Medical Device News March 2024 Regulatory Update

Sponsor:
•Medboard
EU
•EU proposal to prevent shortage - And other things: www.consilium.europa.eu/en/pr...
•Notified Body Survey - Interesting statistics: health.ec.europa.eu/document/...
•Spain: AEMPS consultation - Qualification and Classification of Medical Devices: www.aemps.gob.es/informa/la-a...
•EURL Second Call - More Lab for High Risk IVD: health.ec.europa.eu/latest-up...
•TEAM-NB Position Paper - Reclassification of IVD: www.team-nb.org/wp-content/up...
•EMDN Proposal - Suggest your updates: webgate.ec.europa.eu/dyna2/emdn/
oMDCG 2024-2 : health.ec.europa.eu/document/...
•Does your product qualify for CECP -Notified Bodies should decide: www.ema.europa.eu/en/document...
Training
•Training Green Belt EU MDR - Learn by practicing: school.easymedicaldevice.com/...
oOpen March 25th, 2024 until March 29th, 2024
•TEAM-NB Training - Technical Documentation: www.team-nb.org/wp-content/up...
oApril 29th, 2024
Services
•Packaging and IFU - Design and Production: easymedicaldevice.com/packagi...
ROW
USA
•Fraudulent Lab -: FDA ask you to check your Third Party: www.fda.gov/medical-devices/i...
CANADA
•Consultation on Significant Changes -: Until April 22nd, 2024: www.canada.ca/en/health-canad...
oDraft Guidance: www.canada.ca/en/health-canad...
Mexico
•Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: www.gob.mx/cofepris/articulos...
Saudi Arabia
• SFDA Harmonized Standards - Which one is accepted?: www.sfda.gov.sa/sites/default...
Qatar
• Qatar Telemedicine -Policy to use this technology: www.moph.gov.qa/_layouts/15/d...
Australia
•TGA SOPP requirements -System or Procedure Pack guidance: www.tga.gov.au/sites/default/...
•TGA Essential Principles -Template available: www.tga.gov.au/sites/default/...
•Transition to EU MDR cases - Evidence of transition, DCR, Non-Compliance, Recalls:
owww.tga.gov.au/sites/default/...
owww.tga.gov.au/sites/default/...
owww.tga.gov.au/sites/default/...
owww.tga.gov.au/sites/default/...
PODCAST
•Episode 271-How to get your interview prepared? With Elena Kyria podcast.easymedicaldevice.com...
•Episode 272 -Will EtO gaz become a Medical Device? Christina Ziegenberg: podcast.easymedicaldevice.com...
•Episode 272 -New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: podcast.easymedicaldevice.com...
EASY MEDICAL DEVICE Services:
•Training: school.easymedicaldevice.com/...
•Authorized Representative EU: easymedicaldevice.com/eu-rep/
•Authorized Representative UK: easymedicaldevice.com/uk-resp...
•Authorized Representative Swiss: easymedicaldevice.com/swiss-a...
•Backoffice Services: easymedicaldevice.com/backoff...
•Eqms SmartEye; smart-eye.io
•Conferences: medtechconf.com/

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