Submission of authorisation applications and notifications relating to clinical trials with medical devices

Authorisation applications and notifications relating to clinical trials with medical devices should, when-ever possible, be submitted to Swissmedic electronically via the eGovernment Service eMessage. This electronic processing simplifies the submission process. In the case of submissions on paper by post, additional cover sheets have to be enclosed.

Electronic eDok submission

eDok is a submission format for authorisation applications and notifications relating to clinical trials with medical devices. The eDok application is submitted via the eGov Service eMessage. The upload completely replaces the submission of paper documents.

Subject	Requirement
eDok structure	eDoks must be structured as follows: eDok folder structure (JPG, 307 kB, 16.07.2018) eDok electronic folder structure (ZIP, 6 kB, 11.06.2018)
File formats	In principle, the only permitted file formats are PDF documents and Excel tables (xlsx, .xls, ods). Digitally created documents are preferred, but scanned documents are also accepted. However, scanned documents must correspond to the OCR standard, i.e. the text must be searchable as text.
File size	To ensure an effective review, the maximum file size should not exceed 200MB per PDF file. Larger files must be split.
File names	The file names must be chosen in a way that permits the content to be identifiable and correctly assigned (e.g. study code–document type–version). The maximum length for the file names is 60 characters (incl. file extension).
Preparation for submission (upload eMessage)	The individual documents must be integrated in the eDok structure. The eDok structure must then be packed in a Zip file and uploaded in the eMessage.

Screencast – Submission of authorisation applications and notifications relating to clinical trials with medical devices

Login/self-registration eMessage

www.swissmedic.ch/emessage-en

eGov eMessage

Paper submission

Requirements for paper submission

Subject	Requirement
Cover sheets	The paper documents must be submitted in green (federal) ring binders (width: 7cm). The binders must be labelled in a way that permits the content to be identifiable and correctly assigned via the binder designation. Staples must not be used for paper-based submissions. To separate the individual structured sections for paper submissions, Swissmedic provides cover sheets with section titles and barcodes (can be downloaded from the Swissmedic website). These cover sheets must be printed out by the applicant and inserted in the documents before the corresponding sections. If a section exceeds the volume of a (standard Swiss) ring binder, a cover sheet for the relevant section must be inserted as the first sheet of each new binder.

Subject

Requirement

Cover sheets

The paper documents must be submitted in green (federal) ring binders (width: 7cm). The binders must be labelled in a way that permits the content to be identifiable and correctly assigned via the binder designation.
Staples must not be used for paper-based submissions.
To separate the individual structured sections for paper submissions, Swissmedic provides cover sheets with section titles and barcodes (can be downloaded from the Swissmedic website).
These cover sheets must be printed out by the applicant and inserted in the documents before the corresponding sections.
If a section exceeds the volume of a (standard Swiss) ring binder, a cover sheet for the relevant section must be inserted as the first sheet of each new binder.

Forms

OS000_00_008dfe_VL Cover sheets - Clinical trials of medical devices (PDF, 213 kB, 25.06.2018)

¹ _{This is a prior notification. Authorisation applications and notifications relating to clinical trials with medical devices received at Swissmedic before 6 September 2018 via eMessage will not be accepted.}