Montenegro Medical Device Registration

Unlocking Opportunities in Montenegro’s Medical Device Market: Regulations and Market Dynamics

Updated on 27/01/24

Regulatory Authority: Institue for Medicines and Medical Devices

Link for Regulatory Authority: https://cinmed.me/en/pocetna/

Local Regulation:  Law on Medical Devices (“Official Gazette of Montenegro”, No. 24/19)

Overview:

Montenegro heavily relies on imports for its healthcare sector, with significant contributions from Germany, Italy, Austria, Switzerland, and the United States.The Ministry of Health plays a pivotal role in Montenegro’s medical equipment market, overseeing health policy, proposing healthcare budgets and investment programs, and monitoring state-owned health institutions. Presently, all procurements are conducted through the Ministry of Health.

U.S.-manufactured medical equipment is highly regarded in Montenegro, known for its cutting-edge technology, quality, and reliability. Key areas of opportunity for U.S. medical equipment in the Montenegrin market include cardiovascular diagnostic tools, non-invasive surgical devices, anesthesia and intensive care equipment, diagnostic imaging (CTs, MRIs), radiation therapy equipment, ultrasound equipment, urology equipment, laboratory and testing tools, tissue and blood bank equipment, hospital care devices, and hospital information systems.

Classification:

• Class I
• Class IIa
• Class IIb
• Class III

Listing or Registration Requirements:

1. Determine Device classification
2. Appoint an Authorized Representative
3. Prepare the application form and registration documents
4. A Conformity Assessment Body shall carry out the conformity Assessment procedure

Documents Required for Registration:

• Application on the letterhead of the applicant
• Completed appropriate form
• Declaration of Conformity (DoC)
• EC certificates for medical devices in question
• EN ISO 13485, etc.
• Free sale Certificate
• Insurance policy
• Statement by the manufacturer to provide technical file for a specific medical device, upon the request of the Institute
• Evidence on registration of a manufacturer in the Register of the Institute
• Labeling of outer and inner packaging of a medical device
• Instruction manual for a medical device

Registration Timeline:90 days

License Validity: 5 years

Special Labelling Requirements:

The information on the outer and inner packaging, and in the instructions for use of medical devices sold in the Montenegrin market must be in the Montenegrin 

Market overview:

The projected revenue for Montenegro’s Medical Devices market is set to reach US$55.75 million in 2024. Cardiology Devices emerge as the largest market segment, with an estimated market volume of US$8.86 million in the same year. A steady annual growth rate (CAGR 2024-2028) of 6.41% is expected, paving the way for a market volume of US$71.49 million by 2028.

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

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