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Hot News: MHRA - Statement of Policy Intent: International Recognition of Medical Devices The UK Government has announced a draft policy to recognize international regulatory approvals for medical devices, aiming to facilitate smoother market access in Great Britain. This policy allows manufacturers to leverage approvals from countries such as Australia, Canada, the EU, and the USA, alongside the UK Conformity Assessed (UKCA) marking, thereby streamlining processes and reducing redundant assessments. The Medicines and Healthcare products Regulatory Agency (MHRA) will oversee this initiative, ensuring faster access to quality-assured medical devices for patients while focusing regulatory resources on innovative products. This policy is part of the UK’s broader strategy to enhance post-Brexit regulatory frameworks, maintaining high standards of patient safety and market efficiency. Manufacturers must still comply with specific UK requirements, including labelling and post-market surveillance. Read more about this draft policy at the link below. https://lnkd.in/d4nWf3QP For more details on how this policy could benefit your medical device operations, contact MEDIcept Inc. at [email protected] for expert guidance and support navigating these regulatory changes. #MHRA #Medicaldevices #RegulatoryCompliance #UK #GreatBritain #MarketAccess #Policy #Regulation  

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to recognise approvals from comparable regulatory countries and are looking to introduce Certificates of International Recognition (CIR) for medical devices from some point in 2025. 🌍 What does this mean for the industry? Streamlined Approval Processes: Medical devices approved by recognised regulatory agencies in comparable countries (US, EU, Canada, Japan, Australia) can now be fast-tracked for approval in the Great Britain. This harmonisation reduces duplication, saves time, and accelerates access to innovative medical technologies. Market Access: By aligning recognition with other leading healthcare systems, the MHRA allows easier access to the GB market. This not only benefits manufacturers but also ensures that patients in Great Britain have access to safe and effective medical devices. Enhanced Market Confidence: Certificates of International Recognition provide a mark of quality and compliance, giving healthcare providers and patients increased confidence in the medical devices available in the UK market. 🔍 Key Benefits: Efficiency: Reduced regulatory burden and quicker market entry. Safety: Continued assurance of high safety and efficacy standards.🌟 #MedicalDevices #RegulatoryAffairs #HealthcareInnovation #MHRA #GlobalHealth #PatientCare

For manufacturers of #medicaldevices in the #UK. 🇬🇧 The Medicines and Healthcare products Regulatory Agency #MHRA has introduced a significant step towards enhancing patient safety by laying a new Post-market Surveillance #PMS Statutory Instrument #SI in Parliament. This marks the first major update to the medical device regulatory framework in Great Britain, aligning with the recommendations from the Independent Medicines and Medical Devices Safety #IMMDS review. Key elements of the new legislation: 🔹 Introduction of clearer, risk-proportionate post-market surveillance (PMS) requirements to improve the safety of medical devices. 🔹 Strengthened regulatory oversight to enable faster identification and response to safety concerns. 🔹 Enhanced traceability and reporting mechanisms for manufacturers. 🔹 Support for innovation and growth in the MedTech sector by leveraging real-world data to improve device performance. This SI aims to provide a solid foundation for future reforms, including international reliance measures, which will allow UK patients to benefit more quickly from medical devices approved in other countries. A six-month implementation period is proposed once the Parliamentary process is completed, potentially making this regulation law by Summer 2025. Comprehensive guidance for manufacturers will be issued following the conclusion of Parliamentary proceedings. We are committed to keeping our clients informed of any changes or updates that may impact their business. Don't hesitate to reach out to us if you have any questions or concerns regarding the new legislation or any other regulatory matters. ☞ [email protected] #MedicalDeviceRegulation #PatientSafety #HealthcareInnovation #MedTech #RegulatoryReform #HealthTech #PostMarketSurveillance #Regulatoryaffairs #Regulatorycompliance #healthcare #Publichealth #medicaldevicesafety

