Swissmedic Guidance Regarding System & Procedure Packs
Swissmedic has issued a new guidance document outlining the obligations for the assembly and labelling of systems and procedure…
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New EU Regulation on eIFUs Adopted by Swissmedic
Swissmedic has adopted EU Commission Implementing Regulation (EU) 2025/1234, which extends the scope of electronic instructions…
Notified Body Proposed Reform: EU Medical Device Governance
The EU medical device regulatory landscape is at a critical juncture, as concerns grow over fragmented implementation and the urgent…
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…
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…
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