What is it? Why is it important?

In addition to having studies approved by the Ethics Committee (EC), some studies also require a Swissmedic approval. Main criteria for a Swissmedic approval are study type (e.g. ClinO, ClinO-MD) and the study risk-category.


Except for risk-category A studies, the following studies require a Swissmedic approval.

ClinO (studies with:


ClinO-MD studies with:

  • Investigational Medical Device (IMD) & risk-category C
  • Ionising radiation & risk-category C


Apart from EC and Swissmedic approval, additional approval or consulting requirements exist:

  • ClinO category C studies involving ionising radiation, transplantation of human organs, tissues and cells, require an opinion / approval from the Federal Office of Public Health (FOPH)
  • Before issuing an approval order, Swissmedic seeks the opinions from other legal institutions (e.g. SECB, FOEN)

What do I need to do?

As a SP-INV, access Swissmedic homepage where the application process is explained, including:

  • Ways to compile a Clinical Trial Application (CTA) dossier
  • Separate and specific step-by-step guidance for dossier application for IMP and IMD
  • For ClinO-MD studies, a step by step guidance on how to submit the application dossier via the electronic portal system (service eGov “eMessage”)
  • Guidance on how to submit ClinO studies (without in vitro diagnostics MD combinations) (eDoc structure) by postal mail, either with a full paper dossier or with a paperless dossier


Ensure the application dossier is complete, as it will otherwise be rejected by Swissmedic. You can submit in parallel to EC and if applicable FOPH. All approvals must be received before starting the study.


ClinO studies (without MDs) are submitted by post in both paper and electronic formats:

*Option: full paper submission:*

  • Prepare a binder and include a copy of each document. File with number index
  • Comprise the registers based on “Instructions for filling the eDoc folder structure”
  • Burn a CD. Use the same structure
  • Submit binders and CD by post

*Option: paperless submission:*

  • Print and sign the paper form “Confirmation electronic submission”
  • Burn a CD with documents organized based on “Instructions for filling the eDoc folder structure”
  • Submit the form and CD by post

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


**External Links**

Swissmedic – see in particular

  • Human medicine / Clinical trials / Clinical trials on medicinal products
  • Medical devices / Clinical trials / Authorisation procedure
  • Services & Lists / eGOV services
  • Services & Lists / submissions


**Swiss Law**

ClinO – see in particular articles

  • Art. 30 Exemption from mandatory authorisation
  • Art. 31 Application

ClinO-MD – see in particular articles

  • Art. 7 Exemption from mandatory authorisation
  • Art. 16 Application
  • Art. 18 Studies with devices capable of emitting ionising radiation
  • BASEC – Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTA – Clinical Trial Application
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOEN – Federal Office for the Environment
  • FOPH – Federal Office of Public Health
  • GMO – Genetically Modified Organisms
  • IMD – Investigational Medicinal Device
  • IMP – Investigational Medicinal Product
  • MD – Medical Device
  • SECB – Swiss Expert Committee for Biosafety
  • SP-INV – Sponsor Investigator
Development ↦ Ethics and Laws ↦ Swissmedic Application ↦ Submission

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Ethics and Laws ↦ Swissmedic Application ↦ Submission

Please note: the Easy-GCS tool is currently under construction.