Pure Global

🌐 Medtech Connect 16: AI For Cross Border Regulation 🌐 In the latest episode of Medtech Connect, Medtech Insight senior reporter Hannah Daniel sits down with DJ Fang, COO and co-founder of Pure Global. Tune in as they discuss how Pure Global leverages AI to assist device manufacturers in navigating complex global regulations. Key topics include: 🔹 The role of AI in clinical trials 🔹 Incentives for Medtech innovation across different countries 🔹 The impact of the Biden Administration’s tariffs on certain Chinese-made medical devices Don’t miss this insightful conversation on the future of Medtech and regulatory compliance! Listen now and stay informed on the latest trends in the industry here: https://lnkd.in/d8tNsFGF #MedtechConnect #AI #MedtechInnovation #GlobalRegulation #ClinicalTrials #PureGlobal #MedTech

Exciting Updates from Malaysia's Medical Device Authority (MDA) Malaysia's MDA Certificate is now recognized in the Czech Republic and China NMPA, reducing waiting times for approvals. With endorsements from the USA FDA, UK MHRA, EU – MDR/IVDR, Japan MHLW, Australia TGA, and Health Canada, product registration will follow an expedited route. Additionally, an MOU has been signed with South Korea's MFDS. Key Highlights: Economic Growth: Medical Devices are featured prominently in Malaysia's Industrial Master Plan (NIMP), highlighting their role in economic growth. The government is offering grants for medical device development. Quality Healthcare: Malaysia aims to welcome high-quality medical and IVD devices, enhancing healthcare and medical care standards. License enforcement for performance and safety is mandatory for registered products. Fee Increases: Fees for Class A, B, C, and D devices will rise in 2024/2025 to improve the turnaround for licenses and approvals. Conformity Assessment: All medical device companies must undergo a Conformity Assessment Process, with economical consultancy rates and an international MOU with Local University UTM for testing and courses. IMDEC 2024: Malaysia will host the 1st International Medical Device Exhibition and Conference (IMDEC 2024) on December 10-12, 2024, at KLCC. The event will feature the 28th Global Harmonization Working Party (GHWP) Meeting with 34 national medical device authorities. The Prime Minister and Minister of Health will grace the meetings. SaMD Approval: The approval process for Software as a Medical Device (SaMD) is streamlined. Once approved, companies only need to keep MDA informed of the current version for the next 5 years. Activity Declaration: Starting July 1st, companies must declare their activities (AR, Distributor, Importer) to streamline operations. These advancements elevate Malaysia's position in the global medical device market, ensuring better healthcare outcomes for all. Contact sales at: https://lnkd.in/ei5BRcgN #MedicalDevices #PureGlobal #Regulations #MDA #IMDEC2024 #EconomicGrowth #MDA #IVD #MD

🌟 Promoting High-Quality Medical Device Innovation 🌟 The National Medical Products Administration (NMPA) is dedicated to fostering the high-quality development of medical device innovation through regular regulatory consultations. These efforts focus on: 🔹 Specific Regulatory Plans: Crafting tailored regulatory plans for innovative medical devices. 🔹 Guidance for Registrants: Assisting registrants in enhancing their quality management systems and maintaining continuous compliance. 🔹 Regulatory Updates: Providing instructions for applying for special approval and updates related to medical device approvals or exemptions. 🔹 Compliance and Reporting: Outlining reporting channels and obligations under the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the Medical Devices Implementation Act (MPDG). These initiatives are essential for ensuring that innovative medical devices meet the highest standards of quality and safety, ultimately better serving the public's health needs. Let's continue to drive innovation and compliance in the medical device industry! Read more on PureGlobal.com: https://lnkd.in/dVapDE4W Contact our sales team today, and let us help you Unlock Global Markets #MedicalDevices #PureGlobal #Regulations #QualityManagement #NMPA #MedTech #IVDR #IVD

🌟 New Guide to Requirements and Considerations for Transfer of Rights 🌟 COFEPRIS has released a comprehensive guide on transferring rights for regulated products, including medicines, medical devices, and biological products. Read more on: https://lnkd.in/griwWz88 #PureGlobal #RegulatoryAffairs #MedicalDevices #COFEPRIS #Compliance #MedicalDevicea #MedTech

