Decomplix’s Post

#JFDA_Update: Addressing Medical device shortage in Jordan with a direct submission approach, enabling companies to extend the expired certificates EU MDR via a letter from notified bodies. #JFDA #IQVIA #Regintel #Drugshortage #Jordan #Regulatory #Medicine

🇬🇧 Navigating Transition Periods for Medical Devices in the UK – What You Need to Know Following our recent post on the approaching MDR compliance deadlines in the EU, it's crucial to also focus on the ongoing regulatory changes for medical devices in the United Kingdom. As the UK continues to adjust its framework post-Brexit, manufacturers must stay informed about the specific transition periods that apply to medical devices marketed in this territory. 🔗 Key Transition Dates: The UK government has outlined a clear timeline for the transition to the new UKCA marking system. This timeline is designed to ensure a smooth transition from CE marking to UKCA marking, providing manufacturers sufficient time to comply with the new requirements. 📆 View the full UK transition timeline here: https://lnkd.in/eUb_DTCm #medicaldevices #UKCA #RegulatoryAffairs #UKRegulations #MedTech #Compliance #medxteam 

🤝 Now this is what I call a #regulatory handshake! The #TGA is working on aligning their #EssentialPrinciples with the EU #MDR and #IVDR. They have requested #feedback from the #experts via a #survey, which is live from August 7 to October 14, 2024. 👇 Check out the post below to know more! 🐾Follow RegTrac to stay up to date with latest news from the #healthcare industry! #medicaldevices #medtech #TGA #EUMDR

Hello #Regulatoryprofessionals Want to help shape the future of TGA regulations to align with #EU MDR? Your voice matters! 🗣️ To take this quick survey 👇 Check the original post below. #survey #Medtech #Healthcare

🌍 Ready to navigate the complexities of global medical device regulations? Join our exclusive webinar: "Navigating Regulatory Strategies for Medical Devices: Key Insights for the US, EU, and UK Markets" 🗓 Date: Wednesday, 11 Dec 2024 ⏰ Time: 12:00 pm MT 💻 Where: Online What’s in it for you? Learn the latest FDA requirements for the US. Master MDR compliance in the EU. Understand MHRA regulations in the UK post-Brexit. Gain actionable strategies to accelerate market entry and ensure compliance. 👉 Register Now: https://lnkd.in/gAftM8kc #MedicalDevices #RegulatoryCompliance #MedicalDeviceWebinar #MDR #FDACompliance #MHRA #RegulatoryStrategy #HealthcareInnovation #DQS #MedicalDeviceCertification

🚨 Regulatory News from Australia: Attention #MedTech Professionals! Australia's Therapeutic Goods Administration (#TGA) is aligning its #EssentialPrinciples with #EU regulations to #harmonize global standards. This alignment aims to simplify market entry for medical devices across regions. The TGA is seeking input on aligning the Essential Principles with the EU MDR and IVDR. A #survey is open from August 7 to October 14, 2024. 👉 Have your say and participate here: https://lnkd.in/dJpagF4Q RegTrac provides regulatory partner & support for #medicaldevices and #invitrodiagnostics. Get in touch with us to schedule a 30-minute free consultation with our experts at info@reg-trac.com | www.reg-trac.com #TGAUpdate #RegulatoryAffairs #MedicalDeviceCompliance #HealthcareStandards #regulatoryupdates #regulatorycompliance

📢 Regulatory Update: TGA's Plans to Harmonize Essential Principles with EU MDR/ EU IVDR The Therapeutic Goods Administration (#TGA) is taking significant steps to align Australia’s Essential Principles for medical devices with the #EUMDR and #EUIVDR. 🌍 This consultation aims to strengthen Australia's regulatory framework by ensuring that the #safety and #performance characteristics of medical devices in Australia are consistent with #globalstandards. Key Points: 1️⃣ The consultation will help determine the extent to which the Australian Essential Principles should align with the EU MDR / EU IVDR GSPRs. 2️⃣ Feedback gathered will contribute to improving the regulatory environment for medical devices in #Australia. Are you in the #medicaldevice industry? 🚀 Your input is vital! Check out the post below to to participate in the survey and share your views. 💬 Got questions or need regulatory compliance support? Reach out to RegTrac—we’re here to help you navigate these evolving regulations with ease. Let’s work together to ensure a smooth transition and compliance success! 💡 #MedicalDevices #RegulatoryAffairs #TGA #MDR #IVDR #Compliance #Healthcare

🌍 Ready to navigate the complexities of global medical device regulations? Join our exclusive webinar: "Navigating Regulatory Strategies for Medical Devices: Key Insights for the US, EU, and UK Markets" 🗓 Date: Wednesday, 11 Dec 2024 ⏰ Time: 12:00 pm MT 💻 Where: Online What’s in it for you? Learn the latest FDA requirements for the US. Master MDR compliance in the EU. Understand MHRA regulations in the UK post-Brexit. Gain actionable strategies to accelerate market entry and ensure compliance. 👉 Reserve Your Spot Now #MedicalDevices #RegulatoryCompliance #MedicalDeviceWebinar #MDR #FDACompliance #MHRA #RegulatoryStrategy #HealthcareInnovation #DQS #MedicalDeviceCertification

Do you have a Medical Device product in the EU? Medical device companies that are currently selling products under the old EU Medical Device Directive (MDD) need to take action by May 26th, 2024 to benefit from an extended grace period. The new EU Medical Device Regulation (MDR) brings stricter safety requirements and companies need to comply to keep their products on the market. There are specific deadlines to meet including establishing a quality management system and applying for a conformity assessment. Missing this deadline could mean products are pulled from the market after May 26th, 2024. Check the European Commissions PDF on the extensions: https://lnkd.in/dY8aXenY #MedicalDevices #EUMDR #Compliance #biologit