Medical Device Regulatory Requirements in Cyprus
| Regulatory Authority |
Medical and Public Health Services |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Medical Device Regulatory Information
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
Medical Device Registration
| Click Here
|
| Registration Timeline |
For Class I, it is 1 to 2 months and for other classes, it depends on the classification |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Greek or Turkish Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
Cyprus Medical Devices Authority issues a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE marking in accordance with Regulation (EE) 2017/745 or 2017/746 may be marketed in the Union. |
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 We are not responsible for errors, omissions, or outdated content.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