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Monir El Azzouzi에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Monir El Azzouzi 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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Medical Device News, October 2024 Regulatory Update
Manage episode 444420129 series 2591977
Monir El Azzouzi에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Monir El Azzouzi 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
Medboard: https://www.medboard.com/
EUROPE
- TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf
- TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf
- MDCG 2021-4 Rev 1 update- Deletion, revision, addition of questions: https://health.ec.europa.eu/document/download/9f23fca0-f407-4e45-a464-2d71b575d1fe_en?filename=mdcg_2021-4_en.pdf
- Swissmedic – Deadline for Swissdamed – November 13th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/swissdamed/swissdamed-frist-13-11-24.html
- Swiss review of old legislation devices – Check that all are up-to-date: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/aufforderung-ueberpruefung-altrechtlicher-produkte.html
- UK on their new Regulation – Restart ongoing: https://medregs.blog.gov.uk/2024/09/25/an-update-on-our-plans-for-med-tech-regulatory-change/
EVENTS
- TEAM-PRRC – October 17-18. 2024: https://medtechconf.com/event/team-prrc-third-annual-summit/
- Afrisummit – November 3-6, 2024: https://medtechconf.com/event/afrisummit/
- MEDICA – November 11-14, 2024 : https://medtechconf.com/event/medica-2024/
NB
- ISS IVDR Notified Body – ISTITUTO SUPERIORE DI SANITA’: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1010586?organizationVersion=3
ROW
Middle East
- Saudi Arabia: Labelling Guidance – What should contain a Medical Device Label in Saudi Arabia: https://www.sfda.gov.sa/sites/default/files/2024-10/MDS-014En.pdf
Northern America
- USA webinar on Registation & Listing Requirements – In-Vitro Diagnostics and Laboratory Developed Tests: https://www.fda.gov/medical-devices/cdrhnew-news-and-updates/webinar-registration-listing-requirements-in-vitro-diagnostic-products-ivds-including-laboratory
- USA Guidance on Dental products – Air Powered handpiece, Dental Cements, Dental Ceramics, Impressions:
- Air powered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/air-powered-dental-handpieces-and-air-motors-performance-criteria-safety-and-performance-based
- Dental Cements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-cements-performance-criteria-safety-and-performance-based-pathway
- Dental Ceramics: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-ceramics-performance-criteria-safety-and-performance-based-pathway
- Dental Impressions: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-impression-materials-performance-criteria-safety-and-performance-based-pathway
- Canada policy on Drug/device combinations – Who is who?: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-drug-medical-device-combination-products-decisions.html
South America:
- Brazil bans – Thermometers and Sphygmomanometers with a Mercury column: https://antigo.anvisa.gov.br/documents/10181/6873945/RDC_922_2024_.pdf/1e09cbf1-53db-4609-bea7-34afb7ce633c
PODCAST
- Podcast Nostalgia – Last podcast to listen to-
- Episode 302 – How to do PMCF literature Search for Medical Devices with Cesare Magri 4BetterDevices: https://podcast.easymedicaldevice.com/302-2/
- Episode 303 – UK vs EU vs US – How to switch to another region easily? With Claire Dyson DQS : https://podcast.easymedicaldevice.com/303-2/
- Episode 304 – How to select the best plastic for your Medical Device? Lucas Pianegonda Gradical: https://podcast.easymedicaldevice.com/305-2/
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
314 에피소드
Manage episode 444420129 series 2591977
Monir El Azzouzi에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Monir El Azzouzi 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
Medboard: https://www.medboard.com/
EUROPE
- TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf
- TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf
- MDCG 2021-4 Rev 1 update- Deletion, revision, addition of questions: https://health.ec.europa.eu/document/download/9f23fca0-f407-4e45-a464-2d71b575d1fe_en?filename=mdcg_2021-4_en.pdf
- Swissmedic – Deadline for Swissdamed – November 13th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/swissdamed/swissdamed-frist-13-11-24.html
- Swiss review of old legislation devices – Check that all are up-to-date: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/aufforderung-ueberpruefung-altrechtlicher-produkte.html
- UK on their new Regulation – Restart ongoing: https://medregs.blog.gov.uk/2024/09/25/an-update-on-our-plans-for-med-tech-regulatory-change/
EVENTS
- TEAM-PRRC – October 17-18. 2024: https://medtechconf.com/event/team-prrc-third-annual-summit/
- Afrisummit – November 3-6, 2024: https://medtechconf.com/event/afrisummit/
- MEDICA – November 11-14, 2024 : https://medtechconf.com/event/medica-2024/
NB
- ISS IVDR Notified Body – ISTITUTO SUPERIORE DI SANITA’: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1010586?organizationVersion=3
ROW
Middle East
- Saudi Arabia: Labelling Guidance – What should contain a Medical Device Label in Saudi Arabia: https://www.sfda.gov.sa/sites/default/files/2024-10/MDS-014En.pdf
Northern America
- USA webinar on Registation & Listing Requirements – In-Vitro Diagnostics and Laboratory Developed Tests: https://www.fda.gov/medical-devices/cdrhnew-news-and-updates/webinar-registration-listing-requirements-in-vitro-diagnostic-products-ivds-including-laboratory
- USA Guidance on Dental products – Air Powered handpiece, Dental Cements, Dental Ceramics, Impressions:
- Air powered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/air-powered-dental-handpieces-and-air-motors-performance-criteria-safety-and-performance-based
- Dental Cements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-cements-performance-criteria-safety-and-performance-based-pathway
- Dental Ceramics: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-ceramics-performance-criteria-safety-and-performance-based-pathway
- Dental Impressions: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-impression-materials-performance-criteria-safety-and-performance-based-pathway
- Canada policy on Drug/device combinations – Who is who?: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-drug-medical-device-combination-products-decisions.html
South America:
- Brazil bans – Thermometers and Sphygmomanometers with a Mercury column: https://antigo.anvisa.gov.br/documents/10181/6873945/RDC_922_2024_.pdf/1e09cbf1-53db-4609-bea7-34afb7ce633c
PODCAST
- Podcast Nostalgia – Last podcast to listen to-
- Episode 302 – How to do PMCF literature Search for Medical Devices with Cesare Magri 4BetterDevices: https://podcast.easymedicaldevice.com/302-2/
- Episode 303 – UK vs EU vs US – How to switch to another region easily? With Claire Dyson DQS : https://podcast.easymedicaldevice.com/303-2/
- Episode 304 – How to select the best plastic for your Medical Device? Lucas Pianegonda Gradical: https://podcast.easymedicaldevice.com/305-2/
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
314 에피소드
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