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)

Ordinance on Medical Devices

Official Language:   

Bosnian, Croatian, Serbian

Classification:        

Class I, IIa, IIb and III

Registration Process:     

• 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.