Switzerland follows Swiss Medical Device Regulations (MedDO) aligned with EU MDR.
| 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 |
| Additional Information | Economic operators must register within three months of placing a device on the Swiss market. |