It was a great pleasure to present and speak about African clinical research at PureGlobal's 4th Anniversary of the MedTech Going to Sea Conference. 🌍 I also enjoyed the team-building activities. 🤝 There's so much more to be done in African clinical research. Despite Africa having nearly a quarter of the world's population and disease burden, less than 3% of clinical research is conducted there. 📊 It's time to change this. 🚀 Pure Global Pure Clinical Pure Clinical Lab Network #ClinicalResearch #AfricanResearch #MedTech #Innovation #Healthcare #GlobalHealth #TeamBuilding #PureGlobal #Conference #ResearchDevelopment

🌟 Welcome to the Team, Melanie O.! 🌟 We are thrilled to announce that Melanie O. has joined Pure Global! Melanie brings a wealth of experience and expertise in the Medical Device Industry and will be a valuable addition to our team. In Melanie's own words: "I have been selling customized Global Market Access consulting services to the medical device industry for more than 10 years. My industry expertise and my customer focus will contribute to making Pure Global a market leader in Europe. I am looking forward to this new professional challenge and already enjoy working with Pure Global's smart, energetic and dynamic team." We are confident that Melanie will play a pivotal role in driving our projects forward and achieving new heights. Please join us in welcoming Melanie to the Pure Global family! Let's give her a warm welcome and show her the incredible support that makes our team so special. #PureGlobal #BusinessDevelopment #GlobalMarketAccess #EU #Medtech #MedicalDevices #IVDR

🚨 Exciting Updates in Clinical and Medical Device Regulations 🚨 The Clinical Trials Coordination Group (CTCG) has published a comprehensive Q&A guidance document for clinical drug trial sponsors, clarifying safety reporting issues. Here's what you need to know: 🔹 Active Monitoring Required: Sponsors must actively monitor the RFI (Request for Further Information) folder as the CTIS (Clinical Trials Information System) portal does not send separate notifications. 🔹 Annual Report Submission: Once annual reports are sent, they cannot be changed or cancelled. For critical errors, contact the supervising member country's contact person, listed on the European Commission's website. 🔹 Transition Phase Handling: During study transitions to CTIS, ensure annual reports are sent no later than 120 days from the data lock point (DLP) date, with a possible 60-day extension. 📢 Cofepris has also authorized a groundbreaking clinical trial for the GORE synthetic cornea device, providing new hope for over 3,350 patients in Mexico requiring corneal transplants. This trial, part of 14 recently authorized, underscores the commitment to high safety, quality, and efficacy standards. 📂 Anvisa has restored the document repository for in vitro diagnostic (IVD) medical devices, ensuring seamless access and future submissions. 🌐 The National Medical Products Administration (NMPA) continues to enhance public security and satisfaction by regulating online medical device sales, reducing illegal activities and promoting a safer online purchasing environment. 🔄 Turkey aligns with EU regulations, implementing the "Medical Devices Regulation" and "In Vitro Diagnostic Medical Devices Regulation" to ensure high-risk IVD availability, EUDAMED module implementation, and supply interruption notifications. Stay informed and compliant with these critical updates to ensure the highest standards in clinical trials and medical device regulations. For more detailed information, contact Pure Global sales and let us help you Unlock Global Markets. https://lnkd.in/ei5BRcgN Read more here: https://lnkd.in/d8wXB8dA #MedicalDevices #ClinicalTrials #Regulations #Compliance #MedTech #EUDAMED #COFEPRIS #GlobalMarketAccess

