EUDAMED Registration Webinar for MDR & IVDR
Navigating EUDAMED: Streamlined Compliance for EU MDR & IVDR Success We hosted a webinar on navigating EUDAMED and understanding the…
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FDA MDUFA 2026: Fees & Relief Update
Effective October 1, 2025, the FDA has increased the annual establishment registration fee by 23% under the Medical Device User…
Top Errors When Importing Medical Devices into Switzerland
In regard to importing medical devices into Switzerland under the former Mutual Recognition Agreement (MRA) with the European Union –…
Expansion of Mexico’s Regulatory Pathway for Medical Devices
Mexico’s expedited regulatory medical device pathway, known as the Equivalence Route, was previously limited to recognizing marketing authorizations issued by…
New Publication from Team-NB on Orphan IVD Devices
On 17 July 2025, Team-NB, the European Association of Medical Devices Notified Bodies – released a comprehensive position paper on…
New List of Low-Risk and Deregulated Medical Devices in Mexico
On July 7, 2025, an updated Agreement including an updated list of low-risk and deregulated devices in…
Swissdamed: Device Registration Requirement Updates
Swissmedic has recently expanded its Swissdamed device registration “Questions and answers” section with three new entries…
EU Authorities Urge Medical Device Regulatory Reform
In July 2025, medical device competent authorities from 17 European countries convened in Utrecht to issue a unified…
Medical Device and IVD Registration in Israel
In 2024, Israel reformed its medical device and IVD registration processes for low- and moderate-risk devices to increase the accessibility…
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