Browse our news hub featuring company announcements, regulatory updates, and industry insights to keep you informed and ahead of the curve.
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.
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.
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.
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.
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.
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.
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!
Phyllis Meng, CEO of Pure Global, shares insights into their innovative approach to revolutionizing the medical device industry.
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.
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.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.