🚀 Exciting Updates in Regulatory Guidance for Medical Devices and Health Products! 🌍 The FDA and Health Canada are making strides to enhance the regulatory landscape for medical devices and health products. Here's a quick overview of the key changes: FDA Draft Guidance on Diversity Action Plans: The FDA has issued a draft guidance to improve enrollment from underrepresented populations in clinical studies. This is a crucial step to ensure diverse and comprehensive data for medical product use. - Effective Dates: Changes for software-based medical devices and prescription spectacle lenses took effect on 15 June 2024. For medical devices containing microbial, recombinant, or animal substances, and application audit requirements, the date is 1 July 2024. - Classification Rule 5.5: Applies to devices with non-viable tissues or cells of animal origin, excluding microbial or recombinant origin substances, from 1 July 2024. - Software Device Transition: Sponsors must submit ARTG inclusion applications or TGA conformity assessments by 1 November 2024 to continue supplying higher classification software-based devices. Health Canada’s Proposed Amendments: To tackle drug and medical device shortages, Health Canada proposes amendments focusing on prevention, mitigation, and stakeholder engagement. - Prevent and Mitigate Shortages: Aimed at reducing the impact of unavoidable shortages. - Stakeholder Engagement: Seeking feedback from governments, manufacturers, distributors, importers, healthcare partners, and the public. - Proactive Measures: Designing systems for readiness, early risk detection, and rapid response. ARTG Exemption for Prescription Lenses: Prescription lenses for refractive correction are now exempt from ARTG inclusion before import, export, or supply in Australia. This includes lenses with treatments like anti-reflective coatings or sunglass colourings. - Exemption Scope: Effective 15 June 2024. - Inclusion of Lens Treatments: Covers lenses with various treatments. - Exclusion of Treatment Lenses: Does not cover lenses for myopia control in children. These updates are set to streamline processes, enhance compliance, and ensure the inclusion of diverse international approvals, ultimately driving innovation and improving patient outcomes globally. 🌐💡 Contact our sales team today and let us help you unlock global markets! https://lnkd.in/ei5BRcgN #MedicalDevices #RegulatoryAffairs #FDA #HealthCanada #ClinicalResearch #Innovation #Healthcare #GlobalHealth #Compliance #Diversity #PatientCare #MedTech #GlobalMarketAccess

🌟Unlock the UAE Market with MOHAP Medical Device Registration!🌟 The United Arab Emirates, known for its strategic location and advanced healthcare infrastructure, offers a thriving market for medical devices. With a commitment to healthcare excellence and a growing population, it's an attractive destination for international medical device manufacturers. Why Choose Pure Global for Your MOHAP Registration Needs? Expert Guidance: We navigate the UAE's MOHAP regulations, ensuring your medical devices gain approval swiftly. Seamless Compliance: From classification to documentation, we streamline the process, ensuring all regulatory pathways are followed. Local Representation: If you lack a direct presence in the UAE, we appoint a local Authorized Representative to manage regulatory submissions and compliance, ensuring your products meet all necessary requirements. Key Requirements for UAE Market Entry: Obtain pre-market approval from MOHAP by submitting a comprehensive dossier demonstrating your device's safety, quality, and efficacy. Appoint a local Authorized Representative to manage regulatory processes on your behalf. Join hands with Pure Global and ensure your medical devices reach the UAE market efficiently and compliantly. For more details, contact Pure Global and unlock the full potential of the UAE market today. https://lnkd.in/d-MAwx3D #MedicalDevices #MedTech #UAE #MOHAP #MedicalDeviceRegulation #PureGlobal #MedTechInnovation #MarketEntry #RegulatoryCompliance

🌟🌟 Pure Global's June Regulatory News Update🌟🌟 The UK announced a policy to streamline market access by recognizing approvals from authorities in Australia, Canada, the EU, and the USA. To qualify, products must meet specific requirements, including compliance with relevant legislation, English labeling, Great Britain’s electronic standards, and post-market surveillance (PMS) requirements. Certain products are excluded, and a comprehensive dossier submission is required for approval. HPRA, Ireland’s competent authority, highlighted regulatory milestones and updates for 2024, focusing on compliance and the implementation of EUDAMED. In Australia, the TGA introduced measures to enhance the safety review process for high-risk medical devices in clinical trials. Switzerland updated regulations to align with EU standards, introducing electronic consent and extended data retention. The EU's MDCG issued new guidance on urogynaecological mesh implants and SCHEER guidelines on phthalates in medical devices. Health Canada proposed regulatory amendments to address health product shortages, seeking public feedback. Swissmedic's Swissdamed Actors module will go live on August 6, 2024, requiring economic operators to register. For more detailed information, contact Pure Global. https://lnkd.in/ei5BRcgN Read more at the link below. https://lnkd.in/dgFf4cdd #MedTech #PureGlobal #RegulatoryUpdates #IVD #MD #MedicalDeviceManufactures #GlobalMarketAccess