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, 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.

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.

Last updated on March 28, 2019.

Other Europe (non-EU) Countries: 

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

 

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