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Home > Medical Device made Easy Podcast > October 2023 Regulatory Update


	Podcast:		Medical Device made Easy Podcast
	Episode:		October 2023 Regulatory Update
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2023-10-04 00:00:00
	Description:		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: http s://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/pu blications/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: h ttp s://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 first appeared on Medical Device made Easy Podcast. The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
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