October 2023 Regulatory Update

MEDICAL DEVICE NEWS October 2023 Regulatory Update

The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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

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