Medical Device Registration and Approval in Bosnia & Herzegovina

General country-specific regulatory information is provided on this page for medical device registration and approval in Bosnia & Herzegovina. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Bosnia & Herzegovina, free of charge, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Bosnia & Herzegovina

REGULATORY AUTHORITY: Medical devices are regulated by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina.

CLASSIFICATION SYSTEM: Classification follows the EU model of risk-based classification into Classes I, IIa, IIb, III, and IV.

LICENSE VALIDITY: Licenses are valid for a period of five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

Last updated on March 17 2015.

Other Europe (non-EU) Countries: 

BelarusIceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine

 

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