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Innehåll tillhandahållet av Monir El Azzouzi. Allt poddinnehåll inklusive avsnitt, grafik och podcastbeskrivningar laddas upp och tillhandahålls direkt av Monir El Azzouzi eller deras podcastplattformspartner. Om du tror att någon använder ditt upphovsrättsskyddade verk utan din tillåtelse kan du följa processen som beskrivs här https://sv.player.fm/legal.
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Medical Device News March 2024 Regulatory Update
Manage episode 404874303 series 2591977
Innehåll tillhandahållet av Monir El Azzouzi. Allt poddinnehåll inklusive avsnitt, grafik och podcastbeskrivningar laddas upp och tillhandahålls direkt av Monir El Azzouzi eller deras podcastplattformspartner. Om du tror att någon använder ditt upphovsrättsskyddade verk utan din tillåtelse kan du följa processen som beskrivs här https://sv.player.fm/legal.
EU
- EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/
- Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
- Spain: AEMPS consultation – Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/
- EURL Second Call – More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en
- TEAM-NB Position Paper – Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/03/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf
- EMDN Proposal – Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/
- Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf
Training
- Training Green Belt EU MDR – Learn by practicing: https://school.easymedicaldevice.com/course/gb30
- Open March 25th, 2024 until March 29th, 2024
- TEAM-NB Training – Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdf
- April 29th, 2024
Services
- Packaging and IFU – Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/
ROW
USA
- Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device
CANADA
- Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html
Mexico
- Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es
Saudi Arabia
- SFDA Harmonized Standards – Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf
Qatar
- Qatar Telemedicine – Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf
Australia
- TGA SOPP requirements – System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf
- TGA Essential Principles – Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf
- Transition to EU MDR cases – Evidence of transition, DCR, Non-Compliance, Recalls:
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf
PODCAST
- Episode 271 – How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/
- Episode 272 – Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/
- Episode 272 – New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/
EASY MEDICAL DEVICE Services:
- Training: https://school.easymedicaldevice.com/emd-course/
- Authorized Representative EU: https://easymedicaldevice.com/eu-rep/
- Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/
- Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/
- Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/
- Eqms SmartEye; https://smart-eye.io
- Conferences: https://medtechconf.com/
The post Medical Device News March 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
293 episoder
Dela
Manage episode 404874303 series 2591977
Innehåll tillhandahållet av Monir El Azzouzi. Allt poddinnehåll inklusive avsnitt, grafik och podcastbeskrivningar laddas upp och tillhandahålls direkt av Monir El Azzouzi eller deras podcastplattformspartner. Om du tror att någon använder ditt upphovsrättsskyddade verk utan din tillåtelse kan du följa processen som beskrivs här https://sv.player.fm/legal.
EU
- EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/
- Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
- Spain: AEMPS consultation – Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/
- EURL Second Call – More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en
- TEAM-NB Position Paper – Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/03/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf
- EMDN Proposal – Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/
- Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf
Training
- Training Green Belt EU MDR – Learn by practicing: https://school.easymedicaldevice.com/course/gb30
- Open March 25th, 2024 until March 29th, 2024
- TEAM-NB Training – Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdf
- April 29th, 2024
Services
- Packaging and IFU – Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/
ROW
USA
- Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device
CANADA
- Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html
Mexico
- Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es
Saudi Arabia
- SFDA Harmonized Standards – Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf
Qatar
- Qatar Telemedicine – Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf
Australia
- TGA SOPP requirements – System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf
- TGA Essential Principles – Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf
- Transition to EU MDR cases – Evidence of transition, DCR, Non-Compliance, Recalls:
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf
PODCAST
- Episode 271 – How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/
- Episode 272 – Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/
- Episode 272 – New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/
EASY MEDICAL DEVICE Services:
- Training: https://school.easymedicaldevice.com/emd-course/
- Authorized Representative EU: https://easymedicaldevice.com/eu-rep/
- Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/
- Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/
- Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/
- Eqms SmartEye; https://smart-eye.io
- Conferences: https://medtechconf.com/
The post Medical Device News March 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
293 episoder
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