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.
Hong Kong
The article outlines the key points regarding the classification rules for medical devices in Hong Kong.
Hong Kong
The new article provides further clarifications regarding the applicable classification rules for medical devices.
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