Medsafe
The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
FDA
The article highlights the key points related to the submissions associated with novel medical devices intended to be marketed and used in the US.
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.
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