Medical Device Regulatory Requirements in Croatia
| Regulatory Authority |
Agency for Medicinal Products and Medical Devices of Croatia |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Law about Medical Products
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
Procedure for registration
| Click Here
|
| Registration Timeline |
For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Croatian or English Language |
| Database |
Medical Device Database
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
The technical documentation and declaration of conformity has to be kept for at least five years after placing the medical product on the 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 We are not responsible for errors, omissions, or outdated content.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