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Recent global regulatory updates include changes for software-based medical devices, prescription lenses, and microbial, recombinant, or animal substances. Effective June 15 and July 1, 2024, with reclassification by July 1, 2026. High-risk devices have limited audits; spectacle lenses are ARTG exempt from June 15.

Regulatory Update
June 4, 2024

In May 2024, major regulatory updates were announced across the UK, EU and Switzerland to enhance medical and in vitro diagnostic devices. The COMBINE project was launched to streamline regulations, and new standards and frameworks were proposed to improve safety, compliance, and timely access to innovative treatments.

In an interview with TechNews180, Pure Global CEO Phyllis Meng discusses how AI and data analytics are revolutionizing market access and regulatory compliance for MedTech companies. Meng highlights Pure Global's platform, which provides seamless access to global registration data and clinical trial information, eliminating manual searches.

Unlock efficient market access with Pure Global & MEDIcept's collaboration. From registration to regulatory expertise, we offer comprehensive solutions worldwide. Drive growth & innovation in MedTech.

Regulatory Update
May 2, 2024

Keep up to date on the most recent developments in the EU regulatory landscape for the medical device sector. Explore our thorough overview of recent updates, encompassing fresh standards, legislative measures, and advisory materials. Delve into the details now to ensure compliance.

Phyllis Meng, CEO of Pure Global, shares her inspirational journey to becoming the founder of Pure Global.

Malaysia, a key gateway to Southeast Asia, offers strategic access for businesses. Understanding medical device regulations is crucial for market entry.

In the dynamic world of MedTech compliance, AI plays a pivotal role. It streamlines regulatory research, enhances data analytics for compliance, and automates tasks, ensuring efficiency and accuracy. Looking ahead, AI-driven digital tools promise even greater efficiency, enabling global collaboration and driving the MedTech industry towards innovation and growth.

Regulatory Update
April 5, 2024

Stay updated with the latest EU regulations and guidance in the medical device industry. Check out our comprehensive summary of key updates including new standards, legislative acts, and guidance documents. Dive in now to stay compliant and informed!

Company Update
April 2, 2024

Phyllis Meng, CEO of Pure Global, shares insights into their innovative approach to revolutionizing the medical device industry.

Company Update
March 18, 2024

Pure Global introduces a new brand and website to boost global outreach and improve client service clarity.

Pure Global COO, DJ Fang, Engages in Key Talks at AstraZeneca's China-Brazil Biomedical Forum to discuss medical innovation.

Regulatory Update
March 1, 2024

ANVISA's DICOL Discusses Essential Medical Device Regulations, Enhancing Safety and Regulatory Convergence in Brazil.

Pure Global Secures Two Class II Medical Device Certificates in Brazil, Bolstering International Expansion Capabilities.

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