What is it? Why is it important?

For studies with a Medical Device (MD), Swissmedic acknowledges the receipt of an application dossier within 10 days.

Swissmedic makes a formal evaluation whether the application dossier:

  • Is under their competency
  • Is complete, or if documents are:
    • Missing and/or
    • Incomplete, and/or
    • Not correctly filed

In the event of an incomplete dossiers the SP-INV is asked to update the dossier within 10 days (e.g. can be extended to 20 days).

Swissmedic provides an answer whether the application has been approved:

  • Within 45 days
  • Or up to 65 days if the product:
    • Has never been tested in humans (first in man, phase I studies); or
    • Is manufactured based on new production procedures

In the event Swissmedic is not able to provide a final decision regarding approval:

  • They will provide a list with reasons / questions
  • The SP-INV has 30 calendar days to submit an updated dossier

More

Approval timelines for studies using IMP and MD in combination (in vitro), depend on the conformity of each product (e.g. consult Swissmedic tables regarding potential combination).

What do I need to do?

If prior to approval, Swissmedic requires additional information or changes to the application dossier, submit:

  • A cover letter
  • An updated CTA, if required
  • Additionally required documents and/or information
  • Required modifications (e.g.to submitted documents)

The study can only start after Swissmedic, EC, and if applicable FOPH have approved the study.

As a SP-INV, ensure that after approval:

  • The Swissmedic reference number is included in all future correspondence
  • A robust document tracking system is in place (e.g. ensures that only Swissmedic approved documents are used in the study)
  • Modifications to approved documents are re-submitted to Swissmedic for approval (e.g. only implemented after approval)

File all Swissmedic correspondence including the official Swissmedic approval in the TMF, and if applicable in the ISF of participating study sites.

More

In the event of a re-submission upload corrected or new documents on eMessage portal (service eGOV).

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

FEDLEX – laws are available online under numbers

  • 810.306 ClinO-MD
  • 812.21 TPA

ClinO-MD – see in particular articles

  • Art. 7 Exemption from approval
  • Art. 17 Reviews area
  • Art. 19 Procedure and deadlines

TPA – see in particular article

  • Art. 54 Mandatory authorisation
Abbreviations
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTA – Clinical Trial Application
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • MD – Medical Device
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
  • TPA – Therapeutic Products Act
Development ↦ Ethics and Laws ↦ Swissmedic Application ↦ Approval Medical Device
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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