Swissmedic Information Sheet on Combination Studies: Authorisation
The new article provides further clarifications regarding the authorisation procedure to be followed by the parties interested in conducting combination studies in Switzerland.
The new article provides further clarifications regarding the authorisation procedure to be followed by the parties interested in conducting combination studies in Switzerland.
The new article clarifies the approach to be followed when introducing modifications to combination studies already approved by Swissmedic.
The new article outlines the reporting requirements to be followed by the parties responsible for clinical investigations conducted in Switzerland.
The article outlines the key points regarding the classification rules for medical devices in Hong Kong.
The new article provides further clarifications regarding the applicable classification rules for medical devices.
The document highlights the key points related to the requests for information to be submitted under the existing legal framework.