CASubmissionOfApplication object
Sponsor
Legal representative domiciled in the respective country
A detailed "Medical Devices Information Sheet" (BW101_50_002e_MB Clinical trials of medical devices: Authorisation, notifications and reports) including the required documentation for submission is provided for sponsors, investigators and research institutions in various languages on the Swissmedic website in section:
Medical devices > Regulatory aspects and placing on the market > Clinical trials
NB! Combined trials (medical device & IMP) must be reviewed by Swissmedic as IMP/transplant product trials and also as MD trials. The requirements for both trials must be met and two separate dossiers (full documentation as well as the complete application form, including electronic copy) must be submitted to the corresponding department of the CA.
The explicit submission procedure depends on the licensing status of both the IMP and MD and is specified in the "Information Sheet FAQ" (Q&A related to clinical trials with medicinal products), published on the Swissmedic website in section: Home > Licensing > Clinical trials > Clinical trials on medicinal products > Q&A and important links
