Medical Device Regulatory Updates

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CDRHNew - News and Updates | FDA

https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates

New Emergency Use Authorization QuantiVirus MPXV Test Kit (DiaCarta, Inc.) Updated Emergency Use Authorizations MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.) SCoV-2 Ag...

Medical Devices News and Events | FDA

https://www.fda.gov/medical-devices/medical-devices-news-and-events

January 10, 2023 CDRH Statements - Statements from the Center for Devices and Radiological Health (CDRH), as we discuss significant steps towards continuing to …

Medical Device News | MedTech Dive

https://www.medtechdive.com/topic/medical-devices/

Abbott device approval sets up battle with Medtronic, Nevro for diabetic peripheral neuropathy treatment Three firms are bringing their devices to a $3 billion to …

Compliance with Medical Device Regulatory Changes

https://www2.deloitte.com/us/en/pages/advisory/articles/medical-technology-regulation-change-implications.html

New or updated medical device regulations—from the International Organization for Standardization (ISO), the European Union, and a group of nations that have adopted the …

Medical Devices - Sector - Latest updates - Public Health

https://health.ec.europa.eu/medical-devices-sector/latest-updates_en

MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the …

Worldwide Medical Device Regulatory Updates

https://www.medtechintelligence.com/feature_article/worldwide-medical-device-regulatory-updates/

Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and …

Welcome to the Journal of Medical Device Regulation

https://globalregulatorypress.com/

Since its application on 26 May 2021, Regulation (EU) 2017/745 on medical devices (MDR) requires manufacturers to ensure compliance with all relevant general safety and …

Medical Devices - New regulations - Latest updates

https://health.ec.europa.eu/medical-devices-new-regulations/latest-updates_en

European Medical Device Nomenclature (EMDN) - Questions and Answers News announcement 26 May 2021 Stronger rules on medical devices News …

What's new: Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

Consult the Drug and Health Product Register regularly for Regulatory Decision Summaries for medical devices. Consult the Drug and Health Product Register regularly for Post …

Medical Device News: January 2023 Regulatory Update

https://podcast.easymedicaldevice.com/213-2/

Medical Device News - January 2023 Regulatory update. Watch on. EU MDR extension. Implementation of the Medical Device Regulation …

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