CATrialAuthorisation object
Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)
Other
Clinical trials on Medical Devices of category C (pursuant to Art 20 KlinV/ClinO)/ see also 'Additional Information'
Yes
Yes
All clinical trials need to be registered in a national registry (Art. 64-67 KlinV/ClinO).
An official portal is expected to be available by the end of 2015; entries in www.clinicaltrials.gov will continue to remain acceptable in Switzerland.
More information is provided on the kofam website of FOPH (Email: kofam(at)bag.admin.ch)
Clinical trials of medical devices are categorised into A or C according to Art. 20 KlinV/OClin as follows:
Clinical trials of medical devices come under Category A if:
a. the medical device bears a conformity marking; and
b. it is used in accordance with the instructions.
2 They come under Category C if:
a. the medical device does not have a conformity marking;
b. it is not used in accordance with the intended purposes recognised in the conformity assessment and specified in the instructions; or
c. use of the medical device is prohibited in Switzerland.
Category A trials are exempt from submission obligation (Art. 30 KlinV/ClinO).
NB! Special submission requirements apply to clinical trials on:
(1) Gene therapy/ GMO clinical trials: Additional application documents for Category B and C clinical trials of gene therapy and of genetically modified or pathogenic organisms are required and provided in Annex 4(4) KlinV/ClinO.
Further respective guidelines, checklists and standard forms are provided on the Swissmedics website in section: Licenses > Clinical trials > Clinical trials on transplant products / gene therapy / genetically modified organisms.
(2) Radioactive substances, with regard to radiological protection for trial participants: The sponsor must submit the trial to the CA, the EC and, in addition, to the Radiological Protection Division of the Federal Office of Public Health (FOPH).
Additional application documents for clinical trials of therapeutic products capable of emitting ionising radiation are required and provided in Annex 4(5) KlinV/ClinO.
(3) Combination trials on IMP(s) and transplant products (organs, tissues, cells) must also be additionally submitted to the BAG. Details for submission can be found on their website.
