Medical Device News – July 2023 Regulatory Update

july 2023regulatory update

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

Sponsor Medboard https://www.medboard.com/

EU

Annex XVI transition https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194

Cybersecurity and privacy in AI https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosis

ANSM wants barcode on Field Safety Notice https://ansm.sante.fr/actualites/lansm-demande-aux-fabricants-de-dispositifs-medicaux-qui-envoient-un-avis-de-securite-dy-apposer-le-code-barres-des-dispositifs-concernes

AEMPS clinical trials involving drugs and medical devices https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-procedimiento-a-seguir-en-los-ensayos-clinicos-que-impliquen-medicamentos-y-productos-sanitarios/

Switzerland

Medicinal products with a medical device component https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/am-mit-mepkomponente-uebergangsbestimmungen.html

UK

Implementation of the Future Regulations https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations

eQMS

Do you need an eQMS? https://smart-eye.io

So contact [email protected] to get a demo

USA

Premarket notification for Software https://www.fda.gov/media/153781/download

Webinar – Final Guidance: Content of Premarket Submissions for Device Software Functions  https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023

Australia

TGA Use of market authorization evidence https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds

Malaysia

Malaysia rules on EU MDR extension https://www.mda.gov.my/announcement/1224-announcement-mda-approach-on-expired-ec-certificate-for-new-registration-and-re-registration-of-medical-device.html

Saudi Arabia

Saudi Arabia Webinars

Artificial Intelligence and Software Based on Medical Device https://www.sfda.gov.sa/en/workshop/88535

Introducing the Rules for Classifying the Risk of Medical Devices https://www.sfda.gov.sa/en/workshop/88536

Authorized Representative

Europe. https://easymedicaldevice.com/eu-rep/

UK: https://easymedicaldevice.com/uk-responsible-person/

Switzerland: https://easymedicaldevice.com/swiss-authorised-representative/

Podcast Nostalgia:

The great Misunderstanding with Florian Tolkmitt: https://podcast.easymedicaldevice.com/236-2/

How to connect Software dev and QARA team with Christophe Girargey Wega: https://podcast.easymedicaldevice.com/237-2/

What should you know on the UKCA extension with Alex Denoon: https://podcast.easymedicaldevice.com/238-2/

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

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

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