CASubmissionFormat object
Format option(s)
Paper hardcopy
Data carrier (CD-rom/DVD)
Preferred format
Paper (one copy), in a green ring binder. an additional electronic copy of the documentation can expedite processing and is accepted by Swissmedic.
Standard application form
Form BW101_50_001e_FO (Clinical trials of medical devices: Application for authorization)
Guidance on submission format
Standard form and detailed information sheet on submission format is available on the Swissmedic website in section: Medical devices > Regulatory aspects and placing on the market > Clinical trials
