Medical Device Regulatory Requirements in Monaco
| Regulatory Authority |
Ministry of Health and Social Affairs |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
EUMDR-2017/745
| Click Here
|
| Registration Timeline |
For Class 1, it is 45 days, and for other classes, it is 3 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in French or Arabic Language |
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 We are not responsible for errors, omissions, or outdated content.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