Medical Device Registration in

Switzerland

Ministry of Health

Federal Office of Public Health (FOPH)

Regulatory Authority

Swissmedic

Medical Device Regulation

EU Medical Device Regulation (MDR) 2017/745

Official Language

German, French, Italian and Romansh

Classification

Class I, IIa, IIb and III

Registration Process

  • 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

  • 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).

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