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Pure Global is a trusted global leader and growth partner in the healthcare technology industry. Find regulatory insights from our expert team, AI-Powered regulatory news update tool, and meet us at our next event.

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Regulatory Updates

Be Informed on Regulatory Changes

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

Upcoming Events

find us at future MedTech Events

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

Blog Articles

Get Insights from Industry Experts

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.

In this episode, Medtech Insight senior reporter Hannah Daniel interviews DJ Fang, COO and co-founder of Pure Global. Pure Global employs AI to assist device manufacturers in navigating global regulations. Their discussion covers clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on certain Chinese-made medical devices.

News
July 21, 2024

NMPA fosters medical device innovation through regulatory consultations, tailored plans, guidance, updates on approvals, and compliance with MDR, IVDR, and MPDG.

COFEPRIS regulates the transfer of rights to ensure legal and technical compliance for medicines, medical devices, and biological products. Requirements include an application format, proof of payment, legal documentation, and a notice of operation. Transfers must be transparent, with continuous monitoring. Modifications now resolve within 24 hours instead of 3 months.

Regulatory Update
July 16, 2024

The Clinical Trials Coordination Group (CTCG) published a Q&A for clinical trial sponsors on safety reporting. Highlights include active RFI monitoring, immutable annual reports, and CTIS transition guidelines.

Blog

Recent Blog Posts

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

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.

Blog Article
AI in Medtech Brazil

AI is revolutionizing MedTech in Brazil, enhancing healthcare through process optimization and data-driven decisions. Pure Global ensures swift, compliant market introduction of innovative solutions.

Blog Article
Pure Global: Regulatory Decisions for Global Success

Discover how to navigate commercial and regulatory challenges for global success in the medical device industry. Learn strategies for market access, regulatory compliance, and post-market vigilance

Blog Article
New Standards in Medical Device Cybersecurity

Raising cybersecurity standards for medical devices necessitates manufacturers' compliance with new global regulations.

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.

Conference
Chicago, Illinois
Jul 28, 2024

ADLM

Connect with global leaders in clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking science in laboratory medicine.

Trade Fair
Long Beach, California
Sep 17, 2024

RAPS USA Convergence

An event focusing on regulatory aspects, attracting professionals from around the world to discuss the latest trends and regulations.

Trade Fair
Shenzhen, China
Oct 12, 2024

CMEF Shenzhen

One of the largest medical B2B trade fairs globally, showcasing products and services across medical imaging, diagnostics, health IT, and more.

Trade Fair
Düsseldorf, Germany
Nov 13, 2024

MEDICA Trade Fair

One of the largest medical B2B trade fairs globally, showcasing products and services across medical imaging, diagnostics, health IT, and more.

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