Medical Device Registration in
Switzerland
Ministry of Health
Federal Office of Public Health (FOPH)
Regulatory Authority
Medical Device Regulation
EU Medical Device Regulation (MDR) 2017/745
Official Language
German, French, Italian and Romansh
Classification
Class I, IIa, IIb and III
Medical Device Registration in Switzerland
- Determine the device classification
- Appoint Authorized Representative and Notified Body
- Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
- For other classes, prepare a CE Technical File
- Obtain and register UDI in EUDAMED.
- Technical File should be audited by Notified Body.
- Once approved, prepare a Declaration of Conformity.
- The device can now be marketed in Switzerland
Documents Required for Swiss Medical Device Registration
- CE Certificate
- Technical File
- Declaration of Conformity
- Clinical Evaluation Report (CER)
- Risk Management File
- QMS certificate
- Label, IFU and User Manual
Post-market Requirements
Serious public health threats – 2 day
Death or serious health deterioration – 10 days
Other serious incidents – 15 days
Applicable QMS
ISO 13485
Registration Timeline
3-6 months
Authorized Representative
Yes
License Validity
5 years
Special Notes
- Swiss manufacturers and authorized representatives shall register all medical devices in the Medical Device Database before they are placed on the market. If the manufacturer is not based in Switzerland, their products may only be placed on the market if they have authorized a person based in Switzerland. The mandate must be agreed in writing.
- Labels and IFUs must be drafted in at least two of
Switzerland’s official languages (official languages are German, French and Italian).