Medical Device Regulatory Requirements in Switzerland
| Regulatory Authority |
Swissmedic |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
EUMDR-2017/745
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
In Vitro Diagnostic Ordinance |
| Registration Process |
Market access
| Click Here
|
| Registration Timeline |
4 to 6 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in German, French, and Italian Language |
| Database |
swissdamed
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
Economic operators must register within three months of placing a device on the Swiss market. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025