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Bosnia and Herzegovina

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)

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.

Want to know more about this registration process?