Development↦Ethics and Laws↦Swissmedic Application↦Approval Medical Device
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
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.
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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
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