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.

Documents Required for Bosnia and Herzegovina Medical Device Registration

• The application form for the registration in a Register of medical devices of the appropriate
  class (REG-MD-CL), signed and certified by the applicant, together with the form Annex 1.
• Proof of authorized representation of manufacturers on the territory of Bosnia and
  Herzegovina, original or certified copy (representation contract or letter of authorization).
• Certificate of compliance of medical devices with the directives and regulations of the
  European Union (certificate of CE mark, EC certificate) or a certificate of compliance of
  medical devices, except for medical devices of Class I, the original or a certified copy in the
  country of origin.
• A statement from the manufacturer indicating the compliance with the European directive
  for medical devices with exactly specified class which region a medical device (Declaration
  of conformity), which refers to the relevant class of medical devices, original or certified copy
  in the country of origin.
• Proof that the medical device is marketed in the country of manufacturer or one of the
  countries of the European Union.
• Insurance policy as a proof of insurance of the users from the damage incurred in the
  application of medical devices.
• Certification of the quality system, except for medical devices of class I.
• A certificate of conformity of sterile products for sterile medical devices.
• Description of the method of sterilization and tests for sterility control for sterile medical
  devices.
• Information on medical device (composition, a brief description of the product declared
  purposes).
• Details of the proposed shelf life and storage conditions.
• Packing, form, material, and composition (see attached sample or packaging).
• Instructions for use in a foreign language for products of foreign origin and proposal
  instructions in one of the official languages in Bosnia and Herzegovina.
• Confirmation of measuring compliance for medical devices with a measuring function.
• The proof of payment of Agency`s fees for the registration in a Register of medical devices.
• Proof of payment of administrative fees.

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.

Registration Fee

• Class I: $57-$116 USD
• Class II: $232 – $20 270 USD
• Class III: $29 000 – $40 550 USD

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: info@omcmedical.co.uk