MEDICAL DEVICE NEWS October 2023 Regulatory Update

EU
Manual on Borderline and classification for Medical Devices Update - New entries to the file: health.ec.europa.eu/system/fi...
Q&A on Annex XVI Products - Check transition timeline: health.ec.europa.eu/system/fi...
Italy: Custom-made medical device registration - Specific website available: www.salute.gov.it/portale/new...
Ireland: Custom-made device Webinar October 19th, 2023 - Webinar to join: www.hpra.ie/homepage/medical-...
Team-NB - Training on MDR Technical Documentation for Manufacturers - Date of the event November 7th, 2023: www.team-nb.org/new-team-nb-i...
Technical Documentation template Premium Pack: school.easymedicaldevice.com/...
FIMEA designate first Notified Body under the IVD regulation in Finland - EUROFINS Electric & Electronics Finland Oy: www.fimea.fi/web/en/-/fimea-d...
UK
The innovation Devices Access Pathway (IDAP) - Pilot Phase to join - Answer before October 29th, 2023: www.gov.uk/government/publica...
CH
Swissdamed Survey Report - The EUDAMED for Switzerland to start in 2024: www.swissmedic.ch/dam/swissme...
Conferences
Which conferences to focus on? - I will be going to them so join me.
MEDXD: Digitalisation of Medtech: medtechx.digital/
Afrisummit in Egypt: www.pharmaregafrisummit.com/
Medica: www.medica-tradefair.com/
Team-PRRC: www.team-prrc.eu/
Training
Trainings for you - Self-paced
Vigilance Reporting: school.easymedicaldevice.com/...
Audit Readiness: school.easymedicaldevice.com/...
US
US FDA - De Novo Request - Electronic Submission template: www.fda.gov/media/172450/down...
Webinar US FDA - Cybersecurity in Medical Devices: - November 2nd 2023: www.fda.gov/medical-devices/w...
Webinar US FDA - Breakthrough devices program update - November 14th, 2023: www.fda.gov/medical-devices/w...
Digital Health FAQ - Is your medical device an SaMD?: www.fda.gov/medical-devices/d...
ISO 10993-1:2018 versus FDA - FDA is adding its touch: www.fda.gov/media/142959/down...
Best practice for selecting a Predicate device for your 510K - Method provided. www.fda.gov/media/171838/down...
Saudi Arabia
SFDA Significant changes guidance - Template inside: www.sfda.gov.sa/sites/default...
Malaysia
Malaysia: Workshop preparation of documents for Submission - October 23rd, 24th and 30th: www.mda.gov.my/announcement/1...
Turkey
Mutual Recognition of Authorized rep and NB in Turkey - Good clarification: titck.gov.tr/duyuru/tcokka-mu...
Japan: Essential Principles - In 2023 inclusion of the Cybersecurity risks: www.std.pmda.go.jp/stdDB/Data...
India
India: List of registered medical device testing laboratory - under Indian mdr 2017: cdsco.gov.in/opencms/opencms/...
Podcast
Podcast Nostalgia - Do you remember?
Episode 249: Team-PRRC interviews part 1 : podcast.easymedicaldevice.com...
and 250: part 2: podcast.easymedicaldevice.com...
Episode 251: EUDAMED Updates: podcast.easymedicaldevice.com...
QMS
How Easy Medical Device can help you -easymedicaldevice.com
We can also help you implement our eQMS - Smarteye: smart-eye.io​​​​​​​
► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
#easymedicaldevice #regulatorycompliance

[@ahmadsamirgamil]

Hello Dr Munir, Thanks for your great efforts, Which course should I go for, RADEX course or RAPS if I want to shift from retail pharmacy to regulatory affairs in Dubai?