New Swissdamed FAQs with EMDN and UDI Info
Swissmedic updates Swissdamed FAQ with new details on Actor Registration, UDI modules, and more.
Resources & News
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EUDAMED Free Training From The European Commission
The European Commission is hosting a free training workshop in Stuttgart to prepare for EUDAMED onboarding.
New EU Harmonized Standards for the MDR and IVDR
Harmonized standards in the European Union (EU) play a crucial role in ensuring that products, services, and processes comply…
Switzerland to Approve FDA-Certified Medical Devices in 2025
In Q2 2025, the Federal Council will decide how and at what pace it will implement the Müller motion (20.3211),…
ISO 15223-1 Amendment 1:2025 Updates for Medical Devices
As your Global Partner for Medical Device Regulatory Compliance, MedEnvoy would like to notify manufacturers that the…
Understanding Technical Documentation Under MDR
In our recent webinar, part of our four-part MDR and IVDR compliance series, we explored the complex and…
Navigating COFEPRIS: Medical Device Distribution in Mexico
Mexico is one of the largest importers of medical devices in Latin America yet the importation process is highly…
HPRA Update: Economic Operator Registration Verification
The HPRA (Health Products Regulatory Authority), has posted a regulatory update regarding verification of economic operator registration details…
New COFEPRIS Guidelines for Good Manufacturing Practices
In an effort to streamline processes and strengthen the certification of medical devices in Mexico, the Federal Commission…
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