Swissmedic’s Changes on IVD Notifications
Swissmedic, has recently issued a revised version of a guidance document that addresses In Vitro Diagnostic Devices. This updated guidance…
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Applying for an MD-15 Import License for Medical Devices in India
To apply for an MD-15 Import License in India, manufacturers must abide by the medical device regulations of the…
FDA Final Guidance on Cybersecurity in Medical Devices
On November 2nd, 2023, the FDA organized a webinar to discuss the recently issued Final Guidance for Medical Device…
Inclusion of CH-REP in Communication on Vigilance Topics
Swissmedic has now specified that if the reporting is done by a manufacturer domiciled outside of Switzerland and Liechtenstein, the…
EC Regulation 2023/2197: UDI Assignment for Contact Lenses
The EC has decided to amend the MDR with regards to the assignment of Unique Device Identifiers (UDI) for Contact…
RAPS Convergence Montreal 2023: MedEnvoy Key Takeaways
The MedEnvoy team was present at RAPS Convergence which took place in Montreal Canada from 2nd October to 5th…
Annex II Under the MDR: What is a Technical File?
This article draws from our experience in conducting Tech-File reviews and outlines the key requirements for Technical Files based…
Challenges Selecting Distributors as India Authorized Importers
At MedEnvoy Global, we understand the intricate landscape of medical device regulations in India, and we understand that there are…
Clinical Investigation Under the MDR: When is it Not Mandatory?
Due to the resources necessary to perform a clinical investigation under the…
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