FDA
The new article provides additional details pertaining to the submission template to be used by the parties interested in applying for marketing permission for medical devices utilizing innovative technologies.
MHRA
The article provides an overview of the current reporting requirements for healthcare products allowed to be used for clinical trials.
Swissmedic
The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.
Swissmedic
The new article provides further clarifications regarding the authorisation procedure to be followed by the parties interested in conducting combination studies in Switzerland.
Swissmedic
The new article clarifies the approach to be followed when introducing modifications to combination studies already approved by Swissmedic.
Swissmedic
The new article outlines the reporting requirements to be followed by the parties responsible for clinical investigations conducted in Switzerland.
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