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Executive Summary
North Macedonia is undertaking a series of major health sector reforms. The Ministry of Health has set five core policy areas to improve: health expenditures, health revenues, payment mechanisms, information systems, and advocacy and public awareness strategies.
The main contributors to health system reform in North Macedonia, other than the World Health Organization (WHO), are the World Bank, other United Nations agencies, and the government. Their broad-based efforts focus on several components: health finance reform and management, basic health services, fostering public-private partnerships in the health sector, and pharmaceutical policy.
North Macedonia spends between 1-1.3% of its Gross Domestic Product on the healthcare sector. The disease prevalence pattern is similar to other European countries, with cardiovascular and circulatory disease, neoplasms, metabolic and nutritional diseases, and respiratory diseases as the most prominent causes of morbidity and mortality. Diseases like HIV and tuberculosis (TB) are less prevalent.
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Market Entry
There are no legal barriers to foreign businesses entering North Macedonia. However, serious challenges to doing business in North Macedonia remain, including the country’s opaque tendering process, weak judicial system, and significant levels of corruption.
According to import regulations, all medical equipment entering North Macedonia is exempt from import duties, but subject to an 18% value added tax (VAT). Accessories and spare parts are subject to an 8, 10, or 15% customs import duty.
The CE marking is mandatory, as is compliance with ISO standards.
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Current Market Trends
As part of the government’s health sector restructuring efforts, it has introduced a sector management project to upgrade the Ministry of Health, the Health Insurance Fund, and the capacity of local health facilities to formulate and effectively implement health policies, health insurance, financial management, and provider contracting.
An additional goal of the project is to develop and implement efficient schemes to restructure hospital services, with an emphasis on developing outpatient services and shifting to quality primary care.
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Best Prospects
Invasive and non-invasive surgery equipment; cardiology equipment; EKG and ultrasound machines; defibrillators; vascular stents; pacemakers; oncology equipment; and urology, laboratory, and other testing equipment remain in high demand, as do computer tomography imaging systems, magnetic resonance imaging, and sophisticated digitalized x-ray equipment.
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Main Competitors
European companies remain the main competitors to United States (U.S.)-produced medical equipment and pharmaceuticals. Consumers in North Macedonia are highly receptive to U.S. products, but also very price sensitive. Siemens and Philips are present in the market, as are Hitachi and Toshiba.
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Current Demand
North Macedonia’s healthcare sector lacks enough medical materials, including pharmaceuticals, disposable items, and equipment due to low funding levels to keep up with demand.
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Registration Process
In order to harmonize legislation with European Commission recommendations, the Assembly of the Republic of North Macedonia has adopted extensive amendments to the Law on Medicinal Products and Medical Devices, which came into force on February 1, 2012.
According to this law, all medical devices must be labeled in Macedonian and English and adhere to the provisions of the law. The label must be on the outer and inner packing and must enclose instructions for use.
A packaged medical device must contain at least the following: information on the manufacturer and supplier, information necessary to identify the medical device and contents of the packing, different specialty labels to include: sterile, custom-made, single use, for clinical trials, identification codes, expiry period, storage conditions, special method of use, warnings or precautions, purpose, and other information related to proper use of the device.
Medical devices and pharmaceutical products must be registered at MALMED - the Agency for Medicine and Medical Devices.
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Reimbursement
The government determines a Positive List of prescribed drugs, sold to patients for 20% co-pay. When drugs on the Positive List are unavailable (for any number of reasons), patients may purchase the drugs at full price and apply to be reimbursed up to 80% of the cost. This leaves the system vulnerable to misuse and abuse, but may also benefit the Health Insurance Fund, as many do not apply for the reimbursement because the system is slow and inefficient.
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Barriers
There are no significant trade barriers or limitations on U.S.-produced medical devices.
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Procurement & Tenders
Foreign companies participating in public tenders in North Macedonia can expect to face delays in the preparation of technical specifications, opening and concluding the bid evaluation process, and during the approval process, as well as those caused by bidder challenges to the procurement process. Regulatory procedures can be particularly complex.
More information available here:
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U.S. Commercial Service Contact Information
Name: Arben Gega
Position: Commercial Specialist
Email: gegaa@state.gov
Phone: +389 2 310 2403
