Medical Device Regulatory Requirements in Serbia
| Regulatory Authority |
Medicines and Medical Devices Agency of Serbia (ALIMS) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Medical Device Laws
| Click Here
|
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
Chapter IX of Law on Medical Devices pdf.
| Click Here
|
| Registration Timeline |
3 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Serbian or English Language |
| Additional Information |
Marketing authorisation is valid for five years, starting from the date the decision to grant the marketing authorisation is made |
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 We are not responsible for errors, omissions, or outdated content.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