Bosnia Medical Device Market Country Report

The medical device market in Bosnia-Herzegovina is overseen by the Agency for Drugs and Medicines. Although Bosnia-Herzegovina is not currently a member of the European Union, you may substitute CE Marking for conformity assessment in the country. In addition, either proof of home-country approval or prior market authorization in an EU member state is required to register your device in Bosnia-Herzegovina. Foreign manufacturers must also appoint in-country representation to liaise with Bosnian authorities.

Let Emergo Group assist you in evaluating the Bosnian medical device regulatory framework as it applies to your device(s)

Emergo Group’s Global Regulatory Overview Report service, which draws upon our worldwide network of consultants, industry resources and regulatory contacts, can provide you with in-depth and accurate information on the medical device market in Bosnia-Herzegovina. Our Bosnian country report coverage includes:

• Information on the Agency for Drugs and Medicines
• Product Assessment
• Device Classification based on Agency for Drugs and Medicines Rules
• Bosnian Authorized Representation Requirements
• Medical Device Registration Requirements
• Medical Device Labeling Requirements
• Costs and Timeframes for Commercialization
• Regulatory Roadmap for Bosnia-Herzegovina
• Post-market Surveillance Requirements

If you would like to see what these reports include, you can download a sample Regulatory Overview Report.

Please contact us for more information or a free proposal about our Regulatory Overview Report for Bosnia-Herzegovina.