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