🚀 Exciting news in the world of healthcare regulation! Anvisa has recently introduced Normative Instruction No. 290/2024, a game-changer in streamlining the review process for medical device registrations. This initiative is set to enhance efficiency by leveraging regulatory trust mechanisms, paving the way for smoother approvals of products already greenlit in reputable jurisdictions. 🌐 Recognizing the importance of expediting access to healthcare technologies, the World Health Organization advocates for reliance mechanisms like those championed by Anvisa. By cutting down on bureaucratic hurdles, we can accelerate the delivery of life-saving devices to those in need. 📅 Mark your calendars! Starting June 3, 2024, medical devices authorized by Equivalent Foreign Regulatory Authorities (Australia, Canada, USA, and Japan) will be eligible for abbreviated reviews upon company request. However, it's crucial that these devices maintain consistent production characteristics, indications, and intended use as approved by the recognized regulatory authority. 🔍 At the intersection of innovation and regulation, Anvisa's latest initiative sets a promising precedent for collaborative approaches to healthcare access. Let's work together to ensure safe and efficient delivery of medical devices to patients worldwide. Let Pure Global help you keep your registrations compliant, contact us today: https://lnkd.in/gassTjz2 #HealthcareRegulation #MedicalDevices #Anvisa #Innovation #Pureglobal #RegulatoryPartner #MDR #IVDR #GlobalHealthcare #Medtech

For #medicaldevice manufacturers in #Canada. 🇨🇦 Health Canada | Santé Canada has released updated guidance for manufacturers on leveraging standards to meet the safety, effectiveness, and labeling requirements under the Medical Devices Regulations.  👉 https://lnkd.in/eG_QpuDn This document focuses on how recognized national and international standards can support compliance, particularly when applying for new or amended medical device licenses, special access authorizations, or investigational testing. 🔍 Key points: 🔹 Scope: Applicable across all classes of medical devices. 🔹 Standards Use: Recognized standards offer a clear path to compliance, ensuring consistency in regulatory interpretation. 🔹 Regulatory Collaboration: Health Canada aligns with international norms, helping reduce barriers and speeding up market access for safe, effective products. 🔹 Licensing & Authorization: Manufacturers can demonstrate conformance with recognized standards via a Declaration of Conformity, easing the licensing process. Stay updated with the List of Recognized Standards for Medical Devices as Health Canada regularly revises this list to reflect the latest standards. We're here to support you navigate the regulatory landscape of medical device regulations. Feel free to reach out for guidance and assistance ☞ [email protected] #MedicalDevices #RegulatoryCompliance #HealthCanada #Standards #MedicalTechnology #innovation #technology #publichealth #qualitymanagement #riskmanagement #healthcare #medtechindustry

For #medicaldevice manufacturers in the #UK. 🇬🇧 The Medicines and Healthcare products Regulatory Agency #MHRA has launched a consultation on proposed reforms to pre-market regulations for medical devices. These changes aim to enhance patient safety while increasing access to innovative medical technologies across the UK. This consultation seeks industry and public feedback on four areas: 📌 UKCA Marking: Exploring the removal of physical UKCA marking by enhancing device traceability with Unique Device Identification (UDI). 📌 International Reliance: A proposed framework allowing devices approved by international regulators to enter the GB market faster. 📌 In Vitro Diagnostics (IVDs): Adjusting market access requirements for IVDs based on risk classifications, particularly for Class B devices. 📌 Assimilated EU Law: Maintaining specific EU regulations to ensure a smooth transition as the UK develops its updated regulatory framework. Feedback from this consultation should help shape the Pre-market Statutory Instrument, expected in Parliament next year, and support wider efforts to reduce health disparities and improve patient outcomes nationwide. 🗓 Deadline: 5 January 2025 Do you need support to be compliant with the UK, European or Swiss regulatory requirements for your medical devices? Reach out to us ☞ [email protected] #MedicalDevices #HealthcareInnovation #PatientSafety #RegulatoryReform #MedicalTechnology #HealthTech #UKHealthcare #MedicalRegulations #Diagnostics #HealthInnovation #UKMedTech #PatientCare #regulatoryaffairs #regulatorycompliance

