Gå frakoblet med Player FM -appen!
October 2023 Regulatory Update
Manage episode 378708523 series 2591977
EU
- Manual on Borderline and classification for Medical Devices Update – New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf
- Q&A on Annex XVI Products – Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf
- Italy: Custom-made medical device registration – Specific website available: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6352
- Ireland: Custom-made device Webinar October 19th, 2023 – Webinar to join: https://www.hpra.ie/homepage/medical-devices/news-events/item?t=/custom-made-device-(cmd)-regulation-webinar&id=5ad21426-9782-6eee-9b55-ff00008c97d0
- Team-NB – Training on MDR Technical Documentation for Manufacturers – Date of the event November 7th, 2023: https://www.team-nb.org/new-team-nb-initiative-mdr-technical-documentation-training-for-manufacturers/
- Technical Documentation template Premium Pack: https://school.easymedicaldevice.com/product/eu-mdr-technical-file-premium-pack/
- FIMEA designate first Notified Body under the IVD regulation in Finland – EUROFINS Electric & Electronics Finland Oy: https://www.fimea.fi/web/en/-/fimea-designates-the-first-notified-body-under-the-ivd-regulation-in-finland
UK
- The innovation Devices Access Pathway (IDAP) – Pilot Phase to join – Answer before October 29th, 2023: https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase
CH
- Swissdamed Survey Report – The EUDAMED for Switzerland to start in 2024: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/survey-results-report.pdf.download.pdf/20230919_swissdamed_survey%20results%20report.pdf
Conferences
Which conferences to focus on? -I will be going to them so join me.
- MEDXD: Digitalisation of Medtech: https://medtechx.digital/
- Afrisummit in Egypt: https://www.pharmaregafrisummit.com/
- Medica: https://www.medica-tradefair.com/
- Team-PRRC: https://www.team-prrc.eu/
Training
Trainings for you – Self-paced
- Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
US
- US FDA – De Novo Request – Electronic Submission template: https://www.fda.gov/media/172450/download
- Webinar US FDA – Cybersecurity in Medical Devices: – November 2nd 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-cybersecurity-medical-devices-quality-system-considerations-and-content
- Webinar US FDA – Breakthrough devices program update – November 14th, 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-breakthrough-devices-program-updated-final-guidance-11142023
- Digital Health FAQ – Is your medical device an SaMD?: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs
- ISO 10993-1:2018 versus FDA – FDA is adding its touch: https://www.fda.gov/media/142959/download
- Best practice for selecting a Predicate device for your 510K – Method provided. https://www.fda.gov/media/171838/download
Saudi Arabia
- SFDA Significant changes guidance – Template inside: https://www.sfda.gov.sa/sites/default/files/2023-09/MDS-G12a.pdf
Malaysia
- Malaysia: Workshop preparation of documents for Submission – October 23rd, 24th and 30th: https://www.mda.gov.my/announcement/1285-first-announcement-hands-on-workshop-efficient-way-to-prepare-for-mda-documentation-submissions.html
Turkey
- Mutual Recognition of Authorized rep and NB in Turkey – Good clarification: https://titck.gov.tr/duyuru/tcokka-mutual-recognition-of-authorized-representatives-and-notified-bodies-in-the-field-of-medical-devices-between-the-eu-and-turkiye-19092023160242
Japan
- Japan: Essential Principles – In 2023 inclusion of the Cybersecurity risks: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/MHLW_Notification_122_of_2005.pdf
India
- India: List of registered medical device testing laboratory – under Indian mdr 2017: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1MTE=
Podcast
Podcast Nostalgia – Do you remember?
