Bosnia and Herzegovina Medical Device Registration

Bosnia and Herzegovina Medical Device Registration: ALMBIH Guidelines, Fees, and Process for Seamless Market Entry

Regulatory Authority

The Bosnia and Herzegovina Agency for Medicines and Medical Devices

The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina was established in 2009 to protect and promote public health care by ensuring a supply of quality, safe, and efficient medicinal products and medical devices.

It aims to establish a functional, coordinated, and uniform system for regulation, supervise a unified market for these products and ensure their availability, and provide professional assistance to relevant State and Entities Ministerial Authorities.

The agency also makes proposals and amendments to legislation, harmonizing regulations with international standards.

Link for Regulatory Authority 

http://www.almbih.gov.ba/en/

Local Regulation

Official Gazette of B-H, no.58/08

Classification of Medical Devices

Class I, IIa, IIb, III

Listing or Registration Requirements

1.  An audit by a notified body is required.
2. There are no local testing requirements.
3. There are no clinical evaluation studies required.

   Registration Timeline

   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.

   License Validity

   5 Years

   License Transfer

   A license transfer is possible, but additional paperwork is required.

   When to make this Communication?

   Before placing a medical device into the market.

   Special Requirements

   • Audits: A mandatory audit conducted by a notified body is essential.
   • Local Technical Tests: No specific local testing requirements apply.
   • Clinical Evaluation/Studies: There is no obligation for clinical evaluation studies.

   How OMC Medical can assist you with the Process?

   • Act as your Authorized representative

   Why Choose Us?

   • Working towards client satisfaction
   • Cost effective solutions
   • Project completion before deadline
   • Quality Regulatory affairs solutions

   Contact us for free consultation: sales@omcmedical.com