General country-specific regulatory information is provided on this page for medical device registration and approval in Bosnia & Herzegovina.
We review our Regulatory Information frequently; please check back often for updates
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.
Medical Devices: Class I, IIa, IIb, III
IVD Devices: List A & B, List C, List D
TIMEFRAME: The approval process takes about 90 days from the receipt of a complete application.
Class I: The registration process takes about 90 days after submission.
Class II: The registration process takes about 90 days after submission.
Class III: The registration process takes about 90 days after submission.
IVD Devices: The registration process takes about 90 days after submission.
SPECIAL REQUIREMENTS:
Audits: An audit by a notified body is required.
Technical Local Tests: There are no local testing requirements.
Clinical Evaluation/studies: There are no clinical evaluation studies required.
LOCAL FEES:
Application review fees: Application fees vary depending on the number of products for each registration (up to 25 products, up to 100, over 100).
Class I: $57-$116 USD
Class II: $232 – $20 270 USD
Class III: $29 000 – $40 550 USD
LICENSE VALIDITY: Licenses are valid for a period of five years.
LICENSE TRANSFER: A license transfer is possible, but additional paperwork is required.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required.
Other Europe (non-EU) Countries: Belarus, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine
For detailed device-specific compliance information for each market, including Bosnia & Herzegovina, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
