Serbia
Serbia is a growing market for medical devices, with particular interest in high-quality European products.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Medicines and Medical Devices Agency of Serbia (ALIMS).
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in Serbian. |
| Local Representative | Mandatory for foreign companies. |
| CE Marking | Recognized and preferred for faster market access. |
Challenges and Operational Advice
- Alignment with the EU: Regulations are inspired by the MDR, but practical differences exist.
- Translation: Accurate documentation in Serbian is essential.
Why Choose ISEMED
- Experience in the Balkans
Local support through established partnerships. - Documentation Assistance
Dossier preparation in compliance with ALIMS requirements.
FAQ
- Is a local representative required? Yes.
- Documentation language? Serbian.
- License duration? 5 years.