- Episode 249: Team-PRRC interviews part 1 : https://podcast.easymedicaldevice.com/249-2/
- and 250: part 2: https://podcast.easymedicaldevice.com/250-2/
- Episode 251: EUDAMED Updates: https://podcast.easymedicaldevice.com/251-2/
QMS
How Easy Medical Device can help you –easymedicaldevice.com
- We can also help you implement our eQMS – Smarteye: https://smart-eye.io
The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
293 episoder
Manage episode 378708523 series 2591977
EU
- Manual on Borderline and classification for Medical Devices Update – New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf
- Q&A on Annex XVI Products – Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf
- Italy: Custom-made medical device registration – Specific website available: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6352
- Ireland: Custom-made device Webinar October 19th, 2023 – Webinar to join: https://www.hpra.ie/homepage/medical-devices/news-events/item?t=/custom-made-device-(cmd)-regulation-webinar&id=5ad21426-9782-6eee-9b55-ff00008c97d0
- Team-NB – Training on MDR Technical Documentation for Manufacturers – Date of the event November 7th, 2023: https://www.team-nb.org/new-team-nb-initiative-mdr-technical-documentation-training-for-manufacturers/
- Technical Documentation template Premium Pack: https://school.easymedicaldevice.com/product/eu-mdr-technical-file-premium-pack/
- FIMEA designate first Notified Body under the IVD regulation in Finland – EUROFINS Electric & Electronics Finland Oy: https://www.fimea.fi/web/en/-/fimea-designates-the-first-notified-body-under-the-ivd-regulation-in-finland
UK
- The innovation Devices Access Pathway (IDAP) – Pilot Phase to join – Answer before October 29th, 2023: https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase
CH
- Swissdamed Survey Report – The EUDAMED for Switzerland to start in 2024: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/survey-results-report.pdf.download.pdf/20230919_swissdamed_survey%20results%20report.pdf
Conferences
Which conferences to focus on? -I will be going to them so join me.
- MEDXD: Digitalisation of Medtech: https://medtechx.digital/
- Afrisummit in Egypt: https://www.pharmaregafrisummit.com/
- Medica: https://www.medica-tradefair.com/
- Team-PRRC: https://www.team-prrc.eu/
Training
Trainings for you – Self-paced
- Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
US
- US FDA – De Novo Request – Electronic Submission template: https://www.fda.gov/media/172450/download
- Webinar US FDA – Cybersecurity in Medical Devices: – November 2nd 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-cybersecurity-medical-devices-quality-system-considerations-and-content
- Webinar US FDA – Breakthrough devices program update – November 14th, 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-breakthrough-devices-program-updated-final-guidance-11142023
- Digital Health FAQ – Is your medical device an SaMD?: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs
- ISO 10993-1:2018 versus FDA – FDA is adding its touch: https://www.fda.gov/media/142959/download
- Best practice for selecting a Predicate device for your 510K – Method provided. https://www.fda.gov/media/171838/download
Saudi Arabia
- SFDA Significant changes guidance – Template inside: https://www.sfda.gov.sa/sites/default/files/2023-09/MDS-G12a.pdf
Malaysia
- Malaysia: Workshop preparation of documents for Submission – October 23rd, 24th and 30th: https://www.mda.gov.my/announcement/1285-first-announcement-hands-on-workshop-efficient-way-to-prepare-for-mda-documentation-submissions.html
Turkey
- Mutual Recognition of Authorized rep and NB in Turkey – Good clarification: https://titck.gov.tr/duyuru/tcokka-mutual-recognition-of-authorized-representatives-and-notified-bodies-in-the-field-of-medical-devices-between-the-eu-and-turkiye-19092023160242
Japan
- Japan: Essential Principles – In 2023 inclusion of the Cybersecurity risks: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/MHLW_Notification_122_of_2005.pdf
India
- India: List of registered medical device testing laboratory – under Indian mdr 2017: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1MTE=
Podcast
Podcast Nostalgia – Do you remember?
- Episode 249: Team-PRRC interviews part 1 : https://podcast.easymedicaldevice.com/249-2/
- and 250: part 2: https://podcast.easymedicaldevice.com/250-2/
- Episode 251: EUDAMED Updates: https://podcast.easymedicaldevice.com/251-2/
QMS
How Easy Medical Device can help you –easymedicaldevice.com
- We can also help you implement our eQMS – Smarteye: https://smart-eye.io
The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
293 episoder
Alle episoder
×Velkommen til Player FM!
Player FM scanner netter for høykvalitets podcaster som du kan nyte nå. Det er den beste podcastappen og fungerer på Android, iPhone og internett. Registrer deg for å synkronisere abonnement på flere enheter.