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Healthcare Resource Guide: Macedonia

 

Macedonia Statistics

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Summary
Market Entry

Current Market Trends

Main Competitors

Current Demand

Barriers
Registration Process

Reimbursement

Barriers

CS Contact

Demographics

Capital: Skopje

Population: 2 million
GDP*:
USD 10.909(2016)
Currency:
Denar (MKD)
Language
: Macedonian, Albanian

Summary             

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; provide payment mechanisms; information systems; and advocacy and public awareness strategies.

The main contributors to health system reform in Macedonia, other than the World Health Organization (WHO), are: The World Bank, UN agencies, and the Government. Their broad-based efforts focus on several components: health finance reform and management; basic health services; fostering public-private partnership in health sector; and pharmaceutical policy.

Macedonia spends between 1.0 and 1.3 percent of its GDP 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 TB are less prevalent.

                                          

Market Entry

There are no legal barriers to foreign businesses entering Macedonia. However, serious challenges to doing business in Macedonia remain, including the country’s weak judicial system and significant levels of corruption.

According to import regulations, all medical equipment entering Macedonia is free of import duties, but subject to 18 percent value added tax (VAT). Accessories and spare parts are subject to 8, 10, and 15 percent customs import duty.

The CE marking is mandatory, as is compliance with ISO standards.

 

Current Market Trends

In parallel to health sector restructuring efforts, the health sector management project will continue to be an important focus. The objectives of this project are to upgrade the Ministry of Health, the Health Insurance Fund, and the local health facilities’ capacity to formulate and effectively implement health policies, health insurance, financial management and contracting of providers.

In addition, there is a goal to develop and implement efficient schemes for the restructuring of hospital services, with an emphasis on developing day care services and shifting to quality primary care.

Main Competitors

European companies remain the main competitors to U.S.-produced medical equipment and pharmacies. Consumers in Macedonia are highly receptive to U.S. products, but are also very sensitive to prices. Siemens and Philips are present in the market, as are Hitachi and Toshiba.

Current Demand

Macedonia’s healthcare sector lacks sufficient medical materials, including pharmaceutical drugs, disposable products, and medical equipment due to low levels of funding.

Invasive and non-invasive surgery equipment, cardiology equipment, EKG and ultrasound, defibrillators, vascular stents, pacemakers, oncology equipment, urology, laboratory and testing equipment, remain in high demand as do computer tomography imaging systems, magnetic resonance imaging, and sophisticated digitalized x-ray equipment.

Registration Process

In order to harmonize legislation with European Commission recommendations, the Assembly of the Republic of Macedonia adopted extensive amendments to the Law on Medicinal Products and Medical Devices that came into force on February 1, 2012.

According to this law, all medical devices marketed in Macedonia must be labeled according with the provisions of this law on the outer and inner packing in Macedonian and English language, and must enclose instructions for use.

A packaged medical device must contain at least the following: information on the manufacturer, supplier, information necessary for the identification of the medical device and contents of the packing, different labels like sterile, custom-made, single use, for clinical trials, identification code, expiry period, storage conditions, a special method of use, warnings or precautions, purpose and other information related to proper use of the device and public health protection.

Medical devices and pharmaceutical products must be registered at the Bureau for Medicine and Medical Devices.

Reimbursement

The Government determines the “Positive List” of prescribed drugs which can be reimbursed. However, a lack of available drugs from the list leads to the submission of claims for drug cost reimbursement by the health insurance fund. Patients still must pay 20 percent of the cost.

 

Barriers

There are no significant trade barriers or limitations on U.S.-produced medical devices.

Procurement & Tenders

The experience of foreign companies participating in public tenders in Macedonia has shown that they should be ready to face delays in preparing the technical specifications and starting and finishing the bid evaluation process, as well as delays during the approval process, and delays because of a bidder challenging the procurement process.

More information available here:

 

U.S. Commercial Service Contact Information

 

Name: Arben Gega              

Position: Commercial Specialist          

Email: gegaa@state.gov              

Phone: +389 2 310 2403   

Demographics: as of 30 June 2016 estimates

Population

2 072 490

Life expectancy men/women

70.3 years/males

74.7 years/females

Infant mortality

11.9 infant deaths per 1000 inhabitants

Percent of population older than 65

13.1 %

Annual deaths

20 421 deaths in 2016


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