🚨 The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has announced a groundbreaking proposal to streamline the international recognition of medical devices. This initiative promises to revolutionize the regulatory landscape and enhance global healthcare innovation. Highlights of the proposed framework: 🌍 The framework aims to establish mutual recognition agreements with regulatory authorities worldwide, facilitating smoother and faster approvals for medical devices. ✅ By aligning with international standards, the MHRA ensures that patients benefit from the latest medical technologies without compromising safety and efficacy. 📈 The streamlined approval process will encourage manufacturers to introduce cutting-edge medical devices to the UK market, fostering a more competitive and innovative industry. 💶 This initiative is expected to strengthen the UK’UK'ssition as a global leader in medical device regulation, attract investment, and support economic growth. What it means for the industry: ⌛ Manufacturers will experience reduced administrative burdens and faster time-to-market for new devices. 👩⚕️ Healthcare Providers will have access to the latest medical innovations, improving patient care and outcomes. 🏥 Patients will benefit from quicker access to advanced medical technologies, enhancing overall health and well-being. For more details on the MHRA's proposed framework and its implications, check the comments for sources and further information. #MHRA #MedicalDevices #RegulatoryAffairs #MedicalTechnology

📢 Consultation Open on UK Medical Device Regulations! 📢   The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting input on critical updates to the regulatory framework for medical devices. This consultation is an opportunity for patients, healthcare professionals, researchers, developers, manufacturers, suppliers, and the public to share insights and shape future regulations.   Key areas for input include: 🔹 International reliance 🔹 UKCA marking 🔹 In vitro diagnostic devices 🔹 Assimilated EU law   Your feedback will help ensure safe, effective, and innovative medical device standards in the UK. Don’t miss this chance to contribute to healthcare improvement!   🕒 Consultation closes: 5 January 2025   🔗Participate in the consultation: https://lnkd.in/da-mUgRa 🔔 Check our article: https://lnkd.in/duZaEnF9                                                                                                                         #MHRA #Consultation

On October 22, the Medicines and Healthcare products Regulatory Agency (MHRA) introduced a Post-market Surveillance (PMS) Statutory Instrument (SI) in Parliament, marking the first step in reforming medical device regulations across Great Britain. Key Highlights: - The new legislation introduces clearer and risk-proportionate requirements to enhance the safety of medical devices. - It aims to improve patient safety by allowing manufacturers to identify and address issues earlier, reducing the time for corrective actions. - This SI builds on existing measures, such as mandatory MHRA registration of all medical devices since January 2021, increasing oversight and enabling faster responses to safety concerns. - The regulation is part of a broader framework for future regulatory reform, expected to take effect in Summer 2025, and supports the Government’s commitment to innovation and patient safety. - Guidance for manufacturers on implementation will be published following the completion of Parliamentary processes. For more updates on healthcare regulations, follow Global Regulatory Insights. #MedicalDevices #PatientSafety #HealthcareRegulation #Innovation #MHRA #LifeSciences #GRI

🚨 New MHRA Policy Alert! 🚨 On May 21, 2024, the MHRA announced a groundbreaking policy for the UK market, recognizing international regulatory approvals for medical devices. 🌍 This move aims to streamline the approval process, reduce regulatory burdens, and focus on high-risk and innovative products. Key Points: ➡️ Recognition of approvals from Australia, Canada, EU, and USA. ➡️ Reduced duplication for manufacturers. ➡️ Focus on high-risk and novel devices. Read the full NAMSA details here: https://lnkd.in/ggiQ-_4p #MedicalDevices #NAMSAKnows #RegulatoryAffairs #MHRA #HealthcareInnovation