges in MedTech Going Global and Our Solution

Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.

Medical device supply chain
Blog Article
Managing your medical device supply chain

The connection between supplier controls and business risks is becoming increasingly evident. In this article, we discuss perspectives on how to maintain a compliant medical device supply chain.

Blog Article
Brazil: Adapting to Evolving Regulatory Markets

Brazil aligns medical device regulations with global standards, including Europe and the US. Recent updates and international compatibility attract manufacturers.

Events

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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