Medical Device Registration in
Bosnia and Herzegovina
Ministry of Health:
Federalno Ministarstvo Zdravstva
Regulatory Authority:
The Bosnia and Herzegovina Agency for Medicines and Medical Devices.
Medical Device Regulation:
Medicinal Products and Medical Devices Act (Official Gazette of B-H No. 58/08)
Official Language:
Bosnian, Croatian, Serbian
Classification:
Class I, IIa, IIb and III
Medical Device Registration in Bosnia & Herzegovina:
- Appoint Authorized Representative
- Determine classification for your device
- Submit the Technical File
- Notified Body audit should be conducted
- Once approved, the manufacturer may begin marketing in Bosnia and Herzegovina
Documents Required:
- EC Certificates
- Design evaluation
- Authorization letters
- Free Sales Certificate
- Declaration of Conformity
- QMS certificate
Legalized/Notarised Documents (if any)
FSC
Applicable QMS:
ISO 9001 or ISO 13485
Registration Timeline:
90 days
Authorized Representative:
Yes
License Validity:
5 years
Special Notes:
No local testing and Clinical evaluation studies are required.