ATANIS Biotech AG’s Post

Very interesting info -- the registration regions of Chinese IVD listed companies. This comes from Meng Zhu, CEO of Pure Global IVD during her presentation at CACLP's IVDR webinar.

Looking to enter the Southeast Asian markets? Andaman Medical is your go-to regulatory partner for hassle-free navigation of complex regulations for Medical Devices and IVDs registration. Don't let the regulatory landscape hold you back - reach out to us now to gain a competitive edge! #Asia #SEA #MedicalDevices #IVDs #RegulatoryAffairs

CMEF April 2024 is complete 🇨🇳🎉 After two presentations and MANY requests from manufacturers looking to explore regulatory services, it's safe to say that the event was a huge success. We would like to express our gratitude to those who joined us for our presentations and came to discuss their medical device and IVD registration and regulatory needs. We cannot wait to build partnerships with you! See you next year CMEF 👋 #CMEF #CMEF2024 #RegulatoryAffairs #MedicalDevices Paul Argant Tan Shouzheng LeeWern C.

Dr. Alberto Gutierrez will be co-chairing the “Regulatory Strategies for Point-of-Care Diagnostics Special Forum” at the 16th Annual Next Generation Dx Summit in Washington, DC on August 20th. The forum begins with a keynote presentation entitled “Updates on US FDA POC Test Regulations” presented by Timothy Stenzel, MD, PhD, Former Director, Office of in vitro Diagnostics and Radiological Health (FDA). A panel discussion entitled “Regulatory Strategies for Point-of-Care Diagnostics: Learning from Success Stories and Avoiding Pitfalls” and plenary fireside chat entitled “Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward” feature FDA regulators including Courtney H. Lias, PhD, Acting Director, OHT7: Office of in vitro Diagnostic Devices (FDA), and industry experts. Join the discussion to learn more about the essential components and nuances that are pivotal for regulatory approval for point-of-care diagnostics. #ndapartners #diagnostics #FDA #IVD #LDTs #laboratorydevelopedtests #NGDx #IVDR #regulatorysciences https://lnkd.in/d_z6tMBP.

Andaman Medical was at CMEF and ICMD to guide manufacturers navigating the Southeast Asia market! Get in touch with me if you wish to explore how we can assist you in the region. #RegulatoryAffairs #MedicalDevices

Available data shows that today a considerable number of in-vitro diagnostics currently on the market do not yet comply with In-Vitro Diagnostic Medical Devices Regulation (#IVDR) nor have been replaced by new devices. The situation is especially critical for high-risk IVDs. For that reason, the EU-Commission has recently proposed more time for companies to apply the #IVDR, under certain conditions: IVD-devices may be placed on the market or put into service ONLY IF the manufacturer or the authorized representative has lodged a formal application for conformity assessment with a NB (except with special approval) no later than: -  May 26th, 2025, for class D devices (only 13 months remaining) -  May 26th, 2026, for class C devices (just 25 months remaining) -  May 26th, 2027, for class B devices and for class A devices placed on the market in sterile condition. The later companies start updating their technical documentation or filing them with a NB, the higher the risk becomes to be NOT IVDR-ready by the corresponding due-date. Please feel invited to approach us directly during #RAPSEUConvergence or anytime to evaluate individual support-options. #OneEntourage #IVD #ConformityAssessment #ClinicalTrials

🔍 𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: 𝐍𝐨𝐧-𝐂𝐄 𝐌𝐚𝐫𝐤𝐞𝐝 𝐈𝐕𝐃𝐬 𝐢𝐧 𝐄𝐔 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬    🚀 Join me at @RAPS Euro Convergence 2024 on May 8th, 10:25 CEST, as we explore the regulatory landscape for non-CE marked In Vitro Diagnostic tests in European clinical trials.    🧪 Along with @Dr. Pieter Bogaert, we will dive deep into the complex world of IVD tests that are critical for clinical trials yet face unique regulatory challenges. Our focus will be on devices used in performance studies under the European IVDR, including companion diagnostics and laboratory-developed tests.    📜 We'll discuss the responsibilities of laboratories and trial sponsors and provide a detailed overview of the regulatory requirements and documentation necessary for including these tests in clinical trials.    Feel free to connect with me here on LinkedIn to discuss more on regulatory strategies and innovation in diagnostics!    #IVD #RAPS2024 #OneEntourage #Entourage

What are the main challenges when developing and marketing 𝘪𝘯 𝘷𝘪𝘵𝘳𝘰 diagnostics (IVDs) and companion diagnostics (CDx) in Europe? Sign up for SFL Regulatory Affairs & Scientific Communication GmbH’s upcoming webinar to learn more about the development and conformity assessment of IVDs and CDx in the EU, the UK and Switzerland and latest policy developments: https://bit.ly/45lnFQ2 #EU #UK #CH #IVD #CompanionDiagnostic #DigitalHealth

👉 Let's start the conversation! The FDA's new Final Rule on Laboratory Developed Tests (LDTs) is here, bringing significant changes to the regulatory landscape. Wondering how this affects your lab and what steps to take next?

Survey Data on Medical and Diagnostics Devices Regulation Notified Bodies up to June 2023 The European Commission has provided an update on the status of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Devices Regulation (IVDR) applications with Notified Bodies. The data shows an increase in applications and certificates for both MDR and IVDR, but there are still issues with refusals and incomplete applications. Notified Bodies are urging manufacturers to start their compliance efforts early and follow the guidance provided. A publicly accessible dashboard for ongoing updates is also planned. For more details please click the link! https://lnkd.in/gJAcwDBd #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical