General country-specific regulatory information is provided on this page. Become a LICENSALE.COM
user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.
Medical devices are regulated by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina.
Classification follows the EU model of risk-based classification into Classes I, IIa, IIb, III, and IV.
Licenses are valid for a period of five years.
An authorized representative is required.
Last updated on March 17 2015.
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