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Imagine a future where patient medical records are secure, accessible, and seamlessly transferable between healthcare providers. Also, clinical trials are transparent and it’s possible to identify counterfeit drugs with accuracy. We dove into the world of healthcare onchain in our blogpost below 👇 https://lnkd.in/emz_4F4f

New article! To help Sponsor teams in the overwhelming task of identifying and justifying what is and is not company confidential information (CCI), MMS transparency experts just released a new blog post titled, “Confined Deferrals in Clinical Trial Applications: Anticipating the Revised EU CTR Transparency Rules.” Pre- and post-implementation tips, as well as recommendations for a plan and prepare mindset, are detailed within. Read this: https://hubs.li/Q02FcWKy0 #clinicaltrialtransparency #EUCTR #clinicaltrials

Below the Terms of Reference (ToR) of a new Rulemaking Task “Medical regulation – combination of Part-MED (Annex IV) of Regulation 1178/2011 and Part ATCO.MED (Annex IV) of Regulation 2015/340”: https://lnkd.in/e6Uv88wc The overview of EU regulatory developments (FUTURELEX, Part 1) has been updated accordingly: https://lnkd.in/egKupzC4 #EULegislationforATMANS

Dive into Post-Marketing Medical Device Reporting essentials with #Soterius. From 21 CFR PART 803 to EMA Regulation 2017/745, we unravel key requirements for safeguarding health. Join the regulatory conversation now @ https://bit.ly/49wcszs #ComplianceInsights #MedicalDevices #RegulatoryCompliance

#RegUpdatesWithRegDesk When economic operators find deviations from legal requirements during official market surveillance, 𝐒𝐰𝐢𝐬𝐬𝐦𝐞𝐝𝐢𝐜 will ask for written corrective action. This information sheet helps medical device economic operators create a CAPA plan, outlining essential content requirements. 𝐆𝐞𝐭 𝐒𝐭𝐚𝐫𝐭𝐞𝐝:  👉 https://lnkd.in/d8yWnPkj 𝐅𝐨𝐥𝐥𝐨𝐰: 👉 RegDesk and get daily regulatory alerts straight to your inbox. #correctiveaction  #medicaldevicesafety #marketsurveillance #regulatoryrequirements #swissmedic #switzerland

#RegUpdatesWithRegDesk Health Canada's Regulatory Operations and Enforcement Branch has updated the medical device establishment licence (MDEL) application form for clarity. The form is used to apply for an MDEL, reapply after a cancellation, submit changes, cancel, or reinstate after a suspension. Get daily regulatory alerts sent straight to your inbox - stay informed effortlessly! Get Started: 👉 https://lnkd.in/d8yWnPkj #HealthCanada #MDELUpdates #RegulatoryCompliance #MedicalDevices #LicenseApplication

🌐 Exciting Updates from OMC Medical! 🌐 Thrilled to share insights on the latest guidance from the EU Commission - MDCG 2021-27 Rev.1, focusing on the vital Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. 🤔 What does this mean for the medical device industry? Dive into the Q&A session that sheds light on key aspects and clarifications. Knowledge is power, especially in the dynamic regulatory landscape! 👥 Let's foster discussions and collaborations within the healthcare community. Share your thoughts and experiences regarding these regulations. It's an excellent opportunity to learn and grow together. 🚀 Stay informed, stay compliant! Kudos to OMC Medical for spearheading this initiative and keeping us abreast of the latest developments in the field. Looking forward to engaging conversations and insights from our esteemed network! 💬✨ https://lnkd.in/eezwzXw7 #OMCMedical #MedicalDevices #EURegulations #HealthcareCompliance #MDCG202127 #RegulatoryUpdates #CollaborationInHealthcare #KnowledgeSharing #MedicalInnovation #EUCommission #HealthcareIndustry

BAM! Only January and one of my 2024 predictions is happening harder and faster than I thought 🤗 : today bipartisan(!) legislation was introduced into both(!) houses of the US congress to ban “federally funded medical providers” from using MGI instruments. My prediction was: "MGI - On paper a looks very strong but IMO geopolitics are a huge barrier outside of China. Huawei (networks) has been banned in the US and allies, and is likely to be banned across the EU. Rational or not, human DNA sequences are perceived as a national security risk so I think MGI will run into the Huawei wall." (More great, 100% guaranteed 🤣 2024 predictions here: https://lnkd.in/gecsqHTe) And looks like Illumina found a more effective (than Grail) use for all those lobbying dollars “the legislation stems from one powerful US player's effort to eliminate competition," MGI noted. In unrelated news last year Illumina spent $4M on lobbying and BGI $0.4M 🤔 But seriously this will accelerate the emerging NGS segmentation between human and agricultural sequencing. Ag is incredibly price sensitive but not politically sensitive so is moving to the lowest cost NGS providers. Example: at last week's Plant and Animal Genome Conference Gencove announced a collaboration with MGI for exactly this reason (https://lnkd.in/gDbmEtqT). Ag is a huge TAM, that's one of the reasons I'm on the Gencove board. Microarrays are dead! Also, I've been writing a lot about Illumina moats and I think we should add this to the list - BGI/MGI/Complete is the only competitor with a full line of SR sequencers and this is going to block it out of US human work including the largest TAM - the onco market. Even if it doesn't pass this session, with this legislation hanging out there I think US human markets are gone for MGI. Article quotes - “NEW YORK – The House Select Committee on the Strategic Competition between the United States and the Chinese Communist Party said on Thursday that it has introduced a new bill to ban "foreign adversary biotech companies" from the US, including China's BGI Group.” “If enacted, the legislation would ban federally funded medical providers from using products manufactured by the so-called "foreign adversary biotech companies of concern," including BGI Group and its subsidiaries — MGI Tech and Complete Genomics — along with WuXi AppTec, which it said is affiliated with China’s People’s Liberation Army.”

How #pharma is amping up medical information programs with practical, #AI-driven contact center solutions that help improve the patient experience. https://lnkd.in/gzhvXY_Z

#RegUpdatesWithRegDesk 🌐 Cofepris update: The Draft Mexican Official Standard PROY-NOM-240-SSA1-2024 was published July 24, 2024, and interested parties have 60 calendar days from the date of its publication to submit their comments in Spanish and with sufficient technical support to the National Consultative Committee for Standardization of Regulation and Health Promotion. This draft standard establishes the guidelines for the installation and operation of technovigilance in order to guarantee the protection of patient health and the safety of medical devices in use in the national territory. Follow: 👉 RegDesk and get important regulatory alerts straight to your inbox. #regulatoryintelligence #RegDesk #medtech #holisticRIMS #Cofepris #Draft